MEDICAL DESIGN & OUTSOURCING - January 2018 by WTWH Media LLC

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www.medicaldesignandoutsourcing.com JANUARY 2018

First in, last out:

• LEADERSHIP’S LASTING IMPACT: The Immelt Effect

HOW MEDROBOTICS CEO SAM STRAFACE’S MANTRA HELPED THWART POSSIBLE CORPORATE ESPIONAGE

• This medtech CEO led his company to a $200M buyout

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Medical Design & OUTSOURCING medicaldesignandoutsourcing.com ∞ January 2018 ∞ Vol4 No1

E D I T O R I A L EDITORIAL Founding Editor Paul Dvorak pdvorak@wtwhmedia.com @paulonmedical Executive Editor Brad Perriello bperriello@wtwhmedia.com

What’s your next milestone?

Managing Editor Chris Newmarker cnewmarker@wtwhmedia.com @newmarker

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Senior Editor Heather Thompson hthompson@wtwhmedia.com

the life of medical electronics.

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HERE’S WHAT WE SEE

Trends that mattered for medtech in 2017 The medtech industry saw its transformation accelerate in 2017: Whether it’s the roster of largest companies, business models or the regulatory environment, times are changing. Competition is also heating up in areas including diabetes care and robotic surgery. Here are some trends that especially mattered for the medical device industry this year. 1. The M&A frenzy continued This was another year of big M&A deals in the medical device industry. New payment models have U.S. health providers merging, and medtech companies, in turn, are combining to better compete. Companies supplying and consulting with the OEMs are merging, too. Will the larger companies remain innovative? Will it become even more difficult to start a medical device company because there are fewer prospective future buyers out there? Time will tell.

Chris Newmarker Managing Editor Medical Design & Outsourcing c newmark er@wtwhmedia.com

Medical Design & Outsourcing

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The year’s most significant deals included: • Cardinal Health in April closed on its $6 billion purchase of the medical supplies business Medtronic picked up when it paid $50 billion for Covidien in January 2015. • Abbott in January completed its $25 billion buy of St. Jude Medical. (Abbott later wrapped up its $5.3 billion buy of diagnostics giant Alere.) • Boston Scientific announced in October that it had inked an up-to$300-million deal to purchase Apama Medical and its radiofrequency balloon catheter system designed to treat atrial fibrillation. • Private equity giant Kohlberg & Co. bought specialty plastics manufacturer Pexco and merged it with its PPC Industries holding to create Spectrum Plastics Group. 2. Are we about to revolutionize diabetes treatment? It’s no coincidence that out of the 10 medical device companies spending the largest portion of their budgets on research in 2017, two were in the diabetes space. San Diego–based Dexcom boasts that its G5 Mobile continuous glucose monitoring system gives users glucose readings every 5 minutes and provides them with a trend arrow so they can see where they’re heading, while Insulet seeks to expand the use of insulin pump therapy for diabetes through its Omnipod insulin management system.

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The diabetes treatment space seems on the verge of disruptive innovation – especially when it comes to creating a combined glucose sensor, control algorithm and insulin infusion device that could effectively act as an “artificial pancreas.” Medtronic appears to be ahead in the race; its MiniMed 670G was the 1st hybrid closed-loop system to win FDA approval. But a host of upstarts including Bigfoot Biomedical – which has a partnership with Abbott – think they could do even better. Instead of simply selling its system, California-based Bigfoot is looking to market it as a service with a monthly fee. 3. Hurricane Maria The medical device industry is not immune from extreme weather events such as hurricanes, which are predicted to intensify in coming decades thanks to climate change caused by greenhouse gases. Puerto Rico is still recovering from Hurricane Maria in September. The U.S. territory is home to facilities for Johnson & Johnson, Pfizer, Amgen, Merck, Medtronic, Abbott, Stryker and dozens of others. FDA commissioner Dr. Scott Gottlieb noted in early December that many firms continue to run on generator power; their production levels cannot return to baseline levels.

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4. Tax reform and the medical device tax Congress delivered a major tax overhaul bill to President Donald Trump’s desk before Christmas. But it surprisingly didn’t include an item that the medical device industry had been craving: Permanent repeal of the 2.3% medical device excise tax that was part of the Affordable Care Act. Congress in January ended up suspending the device tax for another two years – ending a period of limbo for the industry. Although Trump and congressional Republicans failed to dismantle Obamacare this year, the new tax bill repeals the individual mandate – undermining the economics behind the ACA. And the medtech industry appears to have dodged a bullet with the tax reform: The R&D tax credit is still intact, though it appears to now be an amortization deduction over five years. M

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CONTRIBUTORS

SEARS

MILLER

DYKEMAN

HAVEN

FAYERBERG

WILLIAMS

DAVID J. DYKEMAN is co-chair of Greenberg Traurig’s Global Life Sciences & Medical Technology Group and cochair of the firm’s Boston Intellectual Property & Technology Group. A registered patent attorney with over 20 years of experience in patents, intellectual property, and licensing, Dykeman’s practice focuses on securing strategic worldwide intellectual property protection and related business strategy for high-tech clients, with particular expertise in medical devices, combination products, healthcare IT and life sciences. ROMAN FAYERBERG is a patent attorney and shareholder in the Boston office of Greenberg Traurig. His patent practice builds on seven years of experience he gained as a research and development engineer at C.R. Bard and Boston Scientific.

Medical Design & Outsourcing

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KEN HAVEN has been CEO of Acorn Product Development since the company’s founding in 1993. Haven has more than 25 years of product development experience including technical leadership roles with NeXT Computer, Attain and Hewlett-Packard. He holds MS and BS degrees in mechanical engineering from Cornell University. RICH MILLER is VP of Engineering at Manta Product Development, an award-winning product development firm located in Cambridge, Mass. CHARLIE SEARS, a principal mechanical engineer, is VP of operations and project management at Goddard Technologies. JEREMY WILLIAMS is a consultant/trainer at RJG (Traverse City, Mich.) with more than 17 years of experience in the plastics industry, serving the medical, automotive, furniture and appliance industries.

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CONTENTS

medicaldesignandoutsourcing.com ∞ January 2018 ∞ Vol4 No1

DEPARTMENTS 06 Photo courtesy of Simon Simard

HERE’S WHAT WE SEE: Trends that mattered for medtech in 2017

ON THE COVER:

08 CONTRIBUTORS

First in, last out: How Medrobotics CEO Sam Straface’s mantra helped thwart possible corporate espionage

58 Leadership’s lasting impact: The Immelt Effect No matter how you feel about his tenure leading the industrial conglomerate, former GE CEO Jeff Immelt helped shape medtech by filling the industry’s corner offices with former employees. 67 How medtech could stop the drug overdose crisis in the U.S. The opioid epidemic is one of the deadliest problems facing the U.S. today. Through the development of new pain management devices, medtech could be a leader in solving the crisis. 79 This medtech CEO led his company to a $200M buyout: Here’s how Guiding a company through a merger or an acquisition can test a CEO’s leadership skills. Here’s how NinePoint Medical CEO Christopher von Jako led his former company NeuroTherm through a deal with St. Jude Medical.

Medical Design & Outsourcing

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IP ISSUES: 5 considerations for patenting combination products

DESIGN SERVICES: Gleaning design opportunities from user research

20 MANUFACTURING & MACHINING: Medical device design transfer: 5 things you need to know

FEATURES

1 • 2018

ENGINEERING 911: What goes into injection molding cooling time?

TUBING TALKS: Why PEEK is so hard to extrude

DRUG DELIVERY: How Flexion’s CEO set his company up for success using a history lesson

ROBOTICS: Designing for robotics: 2 things you need to consider

PRODUCT WORLD: TDK Corporation, Morgan Advanced Materials, Qosina, Sensirion, Murata Electronics

DEVICE TALKS: 3 secrets of medtech success from a true industry pioneer

LEADERSHIP IN MEDICAL TECHNOLOGY

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IP ISSUES

5 considerations for patenting combination products Complexity and ownership issues make combination products a patenting labyrinth. Here are five key points to help you navigate the maze.

David J. Dykeman | G r e e n b e r g Tr a u r i g |

Roman Fayerberg | G r e e n b e r g Tr a u r i g |

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The rise of personalized medicine has spurred another trend: the growth of combination products that blend biologics, drugs and medical devices to improve patient treatment. However, because of the complexity of these combination products, securing a strategic patent can prove challenging. That’s why developers of combination products should aim to develop a “picket fence” around the core technology, filing patents for each individual aspect of the invention and covering incremental improvements. Here are five key considerations for makers of these products:

efficient drug-delivery devices, which in turn would augment the growth prospects for the combination products market. As new device and biologic combinations are created, opportunities and benefits exist for companies willing to develop complex combination products. These products, however, face several unique hurdles in entering the marketplace, namely patenting, regulatory approval and reimbursement. An integrated patent and regulatory strategy that emphasizes the benefits of converging technologies is necessary to succeed in the exploding combination products market.

1. The growth of combination products presents new opportunities and challenges. Combination products are moving healthcare toward providing patients with targeted treatments by incorporating technologies from various fields including biotechnology, medical devices, gene therapy, nanotechnology and drug-delivery systems. These combined technologies provide patients with more targeted and specialized treatments that can improve the efficacy, safety and delivery of medicines while minimizing side effects. The global combination products market is on a rapid growth trajectory. Since 2013, combination product sales have grown about 8% annually, and global sales are projected to reach $115 billion by the end of 2019. A key driver for this growth is the increase in the patient population for chronic diseases. The prevalence of cardiovascular disease, diabetes and respiratory diseases is expected to bolster the demand for

2. A strong patent portfolio can help ensure commercial success. A strategic patent portfolio is crucial to the growth and survival of a company developing combination products. Patents provide numerous business advantages, including securing venture capital funding and gaining leverage for collaborations with other companies. A solid patent portfolio is especially important for combination products, where the path to market is typically long and expensive. Without strong patent protection, there may not be adequate incentive to bring the innovation to market at all. In addition, combination product innovators that address intellectual property (IP), regulatory pathways and reimbursement starting at the early stages of company formation are better positioned for acquisition. Merger and acquisition deals close at all stages, but acquirers are willing to pay a premium for a company that is farther down the approval path and has been de-risked.

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IP ISSUES

3. Innovators should patent the device, the biologic and the device/biologic combination. Before product development begins, conduct a freedom-to-operate (FTO) search on every aspect of the device and biologic to determine whether the company is free of third-party patents and can practice its invention. The FTO search should include third-party patents, trademarks and copyrights, as well as the obtaining of IP assignments of ownership and legal opinions of non-infringement or invalidity. Once the FTO search is completed, the combination product can be designed to avoid infringing any third-party patents, and patent applications can be filed covering white space in the patent landscape. Conducting an FTO search early in the development process can help determine whether and how a company can market its combination product.

Developing a strong portfolio first requires comprehensive patent coverage of the device, the biologic and the device/biologic combination. Comprehensive coverage should include patent claims directed to compounds, diagnostics, therapeutics, methods of treatment, use, manufacture and any other novel aspects of the combination product. When developing a patent portfolio, the combination product innovator should consider the following questions to adequately protect the core technology: • Is the value of the invention in the field fully understood? • Are the inventions protected by narrow claims? • Do the inventions cover all claims that could prevent any competitors from getting around the product?

Development of the portfolio should include patenting incremental improvements to the technology to form a “picket fence” of protection around the core technology. With a picket-fence approach, the company patents all of the incremental innovations surrounding the main invention. This ancillary protection forms a protective barrier around the core technology and prevents competitors from patenting technology that competes with the protected asset. When bringing a combination product to market, product makers must carefully navigate regulatory pathways. First, the company’s regulatory strategy should be considered in conjunction with its ability to obtain and leverage a robust patent portfolio. Be wary of disclosing the combination product or its therapeutic benefits before filing the patent application with the patent office.

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Companies developing combination products should coordinate and monitor the communication among scientists, engineers and attorneys tasked with preparing FDA and patent applications. 4. In joint ventures, establish ownership rights from the outset. For companies entering into joint ventures, issues surrounding ownership of the combination product may emerge. For example, one company may claim ownership of the device, but a second company may claim ownership of the drug or biologic, clouding ownership of the combination product. Therefore, companies entering into agreements with other companies to develop or produce combination products should establish at the outset of the relationship what rights each party will have related to the combination product and what rights each party will retain upon termination of the collaboration. Ownership disputes can be resolved by assigning patent rights entirely to one party or jointly between the parties. Alternatively, ownership disputes may be resolved by exclusive or non-exclusive licensing of the patent rights. 5. Combination products require specialized patent counsel. Due to the hybrid nature of combination products, companies need to find savvy patent counsel to handle both the device and biologic components of the product. Because patent attorneys often specialize in either biologics, pharmaceuticals or medical devices, multiple patent attorneys may be needed to handle combination products. Ideally, these patent attorneys should work together in the same firm to fully and effectively prosecute patents directed toward each aspect of the product. Finding sophisticated patent counsel for combination products may be challenging, but it’s crucial for maximizing the quality of the patent portfolio and its scope of coverage. A new paradigm Combination products are the next wave in healthcare. Not only do they present new business opportunities, but they can improve diagnostics and therapeutics to predict, regulate and monitor pathological responses. They allow pharmaceutical companies to move beyond traditional medicine to a new paradigm for developing a catheter, stent or pill that could forever change how health issues are approached. For medical device companies at the forefront of combination product development, a careful patent and regulatory strategy can address hurdles unique to these products and ensure success in this growing market. M 1 • 2018

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maxon motor at a glance

maxon motor is a worldwide leading provider of high-precision drives and systems. We develop and manufacture brushed and brushless DC motors with a unique ironless core winding as well as motors with no iron cores. maxon motor’s modular system includes planetary, spur and special gearheads, as well as encoders and control electronics. High-tech CIM and MIM components are manufactured in a specialized facility. maxon motor stands for top quality, innovation, competitive pricing as a worldwide distribution network. For more than 50 years, we have focused on customer-specific solutions, quality and innovation. As a result our modular product range has constantly been expanded and now includes: Sensors Servo amplifiers Positioning controllers Customized special drives

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DESIGN SERVICES

Gleaning design opportunities from user research Conducting and integrating user research can significantly improve and streamline medical device design and innovation.

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User research is a critical component of the product development process. The FDA guidance document “Applying Human Factors and Usability Engineering to Medical Devices” and ANSI/AAMI/ IEC 62366 both outline a usability engineering process. It includes user research that should be followed during medical device development and should be an integral part of the product’s design history file. Both of these documents are focused primarily on usability/user research as it relates to the safety of the device. User research conducted during the product development process has numerous benefits. It can be analyzed to gain unique insights. Companies can use this information to gain competitive advantage by identifying new product features and design elements that enhance the user experience, optimize ease of use and maximize user satisfaction. Together, these elements can significantly contribute to a product’s success or failure in the marketplace. The user research process User research focuses on identifying users, understanding their needs, learning what they value and implementing targeted product solutions. It consists of a number of inter-related steps: • Early contextual research evaluates existing and competitive products, consumer trends, emerging technologies and markets. • Follow-on generative research focuses on new product requirements and includes user interviews, direct observation, surveys and focus groups. The results of this initial research are typically documented in task maps and user journey maps that outline the users, use scenarios and use environments and provide a tool to identify use challenges. • Targeted product conceptualization focuses on improving the product’s use and user experience. Outputs include concept sketches, ergonomic study models and proof-ofconcept prototypes. These outputs are reviewed with users through follow-on interviews, focus groups and/or surveys to obtain feedback and confirm the benefits of the proposed product designs and feature sets. The key learnings and design opportunities from this process are then incorporated into the design input specifications for the product.

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DESIGN SERVICES

Case Study #1 – Collaborative industrial automation robot Manta helped develop a groundbreaking new collaborative industrial automation robot that safely works side-by-side with human workers on assembly lines and in other manufacturing locals. User research conducted during the program identified robot user interface control schemes and training sequences to allow easy robot task reconfiguration by average workers without the need for complex programming. In addition, robot form, color, material and graphic options were identified that conveyed trust and confidence to human operators and co-workers. The resulting design has become an iconic figure in the robotics industry and a market success.

Case Study #2 – Portable electrocardiograph device Manta also developed a cart-based electrocardiograph for a large medical device company. User research early in the design cycle identified a key failure mode of existing competitive devices, in which the electrode leads were broken after being run over by the cart wheels during transport in the hospital. In addition, nurse users expressed a strong desire for a secure storage feature to hold their personal belongings. Based on this research, a cradle was designed into the top of the cardiograph to hold the patient interface module, which kept the leads safely away from the wheels during transport. In addition, lockable storage drawers were incorporated into the product to hold the user’s personal belongings.

Benefits of user research Although user research should be conducted during the development of a medical device in order to help ensure device safety, user research can also be used to determine user behavior, motivations and needs as they relate to the use of any product. This data can be analyzed and interpreted to uncover design opportunities and to establish essential design parameters that can significantly affect and contribute to a positive user experience, and correspondingly to a product’s success. M

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Medical device design transfer: 5 things you need to know Moving from design to production can be a challenging process in the medical device industry. Take these points into consideration to enable a smooth transition. There are many publications that discuss product development. However, an area that I find challenging within medical device companies is effectively transferring a product from concept development (R&D) to production (sustaining engineering). Why is design transfer a challenge?

Charlie Sears | G o d d a r d Te c h n o l o g i e s |

• Knowledge: Product teams don’t fully understand what’s necessary for design transfer. During the product development process, due to the development nature of R&D, decisions are made quickly without much thought toward what’s necessary for design transfer. • Time. Product teams don’t have enough time or resources to create the documents at the time the work is being done. Product team members tend to be subject matter experts and will do/know what’s necessary to make the product work. Typically, it’s lack of knowledge and time pressure that will require the team to backtrack their work to provide objective evidence that the product conforms to requirements. If the documentation doesn’t conform to the requirements of the company’s QMS, it’s effectively useless.

Medical Design & Outsourcing

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1 • 2018

If we add time back to the product teams by improving their knowledge and understanding of the requirements for design transfer, we will improve the design transfer process. So how do we improve knowledge and understanding? 1. Clearly capture the requirements for design transfer. Establishing a procedure to ensure that device design is translated into production specifications is a requirement of 21 CFR 820.30 (h) – Design Transfer. Although a single procedure may be too high-level to properly document the data necessary to complete the transfer, the information should be captured in the product development plan. That plan should document all necessary records to ensure the documentation is complete and well-supported by required verification and validation records. While it may be difficult to have a single checklist that covers all transfers within an organization, review requirements must still be understood. You should never have someone withholding approval due to missing information if it wasn’t a documented requirement.

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2. Create a quality system that allows for a level of control appropriate for the activity at the time of the activity. Part of the reason that things aren’t done when they should be is the amount of time and effort it takes to complete them. Typically, it’s not the authoring of documents that takes a lot of time, but the review and approval process that leads to delays. Keep the review and approval process to a minimum level necessary for the stage of product development.

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3. Leverage the engineering build process to create your design transfer documentation. This is the most important thing you can do. Experience has taught us that it’s much easier to document as you go than to look back and document what was done. At a minimum, work with the teams to properly identify procedural changes via redlines or a deviation process. Don’t forget about documenting inspection aids, fixtures, and custom tools. These tend to be developed as necessary and evolve over time; however, if you can document as you develop, you’ll have much less frustration at design transfer.

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Medical Design & Outsourcing

1 • 2018

1/26/18 12:18 PM

4. Maintain a flexible, risk-based approach to vendor selection and product purchasing. R&D teams will purchase anything from anyone; therefore, a fast, flexible purchasing procedure that will allow the product team to quickly procure components while remaining compliant to the QMS is a must. Categorize components based on a risk-based assessment into purchasing categories. Then connect the categories to vendor selection criteria and component inspection requirements.

5. Create and utilize a compliant supply chain process for the manufacture and purchase of products for verification and validation. Products (non-R&D) that will be used to produce records to be used for submission or other regulated activity carry a greater burden of ensuring compliance to specifications than products purchased for R&D. This doesn’t mean that the process needs to be difficult and the specifications complex. Prior to purchasing, using the risk-based approaches

mentioned earlier, the product team must ensure that the requirements of the component are clearly documented and understood. The greater the risk, the greater the requirements. This also includes the vendor. A vendor that’s acceptable for R&D purchasing may not be acceptable for later purchasing. M

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Medical Design & Outsourcing 23

1/25/18 10:09 AM

ENGINEERING 911

Thermal imaging at mold open

Image courtesy of RJG

What goes into injection molding cooling time? Part design, material selection, mold design and processing all play a role when it comes to injection molding cooling time. Here’s a value that probably sticks out in your mind if you’ve been to an RJG training event: 80%. That’s how much of the molding cycle is spent cooling the plastic part to a temperature that’s rigid enough to withstand the forces of ejection. Let’s review four areas that go into this equation:

Mold cooling equation Image courtesy of RJG

Jeremy Williams | RJG |

Medical Design & Outsourcing

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1 • 2018

1. Part design The basis for cycle time is rooted in the decision made by the product design engineer. The thicker the product must be to meet its working conditions, the longer the cycle will be to produce the product. In the previously mentioned formula, h2 represents part thickness. Since the thickness is squared in the equation, it has the most influence over cooling time. For this analysis, we utilized an American Society of Testing and Material (ASTM) Tensile Test Bar. The dimensions are 2.49 in. for length, 0.41 in. for width, and 0.13 in. for a thickness. www.medicaldesignandoutsourcing.com

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Tensile test bar

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2. Material selection By nature, plastic is an insulator. In a melted or molten state, plastic transfers heat slightly better. As it gives up heat, however, its insulative properties increase. Material properties that are used in the equation are:

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• Melt temperature: temperature at which material transitions from solid to liquid; • Mold temperature: temperature range to best achieve surface finish replication of the mold; • Heat deflection/distortion temperature (HDT): temperature at which a material will deflect under load. Typically, the eject temperature in the equation uses a value slightly below HDT. The following equation shows how to calculate thermal diffusivity (alpha symbol or α).

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The variables in the thermal diffusivity equation include: • Thermal diffusivity: rate at which a thermal disturbance (a rise in temperature) will be transmitted through a substance; • Density: quantity of a substance per volume (g/cm3 for plastics); • Specific heat: heat (in calories) required to raise the temperature of one gram of substance by 1 °C. For this test, we utilized a Toyolac 100 with temperature ranges for melt of 446°F to 482°F, mold 104°F to 176°F and HDT of 181°F. Density can typically be found on a material data sheet, but for thermal conductivity or specific heat, contact the material supplier directly or utilize the data within the simulation software. Based on the part geometry and material selection, the estimated cooling time is 18 seconds in simulation. Given all the energy required to melt a material, only 40% must be removed so the part is rigid enough for ejection. 26

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Medical Design & Outsourcing

1 • 2018

11/28/17 10:01 AM 1/25/18 10:17 AM

Generally, we don’t recommend selecting a cooling timer that only meets the HDT. A good rule of thumb is adding 20% to the cooling timer to account for variation. Tighter-tolerance parts will require a larger safety factor. 3. Mold design The design shown with this article is an 8-cavity mold with an “H” pattern runner and a lapped edge gate. Cooling lines have been placed following established guidelines for diameter/depth/pitch. By using proven methods for cooling line design, warp and cooling time are minimized. The mold is also fully instrumented with cavity pressure sensors at post-gate and end of fill in conjunction with in-cavity temperature sensors.

B half mold

Image courtesy of RJG

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ENGINEERING 911

Part surface temperature Image courtesy of RJG

4. Processing So where does that 80% number come from? Let’s look at the data we collected in each of the following process segments: a) Fill b) Pack/hold c) Cooling d) Mold open/eject/mold close For this experiment, we developed a robust Decoupled II process, resulting in the following process parameters:

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a) Actual melt temperature – 456°F Actual mold temperature – 121°F with a flow rate of 3.0 gpm per cooling circuit b) Fill time – 0.26 seconds with a transfer pressure of 8,356 PSIp c) Pack/hold time – 8.0 seconds at 4,150 PSIp d) Cooling time – 10.0 seconds e) Overall cycle time – 21.43 seconds If we add the process times together and divide by the overall cycle time, we reach a value of 0.852, or 85.2%. In the graph (upper left) are the actual part temperatures measured with a surface probe at different time increments during process development. In our experiment, the tensile test bar cooled from 456°F to 203°F in 8.26 seconds (fill/pack/hold time). For the part to get below the HDT, it took an additional 8.47 seconds. A mold closed time past 24.73 seconds is non-value add because the part temperature is no longer decreasing at a high rate. Cooling is a complex subject with many variables. However, with better engineering from part designers, mold designers and processing, we can achieve results close to theoretical. M

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TUBING TALKS

Why PEEK is so hard to extrude The popular material for catheters and minimally invasive tubing can trip up novices when it comes to extrusion.

PEEK has a semi-crystalline structure, but can be extruded to maintain amorphous qualities or to a very hard finish. Image courtesy of Microspec

Heather Thompson | Senior Editor |

Medical Design & Outsourcing

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Polyetheretherketone (PEEK) is known throughout the medical device industry for its toughness, strength and high heat thermal characteristics. It’s often used to replace metal components in medical devices; because it’s a thermoplastic it can be injection-molded or extruded into nearly limitless shapes, profiles and tubes. The material has a semi-crystalline structure but can be extruded to maintain amorphous qualities or to a very hard finish. It can withstand temperatures up to its glass transition point of 289°F, meaning it can withstand autoclave temperatures. The PEEK challenge Although PEEK has been used for more than 25 years in medical tubing applications, newcomers still make mistakes when it comes to its extrusion. “There’s a learning curve when it comes to PEEK,” said Tim Steele, one of the 1 • 2018

pioneers of PEEK medical extrusion and the founder and CEO of Microspec Corp. (Peterborough, N.H.) The first challenge in optimizing the PEEK extrusion process is understanding the melt characteristics of the material. Although much can be gleaned from the technical data sheet, that’s only the first step of many in developing a consistent extrusion process. After the technical data sheet, the first consideration is the size and design of the part to be extruded, as well as the size of the extruder and tools that are going to be used. There are various considerations including screw design, extrusion or crosshead design and the heat profile that plasticates or melts the polymer consistently in the barrel. If the melt is not even and consistent, the extruder output will be poor. If the extruder is not optimized, it can lead to waste and increased production time.

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TUBING TALKS

Another challenge of PEEK is cleanup. The material hardens at even slightly lower temperatures, which can lead to difficulties in purging equipment. “There are purging compounds on the market, but I haven’t seen one that works that well,” noted Steele. The heat is on PEEK is sensitive to heat, and it doesn’t take much of a swing in the heat profile to upset everything in the process. “A good heat profile in the extruder barrel is required to maintain dimensional stability of the part,” Steele said. All extrusion experts have their own crosshead design, but expert houses have developed ways to ensure their crosshead heats evenly throughout and avoids cold spots, he explained. There’s no optimal temperature for extruding PEEK, but, Steele said, a good rule of

thumb is the larger the extruder, the less heat it takes to melt PEEK. The melt temperature changes because in a small extruder there’s less surface exposure to the heated barrel, requiring more time to heat PEEK to its melting point.

material will spend in the extruder. A fast extrusion process with minimal residence is desired because when PEEK melts its molecular weight starts to go down, compromising the physical characteristics engineered into the polymer.

THERE IS A LEARNING CURVE WHEN IT COMES TO PEEK. Depending on the size of the extruder, the heat required to melt PEEK can range from 650°F to 750°F. Material maintenance and dwell time Another indicator of the level of heat required is the residence time the

Again, extruder size matters. Residence time in small machines might be as little as a few minutes. In large machines, it can be longer. However, consider that when using a large extruder, there is more material at stake. Unless the process is as fast as possible, a mistake

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can lead to thousands of pounds of very expensive product going to the dumpster. One of the challenges that can influence residence time is the smoothness of internal machinery, Steele noted. All metal surfaces should be highly polished. Microfractures on any metal surface including the screw or dead spots on the crosshead will slow down the material, creating gels. “Gels are caused by variations in molecular weight that appear in the extruded product,” Steele said. A gel is typically a spot in the melted plastic in which the molecular weight is significantly higher than that of the plastic around it. They can be caused by a few factors. At Microspec, Steele refers to these as e-gels and p-gels. An e-gel is caused when a process is not under control due to uneven heat distribution throughout the extruder and the crosshead. P-gels

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TUBING TALKS

are caused by a dirty reactor when the polymer is manufactured. The trouble is, those higher-molecular-weight areas have an affinity for each other, meaning they tend to grow. There are a few tricks to getting rid of them, with varying levels of success. Steele explained that some extrusion houses put them through a filter pack or screen pack. This can work sometimes, although more often the gels will simply reform downstream. Microspec has proprietary methods for getting rid of gels, and they are closely guarded secrets of the trade. Gels can be a cosmetic problem. The gel spot changes the way the tube reflects light or may cause one section of the tube to feel different, leading to an impression of poor quality. But gels can also cause dimensional problems. Occlusions on the inner diameter of a tube, for example, could impede the progress of a lead during surgery. If the gel is on the outer diameter, it could cause an occlusion that leads to patient discomfort or cause improper fit for a shaft meant to go around the tube. Cooling and annealing The way a component is cooled depends on the desired characteristics of the final part. “Cool it quickly, and the tube stays amorphous and imparts a transparent amber color. Cool it slowly, and crystals form for a tan opaque finish,” Steele explained. Cooling can be done using water, oil or air. The higher the mass of the plastic, however, the slower it needs to be cooled. Sometimes, the PEEK tube will be annealed to enhance crystallinity. To anneal the tube, you have to be in that glass transition stage, but smaller tubes need less time to anneal. Keeping an eye on PEEK PEEK continues to be a sought-after material as an alternative for stainless steel and other metals in components for catheters used for coronary valve, stent or graft delivery. In addition, PEEK can be used as a replacement for steel components used during many minimally invasive procedures. Take care when selecting your extrusion house. They should be able to demonstrate a deep knowledge of work that goes into extruding PEEK, while keeping an economic eye on the cost of the material and the turnaround needs of the OEM. M

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Medical Design & Outsourcing 35

1/25/18 10:28 AM

DRUG DELIVERY

How Flexion’s CEO set his company up for success using a history lesson After Flexion’s first product won FDA approval, CEO Dr. Mike Clayman prepared the company for a commercial launch of the extended-release pain therapy with a look back at other companies’ hits and misses.

Sarah Faulkner | Associate Editor |

Locally acting therapies are like a religion to Flexion Therapeutics co-founder & CEO Dr. Mike Clayman, who spent decades at Eli Lilly alongside that company’s co-founder, Dr. Neil Bodick, watching promising compounds fail in late-stage trials on unanticipated safety results. “That’s part of the reason, not the whole reason but part of the reason, why the industry only has a 60% success rate in Phase III, because you can’t predict what safety’s going to look like if you’re giving a systemically-administered product that has the potential for offtarget effects,” Clayman told Medical Design & Outsourcing.

WE RECOGNIZED AN IMMINENT NEED IN THE STEROID SPACE, WHERE IMMEDIATE-RELEASE STEROIDS ARE INJECTED IN OVER 4 MILLION PATIENTS EACH YEAR.

Medical Design & Outsourcing

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After testing and evaluating a number of in-licensed products, Flexion began with a promising, internally developed candidate – an extendedrelease formulation of triamcinolone acetonide designed to help patients with osteoarthritis manage pain. “We recognized an imminent need in the steroid space, where immediaterelease steroids are injected in over 4 million patients each year. None are formulated for sustained release so, after injection, they flood out of the joint. The pain relief that a patient gets, which is usually pretty good, wanes after two to four weeks. And by convention, steroids aren’t injected any more often than every three months, so there is an unmet medical need,” Clayman told us. Zilretta, as the product came to be named, won FDA approval in October 2017 and officially launched the following month. Along the way from concept to approved pain-relief therapy, Flexion tested and scrutinized 50 formulations before landing on its final version.

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DRUG DELIVERY

“It is not a common story in our space to go from ground-level zero, to go from concept-on-napkin to commercialized product. Yeah, we did a lot of right things, but anyone who claims that there wasn’t a bit of luck along the way in any venture that gets a product to the market is just deluding themselves,” Clayman said. Getting Zilretta to launch also necessitated perseverance, as Clayman persuaded board members of the product’s potential, and needed plenty of clinical evaluation, something he’s particularly fond of. “I love the intellectual puzzle of creating a protocol that will reveal truth about a molecule for a given indication,” Clayman said.

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IT IS NOT A COMMON STORY IN OUR SPACE TO GO FROM GROUNDLEVEL ZERO, TO GO FROM CONCEPTON-NAPKIN TO COMMERCIALIZED PRODUCT. Flexion touts Zilretta as the first intra-articular extended-release therapy for patients with pain associated with osteoarthritis of the knee. The product incorporates triamcinolone acetonide into a polymer, which is then formulated into microspheres that are injected into the joint to provide pain relief for up to 12 weeks. As Flexion moves forward with the product’s commercial launch, Clayman and his team are optimistic about Zilretta’s potential, but the chief executive is quick to note that they have done their homework. “We are super-sensitive to the fact that many small companies launching their

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Medical Design & Outsourcing

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Flexion CEO Dr. Mike Clayman

first product have faltered, at least faltered in terms of disappointing The Street, and so much so that it becomes a topic of regular discussion with investors and you’re put in the position of proving the negative: ‘Tell us why you’re not going to disappoint us,’ which you can’t do until you have the data and sales numbers,” he said. “We went back over the last decade of launches by small companies, 56 companies worth of data, to look at companies that got it right and companies that did not, to tease out the themes, to pressure-test whether we had adequately addressed the issues that had befallen our predecessors,” Clayman explained.

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DrugDelivery_1-18_Vs4.indd 39

The company is well-positioned financially to support a strong commercial launch and recently hired 103 sales representatives to get Zilretta into the offices of orthopedic surgeons, he added. Flexion has also hired Dan Deardorf to lead Zilretta’s launch. Deardorf was VP of marketing for Genzyme’s Synvisc franchise, helping to lead the launch of Synvisc-One, which eventually became one of the most successful products in the intra-articular injection space. “I don’t sit here saying we have it all right, but I think that we’ve gone to extraordinary lengths to understand the history of other companies that have gone

1 • 2018

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DRUG DELIVERY

before us and to aggressively support Dan in his efforts to ensure that we will be successful commercially,” Clayman said. Looking ahead, Flexion hopes to expand Zilretta’s label indication to include pain relief in the hip and shoulder. It’s also conducting clinical studies to see if the product could be used on both knees simultaneously. Beyond Zilretta, Clayman noted that the company is in talks to in-license other locally-acting therapies, in line with the company’s mantra of avoiding the sometimes toxic side effects of systemic medications. “We’re in advanced discussions on an in-licensing candidate,” he said. “Our goal is to build a pipeline of at least three compelling shots on goal, where each one has the potential to be a transformative medicine as a local therapy for musculoskeletal disease.

“Our commitment is to continue to build what we believe is a company that has the potential to become great. Great for us is distinctive results, sustainable performance and a compelling culture. We are heads-down, implementing a plan that will continue to move us in the direction of great. And you know, that journey’s never done.” M

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Designing for robotics: 2 things you need to consider Have an idea for an innovative healthcare robot? Here are a few design principles to help you avoid common pitfalls.

Ken Haven | Acorn Product Development |

When people think of robotics, they often think about warehouses or manufacturing lines, where robots automate multiple processes. But robotics has the potential to reshape the way healthcare is delivered in a variety of applications and locales. While we’re a long way from a robot replacing a physician, there are many opportunities to provide automation in the healthcare arena that can reduce costs and free up healthcare workers’ time to focus more on patient care. Possibilities abound in areas including surgical robots, exoskeletons, telepresence robots and robotics for medication management. No matter the application, there are a few principles to keep in mind when designing for robotics. 1. Design for manufacturability: Emphasis on “design for” The implementation of a DFM approach to design can have a significant impact on the overall development cost as well as the timeline for getting a design through production. Keeping sight of the end goal from the start can ensure higher quality and lower overall cost. While DFM analysis can be done after the design is “completed,” that’s far from the optimum approach.

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For post-design design for manufacturability, you’ve already invested time and money creating the current version. Any changes you make for the parts of the design that are creating potential DFM issues must be analyzed in the context of the impact of those changes on the larger system. Changes will also need to be verified and tested to determine if there is any impact on performance, quality, reliability, etc. DFM done at this stage also means there are now two different versions of the product to document, manufacture and support. Lastly, DFM done post-design is usually very constrained. There are tooling modification limits and previous “baked-in” design concepts which would require a complete redesign to correct. The product is often perpetually compromised and won’t ever have been as cost-effective as one designed with manufacturing in mind. The later in the design cycle all of this is done, the more costly the changes are. It’s crucial to consider DFM from the start! 2. Design for adoptability: Use models Having clear, well defined use models is critical to the success of any product development effort. Let’s start with the environment: Where will the robot be used? We can break use down into several broad categories: • The first is an isolated, (somewhat) fixed environment. This is an environment where a robot is more or less stationary or only moves within a confined space that’s likely to be protected such that direct physical contact with people is not the norm. Think of production lines, or robotic systems that operate inside something. • The second is a somewhat defined environment. This environment may still be somewhat fixed, but the robot has some flexibility in terms of movement and tasks. It may be autonomous, semi-autonomous or remote controlled and will likely be operating near or directly with people. Robots in this category include warehouse “pick-and-place” robots and floor-cleaning robots. • Last is an unstructured environment. This environment changes significantly, requiring the robot (and/ or its operator) to be able to “see/understand” its environment and adapt accordingly. Underwater robots, security patrol robots and autonomous vehicles are examples of robots that fall into these categories. The next set of questions revolve around who will be setting up and using the robot. What is their expected skills level? How difficult will it be to set up the robot? How often will the set-up need to occur? How do you debug/adjust the robot’s behavior? These are important to understand in terms of ease of use and proper integration of the robot into its operating environment.

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The level of autonomy (if any) is another complex area that needs to be clearly defined. If the robot is semiautonomous, when and how does the user interact and intervene? What level of “decision-making” will be the responsibility of the robot vs. not? What are the limitations of the decisionmaking capability? For example, suppose a pick-and-place robot drops an item. Should it try to retrieve it? How many times should it try before it asks for assistance? For successful adoption, what is expected from the user/operator of the robot? What changes will be necessary (and accepted) by customers who wish to adopt this robot to their work? What kind of management/support is needed for the ongoing operation of the robot and who will provide that support?

Will the robot have its own “health” or status monitoring capabilities? Who will it report to in case of difficulty? How will the issue be handled? The work done in defining the use models/cases will have significant impact on the design – and indeed can help control costs. The more they are defined up front, the smoother the design process will be. M

Watch the full case story online www.universal-robots.com/case-stories/tegra-medical/ Find your distributor: www.universal-robots.com/distributors

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HOW MEDROBOTICS CEO SAMUEL STRAFACE'S CONSISTENCY THWARTED POSSIBLE CORPORATE ESPIONAGE

Medrobotics CEO Samuel Straface has a habit of being last out the door – a habit that may have saved his company from corporate espionage. FINK D ENSFO R D A SSO C IATE ED ITO R

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Good leadership isn’t a trait that manifests itself only when there’s a team to oversee. It’s a persistent quality that, when managed correctly, requires constant and consistent effort and can be the most valuable when it’s least expected. This is a truth that Medrobotics CEO Samuel Straface learned on the night of Aug. 28, 2017, after he thwarted what could have been an act of corporate espionage – thanks to a tenacious commitment to his team and his habit of being the last man out the door. “I’ve always been pretty dogged in the pursuit of my vision – and that can be a good or bad trait depending on who’s on the receiving end of it,” Straface told Medical Design & Outsourcing. The night was supposed to be a celebration for Medrobotics executives, engineers and staff. The Raynham, Mass.-based company’s Flex robot-assisted surgery system had been used earlier in the day in the world’s first scar-free robotic colon resection at George Washington University Hospital – a major milestone and the culmination of months of work. But that’s not why Straface remembers the night.

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Although his peers and coworkers left to celebrate together at a nearby pub, Straface ended up spending the night dealing with a man he’d never met before: Dong Liu. In dealing with this stranger, he had to unravel why Liu was alone in a mostly secured conference room with several laptops and recording equipment after every other employee had left for the night. “I'm usually the last person out of the building every night – I generally close the facility and follow after the cleaners,” Straface recalled. “So, I put my hand out and I said, ‘Hi, I'm Samuel Straface. I'm the chief executive officer. Who are you?’” Court documents would later officially identify Liu as a 44-year-old former partner at a Chinese patent law firm who “appears to be a dual citizen of both Canada and China.” After his arrest, Liu was reported to have current passports from both countries. www.medicaldesignandoutsourcing.com

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Per court documents, Liu had entered the U.S. over the Canadian border a day earlier and traveled to Boston, though his motivation is still unknown. Perhaps Liu – as his lawyer would later argue – has suffered a brain injury and just wanted to be seen as brilliant again. Straface said he believes Liu must have scouted out the facility at an earlier date, as he seemed to know the limits of the medical robotics company’s headquarters during his appearance Aug. 28. Staffers later told the FBI that they had seen Liu a month before trying to get into the building, but he was denied entry by an engineer who said he’d have to arrange a meeting, Straface told MDO. The actual night of his intrusion was either intricately planned or incredibly lucky, as he took advantage of the commotion associated with the facilitywide celebration to slip in. “That day, we had made a recommendation to the program leaders

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that they take everyone down to the local pub, which is just short minutes from our facility, and celebrate in the afternoon,” Straface explained. This led to a rush of engineers and employees out the facility’s front door at the same time. It was during that rush that Straface assumes Liu made his entry into the foyer, having already been hiding away in an entryway vestibule. Medrobotics headquarters features a large, two-story foyer with multiple exits to different departments and a staircase that leads to the glass-walled conference rooms where Liu would eventually be caught. “He stayed in there for over two hours,” Straface said. “In that two hours, he was confined to the foyer area because every other door into the main part of the facility, to the offices, labs and conference rooms on the top floor, and to the training facilities and manufacturing facilities on the bottom floor, have a special lock.” The area behind those locked doors is secure, Straface said, and for good reason – Medrobotics is developing technology for the increasingly competitive, multi-billion-dollar robotic surgery industry. Trade secrets and intellectual property are at the core of the company’s value. “He was seen by several staff members as they were rushing for the door to celebrate the big event, in the foyer taking pictures with his camera and watching the promotional video – and that’s fine, it’s all public information,” Straface said. “We believe he tried multiple times to get in through the other doors, but was not able to do so, so he ended up packing himself in a room upstairs sort of overlooking the foyer.” It was one of two glass-walled conference rooms that the company used for non-confidential meetings, Straface said – and was directly on the path from his own office to the front door. “I decided that because I had an early board meeting the next day, I’d take an early night and go home and say hi to my family and try to get an early night’s rest,” Straface said. “So it was about 7:28 when I walked out of the top 50

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I’M USUALLY THE LAST PERSON OUT OF THE BUILDING EVERY NIGHT. SO, I PUT MY HAND OUT AND I SAID, ‘HI, I’M SAMUEL STRAFACE. I’M THE CHIEF EXECUTIVE OFFICER. WHO ARE YOU?’ secured door, past the glass conference room which is on the right, and put one of my feet on the staircase coming down – and stopped.” Straface said he thought he saw something out of the corner of his eyes as he walked past – which would be highly unusual, as he thought he was the last person left in the building for the night.

He had no plans for visitors or meetings and assumed none of his employees would be hiding out in a conference room while their peers celebrated. “I saw what looked like a bank of laptops on the table and a tuft of hair sticking out of the top. You couldn’t identify a person,” Straface said. “The thing that got me was the fact that there were three laptops – side by side – sitting on the conference table with screens facing away from the doors.”

He quickly turned on his heel and walked back into the room, although he had no malicious intent – Straface said he always stopped in to greet faces he didn’t know, even if they were wearing badges. So long as he didn’t know who they were, they earned themselves an introduction. Finding people that are the right fit and maintaining a personal connection with his team is an important aspect of Straface’s leadership principles, he said, so speaking to an employee he might not have met before wasn’t out of the ordinary. “His first response was not good. He just mumbled. He did put out his hand to shake, but mumbled his answer,” Straface said. “So I said, ‘Who are you with?’ and he mumbled again.” Liu, who seemed not to speak fluent English, would eventually offer that he

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was there to see the company’s sales director for its European division. Straface responded that that person had been out of the country for three weeks. Liu then stated he was there to see the company’s head of intellectual property – another no-go, as Straface knew his IP chief was also traveling.

Later, Straface and police would discover that Liu was looking at Linkedin profiles for individuals working at Medrobotics and had boldly listed names to Straface without knowing who they were. FBI documents also indicate that Liu spoke fluent English, though it’s uncertain whether he was intentionally affecting

I’VE GOT AN INTRUDER SITTING IN MY UPSTAIRS CONFERENCE ROOM AND I BELIEVE HE IS HERE FOR CORPORATE ESPIONAGE. In his last attempt, Liu said he was there to meet with the very CEO whose hand he was shaking – which didn’t make sense.

poor language skills or if he was merely struck by being caught. “This all raised red flags for me,” Straface recalled.

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Alone, standing in between Liu and the door out of the conference room, Straface grilled him on who let him in, how long he’d been there and why he was there. Liu had no information to give. “So I said, ‘You sit right there,’ and I just backed to the door, blocking it, and rang the police,” he told us. After quickly being connected with the Raynham police department, things got a little strange. “I said, ‘I’ve got an intruder sitting in my upstairs conference room and I believe he is here for corporate espionage,’” Straface said. “They said, ‘What?’ and I said, ‘Look, it’s 7:30 at night, my entire organization is gone and I’m the last person leaving.’” The CEO stayed in the doorway and remained on the phone until officers arrived. Liu had been in earshot of the entire conversation with the police, but didn’t make any moves. “He would be pretty stupid to try. I’m 6-foot-4, 270 pounds. I’m sort of a big guy, and not unassertive. I was pretty assertive,” Straface recalled. It took only seven minutes for police to arrive, he said. Unsurprisingly, the Raynham PD had never had a call for corporate espionage; after a few minutes of talking with Liu themselves, they decided to contact the FBI. “They were really professional, but very assertive. They were really pushing him to get an answer,” Straface said. “Eventually they came out and one said, ‘You know, I’ve got a feeling you may be right on this one.’ And he instantly says, ‘I’m going to call the FBI.’” The FBI took approximately two hours to show up. After arriving and talking to Liu, the FBI escalated the investigation, bringing in its counterintelligence group after another two hours. The FBI confiscated a number of electronic equipment, including two laptops, two smartphones and a number of SIM cards, an iPad, two digital camcorders and a wealth of digital storage equipment including flash drives and external hard drives, according to court documents. 52

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“So I ended up getting home around 2:00 a.m., and getting to be closer to 3:00. I still had my board meeting at 8:00 a.m., though,” Straface said. “It was only at the end of the board meeting I said, ‘Chairman, I need to tell you something. A funny thing happened last night as I was leaving the facility.’” Charges were filed against Liu in August, but would be dropped, without prejudice, in October. U.S. prosecutors have not revealed why they dropped the charges. Liu’s lawyer alleged that the prosecution lacked evidence and claimed that Liu suffered a brain injury in 2012 and was “struggling to accept the fact he was no longer brilliant.” Liu was released under a nearly $1.5 million bond, under conditions that he participate in a mental

health treatment program, according to court documents. Despite the case being dropped, Straface believes that Liu had a plan that would have put him in direct contact with the facility’s protected areas and the computer systems within them if he hadn’t been caught. “The cleaners, who I normally leave after, would open each of the [secure] doors separately, and [vacuum] the floor around the door – but by doing so, if there is someone already in the foyer … they don’t know the employees. They don’t know names. They don’t know who is in the building during the day. They wouldn’t stop someone who’s already in the building from getting

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through those secured doors,” Straface theorized. “If he got in that door, he would have full access, and that was probably his plan – to get access during the course of the cleaning and pack out or camp out during the night with his recording devices.” Straface surmised that Liu could have observed this behavior by the cleaners from a parking lot that overlooked the foyer. “If he was in the parking lot overlooking the two-story foyer, which is very well lit at night so you can see everything going on inside the foyer, he would have noted that at certain times, late at night and usually after I’ve left, that the cleaners open the secured doors to vacuum,” he said. Liu would have had to deal with overcoming the facility’s cybersecurity to access most of Medrobotic’s sensitive data,

but his intentions are unclear. “You don’t know what he could do. He could implant viruses, take images of papers, all sorts of things,” Straface noted. “There’s a lot of things he could have done, if indeed his true intent was to do harm.” The incident, although troubling, hasn’t set the company back, he added, noting that the closeness of the team at Medrobotics was an essential element in his catching Liu – he never passed a face he didn’t know without saying hi, and that attitude is disseminated through the company. “We have an extremely low turnover for a high-tech company, extremely low. For a couple years, we had a zero turnover rate. We were hiring hand-over-fist, almost as many people as we already had in a given year,” Straface said. “We’ve doubled,

especially in the last year or two. I had a good fortune to have found the right people at the right time who could translate our vision into a real end point that is tangible.” The company’s Flex robotic surgical platform continues to flourish, cleared in 17 countries including the U.S., where it has five separate FDA indications with more in the pipeline. “We are a true surgical platform company covering multiple surgical specialties all over the world. There are not too many companies that can claim that,” Straface said. One thing’s for certain – the next time the team piles out of the office for the pub to celebrate the next milestone, Straface will be sure to scope out all the private conference rooms before he checks out. M

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GE LEADERSHIP

Jeff Immelt Image courtesy of GE

Medical Design & Outsourcing

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Leadership's lasting impact:

t c e f f E t l e the Imm NO MATTER HOW YOU FEEL ABOUT HIS TENURE LEADING THE INDUSTRIAL CONGLOMERATE, FORMER GE CEO JEFF IMMELT HELPED SHAPE MEDTECH BY FILLING THE INDUSTRY’S CORNER OFFICES WITH FORMER EMPLOYEES.

FINK D ENSFO R D A SSO C IATE ED ITO R The right leader at the right company, at the right time, can have an effect that last decades - not only through their own actions but through those they’ve trained and the industry they’ve affected. Last summer, GE’s corner office passed from 16-year veteran Jeff Immelt to former GE Healthcare head John Flannery, ending an era that saw drastic changes at the massive conglomerate and helped spawn a generation of leading executives in the medical device industry. “There’s a great alumni in medtech,” Abiomed CEO Mike Minogue told Medical Design & Outsourcing last year. “Folks joke that there’s a secret GE handshake.” Good or bad – GE shares are off some 45% since late 2016 – Immelt’s nearly 20-year tenure at GE had a lasting effect on the medtech industry. The list of GE alumni now leading medtech companies includes Minogue, Medtronic’s Omar Ishrak, Boston Scientific’s Mike Mahoney, NuVasive’s Greg Lucier, ConforMIS CEO Mark Augusti and Smiths Medical’s Jeff McCaulley, to name just a few.

“GE, I think, taught us a lot of great fundamental aspects of running a business that are true to this day,” Lucier told us during an interview at MassDevice.com’s DeviceTalks event in 2015. “One of the ones that I always hold dear is ‘face reality.’ Don’t, in any way, look through rose-colored glasses of how the world is, but better understand just how it really is and you’ll make better decisions – and you should do that with people as well.” Under Immelt, the company sold off most of its GE Capital business, spun out legacy operations including lighting and appliances and dealt the NBC television network to Comcast. After cutting the fat, Immelt turned his attention to streamlining the divisions that remained, investing in high-tech businesses and information systems. The company re-upped its investment in healthcare, giving what’s now known as GE Healthcare a much bigger role. Immelt also pushed GE into the Internet of Things, creating divisions around information technology and its integration into other industries.

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DON’T, IN ANY WAY, LOOK THROUGH ROSE-COLORED GLASSES OF HOW THE WORLD IS, BUT BETTER UNDERSTAND JUST HOW IT REALLY IS AND YOU’LL MAKE BETTER DECISIONS – AND YOU SHOULD DO THAT WITH PEOPLE AS WELL. “I was with Jeff in the late ‘90s up until the year 2003 up until I moved to San Diego,” Lucier said. “It’s an interesting phenomenon, but that company, GE and specifically GE Medical as it was called back then, in that era, had some remarkable people in it. It was the glory days of that business for GE, and we grew rapidly, both organically and through acquisitions. It spawned a lot of folks

that went to a lot of corners in the healthcare industry. Big corners.” “It was a really special time. I think it was a neat time within the industry, and I think it was a special time within GE. The leadership there was really strong, there were great role models and great mentors to learn business and leadership from, and how to operationalize the business,” McCaulley recalled during another past DeviceTalks interview. McCaulley credited Immelt with creating a culture that fostered personal and professional growth.

“I had seen great cultures in my career, and not-so-great cultures, so you just understand where it works well and why it’s important,” he said. “There was incredible alignment at the top, which I think was one of the most impressive aspects of GE, and I think there was an incredible commitment to developing people.” Boston Scientific CEO Mike Mahoney said Immelt’s influence came into play as soon as he took up the reins at the then-Natick, Mass.–based firm in 2012, helping him in his efforts to turn around the company (including a move to nearby Marlborough). Culture played a huge role in his plans, he said. “The first few meetings I went to [at Boston Scientific] were very, very heavy in bureaucracy. We would do a business review and the binders were 2 feet thick – I’ve got a lot of ADD and I couldn’t

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get through, maybe four pages at max. Things were slow, so we added ‘The Winning Spirit,’ a phrase I learned from Immelt years ago at GE,” Mahoney said. “It’s a way to see opportunities and

apply to their own endeavors. “The most important thing was there was just this winning spirit about GE. You hear people talk about culture as this idea of the beliefs and mindsets

THERE WAS INCREDIBLE ALIGNMENT AT THE TOP, WHICH I THINK WAS ONE OF THE MOST IMPRESSIVE ASPECTS OF GE, AND I THINK THERE WAS AN INCREDIBLE COMMITMENT TO DEVELOPING PEOPLE. have the courage to make decisions and move faster as a company.” Other leaders who came up under Immelt took away different lessons to

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into medical, creating medical as a premiere organization inside of GE,” Minogue explained. “What I took away from GE were the processes and the culture. I came to a company like Abiomed, which was focused around innovation and the patients, and I merged the two together.” On his last day at the office last year, Immelt dropped a few last pearls of wisdom for his soon-to-be-former colleagues. Learning itself, he wrote, is “part of the DNA for all good leaders.” “Every minute I was with the GE team … they were the most important thing in the world to me. I have never met someone more dedicated to what they do than an engineer who works on an aircraft engine or a piece

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of healthcare equipment. You must build personal relationships. Top performers – in any field – want to do work that matters, and they want to be part of something bigger. Leading GE requires an ability to focus on each person, helping them do their best work together,” Immelt wrote in a parting note. M

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The opioid epidemic is one of the deadliest problems facing the U.S. today. Through the development of new pain management devices, medtech could be a leader in solving the crisis. The prescription opioid overdose crisis in America didn’t start until the late 1990s, when pharmaceutical companies touted prescription painkillers that weren’t supposed to be addictive. As a result, medical professionals more frequently prescribed opioid painkillers. Since then, opioid-related deaths have seen a steady increase. From 2000 to 2014, nearly half a million Americans died from a drug overdose, according to the Centers for Disease Control & Prevention. More than 50,000 people died from a drug overdose in 2015. Of those deaths, 33,000 were opioid-related. The Council of Economic Advisers reports that the opioid crisis had an economic cost of $504 billion in 2015, estimating that prescription opioid misuse increased healthcare and substance abuse treatment costs by $29.4 billion. Photo courtesy of istockphoto.com

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“A key solution to the current national crisis of opioid abuse is providing access to alternative pain management solutions for the people who need them,” said Shaye Mandle, CEO of Minnesota’s Medical Alley Assn. “The medical device industry currently delivers many nonopioid alternatives and can play a leadership role in addressing this epidemic.” Medtech could play a role in helping to curb the opioid epidemic with new technologies being developed to treat chronic pain and reduce opioid prescription abuse. There are hundreds of devices and technologies on the market that are designed to reduce pain. These include technologies to treat acute and chronic pain, devices for medication management and pill dispensing, diagnostic tests that can monitor overdose risk and technologies to monitor withdrawal and prevent overdoses.

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Regenesis Biomedical Provant therapy system Photo courtesy of Regenesis Biomedical

“To understand the role that medical devices can play in pain management, it’s important to at least understand the basic mechanism of action of opioids,” said Cary Vance, CEO of Fremont, Calif.–based back pain device company Myoscience. “Opioids act as an analgesic by inhibiting the neurotransmitters; in layman’s terms, they disrupt the pain signal transmission to the brain. Opioids may also help in reducing inflammation of the joints. Unfortunately, the action of opioids is not limited to the peripheral nervous system. They have a significant effect on the central nervous system as well. Their effect on the central nervous system can lead to extended and unwanted

dependence on these drugs, even after the initial purpose of taking these drugs has been resolved.” Medical devices for treating pain couldn’t come soon enough.

In order to get to the point where devices can be used regularly to treat pain instead of prescription medication, there are some hurdles that medical device companies need to overcome. “It is important to understand the cause and mechanism of pain,” Vance said. “The devices can then be designed to address the specific situation rather than have a one-size-fits-all solution. Also, it is important to keep the treatment localized to minimize any unwanted side effects of the treatment.” Here are five ways medical devices are already showing promise treating pain: 1. Using cryoablation to stop pain signals Myoscience uses cryoablation therapy to ablate signal-carrying members of nerves, stopping pain signals from traveling to the brain. Its Iovera system is able to treat several different nerves in the body for pain relief without the need for prescription opioids. “It is very important to identify the source of the pain and the nerves involved in transmitting the pain signals to the brain. Once identified, it will be easier to isolate and treat only those specific nerves,” Vance explained.

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2. Neurostimulation to treat chronic pain Nevro, Stimwave and St. Jude Medical (now part of Abbott) are just a few of the companies marketing spinal cord stimulation or neurostimulation to treat acute and chronic pain. Nevro’s HF10 Therapy is a chronic pain relief system that involves spinal cord stimulation. Mild but high-frequency electrical pulses help interrupt the transmission of pain signals to the brain. Doctors implant a small device that wirelessly transmits the electrical pulses to the spinal cord. The pulses from the device are designed to calm the nerves and reduce pain signals to the brain. The company reports that the average opioid intake of patients was decreased by nearly 70%; the percentage of patients not taking opioids at two years had gone from 14% to 42%. “The largest challenge is the development of robust evidence that can influence guidelines and impact physicians’ clinical practice,” said Dr. David Caraway, chief medical officer at Nevro (Redwood City, Calif.). “Although spinal cord stimulation has been around for over 40 years, the amount of rigorous comparative evidence has been limited until recently.” Nevro HF10 spinal cord stimulation Photo credit of Nevro

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3. Non-invasive pulsed electromagnetic energy Although neurostimulation is one of the most common opioid-free pain management solutions, other devices that have taken another route. Regenesis Biomedical (Scottsdale, Ariz.) created the Provant therapy system, a noninvasive medical device that delivers dual-field pulsed electromagnetic energy to an area of pain for a therapeutic and drugfree solution. It reduces pain by inducing the natural endogenous opioids that form in the body to reduce pain. It can be used at home, twice a day for 30-minute increments. The system is recommended for use in treating postoperative pain and edema of soft tissue and is available through a prescription only. 4. A non-opioid pain relief pump Halyard Health (Alpharetta, Ga.) developed the ON-Q system for post-operation pain relief. ON-Q is a non-opioid pain relief pump that can give a patient over three days of pain relief after surgery. ON-Q delivers an automatic, regulated flow of a local anesthetic through a specially designed catheter inserted near the surgical site or close to nerves. It also offers customizable control for personalized, continuous pain relief throughout the procedure and recovery.

60 Years of Experience Avancen MOD bedside pain management system Photo courtesy of Avancen

5. Bedside pain management Avacen (Mount Pleasant, S.C.) is tackling the opioid problem right from the recovery room with its MOD bedside pain management system. The system is a secure, wireless, patient-controlled analgesia device that houses eight doses of the patient’s pain medication and is safely secured on an IV pole. Each patient using the system is assigned a radio frequency identification wristband that is registered just to them through the device’s software program MODTrac. Clinicians enter the dosage and frequency of the medication into the system, and at prescribed lock-out time intervals, a green light will illuminate to let the patient know that they can take the next dose of oral medication, if needed. An hour after the patient takes their medication, they are asked to rate their pain on a scale of one to 10. Clinicians can then gauge how the medication is working for them.

TO UNDERSTAND THE ROLE THAT MEDICAL DEVICES CAN PLAY IN PAIN MANAGEMENT, IT IS IMPORTANT TO AT LEAST UNDERSTAND THE BASIC MECHANISM OF ACTION OF OPIOIDS

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“Data and changing behaviors are what will drive the cure for the opioid epidemic. This is based on our need for a cultural change,” said Thomas Hickey, director of business development at Avacen. “Up until this point, it has been the practice of many of the medical staff in hospitals to send patients home with a 30- to 60-day supply of opioids. This practice has occurred because the medical staff has no empirical data to rely on. In other words, that’s the way we have always done it.”

Myoscience Iovera system Photo courtesy of Myoscience

Why aren’t more pain sufferers using medical devices? More medical professionals need to become aware that there are medical devices to treat pain, according to Myoscience’s Vance. “Since the use of medical devices is recently being recognized as a viable option for pain management, very few healthcare providers are aware of what’s available,” Vance said. “So, access to such treatments and technologies can be challenging.” Barriers to adoption include access, awareness and overcoming existing physician perceptions, according to Caraway at Nevro.

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“Currently, opioid medication is easily accessible and able to be prescribed by primary-care providers,” Caraway said. “In contrast, to administer spinal cord stimulation, a patient must be qualified as a candidate and be implanted by a trained pain specialist or surgeon.” The FDA, Centers for Medicare & Medicaid Services and the President’s Commission on Combating Drug Addiction & the Opioid Crisis have all listed medical devices as a potential solution to the opioid epidemic. Even with government’s supportiveness

Medical Design & Outsourcing

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1 • 2018

around using medical devices to treat pain, it still takes a while to achieve regulatory approval and reimbursement from payers. “Medical devices are regulated by the FDA and reimbursed by payers such as Medicare (CMS). The FDA and CMS are being collaborative in the process for gaining clearance and coverage to

market devices," said Scott Robey, VP of marketing at Regenesis Biomedical. “The requirements to bring a safe, non-drug solution to these patients are costly and time consuming. And for an emerging company with resource constraints, a more timely, transparent and collaborative process will help accelerate solving the opioid crisis.” M

SINCE THE USE OF MEDICAL DEVICES IS RECENTLY BEING RECOGNIZED AS A VIABLE OPTION FOR PAIN MANAGEMENT, VERY FEW HEALTHCARE PROVIDERS ARE AWARE OF WHAT’S AVAILABLE.

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MERGERS & ACQUISITIONS

This medtech CEO led his company to a

HERE’S HOW

S A R A H FA U L K NER A S S O C I AT E E D ITO R When Christopher von Jako assumed the corner office at NeuroTherm in 2013, the company had gone through two other CEOs in a year's time and was reeling from an FDA warning. And in his first week as the company's chief executive, St. Jude Medical came knocking – they were looking to buy. Von Jako is an M&A veteran: he's been through five of them in his 25-year career in the medical device field. But just days into his time at NeuroTherm, he wasn't ready to sell. Photo courtesy of istockphoto.com

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"I said, 'Well, I just showed up here. I'm not ready to sell the company. We've got to fix some things, and I think we can drive some additional value," von Jako explained. He told St. Jude that when NeuroTherm was ready to sell, he would approach them. But St. Jude, which was later bought by Abbott, was persistent. Eventually, von Jako hired a banker. A year and a half after joining NeuroTherm, he had inked a $200 million deal to sell

Guiding a company through a merger or an acquisition can test a CEO’s leadership skills. Here’s how NinePoint Medical CEO, Christopher von Jako, led his former company, NeuroTherm, through a deal with St. Jude Medical.

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Medical Interconnect Solutions MERGERS & ACQUISITIONS

soon after joining. Von Jako wanted to re-establish a sense of stability and unity among his employees. “The first thing to do was to try and get the employees aligned on what we Building, and retaining, value were trying to get done, so we developed In his first six weeks as NeuroTherm’s chief executive, von Jako set out to speak a new mission statement and a vision statement. All those things brought the with every employee. He held group team together and made sure that people sessions with six employees at a time, to were doing the right things. It was a really introduce himself and form a foundation rewarding experience,” von Jako said. of trust with his colleagues. He assured them that he wasn’t interested in selling the company – because, at the time, he truly wasn’t. “I tried to keep myself open and accessible. My door was open to all of my employees. I would set regular times for me each week to call the sales people in the field, out of the blue, to ask them how things were going,” von Jako recalled. “It’s amazing what we as a company accomplished in the one and a half years before the sale process actually went through.” Over the course of that year, NeuroTherm moved the company’s facility, expanding its team to add an additional 40 employees. It worked Christopher von Jako on clearing up problems with the FDA and continued to build out its R&D capabilities. “I listened, I talked to everybody and And when St. Jude came calling set a vision for the company – where we again, this time von Jako agreed to were heading and how we were driving hear their offer. toward that,” he said. “I came out with “The synergy between St. Jude specific objectives for us as a company Medical and us was obvious. They have after I arrived and then did the same thing a larger sales force. They're in the same again in January of 2014 as well. The goal market space. They are a worldwide, was to bring everybody together.” leading medical device company. They The company itself had experienced could do a lot with the products,” he a lot of change in a short period of time. explained. “They understood the value Just three years earlier, NeuroTherm proposition that we had.” was sold to a private equity company. By July of 2014, they had a deal. Before von Jako, there were two CEOs. St. Jude would buy NeuroTherm and its The second one came after the sale to spinal pain devices for $200 million. the private equity company and left the interventional pain management company and its radiofrequency ablation systems used to treat spinal pain.

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Learning to keep a steady hand Von Jako knew from personal experience that when a company is sold, it can leave employees on the edge of their seats wondering if they’ll still have a job when the dust settles. At the time of his first medtech buyout, he was newly engaged and his job wasn’t a sure thing. “So every deal that I've done, I've always made sure that we've taken care of the employees, because I knew selling to St. Jude meant that people may not have a job in the future,” he said. “I tried to empathize with them and I tried to set the company up so that people could land in the right spots.” He had spent his year and a half as CEO building trust among the employees. Now, he was worried that it would fall apart once they found out he was selling the company.

THE FIRST THING TO DO WAS TO TRY AND GET THE EMPLOYEES ALIGNED ON WHAT WE WERE TRYING TO GET DONE, SO WE DEVELOPED A NEW MISSION STATEMENT AND A VISION STATEMENT. “I tried to explain to them, ‘I really didn't think we were going to sell the company this quickly. That was not what I had in mind and this is the best thing for the owners – and this is the way we move forward,’” he said. “I think having good communication, understanding the employees, is important. Listening to them and empathizing with them and understanding what the situation is going to be. And making sure 1 • 2018

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that it's a good transition for a lot of the employees. I made sure that everybody in the company actually got something.” Although some of NeuroTherm’s employees left, others ended up landing jobs within the newly bought company.

EVERY DEAL THAT I’VE DONE, I’VE ALWAYS MADE SURE THAT WE’VE TAKEN CARE OF THE EMPLOYEES BECAUSE I KNEW SELLING TO ST. JUDE MEANT THAT PEOPLE MAY NOT HAVE A JOB IN THE FUTURE. 4.5”

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“Where there’s change, there’s always opportunity,” von Jako said. After five successful medtech M&As throughout his career, von Jako knows there are essential skills that all leaders need to navigate a buy-out. His top tip for any CEO is to maintain a degree of steadiness and stability. “There are these incredible highs and lows throughout the process and you just have to stay as realistic as possible,” he said. In addition to building a team of strong directors and managers, who von Jako credits with helping him close NeuroTherm’s successful sale, it’s also crucial to advocate for your employees. “Make sure that the employees are going to be taken care of, because you want to retain value on the other side,” he said. “You don’t want good employees to leave, because that’s what the buyers are buying.” “You want to make sure that you’re advocating for the people that really helped you out during the whole process,” he added, “because it’s just going to help the other company as well.” M

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Buyout Feature MDO 1-18 Vs4.indd 84

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1 • 2018

1/26/18 11:29 AM

www .theleeco.com

Go ahead, push us to your limits.

We love a good challenge. If you need a fluid handling component for whatever reason, no matter how extreme, talk to The Lee Company. We’ve been solving complex fluid control problems in all kinds of industries for more than 60 years. Our extensive family of precision fluid control products offers unsurpassed reliability in just about every configuration you could imagine, including:

• Miniature Solenoid Valves

We’re not just talking about off-the-shelf solutions, either. A Lee engineer will be happy to discuss your application, and develop a custom design if needed. From managing nanoliter droplets to creating fully integrated fluidic systems, we’re unsurpassed in breadth and experience to deliver the precise, reliable performance you require. Whatever problem you face, make the solution easy. Contact The Lee Company today.

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8/8/13 10:28 AM 1/24/18 3:55 PM

PRODUCT WORLD

TDK launches AC-DC power supplies series TDK Corp. recently released its new XMS500 series of AC-DC power supplies that are rated at 500W output power and have a Class I and Class II construction. The XMS500 series is able to operate at full load with airflow rates of 1 m/s and are used in home healthcare, hospital, imaging and clinical diagnostic systems applications. The series comes in case styles, standby voltage, a 12V fixed or variable speed fan supply, remote on/off, AC fail and single or dual input fuses. It comes in 12V, 24V, 36V or 48V nominal outputs. It is operable in temperatures up to 70 °C and has a frame measurement of 102-by-180-by-37 mm. The U-channel is 107-by-180-by-39.5 mm. The input to output isolation is 4000Vac, input to ground isolation is 1500Vac, and output to ground isolation is 1500Vac for use in B and BF-rated equipment. TDK Corp. tdk.com

Morgan Advanced Materials touts new CD coating Morgan Advanced Materials’s Technical Ceramics business announced that it is launching a charge dissipative (CD) coating for ceramic parts to support the development of compact medical equipment. Reduced size and improved resolution and imaging performance is in high demand for medical diagnostic imaging equipment like CT scanners and mobile X-ray machines. Morgan’s CD coating of ceramic parts allows for optimum performance at higher voltages. Morgan Advanced Materials is able to supply multiple coated samples with various specific surface resistance (SSR) for manufacturers’s development projects. A development of a measurement system for SSR allows for better consistency and repeatability on ceramic shapes. The latest range of coatings features a blend of titanium and chromium oxides that help create semi-conducting layers while lowering the emission of secondary electronics. Morgan Advanced Materials morganadvancedmaterials.com

Medical Design & Outsourcing

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www.medicaldesignandoutsourcing.com

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Qosina expands stopcocks line Qosina recently announced that it has added 12 new stopcocks to its line of bulk and non-sterile components. The new stopcocks are designed to be REACH and RoHS compliant with low profiles and low pressure ratings. They also feature unique configurations like build-in styles. Qosina offers 100 options of the stopcocks and supplies one-way, two-way, three-way and four-way stopcocks and stopcock manifolds. The stopcocks also have a variety of connections options to choose from like male luer locks, female luer locks, male luer slips, barbs and tubing ports. They also are designed in a variety of materials and colors. Qosina qosina.com

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PRODUCT WORLD

Sensirion unveils RH/T sensor module Sensirion released its CO2 and RH/T sensor module SCD30 that is designed to sense humidity, temperature and carbon dioxide concentration. The sensor features CMOSense Technology for IR detection to accurately measure carbon dioxide levels through a dual-channel principle. The sensor also includes an ambient humidity and temperature sensor that can be outputted by the company’s algorithm through modeling and compensations of external heat sources. SCD30 sensors also have a small module height that allows for it to be used in a number of applications. Sensirion sensirion.com

Partnering to deliver life-changing innovation As a world leader in advanced medical device outsourcing, Integer’s design, development and manufacturing capabilities are unmatched. Our expertise in critical medical technologies ensures the highest quality standards. Let our 600+ engineers around the world take your ideas and create something amazing.

Custom Packaging Solutions Focused 100% on Healthcare For more information, contact us: email: info@nelipak.com | phone: 401.946.2699

Medical Design & Outsourcing

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www.medicaldesignandoutsourcing.com

1/26/18 12:51 PM

Murata Electronics releases Nordic-based BLE module Murata Electronics launched its MBN52832 Bluetooth Low Energy/NFC module that helps enable ultra-low power connectivity for data communication. It is a miniatured device that features Nordic Semiconductor's nRF52832 IC, 32 mHz crystal for timing and an on-board antenna. It also uses pins for an off-board omni-directional antenna and an NFC antenna. Murata Electronics murata.com

Standard Parts. Winco. Sanitary and Stainless Steel Casters JW Winco’s immense offering of Sanitary and Stainless Steel Casters, including: ■ Stainless Steel or Plastic Bracket Casters ■ Fixed and Swivel Types ■ Inch and Metric Size Top Plate ■ Optional Brakes Visit www.jwwinco.com to explore our corrosion-resistant casters lines, or contact us with your application requirements J.W. Winco Inc. Phone 800-877-8351 Fax 800-472-0670 Email sales@jwwinco.com www.jwwinco.com

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DEVICE TALKS

3 secrets of medtech success from a true industry pioneer From stents to TAVR, Stanton Rowe has built a medtech legacy out of accomplishing the seemingly impossible. Here are three lessons from his career.

Chris Newmarker | Managing Editor |

Stanton Rowe has played a major role in two of the top medtech innovation success stories of recent decades: stents and transcatheter valve replacements. Listening to him speak at DeviceTalks West last month, it was obvious that his achievements come from being more than just a by-the-numbers businessman. Rowe, in fact, dared to do the impossible – an instinct he may have honed growing up in Huntsville, Ala., when it was the center of U.S. rocket development during the space race. Rowe’s father worked for the federal space agency as an engineer, he told Medical Design & Outsourcing Executive Editor Brad Perriello. “The impossible is the most fun you can have in medical device development. Just go do the impossible. … Those are the things that really impact patients, too,” Rowe said during the event in Costa Mesa, Calif. Now chief scientific officer and corporate VP at Edwards Lifesciences, Rowe is leading the development of the next generation of transcatheter aortic valve replacement (TAVR) technology – projected to be a $5 billion market by

“We’re not just replacing these valves. In the tricuspid, in mitral, we’re repairing them,” Rowe said. “Doing repair systems under fluoroscopic guidance and echo guidance is the next generation of these therapies, and it’s something to pilot,” Rowe said. “Their development is fraught with the same kind of challenges we had before, which makes it just a ton of fun.” Here are three lessons from Rowe’s career that every medical device developer could take to heart: 1. Customer input only goes so far During the early years of the last decade, Rowe founded Percutaneous Valve Technologies with Drs. Alain Cribier and Martin Leon. Back then, Rowe recalled, cardiothoracic surgeons didn’t have a single positive thing to say about TAVR. Surgeons, after all, do surgery. But what about the patients for whom invasive surgery was not an option? “The multibillion-dollar simple question that no one asked was, ‘Why would I send a non-surgical patient to a surgeon?’” Rowe said. “If you’re doing something that is bold and decisive, you’re probably going to experience some skepticism. “The idea that you go out and garner input from your customers is a fundamental and brilliant idea. But there are points in time where customers … have no idea of what they really want,” he explained. “It can be lonely when you’re doing something really disruptive.”

THE IMPOSSIBLE IS THE MOST FUN YOU CAN HAVE IN MEDICAL DEVICE DEVELOPMENT. JUST GO DO THE IMPOSSIBLE. … THOSE ARE THE THINGS THAT REALLY IMPACT PATIENTS, TOO. 2021. Transcatheter mitral and tricuspid valve replacement technologies under development could prove to be even more lucrative. 90

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Designing RF tissue ablation devices involves multiphysics.

Visualization of temperature, size of completely damaged tissue, and current density between the electrodes of a bipolar applicator.

To properly model radiofrequency tissue ablation, the simulation must account for electric current flow, heat generation, and temperature rise in the human tissue. This is where multiphysics simulation software comes in. The COMSOL MultiphysicsÂŽ software is used for simulating designs, devices, and processes in all fields of engineering, manufacturing, and scientific research. See how you can apply it to modeling tissue ablation procedures. comsol.blog/RF-tissue-ablation

Comsol 1-18.indd 56

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DEVICE TALKS

2. You need answers to the questions During the early days of TAVR, Rowe received a lot of technical feedback from medical experts about why it wasn’t going to work. They said crimping down a heart valve, for example, would destroy tissue; they said the procedure would leave the diseased valve in place instead of cutting it out, so the transcatheter valve would deploy into diseased tissue; they said calcified material from the stenotic valve would fragment, increasing the risk of stroke. How did Rowe answer that? It turned out there was already data on hundreds of people who had received aortic balloon angioplasty and the stroke rate was about the same as surgery. Also, the calcium was encapsulated in tissues on the outer surface of the diseased valve, while the TAVR procedure would take place on the inner surface of the valve.

MDO’s executive editor Brad Perriello (left) interviews Stanton Rowe (right), chief scientific officer and corporate VP at Edwards Lifesciences, at DeviceTalks West, December 2017 in Orange County, Calif. “The impossible is the most fun you can have in medical device development,” Rowe said

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Package Type TO-263 TO-220 OVERMOLDED TO-220 TO-252 TO-263 TO-220AB OVERMOLDED TO-220 TO-3P TO-263 TO-247 TO-220 OVERMOLDED TO-220 TO-3P TO-247 TO-3P TO-268HV SOT-227 TO-247 TO-268HV TO-247 TO-264 TO-268HV TO-264 SOT-227 PLUS247

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Behind the Scenes. Ahead of the Curve. Inside the Corner Office.

THE NEXT BIG THING IN MEDTECH IS HERE WORLD-CLASS EDUCATION AND EXCLUSIVE INSIGHTS FROM THE TOP MINDS IN MEDTECH

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DEVICE TALKS

For any groundbreaking achievement, Rowe noted, there’s a “list of things that you have to have good answers for.” “Think of this as your job.” 3. It has to be about more than money Percutaneous Valve Technologies’ Series B round was led by Medtronic and Boston Scientific, which had seats on PVT’s board along with Johnson & Johnson, which licensed some technology to PVT. But Rowe eventually sold to Edwards in 2004, despite the involvement of a trio of huge medtech strategics. That’s because Rowe saw that it was about more than about money with Edwards. “I did think this technology had its best chance for success at Edwards, because that was core to their business,” he explained. “Edwards was the world’s leading heart valve company. If anybody could add technology to what we had already done, it was Edwards.” Rowe also thought it was good that Edwards had to borrow money for the purchase, because it demonstrated commitment.

Connected Device Development Experts MAKING BRIGHT IDEAS WORK www.sunriselabs.com

WE'RE BACK FOR ANOTHER SEASON OF INSIGHT FROM MEDTECH'S BRIGHTEST MINDS! DeviceTalks, the live interview series from MassDevice, returns in 2018 for another season of insight from the brightest leaders in medtech.   Learn more about our events and stay tuned for more announcements on the rest of our 2018 season.

MINNESOTA

JUNE 4-5, 2018 INTERCONTINENTAL ST. PAUL St. Paul, MN

1 • 2018

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BOSTON

OCTOBER 8-10, 2018 THE WESTIN BOSTON WATERFRONT Boston, MA

WEST

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DEVICE TALKS

IT CAN BE LONELY WHEN YOU’RE DOING SOMETHING REALLY DISRUPTIVE.

“You spend years developing something … it becomes very personal. And so you desperately want to see it succeed,” Rowe said. Rowe also admitted that he made a “really stupid business decision” in 2002 when it came to going ahead with what turned out to be the first successful TAVR procedure on a person, which Cribier performed at Hospital Charles Nicolle, at the University of Rouen in France. The patient was a dying 57-year-old man who was in cardiogenic shock, with an ejection fraction of only 10%. He was not even close to being a candidate for open heart surgery. Why should PVT provide TAVR tech to help him? “We’re going to go try to save his life. I was concerned he was going to die, and then the French regulatory authorities are going to crucify us for killing him,” Rowe said.

And yet there was something else even more important that Rowe had to consider. “Why we were working the way we were? We had a reason for this development that was so fundamental to what we were doing. And I thought at the end of the day, ‘My God, this is why we created this technology. It’s to save even one life. And this is our first opportunity.’” M

Watch the full interview online!

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2018 I N T R O D U C T I O N L E A D E R S H I P

I N

M E D I CA L T E C H N O LO GY

Nominate the company you think has provided leadership in the medical technology industry.

The medical device industry just wrapped up another record year, with blockbuster mergers grabbing headlines around the world and new, innovative technologies emerging seemingly every day. This level of success wouldn’t be possible without the innovation, ingenuity and determination of the people who drive it: leaders. These individuals and companies are working for the growth of the entire medical device industry. The future of medtech will build on the foundation of today’s efforts. Medical Design & Outsourcing would like to acknowledge such achievements on the following pages. We think they deserve recognition from you, too. Vote online for one or more of the companies listed through October.

VOTE

ONLINE

medicaldesignandoutsourcing.com/leadership Nominate the company you think has provided leadership in the medical technology industry.

Medical Design & Outsourcing

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1/26/18 12:42 AM

LEADERSHIP IN MEDICAL TECHNOLOGY Accumold began in a rented garage in 1985. Our primary focus was and still is on very small micro-sized plastic parts and components that other companies can’t produce. The original Micro-Molder® was designed to help manufacture parts with minimal waste and short cycle times for electronic component manufacturing. Although there have been many innovations over the years the basic principals have remained the same and so has our commitment to micro-injection molding technologies.

2018

Micro-Mold®

These minute parts are often measured in microns and are no bigger than 0.5 cubic inches; they typically weigh less than a gram. In addition to their size, these parts have very tight tolerances and must be molded efficiently and precisely — time and time again. Accumold builds specialized molding machines for this unique capability. The machines are engineered to handle volumes from prototypes to millions per year while maintaining consistent, precise tolerances that are unique in the industry. The specialized tooling and molding for micro-sized components are only available at Accumold.

Today the company now focuses on industries that require fast turn around and complex parts for high tech industries such as Micro Electronics, Micro Optics, and Medical, as well as new emerging markets and technologies. Our founders established high standards of quality when the company began. These standards still exist today! We still have many of the original customers that entrusted their most valuable parts production to us. We believe this is due to our professional management staff, expert tool makers, and our top notch production team.

Small Parts

Not every micro-molded application requires microscopic parts, but many require demanding geometry and tight tolerances on a slightly larger scale. Micro-features — incorporating very small features on a normal-sized part up to about 3 inches in diameter — are another of Accumold’s capabilities.

Lead Frame / Insert Molding

Accumold 1711 S.E. Oralabor Road Ankeny, IA 50021 P: 1.515.964.5741 F: 1.515.964.5742 accu-mold.com

VOTE

Insert micro-molding involves molding in or around a wide variety of materials such as plastic, ceramic, glass, fabrics, film or foil. This type of over-molding can be achieved on either the Micro-Mold® or Small Mold platforms with the same high-precision output. The process can be operator loaded or our Automation Team can build a custom loading system for high-volume applications.

Facilities

Accumold is an ISO 13485:2003, 9001:2008 and 14001:2004 certified company with a state of-the-art, 84,000 square foot production plant. The Accumold facilities are located near Des Moines, IA, in the heart of the Midwest. The building is climate controlled and includes four 100K clean rooms and two 10K clean rooms for micro-electronics and medical applications.

ONLINE

medicaldesignandoutsourcing.com/leadership Voting for this company will identify it as a leader in the medical technology industry.

www.medicaldesignandoutsourcing.com

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LEADERSHIP IN MEDICAL TECHNOLOGY

2018

UNRIVALED EXPERIENCE UNRIVALED RESULTS Medical manufacturing is constantly evolving. In order to compete in today’s market you need to rely on a company that has the experience to bring your design to life without compromise. This experience is why AIM Plastics is considered a premier medical plastics manufacturer. AIM collaborates with some of the medical industry’s largest companies looking to fulfill their mid to high volume medical manufacturing needs.

Tool Manufacturing

AIM’s state of the art tool room provides the foundation for our manufacturing by supplying high precision molds, fixtures and gauges.

Advanced Molding

AIM’s Manufacturing Center, which houses a 6,000 square foot ISO Class 7 (10k) Cleanroom, features a full complement of general molding capabilities along with several advanced molding technologies with a tonnage range of 30 to 440 tons. AIM has the ability to support your high volume production needs.

AIM Plastics, Inc.

Scientific Processes / Quality Validation

22264 Starks Drive

AIM utilizes the latest scientific injection molding techniques/ qualification procedures (DOE, IQ, OQ and PQ) to ensure the most robust injection molding processes and tooling capabilities are attained.

Clinton Township, MI 48036 586.954.2553 Rfq@aimplastics aimplastics.com

VOTE

Pad Printing

ONLINE

medicaldesignandoutsourcing.com/leadership

AIM’s value added services include one to four color pad printing with the ability to print 360º. All equipment has gone through installation and operational qualification to meet demanding medical/customer requirements. AIM can support low to high volume productions.

Assembly

With intimate knowledge of your program gained throughout the tooling phase, AIM is best suited for your assembly needs, allowing us to cost effectively ship turnkey sub-assemblies.

Voting for this company will identify it as a leader in the medical technology industry.

100

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LEADERSHIP IN MEDICAL TECHNOLOGY

2018

AllMotion Inc. develops and manu-factures miniature high-performance stepper and servo

4 AXIS Servo Motor Driver Controller

drives for the medical, scientific, optical and general automation markets. Their mission

The EZQuad Servo was designed to allow the rapid implementation of multiaxis stepper motor solutions in products requiring automation.

is to create superior, ultra-compact motion control solutions that reduce costs and readily integrate into OEM instrumentation designs across a wide range of industries. R&D efforts

Measuring only 2.25” x 2.25” X 1.0” (57mm x 57mm X 25mm), the fully intelligent servo motor Controller + Drivers runs 4 fully independent Brushed or BLDC servo motors. Operating from a 7V to 40V supply, the controller regulates to any motor voltage via software command (e.g., 3V motor can be run with 24V supply). Commands can be issued from any serial terminal program (such as HyperTerminal) or from the EZStepper Windows application.

are centered on core competencies of small form factor components that deliver precise positioning control and ease of use. AllMotion provides off-the-shelf motion control devices and custom solutions based on their EZStepper and EZServo motor driver technology. Their servo motor controllers and brushless DC motor controllers feature quadrature encoder feedback, and are

The EZQuad Servo will drive 4 motors at 2.5 Amps each with a setting of move current m=50 %. However, with careful selection of motors and/or improved cooling and/or low move time duty cycle, it is possible to run motors at 5 Amps at m=100%. See Command Set for details.

programmable to allow standalone operation. Based in San Jose, California, the company has proven leadership in miniature motion control, with a full line of intelligent driver/controllers.

Command Set for details.

The Commands are intuitive and simple. For example, the command A10000 will move the servo motor to Absolute position 10000. (This communications protocol is compatible with devices that use the Cavro DT or OEM protocol.)

All Motion, Inc. 30097 Ahern Avenue

The EZQuad Servo is also capable of standalone operation with no connection to a PC. It can be set to execute a preset string of commands upon power up (i.e., only power is required in this mode). The Commands include nested loops and execution halt pending a switch closure, which is useful in stand-alone applications. The EZQuad Servo Motor Controller will typically work with any motor that is 3” or smaller (size23 or smaller). Starter Kits enable a first time user to make Servo Motors move intelligently in less than half an hour.

Union City, California 94587 Sales Office - 510.471.4000 Technical Support - 408.460.1345 Fax - 408.358.4781 Email - support@allmotion.com www.allmotion.com

VOTE

ONLINE

medicaldesignandoutsourcing.com/leadership Voting for this company will identify it as a leader in the medical technology industry.

www.medicaldesignandoutsourcing.com

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Medical Design & Outsourcing 101

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LEADERSHIP IN MEDICAL TECHNOLOGY

2018

Atlas Vac is the industry standard recognized for technical excellence in the design and manufacture of medical device tray sealers used in cleanroom production. Their knowledgeable staff is comprised totally of engineers and technicians who know their product and your issues when it comes to tray sealing. Atlas Vac is the only manufacturer worldwide offering an All Electric Tray sealer for extreme accuracy, Light Curtain Safety Systems, UDI barcode input and audit trail data, Direct Force Sensing

Atlas Vac Machine’s core expertise is the design and manufacture of tray sealing equipment for medical device packaging clean room applications. Whether you require a tray sealer, tooling nests or field service, the engineers and technicians at Atlas Vac Machine are considered some of the most knowledgeable in the industry.

for digital down-force readings, Electric Shuttle Technology for ultra-smooth movement as well as the heaviest cross

Atlas Vac sealers are available with: Direct Down-Force Measurement, Auto Electric Shuttle technology for ultrasmooth movement; calibration ports for all parameter readings; heaviest cross section heater design for even heat distribution; and anodized single-piece CNC precision tooling nests with molded gaskets. All Atlas Vac sealers are PLC controlled for correct validation of processes.

section heater design for even heat distribution and anodized single piece CNC precision tooling nests.

An option for increasing production while reducing repetitive motion issues, Category 3 Light Curtains (OSHA or ISO13849-1 Cat 3 compliant) are available across the entire product line for hands free sealer operation and included standard on the Model 18:30S All Electric Sealer. Atlas Vac Machine, LLC

In addition to standard pneumatic units, Atlas Vac offers an All Electric Model medical device tray sealer. The All Electric Model 1830S provides supreme down-force control unmatched by any other pneumatic sealer. Precision sealing forces are repeatable to the tightest tolerance of any tray sealer available.

9150 Reading Rd. Cincinnati, OH 45215 www.atlasvac.com

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For 2017, with UDI requirements in mind, Atlas Vac has taken the next step to include as a standard feature Data Logging for a complete Audit Trail of not only the dynamic sealing cycle data but also Operator ID’s & PW, sign-ins, PW changes, recipe changes, alarms, date, time and odometer reading all on a new standard 10” color touch screen. Entry by bar code recipe input, tool ID matching and UDI input for lot tracking is also a standard feature.

www.medicaldesignandoutsourcing.com

1/25/18 5:48 PM

LEADERSHIP IN MEDICAL TECHNOLOGY

2018

If you need a trusted outsourcing partner for medical device and pharmaceutical contract manufacturing, turn to B. Braun’s OEM Division — a division of one of the world’s leading health care companies. Whether you are looking for a solution, medical device, fluid administration set, custom kit or individual components, we can provide the products and capabilities to meet your needs. Our dedicated project management teams have the expertise to turn your ideas into reality.

B. Braun OEM Division B. Braun Medical Inc.

For more than 175 years, B. Braun has worked to improve the health of people. With thousands of pioneering achievements in the medical field, the privately owned company remains at the forefront of medical innovation. The OEM Division operation has been part of B. Braun for over 30 years.

824 Twelfth Avenue Bethlehem, PA 18018 1.866.8.BBRAUN (1.866.822.7286) us.bbraunoem.com

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Guided by our Sharing Expertise® philosophy, B. Braun leads the way in developing infusion therapy and pain management products and services that meet the highest standards for quality, safety, sustainability and efficiency.

Every day, 56,000 B. Braun employees worldwide share their expertise with colleagues and customers to enhance safety for patients, doctors and nurses, and to improve working processes in hospitals and medical practices. B. Braun Medical Inc. (B.Braun) has global headquarters in Melsungen, Germany and operations in 64 countries. In the U.S., B.Braun’s corporate headquarters is located in Bethlehem, Pennsylvania with primary manufacturing facilities in Allentown, Pennsylvania and Irvine, California.

medicaldesignandoutsourcing.com/leadership Voting for this company will identify it as a leader in the medical technology industry.

www.medicaldesignandoutsourcing.com

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LEADERSHIP IN MEDICAL TECHNOLOGY

2018

Innovation Through Engineering Collaboration At Bal Seal Engineering, we create custom sealing, connecting, conducting and EMI/ RFI shielding solutions that improve the performance and reliability of the equipment you design and manufacture. For nearly 60 years, we’ve helped some of the biggest names in worldwide industry gain a competitive edge. And in many cases, we’ve helped to develop breakthroughs and shape industry standards along the way. Our collaborative engineering approach enables us to forge “innovation partnerships” with engineers like you who want to make their products stronger, smaller, faster, lighter or more functional.

Custom components that drive tomorrow’s technologies®.

Solutions for Every Challenge:

· Bal Spring

canted coil springs for mechanical connecting, (latching, locking, holding) electrical conducting, EMI/RFI shielding, and thermal management ®

· Bal Seal

spring-energized seals for rotary, reciprocating, oscillating, static, and face sealing ®

· Bal Contact

electrical contacts for conducting of electricity/signal in industrial and medical equipment

Our Bal Seal® spring-energized seals are protecting NASA’s Curiosity rover from extreme conditions on the surface of Mars. Our Bal Spring® canted coil springs are making critical connections in today’s most advanced electric and hybrid vehicle platforms. And our Bal Contact® electrical contacts are helping designers of active medical implantables more efficiently manage the rhythm of the human heart.

In early development or existing product improvement stages, we combine our proven core products with application engineering, precision manufacturing, and material science expertise to produce solutions that break barriers.

Bal Seal Engineering, Inc. 19650 Pauling Foothill Ranch, California 92610 www.balseal.com

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www.medicaldesignandoutsourcing.com

1/25/18 5:52 PM

LEADERSHIP IN MEDICAL TECHNOLOGY

2018

SOLVE ALL OF YOUR MOTION CONTROL NEEDS

Bansbach Easylift® Motion Controls Bansbach Easylift® is a world leading manufacturer of motion control products since 1919. Our uniquely engineered products focus on product performance to provide the highest lifecycles in the most challenging environments. We provide a wide array of motion controls which allows you to streamline your engineering and procurement. Our products include: gas springs, electric linear actuators, linear/rotary dampers, disk dampers, vane

Bansbach Easylift® is known for quality.

dampers, large industrial shock absorbers, mini shock absorbers, wire rope isolators,

We are EASA Form1 Part 21g certified for Aerospace applications. All of our products are maintenance-free, self-contained and provide safe motion for a broad range of applications.

micro-hydraulics and linear actuators. Industries served are: Aerospace, Medical, Defense and Industrial.

Advantages of Bansbach Gas Springs: Highest corrosion resistance achieved through powder coated cylinders and CeramPro® treated piston rod surfaces.

Powdercoated cylinders provide an extremely durable finish and are much better than our competitors’ painted finish.

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Minimal friction for the production of lowest extension forces.

Customer Service - Our dedicated staff is

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Best lifecycles.

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Protection against vibration and light side forces.

Melbourne, FL 32904 www.bansbach.com

1.800.225.4498

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from the Bansbach development laboratory. CeramPro® offers maximum rust and corrosion resistance of the piston rod. This special surface treatment provides an extremely smooth surface with excellent operating characteristics which provide superior protection against abrasion to the rod.

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Bansbach Easylift® 50 West Drive

Our CeramPro® Piston rod surface treatment is a new innovative development

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Integrated grease chamber.

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Low break away forces.

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Installation and storage in any position.

our best asset. When you call you will speak directly to an engineer who will provide you with everything you need to design the best solution for your application.

We have locations around the globe including the U.S., Europe, Singapore and Japan.

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www.medicaldesignandoutsourcing.com

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LEADERSHIP IN MEDICAL TECHNOLOGY

2018

BAYCABLE Interconnect Solutions Our specialty is working with clients to design application specific solutions to complex interconnection problems that are solved by our capability to manufacture custom cable, coil cords, molded cable assemblies and electromechanical sub-assemblies in Fremont, California and Sonora, Mexico. SPECIALTIES: • Silicone and Thermoplastic Molding & Extrusion • In House Cable Manufacturing • In House Mold Tooling • Very Fine Wire Termination

BAYCABLE is vertically integrated and can offer a wide range of manufacturing capabilities including custom cable constructions, full turnkey cable assembly and molding services, component customization, specialized testing, and in house mold tool manufacturing. BAYCABLE delivers unparalleled engineering expertise “an integrated solutions partner” that can help skillfully create the optimal interconnect system for your application.

• Custom Connector Design MARKETS:

Early design collaboration with our Silicon Valley based engineering group takes you from concept through pre-production into the initial production runs quickly, and we provide medium to higher volume production by transferring production to our plant in Sonora, Mexico. Both manufacturing locations are ISO Registered.

• Medical • Industrial • Automotive • Audio • Defense

BAYCABLE has a long legacy of delivering high performance reliable interconnect solutions to our customers.

Bay Associates Wire Technologies 46840 Lakeview Blvd Fremont, CA 94538 510-933-3800 bayinfo@baycable.com www.baycable.com

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1/25/18 5:53 PM

2018

LEADERSHIP IN MEDICAL TECHNOLOGY Expert

About binder USA binder USA is part of the global binder

We are not only experts in manufacturing of a variety of industry standard and binder specific circular connectors including built in and cable connectors for medical technology. We are also experts in the customized development, design and automated manufacturing of connections according to customer specifications.

Group, a family-owned enterprise and one of the market leaders in the area of circular connectors. A combined total of 1,400 employees work at our headquarters in Neckarsulm and subsidiaries in the United States, Singapore, China, Sweden, France, England, and the Netherlands.

Large product selection Our selection of circular connectors ranges from miniature connectors to multi-pin power connectors. With a range of 5,000 catalog items, 3,000 designs and 500 customized parts, we are able to supply exactly the suitable product for nearly every industrial electronics application.

binder USA 3903 Calle Tecate Camarillo, California 93012 805.437.9925 binder-connector.us

Reliability, quality, responsibility binder is a traditional company characterized by values that stand for absolute reliability. Our daily operations are thereby governed by quality and backed by UL listed products and various ISO certifications, including ISO 13485 for medical applications. We take responsibility for our employees and respect the environmental resources.

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LEADERSHIP IN MEDICAL TECHNOLOGY As technology continues to demand precision and smaller tolerances, engineers are turning to Bird Precision microdrilled inserts, fittings and filter components. We offer a high value solution in nozzle, restrictor and orifice applications, all designed with Bird Precision accuracy. If you’re involved in product design and production, you’re always on the lookout for ways to improve manufacture, performance and quality in your products. Now is the time to investigate the wide range of accuracy and workmanship Bird Precision continues to supply for micro miniature components and assemblies. Bird’s early experience in aircraft instrument bearings & micro assembly techniques for timing mechanisms has prepared us well for the critically demanding needs of modern instrumentation.

Bird sapphire and ruby orifices are scientifically designed to insure repeatable flow control of both liquids and gas. Ruby and sapphire materials are used exclusively because of their durable material characteristics. This economical man made crystal has amazing credentials 1. Extreme hardness, 9 mohs scale, next to diamond 2. Practically chemically inert, highly resistant to most alkalis and acids

2018

3. Extreme abrasion resistance, 5 x that of tungsten carbides. 4. Does not outgas, zero porosity 5. Non-thrombogenic, for medical applications 6. Excellent insulator 7. High temperature material, 2000 degree C melting point. 8. No flash points, extensively used in oxygen environments. With such impressive material characteristics, the designer can design with confidence in even the harsh environmental applications

With the development of new laser drilling and wire lapping techniques, we have transitioned into micro miniature orifices, nozzles, filters, and connectors. We offer a whole line of micron level standard products ranging in size from 10 microns (.0004”) up through .080”. Flow rates from under 1cc/min are available. Bird Precision maintains an impeccable reputation for precision component fabrications. A full complement of Swiss CNC, production assembly and specialized secondary machines provide a vertical in house capability, enabling fast prototype and production delivery. Join us as one of our valued customers. We will work together to improve your product through a mutual exchange of ideas, service and quality.

those most demanding applications.

Bird Precision offers a unique series of laser drilled, wire lapped Ruby and Sapphire orifices.

It is this precise methodology and attention to detail that distinguishes us from all other manufacturing methods, yielding production quantities of highly precise flows at reasonable prices.

This unique wire lapping method insures that our orifices are round and highly polished. . This method also removes all possibilities of burrs or loose particles in the orifice area. The orifices are all lapped both sides to impart a very uniform sharp edge to our orifices. It is this edge along with the roundness and high polish that yields a highly repeatable Cd value (Coefficient of Discharge).

One Spruce Street Waltham, MA 02454 800.454.7369 Fax: 800.370.6308

Further the wire lapping method guarantees hole tolerance .0002” or less as standard.

sales@birdprecision.com birdprecision.com

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Bird’s unique manufacturing process

Our orifices and micron level filters are conveniently packaged in a huge variety of stainless, plastic and brass fittings, inserts and connectors. Bird Precision continues to focus on putting orifices and filters where you need them. We also offer a host of standard Swagelok, Smc, Parker and Value Plastics, retrofits

Bird Precision has recently introduced our new Golden Orifices with .0001” total spread for

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1/25/18 5:57 PM

LEADERSHIP IN MEDICAL TECHNOLOGY

Winner of 2016 Leadership in Medical Technology

Emerson leads the medical global assembly

Unmatched Technology, Service and Support for Medical Assembly

technology market offering Branson technology of advanced plastics joining, ultrasonic metal welding and precision

Emerson is uniquely qualified to offer a “process neutral” approach, due to the extensive Branson technology expertise. Employing a “process neutral” approach to application development ensures that customers receive the best solution to address their product specification, regulatory and budgetary needs.

cleaning systems. Our in-depth medical industry experience insures customers receive the most robust manufacturing solution to address product specifications, regulatory, budgetary needs, while providing competitive advantages in product design and application development for benchtop or automated processes. Part of Emerson since 1984, the Branson brand is now aligned with Emerson Automation Solutions, committed to radically improving our customers’ performance with measureable results.

www.bransonultrasonics.com

Branson 2000Xc Ultrasonic Welding System is the latest offering in our ultrasonic portfolio, delivering consistent and precise, high-quality welds, fast cycle times, and the process controls needs of today’s benchtop and automated medicalmanufacturing environments. The 2000Xc assists with global compliance, traceability and security needs, including regulation FDA 21CFR Part 11.

Americas: 203.796.0400 Europe: 49.6074.497.0 Asia: 86.21.3781.0588

Branson 41 Eagle Road Danbury, CT 06810 203.796.0400 info@bransonultrasonics.com

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2018

Branson Laser Welding Systems feature our patented Simultaneous ThroughTransmission Infrared (STTIr) technology to provide ultrafast, particulate-free welds that are precise, visible, have uniform collapse, and are gentle on delicate parts. Laser welding provides the freedom to design parts with complex, contoured shapes for superior aesthetics, maximum product integrity, and enhanced production efficiency. The Branson innovative tool map provides unmatched energy control along the weld channel.

Request the case study to learn how Branson 2000Xc Ultrasonic Welder helped EMD Millipore seal a delicate microfiltration membrane in a critical medical device.

Branson Ultrasonic Precision Cleaning Systems provide aqueous and solvent solutions ranging from small benchtop to industrial, automated solutions.

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www.medicaldesignandoutsourcing.com

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LEADERSHIP IN MEDICAL TECHNOLOGY

2018

Cadence, Inc. is a single source contract manufacturing partner for medical device and diagnostics companies worldwide. Cadence provides end-to-end product realization solutions focused on best-inclass total value. Cadence employs 500 people with headquarters in Staunton, VA and other locations in Pennsylvania, Rhode Island, and Wisconsin. Major Markets Served: • Analytical Science • Cardiology • Drug Delivery • Point of Care • IVD • Fluid Delivery • Interventional Therapy

What makes Cadence different from other companies? Cadence is all about improving product performance and economics. We help develop new products that other cannot, build processes that other will not, and deliver outcomes that simply make the world work better. We use integrated and advanced technologies to make finished devices as a single, turnkey manufacturing partner for medical OEMs. Cadence offers complete services that range from initial design through manufacturing and full supply chain management for single use and disposable medical devices.

• Neurology • Biopsy • Dianostics • Endoscopy • Pharmaceutical

Metals Expertise: • Advanced Welding Lab™ • Micro Machining & Swiss Machining • Laser Welding, Cutting, & Marking • Tube Fabrication including LaserSwiss • Sharps – Specialty Blades & Needles • Precision Metal Stamping • Microstamping & Multi-slide Stamping • EDM – Wire, Ram, & Sink • Nitinol Shape Setting • Custom Automation • IncisionLab™

Plastics Expertise:

• Design Services

• Orthopedics

• Rapid Prototyping

• 3D Printing

• Minimally Invasive Surgery

• Certified Cleanroom Manufacturing

• PEEK Machining

• Opthalmology

• Finished Device Assembly

• Cleanroom Molding

• Complete Supply Chain Management

• Engineered Resins Expertise

• Final Packaging and Labeling

• Sharps Molding & Handling

• Sterilization Management

• Reel-to-Reel Molding

• General Surgery

• Plastic Injection Molding We also provide a very broad set of core

• Insert Molding

capabilities that are competitive and

9 Technology Drive

• Micro Molding

differentiated in the marketplace. Unlike

Staunton, VA 24401

• PEEK Molding

most contract manufacturers, we also have

Cadence, Inc.

sales@cadenceinc.com

significant metals and plastics expertise;

Tel: 540.248.2200

making new products a reality.

Fax: 540.248.4400 cadenceinc.com

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www.medicaldesignandoutsourcing.com

1/25/18 6:04 PM

LEADERSHIP IN MEDICAL TECHNOLOGY

2018

Carlisle Medical Technologies, a business division of Carlisle Interconnect Technologies, specializes in designing and manufacturing cable assemblies and interconnect solutions for the medical market. The company’s focus is within the following areas: Electrosurgical, Interventional, Patient Monitoring, Surgical, Ultrasound and Medical Suites Interconnects. In addition to the vast product breadth, the company provides their customers a higher level of support by offering engineering and qualification services for the medical industry.

Carlisle Medical Technologies: Driven to Solve

For more information visit https://www. carlisleit.com/markets/medical-technology.

Carlisle Medical Technologies is an industry leader in the design and manufacturer of high-performance interconnect solutions for the medical device market. With a global footprint, an award-winning team of engineering experts, and extensive manufacturing capabilities, the company is uniquely able to design, build, test, qualify, and deliver solutions with unparallelled responsiveness and speed-to-market.

A new space for new challenges Today’s medical device market is booming, and Carlisle Medical Technologies has made huge contributions throughout its more than 200 medical OEM partnerships. The company’s pristine new 400,000-square-foot manufacturing space in Dongguan, China, produces everything from molded components to fully-functional assemblies with a constant eye toward excellence. It features:

Carlisle Medical Technologies 100 Tensolite Drive St. Augustine, FL 32092 Unites States +1 (800) 458-9960 +1 (904) 829-5600

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Designated clean spaces: Two manufacturing spaces are built to ISO Class 8 standards, and a sterile packaging area built to ISO Class 7 standards.

www.carlisleit.com/markets/medicaltechnology

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Segmented production lines: Strategic alignment of market segment lines (ex. Surgical, Electrosurgical, Patient Monitoring, etc.) designed for maximum efficiency.

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Innovative equipment: State-of-the-art product qualification and incoming inspection equipment.

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Cost-saving automation: Continuous investment is automation, both in designfor-automation engineering capabilities as well automated production/process equipment.

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Carlisle Medical Technologies works in partnership with its customers throughout the development process, bringing an incomparable breadth and depth of expertise, materials, and solutions to solve your most complex challenges. Learn more at; https:// www.carlisleit.com/markets/medical-technology.

www.medicaldesignandoutsourcing.com

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LEADERSHIP IN MEDICAL TECHNOLOGY For more than 40 years, CGI has enabled design excellence in motion control across a range of industrial applications. The people at CGI have demonstrated a deep commitment to providing the latest technology, innovative product, and unrivaled customer service to earn the reputation as one of the most trusted experts in the business. CGI’s engineering footprint is seen in a range of industries including medical, aerospace, robotic, semiconductor, machine tool, packaging, food/beverage, textile, material handling, telecommunications and specialty machine design. You will find CGI components integrated into industrial robotics and machine automation systems including applications for artificial hearts, robotic surgical systems, laser eye surgical equipment, drills and attachments used for orthopedic surgery. CGI components have played a role in the repair of the Hubble telescope. Astronauts used a CGI precision-crafted wrench to repair the telescope that allows scientist to peer into the deepest recesses of space. CGI technology is also used on the spectacular Bellagio Resort dancing fountains and other hotels in Dubai and China also use CGI technology in their fountains.

2018

Advanced Products for Medical Applications Our core business is manufacturing precision motion control solutions. CGI’s diverse customer base and wide range of applications have earned us a reputation for quality, reliability, and flexibility. Our leadership in the market features a careful blend of cutting edge technology and renowned reliability. With CGI you can count on us to provide the highest levels of manufacturing acumen and expertise while delivering it with the customer service you deserve. Our goal is to be the most trusted partner in your supply chain. Whether it’s an improvement on a current design or groundbreaking new designs, CGI has the know-how and team to enable design excellence. Our team is renowned for being able to provide complex precision- machined component parts of high quality and hold tolerances as tight as 2.5 microns (.0001”). These parts are machined from diverse metals, and involve a variety of hardness, surface treatment, heat-treating and plating requirements. One of the distinct competitive advantages we are able to provide our customers with is an engineering team that is knowledgeable and easy to work with.

CGI, Inc. 3400 Arrowhead Drive Carson City, NV 89706

When comparing the manufacturing capabilities offered by CGI with those of our competitors the clear difference is in the commitment have to exceeding expectations. This commitment can be seen by our customers each day through our investment in technology, our attention to precision and the high level of service we provide.

775.882.3422 Toll free: 1.800.568.GEAR (4327) F: 775-882-9599 cgimotion.com

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www.medicaldesignandoutsourcing.com

1/25/18 6:05 PM

LEADERSHIP IN MEDICAL TECHNOLOGY

2018

Chieftek Precision Co., Ltd. (cpc) is a manufacturer of complete linear motion mechatronic solutions, including profile linear guides, linear motors, compact linear stages, servo drivers, xyz tables, and gantry systems for automation machine tools and robotic industries. With distribution centers in California, cpc provides rapid and firstrate service to American customers. offering German quality with Taiwanese flexibility, prompt delivery and competitive pricing.

Chieftek Precision Co., Ltd. (cpc) includes professional managers, engineers and technicians who devote their efforts to the R&D and manufacture of high-quality linear motion components. Beginning with its first product—MR series linear guides for precision measurement and inspection— cpc soon expanded to offer general-purpose ARC guides for automated machine tools, HRC and ERC guides for heavily loaded axes, and RR guides with roller bearings. After intensive R&D, cpc then began offering P series ironless linear motors (with the highest thrust density and efficiency of their kind). Next came compact C series iron-core linear motors that deliver high thrust with low cogging. For users familiar with tradition belt or ballscrew-driven systems, cpc also packages its linear motors into CLS/CLMS Compact Linear Stages and subsystems. These integrate a linear motor, guide, and positioning in a turnkey package.

Chieftek Precision Co., Ltd (cpc)

As linear motors cannot operate without a control system, today cpc also offers the TC1 series servo drive. The TC1 series features high power density, easy-to-use autotuning and advanced features to let machine builders create breakthrough products.

www.chieftek.com

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2016

CICOIL

A was D Vfounded E R inT1956 I with S Ean M E N Cicoil innovative new product for the early mainframe computers - the flat ribbon cable. The ribbon cable allowed companies like IBM to replace bulky, stiff round cables with sleek, flexible ribbon cables. Named ribbon cables, variations of these flat cables still used in most Cicoil wasare founded in today 1956 with an Cicoil wasprinters, founded in 1956 with an computers, and many innovative new product for the electronic early innovative new product for early mainframe devices. mainframe computers - the flat ribbon computers - the flat ribbon cable. Ribbon cable. The ribbon cable allowed compacable allowed companies like IBM to replace Cicoil Today – Innovating nies like IBM to replace bulky, stiff round bulky, stiff round cables with a sleek, ultracables with sleek, flexible ribbon cables. for the Future flexible alternative. Variations of ribbon Named ribbon cables, variations Cicoil continues its proud history ofof these cables arewith stillstill used today in most computers, flat cables are used today in most innovation, the company’s autocomputers, printers, and many electronic printers, and many electronic and mated, state-of-the-art facility indevices, Valencia, devices. California. By implementing latest have evolved into the Flat the Cables of lean today manufacturing production techniques, that can contain almost any combination of Cicoil continues design and manufacCicoil Todayand – to Innovating conductors fluid tubing. ture the highest for the Future quality products, with fast, responsive lead–times for our customCicoilcontinues Today Innovating Cicoil its proud history of ers. Our efforts have earned numerous for the Future innovation, with the company’s autocustomer and industry awards forValencia, quality, mated, facility in Cicoil state-of-the-art continues its proud history of innovation, delivery, and continuous improvement, California. By implementing the latest lean with the company’s automated, state-of-the-art and our continued R&D hastechniques, resulted in manufacturing production facility in Valencia, California. By implementing multiple US and worldwide patents. Cicoil continues to design and manufacthe latest lean manufacturing production ture the highest quality products, with fast, techniques, Cicoil continues to design and Cicoil Corporation responsive lead times for our custommanufacture the highest quality products, with 24960 Avenue ers. Our effortsTibbitts have earned numerous fast, responsive lead times for for ourquality, customers. Valencia, CA 91355, USA customer and industry awards Our efforts earned improvement, numerous customer Phone: 661-295-1295 delivery, andhave continuous andour industry awards forhas quality, delivery, Fax: 661-295-0813 and continued R&D resulted in and continuous improvement, our continued www.cicoil.com multiple US and worldwide and patents. R&D has resulted in multiple US Visit Cicoil.com topatents. learn more, and worldwide Cicoil Corporation or call (661) 295-1295 24960 Avenue Tibbittsto speak directly toValencia, an Application Engineer. CA 91355, USA Phone: 661-295-1295 Cicoil Corporation Fax: 661-295-0813 www.cicoil.com 24960 Avenue Tibbitts

Leadership in Engineering

The Future of Cabling is Here

2018

LEADERSHIP IN M EDICAL TECHNOLOGY Combine power, signal, video, air & liquid in a crystal-clear flat cable.

CICOIL

Valencia, CA 91355, USA

Visit Cicoil.com to learn more, Phone: 661-295-1295 or call (661) 295-1295 to speak directly 661-295-0813 to an ApplicationFax: Engineer. vote online

Visit Cicoil.com to learn more, www.designworldonline.com/leadership or call (661) 295-1295 to speak directly Nominate engineering leadership for a person or to an Application Engineer. inventor, engineering leadership by a specific department, or an overall company accomplishment.

January 2016

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Leadership in Engineer

Leadership

CICOIL

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Online •The Ultra f!exible: of millions of flex cycles in the tightest bend Drag &Custom Drop FlatFlat Future of Tens Cabling is Here Cable Configurator radius applications Cable Configurator Design your own cable power, signal,Micro video,size air to & liquid inwide a crystal-clear flatfrom cable. •Combine Unlimited variation: 400mm cables, wires in just minutes! Over 200 4 to high-flex 44 gauge,flat also including fiberFuture optics,oftubing, or coax, so you Cicoil cables are the Cabling. Our patented million potential configucan gettechnology the exact cable you need extrusion produces the most high performance flat rations. Drag and drop •cables Extreme Environments: Our cables perform from -65°C to available with the superior attributes you’re looking for: simplicity. The Future of Cabling is Here +260°C, and under exposure to water, steam, chemicals, and oils • Ultra f!exible: Tens of millions of flex cycles in the tightest bend Combine power, signal, video, air & liquid in a crystal-clear flat cable. Submit your configuration radius applications Design your own cable Built-In Flexibility to receive a no-obligation Cicoil’s patented extrusion produces mostwires high from • Unlimited variation: Microtechnology size to 400mm widethe cables, in just minutes! Over 200 In addition to the strong,flexible cable jacketing, every Cicoil cable quote and final drawflat cables available with the superior attributes 4performance to 44 gauge, also including fiber optics, tubing, or coax, soyou’re you million potential configuincorporates finely stranded, ultra-flexible wire conductors. Conductors ing. Order and receive looking can get for: the exact cable you need rations. Drag and drop2 and shields are also specially heat-treated and plated to maximize their your cable in less than • Ultra Flexible: Tens of Our millions of flex cyclesfrom in the tightest • Extreme Environments: cables perform -65°C to bend simplicity. flexibility, while providing extremely long flex life in the most demanding weeks. radiusand applications +260°C, under exposure to water, steam, chemicals, and oils applications. Cicoil flat cables are rated for over ten million cycles, and EZ-Flexx™: Flat Cable • Unlimited Variation:for Micro size to of 400mm wide cables,cycles wires Submit your configuration our cables have performed hundreds millions of flexing Performance, Round from 4 to 44 gauge, also including fiber optics, tubing, or coax, so Built-In Flexibility to receive a no-obligation in some of the most demanding robotic, continually flexing equipment Cable Simplicity you can getstrong,flexible the exact cable you jacketing, need In addition to the cable every Cicoil cable quote and final drawapplications. incorporates finely stranded, ultra-flexible conductors. Conductors • Extreme Environments: Our cableswire perform from -65°C to ing. Order and receive and shields are and alsounder specially heat-treated and plated to maximize their +260°C, exposure to water, steam, chemicals, and oils your cable in less than 2 Standard or Custom Cables flexibility, while providing extremely long flex life in the most demanding weeks. Cicoil’s patented extrusion makes custom cables so you • Improvement Overprocess Round Cables: Flat cables use easy, less space applications. Cicoil flat cables are rated formore over flexible, ten million cycles, and for denser packaging, are inherently and organize can quickly get the exact cable you want. Try our Online Configurator, NEW EZ-Flexx™ our cables have performed for hundreds ofties, millions of flexing cycles wiring need external tracks where you canwithout designthe your ownfor cable in minutes and or getconduits. an immediate Cable Design in some of the most demanding robotic, continually flexing equipment drawing and quote! • Easy to Separate Built-In Flexibility applications. and Strip Conductors Check out cable our many standardfinely cables and assemblies, all wire available from Cicoil incorporates stranded, ultra-flexible • Lighter and More conductors. Conductors and shields are specially heat-treated and stock for immediate delivery. Standard or Custom Cables Flexible plated to maximize their flexibility. Cicoil flat cables are rated for over Cicoil’s patented extrusion process makes custom cables easy, so you ten million cycles, and our cables have performed for hundreds of Complete Cable Assemblies can quickly get the exact cable you want. Try our Online Configurator, NEW EZ-Flexx™ millions of flexing cycles in the most demanding robotic, continually Cicoil can provide complete cable assemblies, with anyget connectors Extreme Environments where you can design your own cable in minutes and an immediate Cable Design flexing equipment applications. Capabilities required by the customer. Every cable assembly is 100% tested by our A Dand V quote! E R T I S E M E N T drawing • Easy to Separate automated testorequipment, so reliability and performance is guaranteed. Standard Custom Cables and Strip Conductors Check out our many standard cables and assemblies, all available from Our award-winning system is certified ISO 9001 standards, inCicoil’s patentedquality extrusion process makes to custom cables easy, • Lighter and More stock for immediate delivery. cluding the can strict AS9100 specification. cable assemso you quickly getaerospace the exact cable you want.Cicoil Try our Online Flexible you shuttle, can design your ownmissiles, cable in and minutes and bliesConfigurator, are used on where the space supersonic industrial Complete Cable Assemblies get an and quote!applications possible. So you robotics, in immediate some of thedrawing most demanding Cicoil was foundedcomplete in 1956 withcable an Cicoil can provide assemblies, with any Sconnectors can rest assured that your cable assembly same A D V will E receive R T Ithe E M dedicaE N T Check out our many standard innovative new product for the early cables and assemblies, all available required by the customer. Every cable assembly is 100% tested by our tion mainframe and ensuring reliable, high performance operation. fromcare, stock for immediate delivery. computers - the flat ribbon Drag & Drop F The Future of Cabling is Here automated equipment, reliability and performance is guaranteed. cable. Thetest ribbon cable allowedso compaCable Configu likeCables IBM to replace bulky, system stiff roundis certified Ournies award-winning quality to ISO 9001signal, standards, in-& liquid in a crystal-clear flat cable. Combine power, video, air Data cables with sleek, flexible ribbon cables. Yes! the Cicoil hasAS9100 you covered for video and highhigh-flex speed data cluding strict aerospace specification. Cicoilflat cable assemCicoil cables are the Future of Cabling. Our patented Named ribbon cables, variations of these transmission 5e,in shuttle, Cat USB 3.0, Camera Link, Coax, and extrusion technology produces the most high performance flat blies are used onwith theCat space missiles, and industrial flat cables are still used today most6A, supersonic Cicoil founded in 1956 withthe an superior cables available with attributes you’re looking for: Controlled Impedance flat cables in was bulk and finished assemblies. computers, printers, electronic robotics, in some ofand themany most demanding applications possible. So you innovative new product for the early devices. •will Ultra f!exible: Tens of millions of flex cycles in the tightest bend can rest assured that your cable assembly receive same dedicawww.designworldonline.com mainframe computers - the the flat ribbon Complete Cable Assemblies The Future of Cabling is Here radius applications Design your ow cable. The ribbon cable allowed compationCicoil and Today care, –ensuring reliable, high performance operation. Innovating Cicoil can provide complete cable assemblies, with any connectors • Unlimited variation: Micro size to 400mm wide cables, wires from nies like IBM to replace bulky, stiff round in just in minutes Combine power, signal, video, air & liquid a crys for the Future 4 toflexible 44 is gauge, also including required by the customer. Every cable assembly 100% tested by fiber optics, tubing, or coax, so you cables with sleek, ribbon cables. million potentia Cicoil continues its proud history of Cicoil high-flex flat cables are the Future of Cabli can get the exact cable you need Named ribbon cables, variations of these our automated test equipment. Our award-winning quality system rations. Drag a innovation, with the company’s autoextrusion technology the most high perform • still Extreme Environments: Our cables perform from -65°Cproduces to flat cables are used today in most simplicity. is certified to ISO 9001 standards, including the strict AS9100 mated, state-of-the-art facility in Valencia, cables available with the superior computers, printers, andand many electronic +260°C, under exposure to water, steam, chemicals, and oils attributes you’re lo California. By implementing the latest lean aerospace specification. devices.

CICOIL

www.cicoil.com

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Cicoil high-flex flat cables are the Future of Cabling. Our patented extrusion technology produces the most high performance flat cables available with the superior attributes you’re looking for:

Drag & Drop Flat Cable Configurator

1 • 2018

• Ultra f!exible: Tens of millions of flex cycles in co th manufacturing production techniques, Submit your Built-In Flexibility Cicoil continues to design and manufacradius applications to receive a no www.designworldonline.com Cicoil Today – Innovating In addition to the strong,flexible cable •jacketing, every Cicoil cable ture the highest quality products, with fast, Unlimited variation: Micro size toquote 400mm wide and fina responsive lead times for our custom- for the Future incorporates finely stranded, ultra-flexible 4wire conductors. Conductors to 44 gauge, also including fibering. optics, tubing Order and its proud of ers. Our efforts have earned numerousCicoil continues and shields arehistory also specially heat-treatedcan andget plated to maximize their the exact cable you need your cable in l innovation, flexibility, with the company’s auto- extremely long flex life in the most demanding customer and industry awards for quality, while providing • Extreme Environments: Our cables perform fro weeks. facility in Valencia, delivery, and continuous improvement,mated, state-of-the-art applications. Cicoil flat cables are rated for over tenand million cycles, and to water, steam, ch +260°C, under exposure California. By implementing the latest lean and our continued R&D has resulted in our cables have performed for hundreds of millions of flexing cycles multiple US and worldwide patents. manufacturing production techniques, in some of the most demanding robotic, continually flexing equipment Built-In Flexibility Cicoil continues to design and manufacapplications. In addition to the strong,flexible cable jacketing, eve ture the highest quality products, with fast, Cicoil Corporation www.medicaldesignandoutsourcing.com responsive lead times for our customincorporates finely stranded, ultra-flexible wire cond 24960 Avenue Tibbitts Standard or Custom Cables ers. Our efforts have earned numerous and shields are also specially heat-treated and plate Valencia, CA 91355, USA customer and industry awards for quality, Cicoil’s patented extrusion process makes custom cables easy,extremely so you long flex life in th flexibility, while providing Phone: 661-295-1295 delivery, and continuous improvement, can quickly get the exact cable you want. Try our Online Fax: 661-295-0813 NEW EZ-Flexx applications. CicoilConfigurator, flat cables are 6:15 rated for over ten 1/25/18 PM and our continued R&Dcan hasdesign resulted in own cableour where you your in minutes and get an immediate www.cicoil.com Cable Designo cables have performed for hundreds of millions multiple US and worldwide patents.

2018

LEADERSHIP IN MEDICAL TECHNOLOGY William L. Clippard, Jr. founded Clippard Instrument Laboratory in 1941. The initial product line consisted of electrical test equipment, magnetic windings, and radio frequency coils. The first miniature pneumatic devices designed and built by Clippard were for use in the manufacture of this equipment. In the early 1950’s, Clippard introduced Minimatic® components as a new product line. The need for miniature pneumatics was so widespread, that the Minimatic line was successful enough to become Clippard’s primary product line.

Precision Flow Control Products & Solutions Web

Visit www.clippard.com to find complete product information, engineering drawings, technical specifications, full color photos, CAD files, order information, literature downloads, helpful calculators, technical assistance, distributor information and more.

Quality

The complete Minimatic line includes over 5,000 standard products. Some of the many products offered include valves, cylinders, fittings, modular components, push buttons, FRLs, electronic manifold cards, circuit analyzers and pre-piped manifold subplates. Special components designed for customer’s OEM applications are also welcomed.

Catalog

Quality remains a primary feature of every product Clippard produces. This is achieved through the excellence in manufacturing practices and craftsmanship that has continued throughout the years. The high standards set by Leonard Clippard, in company relationships with customers, distributors, suppliers and employees continue to be upheld. The company motto, “Quality People, Quality Products”, emphasizes the important role every employee plays in maintaining the company’s reputation. Proudly made in the USA.

Minimatic® is a registered trademark of Clippard Instrument Laboratory, Inc.

Clippard offers a full-line catalog which contains over 5,000 standard products. Call today for a free copy.

Applications

Today, Clippard pneumatic control devices are used virtually everywhere for control, interface, sensing, logic and actuation functions. For medical, analytical, laboratory, diagnostic and other related applications, Clippard manufacturers precision components including oxygen clean, analytical and proportional valves, PTFE isolation and pinch valves, precision regulators, manifolds and more. Custom products and assemblies for specific applications are also welcomed.

Distributors

Clippard

Clippard products are sold through a worldwide distributor network that offers products plus design engineering expertise.

7390 Colerain Avenue Cincinnati, Ohio 45239 877-245-6247 www.clippard.com

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2018

COMSOL is a global provider of simulation

software for product design and research to technical enterprises, research labs, and universities. Its COMSOL Multiphysics® product is an integrated software environment for creating physics-based models and simulation apps. A particular strength is its ability to model multiphysics systems such as the human body and medical devices by accounting for different boundary conditions, material properties, and physics describing physiological mechanisms and medical devices. Electromagnetics, mechanical, acoustic, fluid flow, heat transfer, and chemical phenomena can be included to model ablation systems, hearing aids, stents, hematology analysis, MRI, implantable devices, glucose sensors, ultrasound imaging products, and more. Interfacing tools enable the integration of COMSOL Multiphysics® simulations with all major technical computing and CAD tools to import data and geometries. COMSOL users can convert their models into easy-to-use apps for their design teams, manufacturing departments, test laboratories, and customers throughout the world. Apps are deployed and accessed online through a local installation of the COMSOL Server™ product.

This simulation application runs in a web browser and allows users to calculate the trajectories of platelets and red blood cells in a blood sample as they travel through a filtration device.

Multiphysics simulation of tumor ablation through bioheating. The localized heating is achieved through the insertion of a four-armed electric probe.

COMSOL, Inc. 100 District Avenue Burlington, MA 01803 Phone: +1 781 273 3322 Fax: +1 781 273 6603 E-mail: info@comsol.com www.comsol.com

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Designing a medical device is a company-wide effort. To foster collaboration COMSOL is providing engineers with the tools to optimize a design by taking into account all relevant physics and enable the input of experts from other departments such as manufacturing, physiology, and healthcare compliance through the use of apps. COMSOL Multiphysics® is uniquely positioned to address the modeling of designs such as peristaltic pumps, electrical sensors, piezoelectric valves, and more. The Application Builder in COMSOL Multiphysics® provides design teams with tools to turn detailed multiphysics models into easy-to-use apps. COMSOL Server™ allows worldwide publishing of these apps by hosting them locally and making them readily accessible through the web or COMSOL® Client for Windows®. The adoption of simulation apps makes the workflow streamlined and inclusive. With simulation apps, you do not have to be an expert in numerical simulation to suggest a design iteration based on accurate multiphysics simulation results. www.comsol.com

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www.medicaldesignandoutsourcing.com

1/25/18 6:18 PM

LEADERSHIP IN MEDICAL TECHNOLOGY

2018

Colder Products Company (CPC) is the leading provider of quick disconnect couplings, fittings and connectors for plastic tubing. Our quick connect and disconnect solutions improve the functionality and design of your medical equipment and processes making connections cleaner, faster and safer. Our growing catalog contains over 10,500 fluid connectors—each of which was engineered with thought and purpose.

While CPC quick disconnect couplings are just one small part of a medical device, they play a crucial role. From patient therapy devices to in vitro diagnostics to dialysis, they can improve patient safety, prevent misconnections and increase the overall usability and effectiveness of your medical devices. Our problem-solving team of engineers leverage rigorous design and testing processes, solid modeling capabilities, prototype equipment and an expansive lab to create the highest quality connectors on the market. As such, our couplings are chosen by medical device OEMs around the world for their proven performance in operating rooms, life science labs and home healthcare settings. We’re confident, whether your application calls for non-valved or non-spill, low flow or high flow, reusable or disposable—that our broad range of standard and custom-engineered components can meet your every specification.

CPC – Colder Products Company 1001 Westgate Drive, St. Paul, MN 55114 U.S.A. 800.444.2474 F: 651.645.0091 info@cpcworldwide.com cpcworldwide.com

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LEADERSHIP IN MEDICAL TECHNOLOGY

2018

Data Image is a manufacturer of LCD (Liquid Crystal Display) modules, established in 1997. Currently, we have manufacturing strongholds in Taiwan and China and have a concrete blueprint to expand our core business, LCM manufacturing, in the next five years. Our customers vary in size and industry as well as in the services they require. Today, Data Image offers an array of services to help our customers improve their bottom lines and time to achieve objectives. Data Image is a leader in the engineering of displays because of the history of the upper management of the corporate headquarters, engineering, manufacturing, and sales division. Data Image also strives to be a leader in the display market with innovation, not reactionary change. Data Image also does not focus on one industry, but many. Data Image has been in business now for 20 years. The main reason for our success is the fact that all the current upper management was here at the beginning. This includes the president of Data Image Taiwan, the Data Image engineering manager, the Data Image factory manager in China, and the sales and engineering management in the U.S. office. With this history comes great experience. Data Image has some of the highest quality demands placed on us by our customers and we have learned from these demands and implemented many steps to achieve and exceed these requirements. Data Image management is constantly working with material suppliers to discover new materials to advance our display specifications to answer the call for better technology and improved mechanical abilities. Data Image grew from a simple STN module producer to become a leading manufacturer in the TFT module market to include optical bonding and capacitive touch panels.

Data Image 4202 Metric Drive Winter Park, FL 32792

Data Image has been involved with many markets that have required displays for human interface. In the beginning pagers, printers, alarm panels to now automotive, medical and marine industry requirements.

407-478-4064 www.dataimagelcd.com

Leadership, innovation and broad market makes Data Image a leader.

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www.medicaldesignandoutsourcing.com

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LEADERSHIP IN MEDICAL TECHNOLOGY

2018

We make your medical device promise a reality Donatelle provides component and medical device manufacturing worldwide. We operate under ISO-9001:2015 and ISO13485:2016 certified systems and are FDA compliant. Capabilities include: complete engineering services, rapid prototyping, in-house tooling design and fabrication, processing capabilities for the entire range of engineered resins, micromolding, insert molding, over-molding, white room and clean room molding and assembly, liquid silicone injection molding, as well as precision machining for metal and plastic components.

Donatelle is focused exclusively on medical device design, development and manufacturing, especially for intricate applications - like high-risk, long-term implants and disposables - where precision, tolerances, validation and timelines are critical. For over 50 years, the best, most recognized names in the medical industry have relied on Donatelle.. Donatelle employs a team of over 40 highly specialized engineers, designers, machinists and toolmakers. Our staff is available to supplement your team, and they come with specialty certifications, including: IOPP Packaging, Process Validation, Medical Device Compliance, and Quality System Regulation Compliance.

501 County Road E2 Extension

Our vertically integrated capabilities provide exactly the level of support you need, from a single manufacturing process to a complete solution. We’ll save you time while reducing risk across each manufacturing phase. Plus, we’ve earned - and maintain - an impeccable track record of meeting product development deadlines and more than 99% on-time delivery rate.

New Brighton, MN 55112 Phone: (651) 633-4200 www.Donatellemedical.com

Donatelle provides the highest achievable quality of products and services. We accomplish this through rigorous processes, continual improvement and maintaining effectiveness at all levels.

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We make your medical device promise a reality.

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LEADERSHIP IN MEDICAL TECHNOLOGY

2018

The global quality and value leader in fractional

horsepower motion control is the result of combining precise German engineering and award-winning design with a highly skilled European workforce and state-of-the-art automated production. For over 60 years, Dunkermotoren is the world leader in customized, configurable sole-source motion control solutions composed of long-life brushed motor products and the industryâ&#x20AC;&#x2122;s largest portfolio of integrated intelligent brushless motor-integrated controller solutions with connectivity to CANopen, Profibus, Profinet, Modbus and EtherCAT fieldbuses. Dunkermotoren also manufactures linear motors, AC electric motors, planetary and right angle gearboxes, controls, encoders and brakes. Headquartered in Bonndorf, Germany with production and/or logistics facilities in Europe, Asia and the USA, Dunkermotoren employs over 1100 team members globally and produces over 3 million motors annually for the building automation, packaging, medical, solar, agricultural and mass transportation industries.

Dunkermotoren is a global manufacturer of Brushed and Brushless DC motors and gear motors with continuous output power of 1100 Watts. For over 60 years, Dunkermotoren has been on the leading edge of technology and innovation â&#x20AC;&#x201C; both in product design and automated production. This has led to success as the world market leader in the range of integrated smart BLDC motors and a rapid growth in sales in the US and Asian markets. The award-winning German engineering and manufacturing firm is recognized for its high quality, long-life brushed motor product line and its portfolio of highly integrated brushless motor/controller/gearbox solutions. Dunkermotoren successfully serves the biggest names in the medical imaging, laboratory and diagnostics field including MRI, immunoassay and analysis equipment. Companies that want to automate these processes look to Dunkermotoren for their rotary and liner motion needs. Dunkermotoren is also a leader in providing the motion in the expanding mobile equipment market, where these technologies are brought to the patient. Dunkermotoren also serves many other industries including agricultural, mass transportation, solar, packaging and food processing.

Dunkermotoren USA Inc 1500 Bishop Court Mount Prospect, IL 60056 Phone (773) 289-5555 Email info@dunkermotoren.com www.dunkermotoren.com www.facebook.com/dunkermotor www.twitter.com/dunkermotor www.youtube.com/dunkermotor

This innovative configurable modular component approach creates over a million motion solution possibilities providing finetuned answers to unique challenges using readily available, field-proven components either in a standard or customized configuration. In addition to manufacturing excellence, Dunkermotoren provides extensive technical and application support, recognized by customers as an extension of their own engineering and R&D teams. As a result, customers are able to accelerate project development time, minimize components and reduce their supply base. This innovative approach allows for sizable cost saving on components, assembly and inventories. Being an innovative, all-in-one technical and commercial partner, Dunkermotoren is committed to developing strong, long-lasting relationships with its customers.

The reason for success:

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Through the years, Dunkermotoren has developed components based on a modular approach that includes brushed DC, brushless DC and AC motors, linear motors, planetary and right angle gearboxes, magnetic, incremental and absolute encoders, power-on/ power-off brakes, and a variety of integral and stand alone drives and controllers.

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www.medicaldesignandoutsourcing.com

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LEADERSHIP IN MEDICAL TECHNOLOGY

2018

Delivering stainless steel, high nickel alloy & titanium components to customers in medical, aerospace and high tech manufacturing. Since its inception in1982, Eagle Stainless has a sterling record of on-time delivery, fair pricing, product quality and highly skilled employees dedicated to continuous improvement and training. Eagle has earned its reputation as

Laser welding/cutting - Eagle’s computer controlled laser welding equipment (laser center shown above) enables us to produce extremely close-tolerance cutting, notching, etching and welding operations.

a supplier of choice for off-the-shelf stainless steel products and fabricated stainless steel products. With “Eagle Eye Quality” you are assured:

CNC / Swiss machining Specializing in CNC machining for more than two decades, Eagle Stainless has been delivering some of the most intricately machined part imaginable. Working in diameters ranging from .030” to 2”, we’re ready to meet the requirements of your most demanding application!

Cut-to-length tubing - Eagle’s facilities enable us to cut and deburr any diameter tubing in quantities from a single piece to millions of pieces or more…and from lengths of .010” and longer with standard tolerances (see cutting tolerances below). Closer tolerances are certainly possible, simply request a quote with the details of your application, and we’ll be glad to help.

100% parts made to your specifications. 100% on time delivery. 100% traceable certified material.

Bending / Coiling - The ability to bend tubes without excessive distortion, wrinkling or fracturing is an art born of experience. Eagle craftsmen working with state-of-the-art machinery supply uniformly smooth bends - meeting the tightest customer specifications.

ISO 9001 • ISO 13485

Eagle Stainless Tube & Fabrication, Inc.

Flaring and reductions Flaring and end reduction of tubing is an every day precision process at Eagle. Special tools and procedures have been developed to insure repeatability for proper mating of flared and end-reduced tubes.

Call us. We are ready to help with any of your metal needs! Phone: 800.528.8650 Fax: 800.520.1954 www.eagletube.com

Custom shaped tubing in sizes from .040” to 1.00” to lengths to 17 ft. • Round • Triangular • and more!

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• Oval • Rectangular

• Square • Hexagonal

With a complete in-house tool and die facility, experienced toolmakers will develop a custom extrusion die to yield tubing that will meet or exceed your expectations.

State-of-the-art tube bending

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LEADERSHIP IN MEDICAL TECHNOLOGY

2018

ElectroCraft, Inc. is a global provider of dependable, application-engineered fractionalhorsepower motor and motion products. The ElectroCraft Powering Innovation custom manufacturing services cover the following products: AC motors, PMDC motors, brushless DC motors, stepper motors, servo motors, gearboxes, gearmotors, linear actuators, drives, servo drives and integrated motor drives. Our products are found in thousands of different applications within industrial, commercial and consumer product markets. While ElectroCraft provides a wide array of standard products with many configurable options, we have built our brand on custom OEM solutions that meet the precise performance, cost and quality our customers require. For OEM Customers who are unsatisfied with having to design around inflexible off-theshelf products, our technical knowledge and cusomizable product families provide for a design experience which results in motor and motion systems that provide superior reliability and performance at the lowest possible cost.

ElectroCraft LRPX Series Brushless Planetary Gear Motor

ElectroCraft MP MobilePower™ Geared Mobility Motor

Dependable Fractional-HP Motion, Globally

Compact, powerful performance enables innovative medical devices

For medical equipment OEMs, frustrated with the requirement to design around off-theshelf products from inflexible suppliers, ElectroCraft offers customizable product families

For medical equipment OEMs, frustrated with the requirement to design around off-the-shelf products from inflexible suppliers, ElectroCraft in-class design experience, resulting in motor and motion systems that provide superior offers customizable product families and access to our deep engineering quality, reliability and performance at the lowest possible cost-of ownership. resources. We pride ourselves in providing a best-in-class design experience, resulting in motor and motion systems that provide superior quality, reliability ElectroCraft custom medical motion control services are driven by our engineering and performance at the lowest possible cost-of ownership. and access to our deep engineering resources. We pride ourselves in providing a best-

innovation coupled with our long history in serving medical equipment needs. The

ElectroCraft customare medical control are driven by our engineering company’s products found motion in a variety of lifesolutions science applications ranging from medical innovation coupled with our long history in serving medical equipment needs. The equipment, lab equipment, lab automation, diagnostic and surgical equipment, to company’s products are found in a variety of life science applications ranging from medical ultra-quiet power wheelchair transmissions. equipment, lab automation, diagnostic and surgical equipment, to ultra-quiet power wheelchair transmissions. LRPX Features: Mobility Product Features:

ElectroCraft, Inc. 844.338.8114 www.electrocraft.com

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•LRPX HighFeatures torque density, small form factor life • High torque density, small form factor High load capacity ••High load capacity • Low noise,Low low heat • Low noise, heat generation generation ••Wide ratios available Widerange rangeof ofvoltages voltages and ratios available • Up to IP65 • Up to IP65

• Mobility Very energy efficient, long battery Product Features

• Very energy efficient, Long battery life • Smooth and quiet operation • •High Highstarting startingtorque torque Controllablevariable variablespeed speed • •Controllable • Wide Range of IP Options • Smooth and quiet operation

• Wide range of IP options

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ElectroCraft, Inc. Phone: (844) 338-8114 1 Progress Drive Fax: (603) 742-9080 Dover, NH 03820 www.electrocraft.com www.medicaldesignandoutsourcing.com

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2018

LEADERSHIP IN MEDICAL TECHNOLOGY

A Quick Look at our Off-the-Shelf Products

Get to know the people who make Fabco-Air products!

Multi-axis actuators

Know our people and you will understand the positive difference that FABCO-AIR products can make in your life. Know that we are the ones who will work tirelessly with you to get the results you want! Of course we have all the great, off-the-shelf products you use - the highest quality products with proven performance and reliability.

Pancake® Air Cylinders – Originated in 1958. Today they have evolved into a major product line with 3 body styles available in 8 bore sizes 1/2” to 4” and strokes to 4”.

But, when a standard won’t cut it, we’ll put everything we have into prototyping a special product for you within 72 hours!

Multi-Power® Air Cylinders deliver forces equivalent to low pressure hydraulic systems. Forces as high as twenty-two (22) tons! As example, the power unit on the air press (below) is a 3-piston, 5” bore Multi-Power® cylinder that delivers 5,076 lbs. at 90 psi.

Yes, get to know us. We’ll stand on our heads for you. It’s what we do.

Pneumatic grippers Complete Pneumatic Valve Selection Manual, mechanical, air piloted, solenoid operated control valves. Manifold valves. Specialty valves.

Air-Oil Tanks and Pneumatic Boosters

Fabco-Air, Inc. 3716 N.E. 49th Avenue Gainesville, FL 32609 Tel: 352.373.3578 Fax: 352.375.8024 service@fabco-air.com www.fabco-air.com

and the advanced air prep to drive it all

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medicaldesignandoutsourcing.com/leadership

Interchangeable air cylinders Industrial, Metric, ISO and NFPA standards

Exactly the Service I have been looking for!

Voting for this company will identify it as a leader in the medical technology industry.

www.medicaldesignandoutsourcing.com

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LEADERSHIP IN MEDICAL TECHNOLOGY

2018

Fischer Connectors has been designing, manufacturing and distributing high performance connectors and cable assembly solutions for 60 years. Our connectors are known for their reliability, precision and resistance to demanding and harsh environments. Fischer Connectors’ products are commonly used in fields requiring faultless quality, such as: medical equipment, industrial instrumentation, measuring and testing devices, broadcast, telecommunication and military forces. Primary design and manufacturing facilities are located in Saint-Prex, Switzerland, with additional ISO certified cable assembly operations in the US and Germany. Fischer Connectors has eight subsidiaries and many distributors located worldwide.

1735 Founders Parkway Alpharetta, GA 30009 |

800.551.0121

mail@fisherconnectors.com www.fischerconnectors.com

VOTE

Leadership at Fischer Connectors is more than just a commitment to producing some of the most reliable and innovative connector solutions on the planet. Our leadership involves a strong, long-lasting commitment to our customers, and finding new ways to help them achieve design and product goals while breaking new ground in their respective industries. Our tradition of innovation – Fischer Connectors has been designing and manufacturing rugged, circular connectors and cable assembly solutions for more than 60 years – has served our customers well. We help designers make devices smaller, faster & smarter by imagining and manufacturing innovative connectors, data storage devices, and cable assembly solutions to fulfill industry’s ever-changing needs.

Fischer Connectors, Inc.

678.393.5400

Leadership at Fischer Connectors

ONLINE

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Miniaturization & wearable connectivity solutions to reduce space, weight, and costs

•

Ultra-fast & reliable data transmission to transfer large amounts of data quickly (USB 3.0, HDMI, Ethernet, etc.) & safely

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Sealing & ultra-ruggedness to protect equipment against environmental stresses (corrosion, radiation, temperature, chemicals, etc.)

•

Complete cable assembly solutions designed and manufactured in ISOcertified and ITAR registered facilities.

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Jonathan Brossard, who belongs to the Fischer family that founded the company in 1954, recently took the helm of the company as CEO. He says it is a great honor to serve the company’s many customers. “Customers have been our focus in all the breakthrough innovations we have introduced to the market since the Fischer family founded this company, and they will continue be our focus as we move into the future.”

www.medicaldesignandoutsourcing.com

1/25/18 6:33 PM

LEADERSHIP IN MEDICAL TECHNOLOGY

2018

Fluid Metering Inc. (FMI), manufactures CeramPump® Valveless Piston Metering Pump and Dispensers. CeramPump® fluid control technology utilizes only one moving part, a rotating and reciprocation ceramic piston, to accomplish all fluid control functions within the pump. As a result, valves, typically present in other reciprocating pump designs along with the associated maintenance issues, are eliminated as well. FMI’s product range can accommodate dispenses from 2µL per dispense up to 4 L/ min continuous metering. Once calibrated, FMI pumps will provide drift-free precision of 0.5% for millions of maintenance-free cycles.

Metering Pumps and Dispensers

FMI’s CeramPumps® have been used in many industries where precision, drift free accuracy is important. However, they have are considered a critical component medical, analytical, and biotech instrumentation for precision micro-volume fluid control. Medical Diagnostic, Clinical Chemistry, hemodialysis and Genome Sequencing instrumentation are just a few of the typical applications utilizing FMI’s CeramPump® valveless fluid control.

Valveless, Micro-Volume Fluid Control

FMI pioneered the first valveless rotating and reciprocating piston metering pump concept over 58 years ago. Since that time, FMI’s unique CeramPump(R) valveless fluid transfer technology has proven ideal for critical Medical, Analytical, Biotech, & Laboratory Automation OEM instrument applications.

Our Unique Valveless Pump Design Features: Patented “No-Valve” Pump Design •

Eliminates problems and errors caused by valves which clog, leak, hang up, and require service.

One Moving Part! • Fluid Metering, Inc. 5 Aerial Way, Suite 500 Syosset, NY 11791 USA

FMI’s CeramPump® design utilizes a single, dimensionally stable, chemically inert CERAMIC piston ensuring long term, drift free fluid control. The valveless pumping function is accomplished by the synchronous rotation and reciprocation and reciprocation of the ceramic piston in the precisely mated ceramic cylinder liner. One complete piston revolution is required for each suction/discharge cycle.

516-922-6050

Accuracy, Precision, & Reliability

800-223-3388

•

Fax: 516-624-8261 Pumps@fmipump.com www.FluidMetering.com

Proven Performance! •

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Long term drift free performance measured in millions of “trouble-free” cycles. Fluid Metering Pumps accuracy is held from microliters to the full flow range. Output does not change more than ± 1% of set value. An important cost saving factor considering the waste generated by inaccurate pumps.

Over 58 years of experience and more than 1 million metering pumps and dispensers in service.

ONLINE

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www.medicaldesignandoutsourcing.com

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LEADERSHIP IN MEDICAL TECHNOLOGY

2018

An industry leader in motion control solutions. AMETEK’s, Haydon Kerk Pittman is a leading technology and global manufacturer of linear actuation, rotary motors and customized motion control solutions. Our company of over 600 employees located in manufacturing and sales offices around the world has been serving our customers in the Industrial Automation, Medical Equipment, Lab Instrumentation, Business Machines and Transportation markets for over 85 years.

For more than 85 years Haydon Kerk Pittman, has been reliably solving our customer’s most complex motion control and automation design challenges by providing strong technical support, superior quality and rapid service. We use the strictest quality and engineering standards to design and build our broad portfolio of linear, rotary and customized motion control solutions. Whether used in a robotic surgical application that requires precise motion to meet life-saving medical guidelines, or a rail door system that has long cycle-life and safety needs, or an AGV logistics application where fast delivery and response time are critically important, our customers rely on Haydon Kerk Pittman to ensure that their applications will operate the first time, every time. Our dedicated sales, engineering and operations teams are located around the world in order to provide around the clock service and support to our customers so that they can keep their businesses running safely and efficiently. We are excited and proud of our reputation as global experts in motion control customization, innovative designs and manufacturing quality. Haydon Kerk Pittman has the experience, the people, the technology, and the global coverage to put your challenging ideas into motion. Let us show you how.

1500 Meriden Road Waterbury, CT 06705 haydonkerkpittman.com

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LEADERSHIP IN MEDICAL TECHNOLOGY Created in 2016 and based in Silicon Valley, HP Inc. combines the heart and energy of a start-up with the scale and power of a Fortune 100 multinational corporation. Backed by nearly 50,000 employees and drawing from a 76year legacy of engineered innovation, the company is focused on creating technology that makes life better for everyone, everywhere.

2018

Building on a legacy of leadership in inkjet printing, HP Inc. has turned our engineering insights into a 3D printing breakthrough – HP Multi Jet Fusion technology and the HP Jet Fusion 3D Printing Solution. With the development of a high-speed, synchronous architecture, HP has perfected a system that separates the processes of recoating and printing/fusing during the printing stage. As a result, each process can be separately optimized for performance, reliability, and productivity.

Through our portfolio of printers, PCs, mobile devices, solutions, and services, we engineer experiences that amaze. HP Multi Jet Fusion 3D Printing technology is set to reinvent design and manufacturing, by unlocking the full potential of 3D printing.

More information is available at www.hp.com/go/3DPrinting

HP innovation doesn’t stop at high-speed, synchronous architecture. The HP Jet Fusion 3D Printing Solution includes advancements in the capacity to control print properties for individual voxels – the tiny building blocks of 3D-printed parts. With Multi Jet Fusion technology, product engineers and designers can specify properties for each voxel, defining a 3D-printed part point by point over the surface and within the volume.

3D printing design courtesy of: Invent Medical and Bernard Werber.

HP Inc. 1501 Page Mill Road

Our commitment to unlock the manufacturing potential of 3D printing includes expanding the range of materials that can be used in 3D-printed parts, and making those materials less expensive and more widely available. To make that happen, we initiated the HP Multi Jet Fusion Open Platform – a program for collaborating with industry partners to create more materials and more applications. And with its new enclosed unpacking and automated materials collection and preparation system, HP has introduced a new level of efficiency to the traditionally untidy materials handling process.

Palo Alto, CA 94304 www8.hp.com/us/en/printers/3d-printers.htm

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With the HP Jet Fusion 3D Printing Solution, high productivity, cost efficiency and part quality are compatible forces – giving shape to new era of manufacturing.

ONLINE

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www.medicaldesignandoutsourcing.com

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Data courtesy of NACAR.

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LEADERSHIP IN MEDICAL TECHNOLOGY

2018

igus has been manufacturing engineered plastics for more than 50 years, and develops each of the engineered plastic materials and all technology behind its products. Committed to using its innovative materials to develop products to provide creative solutions, and exceed customer expectations while delivering fast, accurate service across all industries, igus offers over 28,000 products available from stock and ready to ship as early as same-day. igus works with all customers to find the best, most cost-effective solution for all applications via online chat, phone, email, or on site. Online tools and lifetime calculation, cable harnessing, custom component manufacturing, prototyping, and testing available.

Plastics for longer life Throughout the medical industry, igus products are used for a wide variety of applications around the world, based on their cleanroom-compliance, selflubricating abilities, excellent service life, and lack of required maintenance. iglide® plain bearings and drylin® linear solutions are all 100% self-lubricating and maintenance-free, and available in FDA compliant and EU certified, and offer low-vibration and quiet operation in a vast array of applications. chainflex® continuous-flex cables offer more than 800 cable options certified for cleanrooms by the IPA institute, and corresponding energy chain® cable carrier systems allow for safe protection of cables in hoses without lubrication or corrosion, even in chemical and washdown applications.

igus Inc. PO Box 14349 East Providence RI 20914 1.800.521.2747

A variety of online product selection and lifetime calculation tools are available online, without registration, and product samples are widely available across the igus product range. To learn more about igus products for the medical industry, visit www.igus.com/medical.

sales@igus.com www.igus.com

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1/25/18 6:48 PM

LEADERSHIP IN MEDICAL TECHNOLOGY

2018

IKO specializes in quality needle bearings, linear motion rolling guides, precision positioning tables and machine components. Our products include: Linear Motion Rolling Guides. IKO’s linear motion rolling guides reduce linear motion friction in the positioning mechanisms of machines. Needle Roller Bearings. With low crosssectional height and high load capacity, our needle roller bearings deliver rotational motion. Medical machines and devices need linear guides that are compact relative to the loads they carry. They also need to run smoothly with adequate precision while providing design features that ensure that the machine has a long, trouble-free life.

Precision Positioning Tables. Our directdrive precision positioning tables feature a ball screw or motor embedded between the bed and slide table.

Compact. At IKO, we offer an extensive line of miniature linear motion products that can meet the requirements of size-constrained medical applications. Among them are the world’s smallest recirculating ball linear guide, which has a track rail width of just 1-mm and a cross sectional height of 2.5-mm. We also offer a tiny ball-spline guide which has a shaft diameter of 2-mm and a cylinder diameter of 6-mm. IKO International

Smooth. In medical applications, one of these functional requirements is smoothness.

91 Walsh Drive Parsippany, NJ 07054

Many guides can move from point to point quickly, but not all can do so smoothly.

United States www.ikont.com

VOTE

Smoothness counts for more than maximum speed: it also translates to less noise, and quiet motion components are strongly

preferred in any medical machine or diagnostic system used in proximity to patients.

Maintenance-free. The cost of maintenance, particularly lubrication needs, drives up the cost of ownership for many types of moving machines. Medical and lab automation machines are no exception. At IKO, our solution to this maintenance problem is a proprietary technology called “C-Lube.” It allows our linear guides to operate for more than 20,000 kilometers or 5 years without the need to replenish the lubricant.

ONLINE

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www.medicaldesignandoutsourcing.com

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LEADERSHIP IN MEDICAL TECHNOLOGY

2018

Partnering to deliver life-changing innovation Integer is the largest medical device manufacturer in the world, designing, developing and manufacturing devices and power solutions. We have a rich, 70-year history of innovation and manufacturing shaped from the legacy of Greatbatch™ Medical and Lake Region Medical™ that serves our customers with an unmatched breadth and depth of capabilities. We leverage our global presence and extensive design and manufacturing skills

Integer’s global workforce brings a depth of knowledge to every step of the product development process. We are a trusted partner to many of the world’s leading medical device companies who depend on our 600+ engineers, skilled machinists, toolmakers, and quality and regulatory professionals to create the right solution for their products. Our 26 manufacturing sites, located in seven countries, operate under multiple ISO certified systems and are committed to ensuring the products we produce meet or exceed the highest standards set by the FDA, the European Community and other internationally recognized agencies. Additionally, with full control of the product’s supply chain and dual-site manufacturing capabilities, our partners receive unparalleled service.

to partner in the development of quality components to complete systems.

Our capabilities include: Contract Manufacturing – molding and machining, welding and processing, mechanical, coatings, rapid prototype, full device assembly, packaging and sterilization, dock-to-stock supply chain management, lean and continuous improvement, design for manufacturing, and large scale manufacturing transfers.

Integer 2595 Dallas Parkway Ste 310

Components to Complete Finished Systems – custom design, development and manufacturing of batteries, chargers, power supplies, capacitors, feedthroughs, filtered feedthroughs, enclosures, subassemblies, titanium nitride coated electrodes, leads and adaptors, and implantable pulse generators.

Frisco, TX 75034 www.integer.net

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Our products are found in virtually any and all medical device markets; from cardio and vascular to neuromodulation to orthopedics. Please visit our website for more information.

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1/25/18 6:49 PM

LEADERSHIP IN MEDICAL TECHNOLOGY

2018

Interpower® is the premier supplier of

power system components offering a full line of North American and international products, including hospital-grade products, power cords and cord sets, IEC 60320 inlets and outlets, accessory power strips, power entry modules, cable, plugs and sockets, the Interpower International Power Source, plus more.

Design. Easy. Fast. We at Interpower®

There are no minimum order or dollar requirements, same day shipping on in-stock Interpower products, and a 1-week U.S. manufacturing lead-time on non-stock Interpower products. All Interpower manufactured products are made in Iowa and 100% tested.

want to make it easy for you to design, build, and maintain products for North American and global markets—that’s our mission. We strive to provide our customers with quality products that delight—FAST. Designing products with the global customer in mind can give a company a competitive advantage and may increase customer relations. It’s imperative that companies know that their products will function properly in the areas they are meant to be used. As the premier supplier of AC power system components, Interpower hospital-grade products are designed for use in medical settings throughout the world. We have an extensive range of clear, black, and gray plugs along with IEC 60320 C13 and C19 connectors available in five different configurations (straight plus four angles). Connector locks can help prevent accidental removal or interruption. For those products that will be used in North America, they are UL and CSA approved and carry the green dot.

Additionally, we carry power cords and cord sets, accessory power strips, cable, IEC 60320 inlets and outlets, power entry modules, and more! We offer value-added options such as specialized packaging, labeling, cord lengths, and colors.

Interpower® Group of Companies P.O. Box 115, Oskaloosa, IA 52577-0115 (800) 662-2290 sales@interpower.com

Interpower offers a 1-week U.S. manufacturing lead-time on non-stock Interpower products. We have same day shipments on in-stock Interpower products and no minimum order or dollar requirements. Interpower manufactured products are made in Iowa and 100% tested.

www.interpower.com

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ONLINE

Free technical support at Interpower is available. Please check our website at www.interpower.com, e-mail us at sales@interpower.com or contact Customer Service at (800) 662-2290.

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www.medicaldesignandoutsourcing.com

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LEADERSHIP IN MEDICAL TECHNOLOGY INTROTEK INT’L designs, manufactures and markets non-invasive ultrasonic air bubble and liquid level detection systems Beginning operations in 1981, we became a wholly-owned subsidiary of Magnetrol International—a worldwide leader in industrial level and flow instrumentation in 1986. Since then the companies have engaged in collaborative R&D efforts for the enrichment of both firm’s product lines. Introtek’s production operations represent the leading-edge in manufacturing. Our manufacturing practices conform to the identical standards as those of medical device manufacturers. An ISO certified company, our quality system is also TUV certified to meet the established requirements for the development, production and distribution of our complete product line. Introtek stands behind the quality of every product with a three-year product warranty. Whether you require standard or custom designed sensors and electronics, our comprehensive design and manufacturing capabilities—along with our solid record of O.E.M. service proficiency—will provide you with the most reliable ultrasonic-based detection products available today.

Introtek International 150 Executive Drive Edgewood, New York 11717 Phone: 631-242-5425 Fax: 631-242-5260 General E-Mail: info@introtek.com Sales: sales@introtek.com

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INTROTEK, the Global leader for over 35 years, has produced non-invasive, ultrasonic air bubble detectors, continuous liquid and point level sensors, and optical blood component detectors for companies in industries such as medical device manufacturing, chemical processing, pharmaceutical development, clinical laboratories and food & beverage manufacturers. Since it’s early conception, Introtek has maintained its commitment in providing safe, reliable products to ensure customer satisfaction. Our products lead the way in meeting O.E.M. customers’ needs for sensors and electronics that are compact, accurate, highly reliable and reasonably priced. Introtek’s standard sensors attach at the desired point of detection to the outside of stainless steel, or rigid and flexible plastic Introtek’s Engineering Design Team specializes in taking custom requirements from concept to completion using highly innovative ideas, while working closely with the customer in order to obtain maximum results. Introtek’s AD8 / AD9 / ADU Integral Ultrasonic Air-In-Line, Air Bubble Sensors incorporate Introtek’s latest generation “MEC” pulse-type ultrasonic circuitry. The microcontroller based circuitry is located integrally in the sensor assembly. Custom algorithms to control functionality, such as AD9 ADU response times, time delays and more can be designed at Introtek based on customer requirements. ADU Series Sensor for non-standard soft tube sizes between 1/8” - 3/18” where standard AD9 housings are not available and can eliminate tooling costs for low volume requirements for some odd sized tubes. INTROTEK® Drip Chamber and Drip Level Detect Sensors are custom designed for use with a variety of drip chambers or larger OD tubing to overcome conditions such as relaxation, slippage or vibration, which would normally cause false air alarms. These sensors are designed to meet OEM Point Level Sensor Drip Detect Sensor form, fit and functional specifications. Sensors are available with integral or remote circuitry and panel mount or self-standing designs.

2018

Introtek’s line of Non-invasive liquid level detectors provide the ultimate solution for almost any liquid level detection application.

PLD

CLD

Introtek’s PLD – Point Liquid Level Detector is extremely user-friendly with a sleek compact, non-invasive design, incorporating integral electronics that never require calibration. The PLD is the most advanced pulse wave, ultrasonic sensor available for liquid level detection, emphasizing reliability, accuracy and repeatability. Introtek’s CLD – Continuous Liquid Level Detector is a pulsed ultrasonic, continuous level sensor, scalable for small to large vials, containers and tanks for industrial, laboratory, pharmaceutical medical & beverage applications. Our unique, non-invasive design enables the liquid level from the bottom of vessel to be monitored quickly, accurately and dependably. Introtek’s CLM – Continuous Liquid Detector for Metal Tanks delivers the answer for challenging non-invasive liquid level CLM monitoring for a variety of fixed tanks and vessels comprised of, Stainless Steel, Copper, Aluminum, Teflon and Plastic. The CLM is designed to operate under a wide range of supply voltages. Additional features include a bi-color LED visual indicator assuring optimum transducer placement, standard dip switch capability providing field adjustment for 8 various discreet tank levels. INTROTEK INT’L designs, manufactures and markets non-invasive ultrasonic air bubble and liquid level detection systems Beginning operations in 1981, we became a wholly-owned subsidiary of Magnetrol International—a worldwide leader in industrial level and flow instrumentation in 1986. Since then the companies have engaged in collaborative R&D efforts for the enrichment of both firm’s product lines. Introtek’s production operations represent the leading-edge in manufacturing. Our manufacturing practices conform to the identical standards as those of medical device manufacturers. An ISO certified company, our quality system is also TUV certified to meet the established requirements for the development, production and distribution of our complete product line. Introtek stands behind the quality of every product with a three-year product warranty. Whether you require standard or custom designed sensors and electronics, our comprehensive design and manufacturing capabilities—along with our solid record of O.E.M. service proficiency—will provide you with the most reliable ultrasonic-based detection products available today.

www.medicaldesignandoutsourcing.com

1/25/18 6:51 PM

2017 V

LEADERSHIP IN MEDICAL TECHNOLOGY

s inception in 1983, IXYS ation (Nasdaq: IXYS), a Valley power semiconducSince its inception in 1983, IXYS pany, has been developing Corporation (Nasdaq: IXYS), a Silicon ogy-driven products to im• MOSFETs • BiMOSFETs company, ower conversion efficiency, Valley power semiconductor • XPT IGBTs e clean energy, improve • Standard Rectifiers has been developing technology-driven • Schottky Diodes ion and provide advanced Rectifiers products to improve•• Fast power conversion All in Discrete and Module Packages s in the transportation, mediVisit our website: www.ixys.com generate clean energy, improve telecom industries.efficiency, IXYS neer in the development of automation and provide advanced emiconductors, integrated products in the transportation, medical and RF systems that efand telecom industries. IXYS is a y monitor electrical voltage to • Microcontrollers pioneer of power e maximum effect with least in the development • SOCs • Creative Reference Designs ture of energy. semiconductors, integrated circuits and RF

THE WORLD OF IXYS

• MOSFET Gate Drivers • IGBT Gate Drivers IXYS brings together all the building blocks required for • Optocouplers • Solid Relays a State designer of power conversion at almost every power www.ixysic.com or www.ixys.com

level. From Milliamps to Megawatts IXYS is able to provide the best available rectifier, switching, isolation and control products together in one place.

IXYS Power is providing efficient solutions for virtually any power conversion application. Rectifier products such as Schottky diodes, line frequency and fast diodes • IGBT Press Packs • Rectifier Diodesas (Studs and Capsules) as well thyristors are available in discrete packages as • Fast Recovery Diodes (Studs and Capsules) well as modules. For your switching needs IXYS offers • Phase Control Thyristors • Fastsome Switching Thyristors edge and the highest power available leading www.ixys.com or www.ixyslongbeach.com in MOSFET, IGBT, BI-MOSFET and GTO technology which are offered in discrete solutions and both industry standard and custom multichip module package outlines. In addition, we have the ability to offer these power products • IGBT Press Packs as customer specific sub systems which may be • Rectifier Diodes (Studs and Capsules) assembled world wide. • Fast Recovery Diodes (Studs and Capsules)

www.ixys.com or www.zilog.com

systems that effectively monitor electrical voltage to produce maximum effect with

uckeye Drive -457-9000 8-416-0223 s.net

least expenditure of energy. • GaN Amplifiers • Gunn Diodes • Wireless Amplifiers • HBT Amplifiers • WiMax Power Amplifiers • Microwave Amplifiers • MMIC Amplifiers • GaAs FET Devices www.ixys.com or www.mwtinc.com

• Phase Control Thyristors • Fast Switching Thyristors Providing solutions for www.ixys.com or www.ixysuk.com

isolation, control and feedback, IXYS IC division (CLARE) designs and produces SOI base HVIC´s flexible display drivers, driver IC´s, optically isolated drivers, solid state relays (SSR), isolated AC switches, optocouplers, photovoltaic chips and ASIC´s. With the IXYS San Sebastian Division (ISS), we provide advanced RFID IC´s, solutions and Custom IC design.

• Laser Diode Driver Module • Pulse Generators • Signal Generators • RF Power MOSFETs • RF Power Modules • RF Drivers www.ixys.com or www.ixyscolorado.com

IXYS www.ixys.com or www.radiopulse.co.kr/eng

v ot e

e vote onli

Tel: 408.457.9000

Fax: 408.416.0223 info@ixys.net

www.ixys.com

l in

v o t e o nl i n

l in e

• Zigbee Wireless 1590 Buckeye Drive

vot e o

signworldonline.com/leadership

VOTE

• Portable Solar Chargers • Solar Cells Through MWT and IXYS Colorado, Ixys • Solar Bits/Modules and • Solar Dies microwave products. Visit our website: http://www.ixyskorea.com or www.ixys.com

manufactures RF

With Zilog´s industry proven and rugged MCU´s, we complement our POWER and IC products with matched digital power management and embedded control. Ixys has introduced unique power management reference designs to control motors, LED light, battery • RFID Ics charging motion sensing. The added S3 low cost • Customized Designand Services • RFID Accessories MCU product lines serve consumer white goods, www.ixys.com or http://www.incide-semi.com/ home automation and remote controls. With the Radio Pulse Divison we offer SOC´s that integrate RF Zigbee transceivers and MCU´s for the consumer security, 1-408-457-9069 industrial, home automation, energy management, LED lightning and IoT markets. Bringing all of these technologies together under one company allows THE WORLD OF IXYS to offer the power conversion designer a one stop solution.

engineering leadership for a person or ngineering leadership by a specific nt, or an overall company accomplishment.

DESIGN WORLD

2018

January 2017

ONLINE

For further information visit: www.ixys.com

www.designworldonline.com

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www.medicaldesignandoutsourcing.com

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LEADERSHIP IN MEDICAL TECHNOLOGY Hygienic Design Leveling Feet, Stainless Steel, with Mounting Holes

HELPING ENGINEERS SUCCEED JW Winco, Inc. A Ganter Company, is a leading supplier of Standard Industrial Machine Components and Assembly Hardware that also specializes in offering value-added services to engineers. Along with an extensive selection of high quality parts, JW Winco strives to make an engineer’s job easier. The company’s new mobile-responsive website at www.jwwinco.com is dedicated to providing the customer with modern navigation and usability. The new website’s home page allows visitors to see new product availability, plus special application possibilities for various products. Features include filtering capabilities to find products faster and easier, the ability to build and price parts to easily create the standard part required for the design, modern CAD program for improved drawing and CAD model accuracy, and multiple languages capabilities, English and Spanish now available with a French version coming soon. Customers can check product availability and pricing online, set up an account, or make a purchase easily 24/7 with a credit card. JW Winco prides itself on its knowledgeable technical sales associates, who provide assistance with products and applications. Customer service is a top priority. To provide customers with complete solutions, JW Winco also offers secondary machining, special kit packaging, and bar coding. For more information, visit www.jwwinco.com, call 800-877-8351, fax 800-472-0670, or email sales@ jwwinco.com.

The smallest of areas on equipment can contaminate entire production lines. Therefore, Winco now offers a special series of “hygienic” Standard Parts with significant characteristics.

These 3-A and RoHS compliant hygienic leveling feet with mounting holes are certified according to 3-A Sanitary Standard guidelines and meet EHEDG (European Hygienic Engineering & Design Group) requirements, making them ideal for use in sanitary applications, as the bottom seal protects the area beneath the foot plate from dirt. The food industry, medical technology and the pharmaceutical industry, product safety and consumer protection are becoming increasingly important. JW Winco’s new Hygienic Design products can assist the production process in sensitive areas and facilitate the manufacturing of products free from preservatives that have long shelf life. Hygienic Design products minimize and reduced cleaning process (this can be up to 25% of the production time), therefore; • more time available for production • less fresh water consumption • lower energy consumption • less cleaning agent required • less production of waste water

2018

housed fully in the operating button and protected from malfunctions. The stainless steel GN 414 is made of AISI 303 stainless steel and the plunger pin chemically nickel plated. The knob is technopolymer plastic in matte black-gray, and the safety push button is also made of technopolymer plastic and matte red in color.

More information can be found at http://www.jwwinco.com.

GN 256 Silicone Conical Type Vibration/ Shock Absorption Mounts, with Stainless Steel Components, Tapped Hole and Threaded Stud versions

These RoHS compliant silicone shock absorption mounts are used as end stops, leveling feet or setup elements for machines and systems, e.g. for conveyors. The silicone rubber used absorbs vibrations, has a dampening effect, is ageresistant and has an increased working temperature range, resistant up to 392 °F (200 °C). Thanks to the material purity, use is possible in the food and medical industries. Available in both tapped and threaded stud versions, in a number of thread sizes and combinations, opens up the range of applications these mounts can be used in.

More information can be found at http://www.jwwinco.com.

• lower total costs and saving of resources

More information can be found at https://www.jwwinco.com.

800-877-8351 fax 800-472-0670

GN 414 Metric Size, Stainless Steel Safety Indexing Plungers

sales@jwwinco.com jwwinco.com

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These RoHS compliant safety-indexing plungers are used when the inadvertent retraction of the plunger pin is to be prevented. The protruding plunger is first locked and may be unlocked for pulling only by exerting axial pressure on the red safety push-button. The safety lock engages in the front end position, i.e. automatically if the indexing pin protrudes, with the locking mechanism

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LEADERSHIP IN MEDICAL TECHNOLOGY Spring Design & Manufacturing

2018

Our custom design and precision manufacturing capability are supported by a complete machine shop staffed by a professional crew of toolmakers who utilize Dessault Systemes Solid works for design, and Charmilles EDMs for tool and die production. This allows us to build, maintain, and repair all tools utilized in our production areas. We design and build many of our own high speed, automated, spring manufacturing machines. This “on-site” capability further reduces cost and lead time for our customers.

Excellence John Evans’ Sons, is the international leader in the design and manufacturing of constant force springs, constant force spring assemblies and precision specialty

We have been recognized for outstanding design, quality and on-time delivery by major medical device manufacturers. Some examples of products that have utilized our design and engineering include:

springs for the medical device industry. We are a trusted medical device industry spring supplier, as evident by our

• World class surgical robots

commitment to manufacturing excellence.

• Surgical staplers

All of our products align with strict quality

• A wide range of various medical device assemblies and support equipment

standards. We are ISO 9001 and ISO

With respect to the medical device industry, we offer several counterbalance options to assist/enhance articulated instruments and assemblies, many medical equipment designers utilize constant force springs, constant force spring motors, spiral torsion springs or spring reels. The capabilities of these products have significant benefits compared with traditional helical springs and gas springs.

13485 certified.

Constant Force Springs • Constant load • Smooth range of motion • Minimal starting force

Spiral Torsion Springs • Develops high torque

John Evans’ Sons, Inc.

• Rotation in two directions

1 Spring Ave.

• Compact, easily mounts in many designs

Lansdale, PA 19446 www.springcompany.com

Spring Powered Reels • Wide range of forces, cable lengths, & travel • Mounts quickly & easily • Metal and plastic available

We provide impeccable service from start to finish and set the standard for world-class precision

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spring products.

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LEADERSHIP IN MEDICAL TECHNOLOGY

2018

Quality Interconnect Components and Electronic Hardware Leading edge technology and precision manufacturing have defined Keystone’s performance since 1950. Their latest catalog M65 reflects this tradition. Keystone personnel take pride in meeting all requirements, efficiently and promptly. Our skilled and dedicated technicians, experienced production personnel and customer service teams have made us an industry leader. All Keystone facilities are fully integrated with 3D/ CAD product modeling and CAD/CAM precision tool and die operations. Applications and Engineering specialist utilize progressive dies, four-slide, wire forming, in-die tapping and high-speed blanking along with automated machining to produce tight tolerance standard and custom products. Secondary operations include Tapping, Drilling, Assembly and Finishing.

Battery Clips, Contacts, Holders & Retainers Advances in portable electronics and LithiumIon battery technology demand dependable battery connections. Keystone leads the way with a vast range of reliable, high-quality, costeffective products for most battery types.

Space-Saving Fuse Clips & Holders Fuse clips and holders for Electronics, Datacom, Telecom, Automotive and Solar use. Keystone answers your needs with SMT, ThruHole and rivet mount products.

PCB Test Points & UL Approved Terminals Low Profile and limited space drive today’s PCB connectivity designs. Keystone is the right fit with Solder and Solderless PCB Quick-Fit, Snap-on, Snap-Fit and Screw-on Terminals as well as Color-Coded Screw Terminals & THM and SMT Test Points and more.

Spacers, Standoffs/Supports - Metallic & Non-Metallic Diverse insulated and non-insulated spacers and standoffs are available in a wide range of lengths, thread sizes, hole sizes, mounting styles & materials. Choose from English or Metric type products for your PCB, panel and mounting applications.

Pins, Plugs, Jacks & Sockets, Industry’s Most Diverse Group Keystone’s USB 2.0, 3.0 & 3.1 Jacks & Plugs, Micro Pins/Jacks, Banana and Phono Plugs & Jacks are designed for use in the latest Mobile & Computer Electronics, Home Theatre, Test Gear and Industrial Interconnects.

Panel Hardware, Handles, Screws & LED Spacers Check out Keystone’s value-added products: Fan Filters & Guards, LED Lens Caps, Holders & Spacer Mounts, Jack Screws and Connector Hardware, Instrumentation Handles, Cable Clamps, Knobs and more.

Application engineering services are available for product modifications or special design requirements. Keystone is an ISO-9001:2008 certified company and complies with RoHS and REACH directives. View inside the walls of Keystone Electronics and learn about our design and manufacturing capabilities, our customer service team and our complete line of interconnect components and electronic hardware. https://www.youtube.com/ watch?v=YhVH3DCngH0 There’s a Keystone in every great invention… Follow our latest blog. http://www.keyelco.com/blog.cfm

55 South Denton Avenue New Hyde Park, NY 11040 800.221.5510 or 516.328.7500 www.keyelco.com

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LEADERSHIP IN MEDICAL TECHNOLOGY

2018

LEMO®, founded in Switzerland in 1946, took its name from the company founder, engineer Léon Mouttet. Originally a manufacturer of contacts in noble and rare metals, the company took a major step forward in 1957 with the introduction of the push-pull selflatching connector. REDEL, LEMO’s plastic connector solutions for medical device interconnect companies, are one of LEMO’s top selling product lines due to their high-quality and reliability. These connectors can be found in wearable electronics, catheters, scopes, surgical robotic navigation, x-ray equipment and dental equipment. LEMO purchased Northwire, Inc., a wire and cable manufacturer, in the Summer of 2014, for the ability to offer a complete solution.

LEMO USA, INC. 635 Park Court, Rohnert Park, CA 94928 USA 707.578.8811 F: 707.578.0869 info-us@lemo.com www.lemo.com

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The Original Push-Pull Connector

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LEMO is the acknowledged leader in the design and manufacture of precision custom connection and cable solutions. LEMO’s high quality push-pull connectors are found in a variety of challenging application environments including medical, industrial control, test and measurement, military/aerospace/aviation, audio-video, and telecommunications. LEMO has been designing precision connectors for seven decades. Offering more than 75,000 combinations of product that continues to grow through custom specific designs. LEMO, and it’s affiliated sister companies REDEL, NORTHWIRE and COELVER, currently serve more than 100,000 customers in over 80 countries around the world. LEMO USA recently acquired ISO13485:2003 Certification for the medical cable assembly

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market.

www.medicaldesignandoutsourcing.com

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LEADERSHIP IN MEDICAL TECHNOLOGY Optimized Step Motors and Motion Control Products for Your Specific Application Lin Engineering designs and manufactures step motors and motion control components. Their motors and products are routinely used in medical, aerospace, automation, and many other applications, because their products can be optimized for each specific application. This is why thousands of Engineers from around the world trust the accuracy, reliability, and consistency of their products and their top-notch support.

Lin Engineering will grow with your needs. Lin Engineering is capable of producing step motors and motion control components that will fit your specific requirements. They will also scale with your needs--from small bath volume to OEM quantities. Their line of standard products and specialty products will meet your exact requirements. They will deliver optimum torque, high precision, reduced resonance, or provide a product that can operate in various environments such as vacuum, hot/cold environment, or even submersion. For high-volume orders, they can works directly with your engineering team throughout the design phase of your project to ensure the best overall system optimization and motor fit while avoiding over-engineering. Their experienced engineers can help you eliminate costly complexities and overdesigning while keeping in mind future developments and improvements. Their Northern California manufacturing facility doubles as their prototyping facility, which means their engineers work within the premises of the manufacturing facility, and have access to the same tools that will be used to produce your motor in volume. This gives them a much higher flexibility to

Lin Engineering 16245 Vineyard Blvd

2018

try out different components and windings to ensure the motor will perform at its best. This also ensures that prototypes operate the same as the manufactured parts. Plus, they test each motor in real time. Best of all, they can grow with your needs. The benefit of having multiple manufacturing facilities—within the United States and in Asia— allows them to maintain whatever volume you need, as well as handle spikes with minimal concern.

Morgan Hill, CA 95037 www.LinEngineering.com

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LEADERSHIP IN MEDICAL TECHNOLOGY

2018

Linemaster Switch Corporation’s mission is to provide a superior foot switch at an affordable price without compromise. Our primary function is to design and manufacture custom and standard foot controls per the specifications of our customers. Linemaster offers a wide range of foot switches consisting of USB, Linear Hall Effect, Electric, Air Powered, Variable

Linemaster – Leader in Engineering

Speed Control, and Wireless to the medical market. Linemaster’s high quality

Linemaster has been the leading manufacturer of medical grade foot controls since 1952. Linemaster has used 65 plus years of foot switch knowledge to become the vendor of choice by the majority of the major medical OEM’s that require a sophisticated foot switch or hand control solution.

controls serve as a perfect human interface device accessory for thousands of different medical applications worldwide.

Linemaster’s engineering expertise and product knowledge has been an asset to Medical OEM’s in search of a completely custom medical grade control to complement their equipment.The

ability to converse with our customers on a consistent basis and obtain their required needs, allow us to turn those ideas into 3D models, working prototypes, and production units. During the design phase, Linemaster offers our customers electrical and software support to make sure that the controls operate flawlessly with the OEM’s equipment.This attention to the customer and their needs makes Linemaster the leader in Engineering in the foot control arena. Over the years Linemaster has transformed from a manufacturing house that provides high quality foot controls to a full design house that offers the customer our design services, while at the same time providing a highly reliable, ergonomic, and aesthetically pleasing human interface device.

Linemaster Switch Corporation 29 Plaine Hill Rd. Woodstock, CT 06281 860-974-1000 www.linemaster.com info@linemaster.com

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LEADERSHIP IN MEDICAL TECHNOLOGY

2018

Master Bond is celebrating 40 years of formulating cutting edge adhesives, sealants, coatings and potting/encapsulation systems for challenging medical device applications. High Performance Adhesives, Sealants & Coatings Our expansive line of epoxies, silicones, UV curable and LED curable compounds can be customized to meet a myriad of property requirements including: • High/low temperature resistance • Electrical conductivity/insulation • Thermal conductivity • Sterilization resistance • High/low viscosity • Flexibility and toughness • Optical clarity Developed to withstand harsh environmental conditions, our products feature superior longterm durability. They are used in a variety of industries and are designed to meet stringent industry standards and are certified for: • USP Class VI • ISO 10993-5 • NASA low outgassing • FDA CFR 175.300 & FDA CFR 175.105 • UL 94V-0 & UL 94V-1

Outstanding Customer Support Master Bond makes customer support a fundamental priority in the adhesive selection process. Our technical specialists have decades of experience and will work with you, one-on-one, throughout the design, prototyping and manufacturing stages of your application.

MasterSil 912Med: Biocompatible Silicone Passes USP Class VI Testing MasterSil 912Med is a single component silicone with a paste viscosity offering a non-corrosive, neutral cure. Complying with USP Class VI and ISO 10993-5 specifications, it resists many kinds of sterilization including gamma radiation, EtO and some types of liquid sterilants. MasterSil 912Med withstands rigorous thermal cycling as well as thermal and mechanical shock. UV15DC80Med: Features Superior Sterilization Resistance Master Bond UV15DC80Med is a special dual cure epoxy based system that offers a primary cure using UV light along with a secondary heat curing mechanism. This enables the adhesive to cure areas on parts that do not allow UV light curing because of “shadowing” issues. It also meets USP Class VI specifications and passes ISO 10993-5 cytotoxicity testing.

Master Bond 154 Hobart Street Hackensack, NJ 07601

See how Master Bond began in a video that celebrates our 40 year history as an adhesives formulator.

Tel: 201-343-8983 Fax: 201-343-2132 www.masterbond.com technical@masterbond.com

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2018

LEADERSHIP IN MEDICAL TECHNOLOGY maxon drives set the world in motion. maxon motor combines electric motors, gears and DC motor controls into highprecision, intelligent drive systems that can be custom-made to fit the specific needs of customer applications. maxon motor helps provide innovative solutions at competitive prices for numerous applications in various markets, such as industrial automation, medical, robotics and aerospace.

Offering solutions that fit your customized needs maxon precision motors focuses on comprehensive solutions optimized through a diversified product range and client consultation. maxon motor manufactures small, highquality brush and brushless DC motors ranging in size from 6 mm to 90 mm. maxon’s rhombic wound ironless rotor motors provide exceptionally high efficiency, low EMI emissions, fast acceleration, no preferred rotor position, torque constants and long

service life. The drive components are assembled and designed according to your individual needs. Our modular system includes planetary, spur and special gearheads as well as encoders and control electronics. With over 50 years of experience, high-tech innovations and superior product quality, maxon is the reliable partner in drive technology. Individual, customized drive solutions are our greatest strength.

Customized drive solutions in a few easy steps DC brushed and brushless motors configurable online and ships in 11 days. maxon motor’s X drives are extremely powerful and are easily configured online. Customers can fit the drives with specific mechanical and electrical components specific to their application needs. It is possible to customize the shaft lengths, winding types, ball bearings and much more. When combined together with maxon encoders and planetary gearheads, you form a highprecision, robust drive system ideal for any application from aerospace to medical to robotics. In fact anywhere that requires a compact, powerful, quiet and strong drive system. In addition, detailed product data may be viewed immediately online and 3D CAD data for the configuration is available for downloading.

maxon precision motors, inc. 101 Waldron Road Fall River, MA 02720 508.677.0520 info@maxonmotorusa.com maxonmotorusa.com

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The first sterilizable drive system now available. maxon offers a sterilizable ENX EASY encoder, providing its customers a complete system with BLDC motor, gearhead, and sensor that withstands more than 1000 autoclave cycles. The world’s first steam sterilizable encoder ENX EASY is available in an incremental (1024 counts) and an absolute version (4096 steps) for diameters of 13 and 16 mm. The encoder can be integrated into the brushless drives ECX 13 and ECX 16 SPEED without increasing the length. When the gearheads GPX 13 and GPX 16 SPEED are added to the combination, our customers receive a fully sterilizable positioning system.

www.medicaldesignandoutsourcing.com

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LEADERSHIP IN MEDICAL TECHNOLOGY

2018

Your Reliable Power Partner MEAN WELL was established in 1982 and is a leading standard switching power supply manufacturers in the world. MEAN WELL USA was established in 1999 as a sales and support center for customers in North America and Canada. Located in Fremont California, MEAN WELL USA offers customers local engineering and technical support as well as a local warehouse to provide just-in-time delivery for any power supply requirement. Our trained staff of sales and technical engineers can help you select from a wide assortment of power supplies the best one that fits your needs.

“Total Quality Assurance and Customer Satisfaction” are the central goals of our company. We believe that our industry is one where reliability in long-term use, functionality and cost are all of great importance, but that it is reliability that differentiates the truly superior products. So, every product in the MEAN WELL range is the result of rigid procedures governing design, design verification test (DVT), design quality test (DQT), component selection, pilot-run production, and mass production. We have recently implemented a new and highly efficient computerized management system. This system allows improved administration of sales, purchasing, manufacturing management, shipping, customer service, and quality analysis, allowing us to ensure the best QCDS (Quality, Cost, Delivery Time, Service) for our customers

Our goal is to offer total solutions that satisfy our customer’s requirements.

We have earned a good reputation based on the quality, competitive prices and punctual delivery of our products. Currently, we have around 200 distributors and thousands of customers throughout the world. We have formed long-term associations with most of our customers, working together for many years, developing many treasured relationships. MEAN WELL USA, Inc.

9000 Standard Models

44030 Fremont Blvd. Fremont, CA 94538 mwsales@meanwellusa.com www.meanwellusa.com

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We have over 9,000 standard models widely used in automation, communication, LED lighting, medical, moving sign, and office automation fields. NMP family, MEAN WELL new launched industrial and medical miniature power supply, has multiple intelligent control mode. Users can set and modify output voltage and power as their wish through modules combination. Products are equipped with diverse remote control signals, and smart cooling fan can self-adjusts its spinning speed according to environment temperature to boost product efficiency, product lifecycle, and energy conservation. Passing medical and ITE dual international regulations, NMP series is an intelligent multi-module power supply with high performance and energy conservation.

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LEADERSHIP IN MEDICAL TECHNOLOGY

2018

Full Service Contract Manufacturer • ISO 13485:2016 Certified • FDA registered • Clean Room Molding • Clean Room Assembly

Medbio

• Clean Room Packaging

Located in West Michigan, Medbio is an ISO 13485:2016 certified contract manufacturer offering innovative manufacturing solutions for the medical and biotechnology industries. We specialize in precision injection molding, assembly, packaging, project management, and design support.

• Precision Injection Molding • Insert & Over Molding • Micro Molding

Our facility contains a certified ISO Class 8 clean room for molding, along with a certified ISO Class 7 clean room for assembly and the molding of implants. We have flexible capacity to handle major projects or small custom orders. We mold most medical grade thermoplastics, including implant grade “PEEK”. We currently mold products for OEMs in Orthopedics, Cardiovascular, Ophthalmology, Neurological Surgery, General Surgery, Wound Care, Biotech (diagnostics & cell growth), and Dental. Members of our leadership team average over 25 years of medical device industry experience, so we know what it takes to get a new product to market. Supported by a staff of 23 Engineers, Medbio is able to help our customers through all phases of their project. A commitment to delivering quality service and value to every customer is a priority at Medbio. We’ve earned a reputation of excellence and strive to exceed those expectations. Please contact John Woodhouse, Director of Sales & Marketing, to begin your next project with Medbio and become one of the customers we so greatly value.

Medbio 5346 36th St SE Grand Rapids, MI 49512 P: 616.245.0214 medbioinc.com

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LEADERSHIP IN MEDICAL TECHNOLOGY

2018

Founded in 1990, MEDEFAB has built a solid reputation within the OEM medical manufacturing community, for quality and precision products. Unlike most extrusion houses, MEDEFAB extrudes and engineers their catheter and tubing products into a variety of medical device components. These are then used as a single component, or as a sub assembly in surgical procedure Kits, or finished devices, for the World’s leading Brands. In addition, MEDEFAB’S specialized proprietary processes, are provided to other contract manufacturers, as well as single source providers and development houses. With 25 years of experience and a continually expanding manufacturing facility and available services that we can offer to our customers, MEDEFAB has morphed into southern NH’s best kept secret.

Major Markets MEDEFAB’s OEM products, are produced for and in partnership with, many leading medical device companies and a host of smaller device manufacturers. Products are used in and support numerous primary medical fields as well as surgical applications, diagnostic purposes and ancillary devices.

Services Offered

MEDEFAB 81 Turnpike Road Jaffrey, NH 03452 Phone: 603.532.5656 Fax: 603.532.5921 Email: info@medefab.com www.medefab.com

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As a full service OEM custom Extruder/Medical Device Manufacturer, all items are produced in house. Production services offered Include: Tubing extrusion of most thermoplastics, loose piece and insert over-molding, on a variety of substrates utilizing numerous molding compounds. Catheter and Tube based finishing operations include flaring, shaping, tipping, hole and eye placement, performed using precision custom equipment, developed and built in-house. Complete pad printing services are available for catheter based devices, tube and component marking utilizing multicolor, long length and 360 degree wraps. Hot stamping services and polyolefin marker bands, produced on custom equipment is also available. Complete turnkey manufacturing includes assembly, pouching packaging and sterilization. Custom processes and fixturing are tailored to each customer’s specific and unique needs and produced in house. Strict control over the manufacturing process results in high quality components and devices.

www.medicaldesignandoutsourcing.com

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LEADERSHIP IN MEDICAL TECHNOLOGY

2018

Memory Protection Devices, Inc. (MPD) is an ISO 9001 certified global manufacturer of battery holders,battery contacts, auto plugs, auto sockets, fuse holders, DC jacks, DC plugs, and other electronic components and devices. Our parts are manufactured to rigorous standards in factories located around the world, which meet not only our quality requirements, but our social ones as well. We believe that many components have not been given as much thought as they deserve, and every day we work to find the next innovative design. After all, a defective component can cause

MPD is one of the world’s largest creators and suppliers of innovative and cost-effective battery and coin cell holders and contacts. We created the coin cell holder, and it is still the core of our product line. MPD also offers a full line of automotive plugs, cord sets and other components like fuse holders and power plugs, jacks and adapters. Another advanced concept introduced by MPD is our line of “Gliders’: hybrid coin cell holders that combine the low cost of retainers with even higher reliability than standard coin cell battery holders. MPD is proud to be partnering with Microsoft to bring you the patented new Instaload technology. Gliders, SnapDragon and Instaload are the next chapter in the story of MPD’s quest to make sure that battery holders are as technologydriven as the products in which they are used.

complete failure in most devices, and a poorly designed one can cause many inconveniences to end users. It is due to this core value that MPD is viewed as the industry’s leading innovator.

200 Broad Hollow Rd., Ste. 4 Farmingdale, New York 11735 Phone: 631-249-0001

Products and services include electronic design, prototypes and mass production for Battery holders, contacts and sockets and other power connection related products. Since 1980, Memory Protection Devices, Inc has been offering battery holders and contacts for lithium coin cells and alkaline cells. We offer products based on a range of standard products and custom proprietary solutions. SnapDragon and Gliders were the last chapter in the story of MPD’s quest to make sure that battery holders are as technologydriven as the products in which they are used, stay tuned for more announcements in 2016. New products, new ideas, new designs coming your way soon !!

Fax: 631-249-0002 memoryprotectiondevices.com

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LEADERSHIP IN MEDICAL TECHNOLOGY As the exclusive provider of FAULHABER products for North America, MICROMO creates value through advanced design and engineering services.

2018

MICROMO A SOLUTION FOR EVERY MOTION APPLICATION

We’re proud to offer the broadest range of high precision, high performance products for micro motion applications in the medical market. MICROMO brings together the highest quality motion technologies and value-added services in North America plus global engineering, sourcing, and manufacturing to deliver the best micro motion solutions. MICROMO partners with customers to deliver quality, innovative solutions faster and better every time. Contact the MICROMO Team today. MICROMO is your full service, value added outsourcing partner: • •

ISO 9001 and 13485 certification Custom design and complete clean room subassembly Express prototyping Machining center State-of-the-art testing laboratory Energy-efficient solutions and enhanced product life

• • • •

MICROMO’s benchmark contributions with motion solutions are a part of many leading products and applications in markets such as Medical Devices, Robotics and Automation, Optics and Photonics, Aerospace, Defense and Instrumentation.

MICROMO 14881 Evergreen Ave. Clearwater, FL 33762 T: (800) 807-9166 F: (727) 572-7763 www.micromo.com

EXCELLENCE IN MICRO MOTION SOLUTIONS

Since 1961, MICROMO is the trusted partner of OEMs for micro motion solutions and sub-assemblies. As the industry leader with micro motor, encoder technology as well as design customization, we bring together value-added services and cutting-edge technologies from around the world through high efficiency, high performance rotary and linear offerings, such as brushed, brushless, stepper, thin-profile DC, piezoelectric & linear motors.

YOUR SOLUTION, OPTIMIZED

MICROMO creates value through advanced design and engineering services: • Precision Actuation Systems • Design and Integration Components • Drive and Control Integration • Performance and Cost Optimization

QUALITY LEADERSHIP

MICROMO is ISO 9001 13485 certified and RoHS compliant. With the FAULHABER Group’s ISO 14001 certification, MICROMO provides the highest quality standards for the design, development and manufacturing of fractional horsepower drive systems for diverse markets.

TECHNOLOGY LEADERSHIP--IT ALL STARTED DECADES AGO WITH THE “FAULHABER COIL.”

Decades ago, Dr. Faulhaber patented the first selfsupporting, ironless, skew-wound rotor coil, and the FAULHABER Group motor technologies grew from this revolutionary patented system. The system centers on winding hollow, low-inertia moving coils for maximum power and efficiency in the smallest physical spaces. By remaining close to the company’s engineering roots, MICROMO is the premier provider of micro motion control systems. MICROMO’s product line includes fractional horsepower DC coreless motors, PMDC motors up to 1,000 Watts, brushless DC motors, stepper motors, piezo motors, linear servo motors, precision gearboxes, optical and magnetic encoders, fail-safe brakes, tachometers and tacho-generators, controllers, micromechanical systems, complete servo systems, and custom subassemblies that incorporate these products for integration into OEM devices.

IT’S ALL HERE IN NORTH AMERICA

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From concept to delivery, MICROMO (Clearwater, FL) provides it all. With on-site machining and assembly facilities, a versatile standard product line, an Advanced Engineering Group, and over 5,000 special executions, customization is MICROMO’s strength. MICROMO’s operations include a state-ofthe-art CNC machining center, a 12,000 ft² clean room assembly operation (class 100,000 capable), and a design, R & D and engineering testing center. All application work is carried out by in-house engineering staff. MICROMO’s engineering team partners with over 3,000 customers for the design, specification and after sales support of industry leading motion control products. With extensive local inventory and online product analysis and purchase via the MICROMO Motion System Selector™, many products can be delivered in three days or less to meet immediate design and testing requirements.

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LEADERSHIP IN MEDICAL TECHNOLOGY Model Solution Does More: Precision Prototyping, Tooling & Manufacturing Services Medical equipment manufacturers rely on Model Solution for quality products delivered quickly. More than design validation, tooling, model making, injection molding, or 3D printing, Model Solution offers more design and manufacturing services, expertise, and support to accelerate medical product development -- getting you to market faster.

Automatic Medicine Dispenser

Approachable Model Solution fine tunes your medical device design through strategic collaboration among designers, engineers and modelers. We serve as an extension of your design team to offer the most efficient, appropriate and cost-effective solution. Model Solution is the one-stop source for: • • • • •

complex tooling precision prototyping & modeling design for manufacturability low volume manufacturing and everything in between

Model Solution supports a wide range of medical device manufacturers including makers of diagnostic, lab, monitoring, portable, surgical, therapeutic and treatment medical devices. Model Solution delivers products with vivid colors, innovative materials and state-of-the-art finishes that meet your look, feel, function and build requirements. Model Solution’s precision, speed, expertise and innovation make it the default choice for your next medical device project.

Precision Prototyping & Modeling 24-hour Support Model Solution does more – especially when it comes to innovative medical product design & development. With a new North American headquarters and rapid prototyping center in Silicon Valley, Model Solution supports customers with rapid sketch and mock-up capabilities, local project management and 24hour global support including same-day technical assistance. Model Solution condenses the medical design cycle and delivers prototypes and models to validate the design functionality and evaluate the color, material and finish.

Tooling from Prototype to Production Model Solution has simplified and accelerated the tooling process with its new ProtoTool program - saving time and money. Using robust steel mold-cores that last longer than Medical Suction Injector aluminum molds, Model Solution eases the modification process for fine-tuning designs and gets medical products to market faster. From prototype to production – from plastics to metals to silicone, Model Solution precision prototype, preproduction and production tooling means more quality parts delivered quickly.

Manufacturing Manufacturing made easy – Model Solution embraces the production experience, from concept to prototype to Lot-B production. Offering metal stamping, plastic injection molding, compression molding and clean-room molding services, Model Solution delivers machined or molded parts in the color, finish and material you specified – FAST. Model Solution also offers subassembly or finished product assembled in production quantities up to 100,000 pieces to bring product to market even faster.

Model Solution 1.669.241.8233 Email: rfq@model-solutions.com www.model-solutions.com

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LEADERSHIP IN MEDICAL TECHNOLOGY

2018

End-to-End Metal Component Suppliers MW Medical Solutions specializes in designing, manufacturing and supplying highly engineered precision metal components and assemblies for medical OEM and medical device contract manufacturers. Our network of industry leading brands includes BellowsTech, FL; Economy Spring, CT; Helical Products, CA and Servometer, NJ. Our combined strength of core competencies delivers a unique set of specialty products in drug delivery as well as surgical instruments and an unprecedented level of excellence

Industry Know How.

Advanced Manufacturing Services:

For over 100 years we have specialized in the science of quality engineered and often complex drug delivery and medical device components. That combination of knowledge and expertise provides an unprecedented level of security and confidence to our customers.

• Assembly – Final Assembly • Micro-Machining • Laser Swiss Machining • Packaging • EDM

in engineering expertise. ISO 13485

Trusted Partner.

Compliant. FDA registered.

• Heat Treating

Our network of professional design engineers offer valuable product lifecycle experience. They perform design optimizations for you that improve on manufacturability and automation. We also offer collaborative design partnerships for new product developments. Through countless product launches, our teams are committed to our customers from prototype to full production runs, customer service, inspection and quality control.

• Rapid Prototyping • Electroplating • Welding • Soldering • 3D Printing

Quality and Industry Approvals. MW Medical Solutions is focused on continuous improvement and commitment to exceptional levels of quality and service at every stage from concept to delivery.

MW Industries, Inc. 9501 Technology Boulevard, Suite 401

• ISO 9001:2008

Rosemont, IL 60018

• ISO 13485 Compliant

mwmedicalsolutions.com

• ISO 8, Class 100,000 Clean Room • FDA Registered Facility • REACH

• Fluid Delivery • Dispensing Tips • Specialty Needles • Cannula and Assembly Products • Catheters

• RoHS

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Applications:

• Laparoscopic Devices

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• Home Dialysis Pumps

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LEADERSHIP IN MEDICAL TECHNOLOGY

2018

Healthcare-Focused Custom Packaging Solutions With facilities in Cranston, RI; Phoenix, AZ: Whitehall, PA; Liberty, NC; Venray, the Netherlands; Galway, Ireland; Juncos & Humacao, Puerto Rico; and San Jose, Costa Rica, Nelipak® Healthcare Packaging designs, develops and manufactures custom thermoformed packaging products that provide superior protection for medical devices and pharmaceuticals. The company offers medical trays and blisters, surgical procedure trays, pharmaceutical handling

Nelipak Healthcare Packaging has cultivated a global team of first-rate, 100% healthcare-focused engineers and designers that apply extensive expertise to develop custom packaging solutions which meet our customers’ unique and specific needs for pack performance, functionality and product protection – all while adhering to the stringent considerations of surgical environments.

trays, custom built sealing machines and other value added services.

Nelipak is a true partner that adds value to our customer’s packaging products from the earliest design phase through to manufacturing and validation. Nelipak’s development process starts with our experienced team providing sketches or digital images followed up with detailed CAD drawings and prototypes. As the project progresses, pre-production items will be made and then tooling is created, tested and put into production once approved. Throughout this process we have ongoing dialogue with our customers about the design, progress and potential modifications to ensure satisfaction.

Design Expertise and Technology Nelipak understands that modern software and technology is critical to a successful outcome and keeps abreast of the latest developments to maintain our leadership position through regular investments in new and upgraded systems.

Nelipak Healthcare Packaging 21 Amflex Drive Cranston, RI 02921

Waste and Cost Reduction through Design

www.nelipak.com

Our engineers and designers always keep in mind that the package should fit all your requirements, and provide the most costeffective solution while minimizing waste.

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LEADERSHIP IN MEDICAL TECHNOLOGY

2018

Custom Medical Extrusions Incorporated in 2001, New England Tubing Technologies occupies a 14,000 square foot state-of-the-art controlled environment manufacturing facility in the beautiful White Mountains of New Hampshire. Partnering directly with the world’s leading medical electronics and device manufacturers, we design custom braid or spiral reinforced tubing, lined catheter shafts, and hybrid tubing built to exacting specifications.

NEW ENGLAND TUBING T E C H N O LO G I E S

Working directly with clients in the medical electronics and device industries, as well as with other custom industrial and commercial projects, we design and manufacture custom braid or spiral reinforced tubing, lined catheter shafts, multi-durometer and multi-lumen tubing, hybrid tubing configurations, as well as medical braid. Building on the decades of extrusion and wire-processing experience of our parent company, New England Wire Technologies, New England Tubing is advancing innovation in thin-wall, tight tolerance tubing, reinforcing, bonding layers of thermoplastic to fluoropolymer, and braiding all types of round and flat wire.

New England Tubing Technologies

Our team of design engineers work personally with each customer to develop innovative, one-of-a-kind tubing solutions and custom OEM components from their specifications or to meet unique performance characteristic requirements.

132 North Main Street Lisbon, NH 03585 United States www.newenglandtubing.com

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We also offer a wide range of value-added and post-processing services—tipping, hubbing, flaring, Parylene coating, centerless grinding, and cut to length options. Through true vertical integration of manufacturing processes, New England Tubing Technologies is able to offer customers everything from rapid prototyping services and small quantity orders to full production and value-added services. Let us help you dream beyond today’s technology and achieve the impossible!

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LEADERSHIP IN MEDICAL TECHNOLOGY

2018

New England Wire Technologies is a privately held company with an employee

Founded in 1898 in response to the birth of the communication age, today New England Wire is advancing innovation in several industries including medical device and electronics, aerospace, defense, robotics/automation, power generation, and alternative energy. Our capabilities include custom Litz wire, miniature, micro-miniature, single and multiconductor cables, low-noise, high temperature, coaxial and hybrid cables. Since the 1960’s, we have provided cabling and insulating services to the superconductor industry where our products are integrated into most of the major accelerator projects, ore separator magnets, NMR magnets, and superconducting magnetic energy storage (SMES) magnets.

stock ownership program. For over 115 years, we have manufactured the most technologically advanced wire and cable in the industry. Our 400,000 square foot, state-of-the-art facility, located in Lisbon, NH, houses manufacturing, R&D, quality/ testing, tooling/machine fabrication and office space. With almost 400 employees, we operate 3 shifts per day, five days a week. As an ISO9001 registered company, we specialize in technical cable solutions, short lead times, and unparalleled customer service.

NEW ENGLAND WIRE T E C H N O LO G I E S

New England Wire Technologies 130 North Main Street Lisbon, NH 03585 603.838.6624 www.newenglandwire.com

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Through our creative design and development expertise, our engineering staff specializes in product development, concurrent engineering, design for manufacturability, and quick-turn prototyping. Our on-site manufacturing processes include wire drawing, plating, braiding, insulating, and extrusion services. And, since all of our proprietary equipment and tooling is designed and built in-house, we have complete control while also offering quick modifications when needed. Through true vertical integration of the manufacturing processes, our customers’ design-to-market curve is the shortest in the industry! New England Wire Technologies is committed to being the premier custom cable manufacturer of choice for customers in existing and emerging worldwide specialty cable markets. We help our customers dream beyond today’s technology and achieve the impossible!

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LEADERSHIP IN MEDICAL TECHNOLOGY

2018

Nitto Kohki USA Nitto Kohki USA, Inc. designs, develops, engineers, and continuously improves high quality air compressors and vacuum pumps for applications like medical devices, laboratory equipment, applied robotics and environmental sensing equipment. Nitto Kohki’s unique linear free piston design has one moving part per pump— the piston. The result is a pump with exceptionally reliable performance in tough medical applications. The linear free piston concept enables Nitto Kohki pumps to be smaller and lighter than conventional aerators, allowing designers greater flexibility in system design.

Nitto Kohki leads through exceptional product design and execution, with pumps that meet the rigorous demands of today's medical device industry. Nitto Kohki pumps feature a unique, patent-awarded linear-motor-driven free piston system that is globally proven in the medical device, instrumentation, and other critical industries. This unique design theory eliminates the wear components typically found in conventional air compressors and vacuum pumps, such as crank shafts, connecting rods and ball bearings. The only moving part is the piston! Also eliminated is the need for any lubrication. Fewer parts translate into fewer problems.

Nitto Kohki USA, Inc. 46 Chancellor Drive Roselle, IL 60172

WHY DESIGNERS CHOOSE NITTO KOHKI

• Exceptionally reliable performance for critical applications • World class manufacturing expertise ensures consistent product quality • Clean, simple design maximizes performance, minimizes maintenance — adding value over the integrated product lifecycle.

www.nittokohki.com

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LEADERSHIP IN MEDICAL TECHNOLOGY Norman Noble, Inc. is the most technologically advanced contract manufacturer of vascular implants and devices in the medtech industry supplying the top medtech OEM‘s in the world. Some of the products we manufacture for our customers include:

2018

Nitinol Impant Manufacturing Noble S.T.E.A.L.T.H. (System To Enable Ablation Laser Technology Haz-free). Our athermal laser machining process was developed to create highly precise features in any material, including bioabsorbable polymers, shape memory metals and other bioresorbable alloys, without producing any heat affected zone (HAZ).

• Vascular Stents (Cardio, AAA, Peripheral, Carotid, Venous, Neuro) • Transcatheter Heart Valve Components • Vascular Closure Implants • Neurovascular Clot Pullers and Flow Diverters • Vena Cava Filters • Orthopedic Anchors, Screws, Plates • Atrial Fibrillation Devices • Heart Pump Components

Noble SynchroFlash: A new capability that combines Swiss turning & milling with laser machining to create one, highly efficient and cost-effective operation. Noble SynchroFlash provides cost savings, faster production, better quality and higher yields versus competing manufacturing methods, which require multiple, separate processes.

Norman Noble Inc. 5507 Avion Park Drive Highland Heights, OH 44143 800.474.4322 www.nnoble.com

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LEADERSHIP IN MEDICAL TECHNOLOGY NSK is a world class manufacturer of motion and control products. Founded in 1916, NSK was the first company in Japan to develop and produce bearings. For the last century, NSK has proven to be an industry leader backed by superior quality, engineering research and technical innovation. NSK manufactures and distributes a wide range of rolling element bearings, linear motion, mechatronics and automotive component products. Striving to set the future in motion, NSK will constantly find ways to innovate and bring value to society by creating new products and technologies for the next 100 years. Operating in the Americas, NSK Corporation is a member of the NSK Ltd. Group and is headquartered in Ann Arbor, Michigan. NSK Corporation has a network of sales and engineering teams working in partnership with customers to deliver high performance products, application-specific solutions, superior technical support and exception service to the Americas market. The company’s strategically located manufacturing and distribution centers supply both original equipment manufacturers and the industrial aftermarket through a broad distribution network.

2018

Constantly Striving to Provide Innovation to Med Tech Industry In the field of motion control, innovative engineering is paramount to optimal design and performance. NSK has proven to be an industry leader dedicated to applying innovative, technical solutions for the future advancements required in medical, biotech and pharmaceutical industries. NSK linear motion and bearing solutions have been used for imaging, diagnostic, surgical robotic and medical equipment applications. As NSK continues to expand its capabilities, new product solutions are engineered. Our dedicated team of engineering staff collaborates with the customer to develop an integrated system. We understand the importance of delivering solutions to an environment that is constantly evolving and looking to new technology in order to improve outcomes within the field of medicine.

Innovative Engineering + Precise Motion = MBSA Series The Motorized Ball Screw Actuator (MBSA Series) combines one of NSK’s precision ground ball screws with a NEMA stepping motor. This innovative new product delivers a compact design eliminating the need for motor couplings. Superior to a lead screw, the precision ground ball screw offers: • Longer Life • Higher Efficiency • Improved Rigidity • Lower Friction • Smooth Operation • Zero Backlash Designed to fit a configurable encoder that is mounted to the back of a stepper motor, the MBSA Series design allows you to select the controller/driver of your choice.

NSK Americas

For more information about the MBSA Series and other innovative product solutions for medical applications, http://www.nskamericas.com/ball-screws-564.htm.

4200 Goss Road Ann Arbor, MI 48105 1-800-255-4773 info@nsk-corp.com nskamericas.com

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LEADERSHIP IN MEDICAL TECHNOLOGY You Have a Product Idea. We’ll Make It A Reality. Okay Industries is an ISO 13485 certified and FDA registered company specializing in advanced technologies in Swiss-type turning, laser tube cutting, welding and surface treatments; complex metal stampings; multi-axis CNC milling/turning and automated assemblies. OKAY offers in-depth product design assistance and process knowledge to meet the stringent requirements of the medical device component and sub-assembly markets.

With over 100 years of experience, Okay Industries is an engineeringdriven medical device component and subassembly contract manufacturer you can rely on for highly manufacturable solutions that meet the most complex design and quality requirements.

Expertise includes stamping Titanium, Nitinol, and Stainless Steel, Accu-Blade® technology for grinding surgical blades and scissors and Accu-Laser Swiss

We truly are a strategic partner focused on providing technical and human resources to help you design, manufacture and deliver the next generation of medical devices with precision and speed.

processing.

You can trust our world-class laser processing, precision CNC machining, metal stamping and quality systems to enhance your products. Our investments in robotics and automated vision systems deliver process improvements that maximize manufacturability, reduce costs and ensure consistent performance. Our interactive R&D laser lab – Okay LaserWorks –gives you access to fully dedicated, production-grade laser technologies and the thought leading support of Okay’s laser engineers. Together we can collaborate to solve design challenges, prototype and test concepts, reduce time to production and provide a reliable, repeatable manufacturing processes.

Okay Industries 200 Ellis Street New Britain, CT 06051 www.okayind.com

Okay’s highly skilled engineers, designers, machinists, toolmakers, project managers, planners, operators and administrative professionals are committed to improving your products in two Connecticut-based plants and our international plant in Alajuela, Costa Rica. Our global team is committed to being the solution-driven partner you can rely on to ensure healthy patient outcomes in communities around the world.

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LEADERSHIP IN MEDICAL TECHNOLOGY

2018

Award-Winning Electronic Enclosures OKW Enclosures, Inc. is a specialist manufacturer of enclosures for OEM electronics. The company’s extensive and award winning program includes pocket-size, handheld, desktop, portable, wall mount and DIN rail enclosures, plus accessories and a large range of tuning knobs.

OKW manufactures advanced enclosures for today’s electronics equipment. The enclosures can be supplied fully customized to customer specifications. The range includes the following popular versions:

Handheld Enclosures

OKW also offers a comprehensive customizing service which can supply the enclosures fully finished with all the modifications necessary for mounting the customer’s components. Options include CNC machining, custom colors and materials, digital printing and much more. Free samples are available for evaluation.

Modern and ergonomically designed enclosures for mobile electronics used both indoors and outside. Standard features include recessed tops for locating membrane keypads, battery compartments for AAA, AA and 9V cells, integrated cable glands, infra-red versions, sealing kits up to IP 65, desk stations for charging and wall holders for storing. Many of these enclosures can also be used as wearable devices with the optional wrist/hand straps, belt/pocket clips and lanyards.

Instrument Enclosures

Stylish high quality enclosures for table-top and portable electronic instruments. Large range of designs in plastic or aluminum with removable front panels or sloping front sections. Options include aluminum or plastic front panels recessed for membrane keypads, ventilation slots, battery compartments, bail arms or integrated handles and non-slip feet.

Wall Mount Enclosures

OKW Enclosures, Inc.

Advanced wall mount enclosures for indoor and outdoor electronics equipment. Stylish and modern design sets these enclosures apart from the norm. Standard features include hidden fixing screws for a clean and tamper-proof assembly, recessed top for a membrane keypad, standard ingress protection up to IP 67 ( NEMA 4X) and hinged solid or transparent lids.

Abele Business Park 3000 Old Pond Road Bridgeville, PA 15017 United States Tel: (800) 965-9872

www.okwenclosures.com

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LEADERSHIP IN MEDICAL TECHNOLOGY Modern CAD in a Secure Cloud Workspace Onshape is a modern professional 3D CAD system that eliminates design gridlock: the constant waiting, distractions and hassles that prevent engineers from doing their best work. Onshape users in 170+ countries have logged over 3 million hours modeling robotics, biomedical devices, industrial machinery, power turbines and many other products. Based in Cambridge, Massachusetts,

Onshape is a modern CAD system that frees engineers to focus on doing their best work. Unlike old CAD systems, Onshape unites modeling tools and design data management in a secure cloud workspace that is accessible on any computer, tablet or phone. You’ll never lose your data or deal with design gridlock ever again.

Onshape was founded by the original creators of SOLIDWORKS® and its team includes elite engineers from cloud

Old tech belongs in a museum, not on your desk. The truth is that many engineers are still using file-based CAD technology that’s more than two decades old. These CAD systems were breakthroughs at the time, but they were never meant for teams. Ironically, they are now slowing companies down by blocking collaboration, creating multiple file versions that result in costly errors, and causing engineers headaches from system crashes and lost work.

infrastructure, data security and mobile.

Onshape 1 Alewife Center Suite 130 Cambridge, MA 02145 www.onshape.com

Using a unique database architecture, Onshape:

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Enables multiple engineers to simultaneously work on the same design.

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Requires no downloads, installs or IT support.

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Provides new team members with instant CAD access.

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Has built-in data management, preventing engineers from overwriting each other’s work.

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Automatically upgrades your system every three weeks.

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Eliminates software incompatibility problems. Every Onshape user in the world is always on the same software version – the latest one.

www.medicaldesignandoutsourcing.com

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LEADERSHIP IN MEDICAL TECHNOLOGY

2018

Leader of orthopedic medical device outsourcing Orchid is a worldwide leader of orthopedic medical device outsourcing, providing contract design and manufacturing services. We are a strategic sourcing partner that can handle an entire project or provide services at a Single Point in the process. We have the broadest portfolio in the industry, ranging from design and development through finished goods manufacturing and packaging, and we improve our customers’ supply chains through our supply chain solutions.

Orchid is driven to success through our customer-focused team, living out our core purpose and values and striving for continuous improvement. We are a complete value stream partner for our customers. As the market changes, so do our customers’ needs, and we are deliberate in adapting to be the best partner we can be. We offer the most orthopedic solutions under one roof. We partner with our customers to provide value-added solutions, including managing supply chains, ensuring risk mitigation, tying value streams together and providing a complete and finished product already in the package.

Orchid Orthopedic Solutions 1489 Cedar St. Holt, Michigan 48842 United States

Orchid Design’s design-to-manufacturing services help customers overcome complex and challenging processes related to product design and development. Orchid’s culture of continuous improvement continues to produce innovative products and solutions that better meet the needs of our customers. Orchid specializes in delivering the highest levels of quality, efficiency, and compliance on a local, federal, and international scale.

www.orchid-ortho.com

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LEADERSHIP IN MEDICAL TECHNOLOGY PTI Engineered Plastics is a custom

Art to Part

injection molder and manufacturer of plastic

PTI can take you from mind to manufacturing® starting with their industrial design and development studio. PTI Design can optimize your design, or take your idea through their fivephase process to ensure your product has a competitive edge in the market.

components and assemblies. PTI is a diverse company servicing the medical, automotive, defense/aerospace, consumer products, and electronics industries. From low to high

State of the art tool room

volume, simple to complex, prototype to

The PTI Tool Room has a fully-integrated network, (18) highspeed vertical machining centers, three of which are Makino with spindle speeds of 20,000 RPM’s complimented by a Makino Horizontal Machine. All machines utilize thermal shrink collet tooling for precision and accuracy. The EDM department includes (4) high-speed graphite robotic load machining centers with spindle speeds up to 54,000 RPM. They also offer plunge EDM machining and wire EDM capabilities. PTI uses an array of materials from aluminum, mild steel, hardened steels and stainless. Injection mold types include: unit-mold insert, free standing, shuttle loading, hot runner, single cavity and multiple cavity. PTI's P3™ Proprietary Process can create ready for production prototypes.

production, PTI has delivered quality end products for over 30-years. Certifications PTI is FDA, UL, and ITAR registered and ISO 13485, ISO 9001, ISO 16949, and AC8160 certified

There’s a science to being a highly productive plastics company. PTI's Production floor currently hosts (50) injection molding machines ranging from 12-750 tons of clamping force, with .33-98 oz. shot capacity. Manufacturing capabilities include low and high volume production, insert/overmolding, high-temperature molding, contract manufacturing, assembly and packaging.

Meeting the demands for controlled environment manufacturing. Services within ISO Class 8 Cleanroom include injection molding, assembly, secondary operations and packaging.

Saving you time and money. PTI offers an array of secondary services including plastic joining and part decorating services.

Plastic part validation have you buried? Let us dig you out.

PTI Engineered Plastics

PTI is fully versed and staffed in the IQ/OQ/PQ validation processes.

50900 Corporate Drive Macomb, MI 48044

Why Validate?

586.263.5100

• To ensure that the design, process, and products are created in a manner to prevent loss of life and harm.

teampti.com

• To produce safe parts for their intended use. • To reduce part rejection rates.

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• To ensure that the part meets the application requirements, specification, and regulatory obligation. • To prevent part failures in the field.

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LEADERSHIP IN MEDICAL TECHNOLOGY Qosina is a leading global supplier of thousands of stock components to the medical OEM and pharmaceutical industries, offering free samples, low minimums and just-in-time (JIT) delivery. Companies purchase from Qosina to eliminate tooling costs and receive immediate delivery from our inventory. We provide in-stock solutions based on the specific needs of your projects. Qosina is based in Ronkonkoma, NY, operating in a 95,000 square-foot facility with an ISO Class 8 Clean Room and is ISO 9001, ISO 13485 and ISO 14001 registered.

Qosina 2002-Q Orville Drive North Ronkonkoma, New York 11779 631.242.3000 www.qosina.com

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Whether you need molded or extruded components, high value plastic or metal, hard-to-find items, subassemblies or tubing, call Qosina today and speak with one of our highly-trained customer service specialists. We accept sourcing requests to modify any existing component or will build new tooling to meet your exact project requirements. We pride ourselves on our prompt, efficient customer service. Orders and sample requests are processed the same day.

Our Extensive Inventory

Angiographic Needles Applicators Bioprocessing Components Catheter Hubs Check Valves Clamps Clips Compression Fittings Dilators ENFit™ Connectors Extension Lines Forceps Hemostasis Valves Instrument Guards Kit Components Luers Masks Needleless Injection Sites NRFitTM Components Ports Pouches Quick Disconnect Couplings Respiratory Safety Scalpels Sanitary Fittings Single-Use Stainless Steel Spikes Sponges Stopcocks Swabs Syringes Torquers Trays Tuohy Borst Adapters USP Class VI Tubing

Our Services

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Comprehensive print and online catalogs On-hand inventory of 5,000+ SKUs Low minimum orders Free samples of most items Supply chain management Modification of existing tools New product design and development Exhibit at over 20 trade shows, both domestically and internationally Qosmedix®, a division of Qosina, serves the cosmetic, skin care, spa and salon industries.

www.medicaldesignandoutsourcing.com

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LEADERSHIP IN MEDICAL TECHNOLOGY

2018

Resonetics is the leader in laser micro manufacturing for life sciences. Core competencies are laser ablating, cutting, drilling and welding. Resonetics’ expertise started in polymer processing and has expanded to metals and glass. Our passion for laser technology complements our customers’ passion for improving and saving lives. In addition, Resonetics has many industry firsts and is serious about innovation; we invest in internal R&D initiatives each year, resulting in many process patents and novel applications for next generation life science applications.

Challenging the Limit of Laser Micro Manufacturing At Resonetics, we lead through our Advanced Technology Group (ATG) that thinks outside the current parameters of laser processing to solve customers’ most challenging technical problems. The ATG has produced many technical advances including a wide range of next generation capabilities like 3D micro ablation, precision nitinol cutting, advanced nitinol heat setting and electropolishing processes, and specialized multilumen ablation. A key innovation is 3D micro machining of metals. This is completed through a 3D micro ablation process, which is a miniaturization of swiss CNC machining. The coupling of a precision ablation laser with a multi-axis workstation has enabled the micro scale manufacturing of parts in a variety of metals (Stainless Steel, Cobalt Chrome, Platinum, Platinum/Iridium, and Nitinol to name a few).

44 Simon Street Nashua, NH 03060 603.886.6772 603.886.3655 Fax sales@resonetics.com resonetics.com

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3D micro ablation was developed based on the unmet customer needs in the Neurovascular and Ophthalmic markets, which required metal parts an order of magnitude smaller than CNC machining. To innovate nitinol laser cutting, Resonetics combined a precision motion control workstation with a next generation laser and fundamental process knowledge to create a stent cutting system that is second to none. This technology is capable of holding single micron standard deviations on 25 micron struts across 50 mm long stents. Additionally, in 2017, Resonetics’ technical team focused on process improvements of nitinol electropolishing. Electropolishing advances coupled with precision cutting give increased performance and manufacturing yield.

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LEADERSHIP IN MEDICAL TECHNOLOGY

2018

PROTOTYPE TO PRODUCTION – WE PLATE THE UNPLATEABLE

SAT Plating has expanded the range of plateable materials to include those considered highly difficult-to-plate: • ABS | PC/ABS • PEEK • PEI (Ultem™) • Nylon • Carbon Fiber materials • ASA • TPO’s Just to name a few! SAT’s Surface Activation process, along with the collection of other Adaptive Plating Technologies™, can be selectively applied to:

SAT Plating has unique and groundbreaking plating capabilities to help the medical industry develop advanced and innovative product solutions for their customers.

A new world of product design and engineering is possible by expanding the range of useable plastics and plateable product configurations. This is made possible by SAT Plating’s proprietary Surface Activation® technology enabling SAT to permanently improve the atomic structure of the polymer surface while using: No Plasma – No Corona – No Abrasive Blasting – No Hazardous Chemical Etching of the substrate. The result is superior adhesion of metal platings with no dimensional changes or erosion of fine details in your part. Surface Activation®, along with the collection of Adaptive Plating Technologies™, can be selectively applied to Films | Carbon Fibers | Fabrics | Tubes |Rapid 3D | Injectionmolded Parts as well, enabling best-in-class performance for:

PERFORM!

• Structural, Functional and Appearance Finishes • Superior Plateability • Selective Plating • Stronger Adhesive Bonding • Superior Paint Adhesion

SAT Plating

• Anti-static Qualities

1837 Thunderbird St.

• More Reliable Product Performance – through time, temperature and other environmental variations

Troy, MI 48084 www.satplating.com

SAT Plating’s technologies ensure: • High-definition – selective plating of conductive surfaces, antennas, functional and appearance coatings

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• Repeatability – ensuring high-quality and scale of production volumes • Cost Savings – through expanded range of polymer and material choices and potential elimination of production steps For more information on Surface Activation®, please visit our website at www.satplating.com. To learn more about the latest developments at SAT Plating, contact: Technical Sales at +1 248.273.0037 | technicalsales@satplating.com

SAT PLATING – MAKING PLASTICS PERFORM! www.medicaldesignandoutsourcing.com

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LEADERSHIP IN MEDICAL TECHNOLOGY

2018

SCHOTT has been serving the medical and dental device industry for over 40 years. Our components illuminate, transfer images, connect and protect sensitive electronics. SCHOTT products add new features to medical devices that allow manufacturers to design unique, highperformance instruments. With fiber optic lighting and imaging components and autoclavable LEDs, SCHOTT serves many applications, including endoscopy, X-ray and dentistry. Our gas-tight electronic packages and medical connectors provide long-term protection for sensitive electronics, even after many uses and autoclaving cycles. Pushing innovation with reliable technology and custom-design capabilities is what positions SCHOTT as a premier supplier for the medical industry. SCHOTT Solidur® LEDs and Eternaloc® medical connectors made with hermetic glass- or ceramic-to-metal sealing technology are two examples of components that support increased capabilities and long-term functionality for medical devices. Solidur® LEDs and Eternaloc® medical connectors can be sterilized over 3,500 times at 275 degrees Fahrenheit in humid conditions, expanding the range of design possibilities available to medical device engineers and offering opportunities for new and distinct designs while meeting challenging autoclaving requirements for medical devices. The small size and flexible dimensions of sterilizable Solidur® LEDs allow them to be integrated directly at the tip of devices, bringing light closer to treatment areas. Eternaloc® medical connectors enable steady power supply and data transmission for medical instruments.

SCHOTT Electronic Packaging 15 Wells Street

Thanks to the use of non-aging materials, they remain reliably gastight and prevent moisture permeation even after thousands of steam sterilization cycles, protecting sensitive electronics from any harmful external elements, even in the harsh conditions of the autoclave.

Southbridge, Massachusetts 01550 www.us.schott.com/medical

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LEADERSHIP IN MEDICAL TECHNOLOGY

2018

SETTING IDEAS INTO MOTION Stock Drive Products/Sterling Instrument is a leading manufacturer of timing belt and pulley drive systems, precision gears, gear assemblies, molded components, and other machined parts. SDP/SI stocks a wide selection of small mechanical components that can ship the same day. Extensive online resources include design tools, a library of technical information, 3D CAD models, and detailed product specifications. SDP/SI engineers provide technical support and custom solutions. Find the parts you’re looking for; get the new SDP/SI Inch Master Catalog.

Stock Drive Products/Sterling Instrument (SDP/SI) is a manufacturer of motion control and small power transmission components. Design engineers and original equipment manufacturers rely on SDP/SI for high-quality components, subassemblies, and engineering expertise. As a company founded and managed by engineers we understand and respond to the developing needs of our customers better than anyone. Standard sizes or customized, our precision gears, high-quality machined parts and molded components can be utilized in a wide variety of applications and industries. SDP/SI manufactures thousands of inch and metric, precision and commercial quality, small mechanical components. With years of application and product experience our engineers can assist in selecting the best part for your need. We also manufacture custom components and assemblies to your exact specifications. Stock Drive Products/Sterling Instrument is a Designatronics company, serving customers globally since 1950. ISO 9001:2015 + AS9100D registered.

Stock Drive Products/ Sterling Instrument

CUSTOMIZED COMPONENTS AND ASSEMBLIES

250 Duffy Avenue

SDP/SI offers a wide variety of products and services used in applications worldwide, including aerospace, defense, military and commercial aircraft, robotics, and medical.

Hicksville, NY 11801 USA Tel: 516.328.3300 Email: sdp-sisupport@sdp-si.com sdp-si.com

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Timing Belts and Pulleys

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Precision Gears

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Precision Gearboxes

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Precision Machined Components

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Molded Components

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Miniature Components

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Mechanical Assemblies

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Contract Manufacturing

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LEADERSHIP IN MEDICAL TECHNOLOGY

2018

Leader in linear transformers and SMD inductors Signal Transformer has almost 60 years of experience manufacturing transformers, chokes, inductors and custom or modified standard products. Signal also leads the industry with custom-tailored design solutions through our direct engineering support team. Signal offers the most comprehensive line of certified standard power conversion products on the market today.

Signal Transformer is known as the world’s leader of wire-wound magnetic solutions since 1959, with almost 60 years of experience manufacturing transformers, chokes, inductors and custom or modified standard products. Signal offers the most comprehensive line of certified standard power conversion products, utilizing our vast engineering, manufacturing and regulatory resources. Signal Transformer also excels in the design and manufacture of cost-effective, specialized platforms. Signal embraces the entire wire-wound components spectrum. We maintain an extensive stock of standard ‘off the shelf’ products, but some applications will require either product modification or a totally new design. Signal takes pride in demonstrating its capabilities in such instances by creating designs that are not bound by convention, but defined by customers’ needs. Our personalized, pro-active approach of working closely with customers’ engineers has always been the keystone that defines our customer support.

Signal Transformer

Signal’s array of standard products already offers the user a vast selection of voltages, terminations and sizes and, in most cases, your solution may be as simple as selecting a standard part from our catalog. If that’s not the case, give us a chance to speed your product to market. At Signal, ‘Total Customer Satisfaction’ signifies ‘Total Commitment to Service.’ We don’t just pride ourselves on our excellent products, but we look beyond the product. Customers experience our genuine care.

500 Bayview Avenue Inwood, NY 11096 belfuse.com/signal sales@signaltransformer.com techhelp@signaltransformer.com

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LEADERSHIP IN MEDICAL TECHNOLOGY SMAC Moving Coil Actuators manufactures a wide range of precision programmable electric actuators based on its patented moving coil technology. These proprietary and patented moving coil linear motor based designs are technically far ahead of old generation pneumatic and electric actuators, including moving magnet linear motors. SMAC’s technological edge, combined with continuous costdown/ qualityup process and its worldwide sales basis makes SMAC the most dynamic electric actuator

The ability to do work and verify quality at the same time. Benefits of Moving Coil Technology

• Lower moving mass with the voice coil actuator means extremely high acceleration and velocity, as opposed to the heavier “moving magnet” technology used in most linear motors. • Safe and energy efficient: operates at low current, typically at 1.5 amps at 24 volt DC.

manufacturer in automation today.

• Quiet (< 55dB), airless operation: no expensive compressed air generation required. No air consumption or air leaks to attend to. No compressed air generating environmental particulate contamination.

Ideal for applications such as: · Luer capping · Vial capping · Press-on capping · Validation of prototype and production components · Small part assembly and verification · Inspection · Soft diversion and/or ejection of fragile containers · Handling of hazardous materials · And many more

• Long Cycle Life: >100 Million Cycles. 10x that of air cylinders or ball screw actuators. • Linear Rotary: SMAC invented linear rotary technology in 1998 and since have become the preferred solution for small parts assembly in the electronics industry, thread check in the automotive industry and capping in the packaging industry.

or visit www.smac-mca.com

• Force Mode: Force Mode is open loop, using no feedback from the encoder. The actual position is still monitored but has no effect upon the output.

SMAC Actuators Unique Features Soft-LandTM

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SMAC actuators are totally programmable in force, acceleration and velocity. They give you flexibility to run various products with a quick change over at the touch of a button. Multiple motion profiles (programs) can be stored/ preset in the SMAC controller. The actuator can operate in three different modes:

• Position Mode: Position Mode will allow the actuating rod to be moved to various positions along the stroke using acceleration, velocity and force. It is possible to perform absolute, relative and “learned position” moves.

Email: info@smac-mca.com

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Programmable Features

• Velocity Mode: Velocity Mode allows the actuating rod to be moved with a given velocity, acceleration, force and direction. Typically used for a “Soft-Land” routine.

Phone (760) 929-7575

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A patented capability to apply controlled light force without damaging parts/ materials being handled

Feedback

Built-in sensing that can report if the desired work was accomplished or not. It can be used for Data Acquisition.

Linear Rotary Motion

The precision Z-theta motion within one small compact actuator, providing convenient pick, orient, and place movements.

IP Protection

Optional IP65 and IP67, dustproof and waterproof features

Graphical User Interface

Easy-to-use GUI’s available for many popular applications (e.g., thread inspection, gauging, and more).

Affordable

Prices competitive with traditional pneumatic actuators.

www.medicaldesignandoutsourcing.com

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2018

LEADERSHIP IN MEDICAL TECHNOLOGY For over 50 years, innovation, quality and engineering has been at the core of Smalley’s business, this commitment has led Smalley to become the leading manufacturer of Spirolox® retaining rings and wave springs. Their commitment to service combined with a reputation for on-time delivery has earned Smalley approved supplier status with leading OEM manufacturers around the world.

lug or ear free ring makes it ideal for tight radial applications. Spiral rings offer a 360 degree retaining surface, require no special tools for installation and removal, and are interchangeable with ordinary stamped ring grooves.

Smalley engineers have designed or specified thousands of parts globally across nearly every industry. They provide free design consultations, to ensure your unique application considerations are taken into

Quality Parts:

account. Standard or custom, Smalley provides you with the right part, in the right

Wave Springs:

material, for your application.

Wave springs offer up to 50% space savings in comparison to a traditional coil spring. The smaller springs operates at a shorter work height which means a smaller spring cavity and weight savings from less material. This provides an opportunity for overall cost savings. Wave springs operate as load bearing devices. They take up play and compensate for dimensional variations within assemblies. A virtually unlimited range of forces can be produced whereby loads build either gradually or abruptly to reach a predetermined working height. This establishes a precise spring rate in which load is proportional to deflection.

Smalley Steel Ring Company 555 Oakwood Road Lake Zurich, IL 60047 Phone: +1 847 719 5900 Email: info@smalley.com smalley.com

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Small Diameter Products:

Smalley’s expanded manufacturing capabilities allow for Wave Springs and Spirolox Retaining Rings down to .157” in diameter.

Manufacturing Process:

Smalley parts are formed through the unique process of Edgewinding. Rings and springs are manufactured from round wire that is flattened and coiled on edge. The flat wire has a grain structure that is linear, providing exceptional strength and dimensional stability. This process reduces scrap, allowing for the economical production of special alloy products, fast prototypes, and large volume orders.

Custom Solutions:

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Spirolox® Retaining Rings:

Spirolox retaining rings come standard in 302 & 316 stainless steel and are available in other exotic alloys. They are specified because of their unique advantages over a traditional stamped ring. They have No Ears to Interfere® with mating assembly components. The

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Smalley prides itself on being a trusted partner to OEMs world-wide. In order to better serve customers across all industries Smalley is certified to ISO 13485, ISO 9001, AS9100, ISO 14001, and ISO/TS 16949 certified.

Do not sacrifice application performance due to part availability, at Smalley, customs are standard. Our No-Tooling-Cost™ process provides an economical means of manufacturing a custom ring or spring to your exact specifications. Change the diameter, material thickness, alloy or nearly any product characteristic to fit within your assembly.

Free Samples:

Smalley will send free samples of any of the 10,000 standard parts offered in the catalog. Simply go to smalley.com/samples to request free samples.

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LEADERSHIP IN MEDICAL TECHNOLOGY

2018

Check Valves, Pumps, & More Smart Products USA, Inc. designs and manufactures check and pressure relief valves, JACO Smart Fittings, liquid and air pumps, and related components. Our products provide accurate, reliable flow control in advanced, low pressure, low flow systems. An ISO 9001:2008 Certified Company.

People often ask, what makes your valves smart? The answer is the ability to take customizable components - plastic body material and o-ring and pair them with a precise opening pressure. This custom configuration coupled with a wide range of styles allows for over 3 million possible combinations to create an exclusive low pressure, low flow valve to meet a specific design criteria. Ideal for liquid or gas applications, our valves are in a wide variety of medical devices. They are also economical, FDA & NSF compliant, corrosion resistant, as well as able to withstand operating temperatures ranging from sub-zero to 400Â°F, depending on materials specified. The thermoplastic materials used in these check valves provide improved corrosion resistance and make them a superior alternative to comparable metal valves. The majority of our check valves incorporate a low inertia poppet design with double-tapered o-ring seats to achieve a fast, positive seal in ultra low pressure applications. Additionally, most of our check valves can also be used as pressure relief valves as long as the o-ring side vents to atmosphere. We provide a unique and quality product for every customer based on liquids/gasses used, application environment, and intended shelf life.

Smart Products USA, Inc. 644 Fanning Fields Road

Smart Products USA, Inc. also provides additional services such as custom designs, special testing, custom assemblies, and other value-added services.

Mills River, NC 28759 www.smartproducts.com

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LEADERSHIP IN MEDICAL TECHNOLOGY

2018

Innovating Shock & Vibration Solutions Sorbothane, Inc. serves widely varied market segments with Standard and Custom Engineered components. MARKETS SERVED TRANSPORTATION SHIPPING & LOGISTICS • Sorbothane® Safeguards Precious Cargo PRECISION LABORATORY EQUIPMENT • Sorbothane® Isolates Disruptive Vibration MOBILE ELECTRONIC DEVICES • Sorbothane® Attenuates Impact Shock & Isolates Vibration CONSUMER & COMMERCIAL PRODUCTS • Sorbothane® Damps Unwanted Vibration & Noise INDUSTRIAL & MANUFACTURING EQUIPMENT • Sorbothane® Extends Equipment Life AEROSPACE & AERONAUTICAL • Sorbothane® Protects Critical Components MEDICAL EQUIPMENT • Sorbothane® Protects Performance SPORTING GOODS & FITNESS • Sorbothane® Protects, Cushions & Comforts Sorbothane, Inc. is located in Kent, Ohio and operates 10 specialized pouring machines. With 64,000 square feet of manufacturing space and supply support systems in place, the Sorbothane team stands ready to meet any production need. Sorbothane, Inc. has an engineering design staff that specializes in shock and vibration solutions plus an in-house testing and quality assurance lab.

Sorbothane® is a proprietary visco-elastic material that has been specified by engineers worldwide for over three decades. Sorbothane® is a highly damped polymeric solid that “flows” like a liquid under load. Its superior damping and isolation properties have been scientifically and real-world proven. Sorbothane® is ideal for engineering design applications requiring shock absorption, vibration isolation and acoustic damping. Produced in a durometer range from 25 to 85 - Shore 00 scale Sorbothane® is considered a super soft polyurethane.

CUSTOM Sorbothane® SOLUTIONS Unique applications call for very innovative solutions. Our engineering team will help design the custom Sorbothane® component perfect for your individual product specifications. Since 1982, Sorbothane, Inc. has engineered individualized shock and vibration solutions for numerous and diverse markets.

Unique applications call for innovative solutions. Standard Sorbothane® parts and custom engineered solutions are available to meet individual product objectives.

Sorbothane, Inc. - Innovating Shock & Vibration Solutions

STANDARD Sorbothane® PRODUCTS Sorbothane, Inc. offers an extensive line of standard Sorbothane parts.

Our goal is to protect the performance and integrity of your product.

For over 33 years Sorbothane, Inc. has been - and will continue to be - the innovative and trusted choice of engineers worldwide for developing materials and components that isolate vibration, attenuate shock and damp unwanted noise.

These standard products have been developed over 30 years and are selected for their specific shock absorbing and vibration isolating applications. The Sorbothane® Standard Products Guide is available at www.sorbothane.com or by contacting Sorbothane, Inc. directly.

2144 State Route 59 Kent, Ohio 44240 Phone: 800.838.3906 www.sorbothane.com

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LEADERSHIP IN MEDICAL TECHNOLOGY

2018

Spartan Scientific strives to meet tough

challenges with innovative design. We are known for our quality solenoid valves, electronic shut off valves, air compressor drain valves, condensate drain valves and water drain pump valves. Our Media Separated valves offer peace of mind and play a major role in the medical industry. These valves have been designed to work great with dialysis machines, ventilators, respirators, and endoscope reprocessing. Commonly used with air, liquids, gases, and a variety of different chemicals, these work as isolation valves to separate the media from any contaminate objects.

Spartan Scientific was formed in 1978 with a mission to redefine industrial solenoid valves and related products. We started with DIN quick connect solenoid coils, quick mounting solenoid operators and interchangeable coil versions. Spartan has effectively reduced installation costs and related setup while reducing retrofits and service times. Spartan solenoid valves incorporate fully encapsulated coils and the highest quality brass and stainless steel in every assembly. Our solenoid operators can be placed directly into your assembly for a neater, more compact end product which meets functional as well as aesthetic demands. Many of the products manufactured by Spartan Scientific are specials, or variations of standard products. If you do not see a specific valve or accessory, please ask one of our sales consultants for additional information or the possibility of Spartan producing a special product for your application.

Our Philosophy

Spartan Scientific 8510 Foxwood Court Youngstown, Ohio 44514 Phone: 330-758-8446 Toll Free: 855-629-4648 Email: customerservice@spartanscientific.com www.spartanscientific.com

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Our Vision: Helping our customers meet their goals, one valve at a time.

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Our Mission: Customer centered product development committed to reliable and innovative media control products coupled with service excellence.

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Our Business Policy: Initiative and Continuous self-improvement, Innovation, development, together with Partnership and Cooperation.

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Our Core Value: Excellence, Awareness to detail and Gratitude with a sense of urgency all with a foundation based on integrity.

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Spartan Scientific Spirit: Say what we do, Do what we say. No excuses. Action and response. Pursuit of excellence.

Cost Efficiency, Quality & Rapid Response

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Value we bring is the key to success. Spartan Scientific implements continuous improvement in all areas of our business. Our core strength is our ability to react and produce a product quickly to specification that incorporates electronics coupled with fluid power.

Quality Policy Total customer satisfaction through unmatched quality, products, service, and integrity.

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2018

LEADERSHIP IN MEDICAL TECHNOLOGY Medical Injection Molded Plastics

The Spectrum Plastic Group’s injection molded solutions are premium, high quality component and full assembly medical plastics

PRECISION MOLDING

and silicone. We are a major supplier to

The Spectrum Plastics Group has a long history in precision injection molding, developing and manufacturing insert-molded, over-molded, and micro-molded engineering products for MIS reusable and disposable devices and medical instruments.

orthopedic, dental, drug delivery, sports medicine, gastrointestinal and medical device market customers. Spectrum Plastics Group has a long history and is a recognized leader in engineered, performance medical plastics, including implantable and bioresorbable materials. Time and again, medical companies have turned to the Spectrum Plastics Group

SILICONE MOLDING

with confidence for their device and medical

Silicone Molding is as much as specialty of the Spectrum Plastics Group as precision thermoplastic injection molding. Our capabilities include liquid injection molding (LIM/LSR) as well as silicone rubber transfer and compression molding, also in over-, insert-, and microvarieties.

product requirements. .

BIOABSORBABLES

Experience counts with implantable plastics and bioresorbable plastic component and solutions manufacturing. The Spectrum Plastics Group truly helped pioneer thermoplastic implantable and bioresorbable components a decade ago and we have only become wiser and more efficient ever since.

Spectrum Plastic Group 2500 Northwinds Pkwy, Suite # 472 Alpharetta GA 30009 Phone: 404-564-8560

MICROMOLDING

Fax: 404-564-8579 www.spectrumplasticsgroup.com

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The Spectrum Plastics Group has developed micro molding capability as part of its comprehensive portfolio of plastic manufacturing processes. Micromolding refers to the molding and manufacture of small parts, often less than a single gram or even pellet in size, or of parts with features that are unusually diminutive in size.

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LEADERSHIP IN MEDICAL TECHNOLOGY

2018

STEUTE has specialized in designing and manufacturing off-the-shelf-custom built (with no tooling or NRE costs) and fully-custom cabled and wireless, medical-grade foot switches expressly for medical device OEM’s for more than 60 years.

STEUTE has been designing and manufacturing medical-grade foot switches expressly for medical device OEMs worldwide since 1952. During that period we have tooled a wide range of platforms/consoles, actuators, detents, carrying handles, and analog and digital output devices. These components, coupled with the wide array of connectors, cables, strain reliefs and our in-house graphics capabilities, has enabled us to address an infinite number of medical device OEM foot switch needs with our unique “off-the-shelf-custom” program.

Our staff of 280 employees understands your need to demonstrate your medical devices’ superiority with an easy-to-use foot control that is ergonomically-designed for operator comfort and optimum functionality.

Within this program we can satisfy a wide variety of performance requirements, with a fullycustom designed and built foot switch that requires no tooling investment or NRE costs to the medical device OEM.

With offices in 30 countries, our worldwide team is ready to share our ideas for realizing a human interface that optimizes your device’s performance and market appeal. Call for a no-obligation design consultation, or a complimentary evaluation sample.

• • • •

Each unit is developed with the following key objectives: Optimum medical device functionality Operator comfort and ease-of-use Aesthetically complimentary to the OEMs device design Full compliance with IEC, UL, CSA and FCC requirements.

In addition, STEUTE has pioneered the use of wireless foot switch technology expressly for use in medical environments. Now into our fourth generation, we offer our proprietary 2.4 GHz frequency-hopping system featuring: • • • • • • •

Safe, noise immune operation Encrypted communication protocols Low power consumption Real-time battery charge status Optional “sleep-mode”. Fast wake-up time Worldwide acceptance.

Today we have thousands of safe, reliable cabled and wireless foot switches installed in diagnostic and therapeutic applications worldwide. Typical applications include: • • • • • • • • • • • •

STEUTE Meditech, Inc. 901 Ethan Allen Highway, Suite 102 Ridgefield, CT 06877 203.244.6302 Email: info@steutemeditech.com www.steutemeditech.com

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Radiology equipment Ultrasonic diagnostic systems Surgical microscopes Electrosurgical generators Laser-based surgical, dental & dermatology equipment Cataract (PHACO) systems Ophthalmic surgical equipment Examination tables/chairs Biopsy systems Bone shavers & saws MRI systems Navigation & imaging systems

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LEADERSHIP IN MEDICAL TECHNOLOGY Sunrise Labs is a full service product

2018

Making Bright Ideas Work

development firm specializing in complete product development, Project Rescue, and engineering services, leveraging ISO-13485

For over 25 years, clients have come to Sunrise Labs for complete product development, Project Rescue, and engineering services, leveraging our ISO-13485 certified process.

certified process.

Client success stories reflect our strengths in system engineering, project management, and a full range of technical disciplines to turn novel ideas into commercially viable products. We are known for solving tough engineering problems nimbly and with integrity. Our team has deep experience developing medical devices, combination products, and life science instrumentation. Our extensive project portfolio includes patient monitoring solutions, imaging, cardiac, neuro, and IVD applications. Our team boasts expertise in software and electronics, optics and mechanical engineering, spanning portable, wireless, and battery powered devices connected to mobile phones, tablets, and back-end systems, to complex instruments with high-performance analog conditioning, closed loop controls, real-time multitasking software, and intuitive user Interfaces. Sunrise Labs’ facility is one hour north of Boston in Bedford, New Hampshire. We proudly employ over 75 dedicated employees in a high performance culture based on engineering excellence, mutual respect, ethics, and integrity. We look forward to working with you to meet your product development needs!

Sunrise Labs 25 Constitution Drive Bedford, NH 03110 Tel: 603.644.4500 sunriselabs.com

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LEADERSHIP IN MEDICAL TECHNOLOGY Tech-Etch has been a leader in the manufacture of precision engineered parts, EMI/RFI shielding products, and flex and

2018

Precision Parts for the Medical Industry

rigid-flex circuits for the medical industry for over 40 years. Our technology has enabled the development of cataract lens replacement surgery, artificial heart valves, and medical diagnostic ultrasound imaging. The Tech-Etch Quality Management System is registered to both ISO 9001:2008 and AS9100. Corporate headquarters is in Plymouth, Massachusetts, and additional facilities are located in Fall River, MA and Litchfield, Minnesota.

Precision Parts, Flex and Rigid-Flex Circuits & EMI Shielding Products Tech-Etch photo etches precision parts for medical imaging, implants and surgical devices. Light gauge parts are manufactured from a wide range of medical materials, including elgiloy, titanium, tungsten, nitinol, stainless steels, niobium, molybdenum, and copper alloys. Applications include maxillofacial screens and cranial closure implants, HTC grids, X-ray ID tags, stents, vascular stiffeners and closures, haptics, needles, surgical blade blanks, springs, and interconnects. Standard and custom EMI/RFI shielding products include finger stock gaskets, board level shielding, knitted wire mesh gaskets, conductive elastomers, metalized fabric, conductive foam, and shielded honeycomb vents and filters. Shielding solutions are offered to address interference at the component level, board level, or the assembly/enclosure level.

Tech-Etch, Inc. 45 Aldrin Road Plymouth, MA 02360 www.tech-etch.com

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High reliability, fine line flex and rigidflex circuits are produced for demanding applications, including implant, diagnostic, and therapeutic medical electronics. By using an additive process, features as small as .001” can be produced at production levels. Laser processing supports precision drilling of hole sizes down to .001” dia. for micro via and blind via multilayer construction. In-plant, valueadded operations include precision hand assembly as well as automated SMT assembly supporting package sizes down to 0201 and .4mm leaded devices.

www.medicaldesignandoutsourcing.com

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2018

LEADERSHIP IN MEDICAL TECHNOLOGY Tegra Medical makes products used in a variety of markets including: • Orthopaedics • Cardiac care • Women’s health • Neurology • Ophthalmology • Radiology • Pain management • Diabetes and other medical specialties The types of procedures often include arthroscopy, endoscopy, joint reconstruction,

Tegra Medical is an end-to-end contract manufacturing solutions provider, known as the company “where medical devices come to life.” Our customers look to us to manufacture everything from complex components to finished devices – from the sharp “business end” to the molded plastic handle – including assembly, sterilization and packaging. We have four locations in the U.S. and Costa Rica and are ISO 13485 and FDA registered and QSR compliant.

biopsies, and drug delivery using a wide range of devices such as implants, needles, cannulas, fixation systems, probes, wires, catheters, stylets, mandrels and many more. See our website for details.

Manufacturing Capabilities Our vast range of manufacturing capabilities include insert and injection molding of PEEK and other materials, CNC Swiss machining, CNC milling/ turning, laser processing, EDM, electropolishing, process validations, needle pointing, gundrilling, grinding, passivation, electrochemical machining, Nitinol shape setting, wire and tube forming, stamping and cleanroom molding and assembly. We finish, assemble, package and manage sterilization.

Where medical devices come to life.SM

Tegra Medical 9 Forge Park Franklin, MA 02038 info@tegramedical.com T: 508.541.4200 F: 508.553.4100

Product Development Our dedicated GENESIS Tech Center® resources are focused 100-percent on prototyping, development and pilot production to help launch your products quickly and cost-effectively.

www.tegramedical.com

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Wire and Hypotube Shipped Overnight We offer over two million feet of coated and uncoated stainless steel wire and tubing, plus Nitinol wire for same-day shipment. Custom cutting, grinding, and finishing is available in a few days.

“Where medical devices come to life.” is a trademark and Tegra Medical and GENESIS Tech Center are registered trademarks of Tegra Medical.

www.medicaldesignandoutsourcing.com

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LEADERSHIP IN MEDICAL TECHNOLOGY

2018

Teleflex Medical OEM is the partner that can hear what you are saying, understand your needs, and arrive at innovative, highly-customized solutions. We are a well-qualified team of engineers, material and polymer experts, and skilled technicians that will seem like a natural extension of your own R&D department and operations staff. Together, we can develop custom-engineered solutions for: • Extrusions • Diagnostic & interventional catheters • Balloons and balloon catheters • Introducers • Specialty sutures, braids, and fibers • Bioabsorbable sutures, yarns, and resins

Work With The Experts™ at Teleflex Medical OEM Teleflex Medical OEM is a proven global medtech leader. Why? To start, we can develop and deliver specialized devices that touch nearly every organ and system in the human body. We offer a true, full-service partnership with the total resources to help get your great idea into the market quickly. That includes extensive, fully-integrated, inhouse capabilities; deep expertise in device development and manufacturing; advanced technologies; and decades of experience.

Teleflex Medical OEM 1425 Tri-State Parkway Suite 120 Gurnee, Illinois 60031 www.teleflexmedicaloem.com

Add to all that: an award winning Customer Solution Centre that is the epicenter for device development.

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The result: Teleflex Medical OEM is the end-to-end solution provider for everything from raw materials to components to finished devices.

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Let’s get to work on your next project.

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www.medicaldesignandoutsourcing.com

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LEADERSHIP IN MEDICAL TECHNOLOGY

2018

Automatic Assembly Equipment Innovator

The Arthur G. Russell Co., Inc. (AGR) develops state-of-the-art automatic assembly equipment for the medical device, consumer and electronics industries. Headquartered in Bristol, Connecticut, AGR is an ISO 9001:2015 registered private company with

Arthur G. Russell Co. Inc. (AGR) understands

over 70 years of designing, building, installing,

your automation needs. With over 70 years of experience designing, building and installing automation systems and equipment, we have helped get thousands of products into the market. We know that quality and dependability are as important on the assembly line as in the final product. That's why AGR works with you from the start - custom designing an automation system that will exceed your expectations.

and supporting world-class assembly, test, inspection, and packaging systems.

AGR’s extensive industry experience has provided practical engineering “know-how”, resulting in superior automation concepts. We design and build equipment to “machine tool” quality that is proven to provide years of reliable service. Our use of heavyduty construction methods and components, cam and servo-driven mechanisms, and state-of-the-art control and inspection systems, are our trademarks. Through dedication, focus, and experience, AG Russell is able to meet your most demanding automation applications. Providing more than just assembly equipment; we provide you with “the edge” you need to stay competitive in your market.

In addition, AGR has a worldwide base of assembly, packaging and parts feeding systems. Our approach to automation is suited for medical devices, consumer products, electrical, electronic devices or any other product that requires a robust and reliable system for assembly, test and or packaging. Headquartered in Bristol, Connecticut, The Arthur G. Russell Co. is an ISO 9001:2015 registered private company.

ARTHUR G. RUSSELL 750 CLARK AV BRISTOL, CT 06010 860.583.4109 arthurgrussell.com

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LEADERSHIP IN MEDICAL TECHNOLOGY For over 70 years, The Lee Company has pioneered the development of miniature fluid control components for aerospace hydraulic and fuel systems, automated liquid handling in medical and scientific instrumentation, medical disposable applications, down-hole oil tools,machine tools, inkjet printing, and other industries worldwide. Products include miniature solenoid valves, high-speed micro-dispense valves, nozzles, dispense pumps, custom manifold systems, inert tubing, Lee Plugs, check valves, shuttle valves, pressure relief valves, directional flow controls, safety screens, flow restrictors and associated fluid handling components. Lee’s unique capabilities in miniaturization and engineering expertise (one of every eight employees is a graduate engineer) keep the company at the forefront of fluid flow technology, and enable it to work effectively with customers to solve difficult fluid control problems. The Lee Company employs over 1,000 people at its Technical Centers in Westbrook and Essex, Connecticut where all engineering and manufacturing is performed. Lee Company sales offices, staffed by degreed sales engineers, are located throughout the United States and Europe, and the Company’s distribution network spans the entire globe.

The Lee Company 2 Pettipaug Road, P.O. Box 424 Westbrook, CT 06498 Phone: 860.399.6281 Toll Free: 800.533.7584 Fax: 860.399.2270 E-mail: inquiry@theleeco.com www.TheLeeCo.com

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2018

Ultra Miniature 2-Port HDI Solenoid Valve The Lee Company continues to redefine miniature fluidics with the introduction of an even more compact High Density Interface (HDI) solenoid valve. Now available in magnetically latched and non-latched designs, this 2-port normally closed valve is exceptionally small in size, light weight, and offers consistent performance throughout its life. Both designs are offered in plug-in and face mount styles. In today’s culture, the persistent demand for reliable and innovative products compels companies to integrate new and more advanced technology into smaller packages. Our ultra miniature 2-port normally closed solenoid valve offers similar performance characteristics to our traditional 3-port HDI design, but in a smaller package.

Miniature Stepper Dispense Pump Designed for Flexibility and Cost Savings After 20 years of experience designing and manufacturing dispense pumps for in vitro diagnostics and scientific instrument applications, The Lee Company is pleased to offer its most cost effective design yet. The new LPD Series variable displacement pump meets the demands of modern day applications: consistent performance and significant cost savings in a compact lightweight package. Designed to be completely maintenance free, this miniature, chemically inert pump is readily available in 50, 250, 1,000 and 3,000 microliter full dispense volumes. Standard performance models meet the demands of most applications, while high performance models are available for the most demanding applications. The LPD Series Pump can be customized for a variety of performance characteristics, feedback options and port head materials. Contact your local Lee Sales Engineer today for additional information.

Quick Installation Lee Plug®

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The Lee Company’s new Quick Installation Plug combines ease of handling and installation with the proven reliability and performance of Lee Plug® expansion plugs. A leak-tight seal is created from Lee’s controlled expansion principle. In addition, these plugs are compliant with RoHS, REACH, WEEE and ELV requirements. Quick Installation Lee Plugs are offered in four sizes: .093, .125, .156 and .187.

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www.medicaldesignandoutsourcing.com

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LEADERSHIP IN MEDICAL TECHNOLOGY

2018

Innovative. Life. Solutions.

Triangle partners with global OEMs to design, manufacture and bring to

For more than 63 years Triangle has partnered with global OEMs to engineer and manufacture a broad range of medical devices and surgical implants and tools for all facets of the orthopedic industry. From early-stage design, development and prototyping to preproduction and volume production, Triangle facilitates the process from concept to market launch with speed and economy, achieving the highest quality standards.

market a broad range of devices for all facets of the orthopedic industry. We are a leading provider of medical instrumentation and implantable devices

Always on the cutting edge, we invest in the most advanced equipment and technology available. But our high-tech tools are only as powerful as the people behind them. That is where our team of Triangle Associates excels. They are highly trained and experienced specialists who work side-by-side with our clients to bring to market some of the industry’s most advanced products for the orthopedic, ENT, cranial, trauma, rehabilitation and sports medicine markets.

that touch almost every part of the human body, with expertise in powered hand tools, hip and knee implants and spinal and trauma devices. What distinguishes Triangle is our

Whether a client needs help with early stage product development or guidance during the latter stages of the process, our focus on developing finely tuned processes and delivering a positive customer experience allows Triangle to customize our services to your specific needs.

unwavering commitment and responsibility to achieve the highest quality possible, providing meticulous, step-by-step processes and documentation that

We are the critical link between design development and product realization, redefining the concept of a true dedicated manufacturing partnership. We leverage this expertise in process development, putting our learning curve to work for each and every client that we partner with.

industry standards demand. We leverage this expertise for each and every client that we partner with.

CAPABILITIES OVERVIEW

Innovative. Life. Solutions.

• Design for Manufacturability, Reliability and Inspection • Design for Verification and Prototyping • Process Development and Validation • Gaging and Inspection Protocols • Full-scale Production • Inventory Management

25 Park Way Upper Saddle River, NJ 07458 T 201.825.1212 www.trianglemfg.com

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AREAS OF EXPERTISE • Hip, Knee, Shoulder, Spinal and Trauma Implants • Surgical Navigation Devices • Powered Spinal Instruments • Powered Drill and Shaver Systems • Powered Surgical Instruments • Customs • Plastics • Impactors

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LEADERSHIP IN MEDICAL TECHNOLOGY Universal Robots has reinvented industrial robotics with the lightweight and flexible UR robot arms. The Danish-designed robots automate production in all industries – even in SMBs that regard automation as costly, cumbersome, and difficult to integrate. The robots can work alongside personnel and are easily moved around production sites to complete even the most detailed tasks. Programming is intuitive, eliminating the need for skilled programmers; simply grab the robot arm to show it the desired

2018

Universal Robots: The world’s #1 collaborative robot Traditionally, robots were suited to highspeed, low-variability tasks, with fixed guarding and custom integration. The emergence of collaborative robots – or cobots – changed this. The cobot pioneer, Universal Robots, has lowered the automation barrier tremendously by offering flexible, user-friendly robot arms that can easily be moved between tasks in medical device manufacturing, offering significant product optimization and increase in product quality.

movement, or use the touch screen. The robots are sold worldwide, typical ROI is 10.5

With traditional robots, the capital costs for the robots themselves account for only 25 to 30 percent of the total system costs. The remaining costs are associated with robot programming, setup, and dedicated, shielded work cells. The “out of box experience” with Universal Robots collaborative robot arms is typically less than an hour. That’s the time it takes to unpack the robot, mount it, and program the first simple task through an intuitive touchscreen user interface. Or, by simply grabbing the robot arm, showing it the desired path of movement. With more than 19,000 cobots installed worldwide, Universal Robots is the unrivaled market leader of the collaborative robotics industry and continue to push the envelope for new human-robot interaction.

months - fastest is 34 days in the USA.

Since the UR cobots can be set up quickly and operate with no safety fencing alongside employees, the overall cost of deployment is significantly reduced. According to the old rule of thumb, the cost of a robot would be equivalent to one worker’s two-year salary. But collaborative robots are closer to one fourth of that price:

Universal Robots USA, Inc. 5430 Data Court, Suite 300 Ann Arbor, MI 48108 1.844.462.6268 Email: ur.na@universal-robots.com www.universal-robots.com

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www.medicaldesignandoutsourcing.com

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2018

LEADERSHIP IN MEDICAL TECHNOLOGY Miniaturized & high-precision complex products

Valtronic offers a full range of solutions from design and development to industrialization and manufacturing. For more than 35 years, we have helped hundreds of companies in the world develop and produce Class II and III medical devices.

We innovate and manufacture miniaturized and high-precision complex products for our worldwide medical device partners. Our customers are leading suppliers of active implants,

Leading The Way In Medical Device Innovation

medical-grade wearables as well as medical and portable medical equipment.

With more than hundred projects executed in the medical device industry, Valtronic is a leading partner for companies pioneering the medical field with next-generation technology and products that help improve lives.

For over thirty five years, we have helped hundreds of companies develop and produce Class II & III medical devices as

Innovating Tiny Devices With Huge Impact

well as advanced miniaturized electronic

As the leading manufacturer of Class III implants, our team has the expertise needed to manage the design, development, manufacturing, production, distribution, testing and quality requirements associated with the production of even the most complex implants.

assemblies. Headquartered in Switzerland, our company spreads over three continents with design, development, industrialization and manufacturing sites in

Medical-Grade Wearables

Switzerland, the U.S.A. & Morocco.

Valtronic offers unique Class I and II electro-mechanical systems and solutions to meet complex and traditional medical device manufacturing challenges.

Portables

By applying expertise in electronic miniaturization technologies and medical product development, Valtronic helps its partners create compact, userfriendly therapeutic components adaptable to many medical applications. Through engineering, design and development, project management, and manufacturing, the group can help develop turnkey solutions for all of your organization’s portable medical device needs.

29200 Fountain Parkway Solon, Ohio 44139 www.valtronic.com

Medical Equipment

Valtronic is the partner of choice for the world’s leading medical equipment companies. Besides Innovation, which is paramount in improving lives, Valtronic provides the solutions which allow for optimized equipment size reduction, thus making it more and more possible for patients to receive long-term treatments at home. With its expertise in electronic miniaturization and highprecision complex devices, Valtronic is a vertically integrated solution provider whatever the complexity and challenge of our customers’ project.

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LEADERSHIP IN MEDICAL TECHNOLOGY The first Wabash press was built in 1941 for a Wabash, IN high school science teacher who wanted a hydraulic press in his lab

2018

Standard and Custom Press Leader One such machine is Wabash’s hybrid servo-pneumatic MICROLIM™ Liquid Silicone Injection

to teach students about molding and

Molding Machine, ideal for clean room and medical applications. Designed for shot sizes up to 15cc with excellent shot to shot repeatability, the MICROLIM features a patented plunger design with “center shutoff” nozzle for accurate shot size control. The injection head is easily removable for quick cleaning and changeover. Features maximum clamp force of 17 tons and platen size of 9” X 9”.

laminating various materials. Since this first press, Wabash has expanded into presses for compression molding, transfer molding, liquid silicone injection molding, C-frame presses and presses with vacuum assist

Wabash manufactures other hydraulic and pneumatic presses in sizes from .5 to 1200 tons, and bed sizes from 6” x 6” to 6’ x 12’. Custom presses can be designed to meet specific applications with various options and accessories available. Applications for Wabash presses include ASTM polymer testing, proppant crush testing, rubber, plastics and composites molding, R&D, laboratory and other specialized processes.

and are available in hydraulic and pneumatic versions. Today, Wabash is a leading worldwide supplier of standard and custom engineered presses to the aerospace, medical, recreation, automotive, education and energy

Wabash offers complete new equipment start-up, preventative maintenance, field service needs and calibration services. Rebuilds, retrofits and system upgrades for Wabash Equipment are available, as well as used equipment and trade-in options.

markets.

Wabash’s sister company, Carver, Inc., manufactures bench-top and floor standing laboratory presses. The new AutoSeries Plus is the most powerful and versatile laboratory press on the market with several new and enhanced features. Carver supplies laboratory presses for laminating, pelletizing, bonding, molding, fluid extraction, and other applications.

Wabash MPI P.O. Box 298 Wabash, IN 46992 - 0298 260.563.1184 www.wabashmpi.com

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LEADERSHIP IN MEDICAL TECHNOLOGY

2018

Custom Designed Polymer Solutions Zeus is your global leader in polymer extrusion technologies. We have been serving our customers for over 50 years in medical, aerospace, automotive, energy exploration, and fiber optics industries. Our polymer products have found their way into almost every medical niche while our aerospace and automotive customers rely on our Thermally Stable PEEK Insulated Wire and fiber optics coatings. These customers also know that replacing metal with Zeus performance polymer tubing and heat shrinks gives them added protection and saves them weight. Zeus products are everywhere you are! We listen, innovate, and respond with the solutions that our customers demand.

Zeus has been finding solutions to the most demanding market needs including the medical industry – for 50 years! Our success has been founded on continuous efforts towards innovating and partnering with medical professionals and manufacturers just like you. We specialize in customization and specialty applications. Our scientists, engineers, and technicians work with you to develop products that are stronger, safer, and more durable to improve clinical outcomes and raise the level of patient care. To meet the demands of an industry that is always evolving, we have developed products for a broad spectrum of medical applications incorporating the polymers and properties that matter most. We are experts in extrusion technology. Our fluoropolymers, nylons, LCP, and other engineered plastics are embedded in nearly every medical niche. We make all of the necessary components for v ascular catheters – from PTFE mandrels, to the thin-walled StreamLiner™ series of PTFE base liners, to high performance LCP monofilament, to peelable heatshrinks.

Zeus

Beyond our catheter components, we make a number of other medical products, many of which were inspired by you. Our Absorv® bioabsorbable extrusions are the perfect foundation to create vascular scaffolds. These products safely exist within the body for limited time and then disappear. Bioweb® electrospun composites are nonwoven PTFE with microporous properties to support new tissue in-growth. Our Aeos® ePTFE suture monofilament provides a brandfree and license-free option for physicians and manufacturers to create their own suture lines. Serving all medical markets, Zeus gets you to where you need to be in the body.

3737 Industrial Blvd. Orangeburg, SC 29118 United States www.zeusinc.com

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AD INDEX

SALES Mike Caruso mcaruso@wtwhmedia.com 469.855.7344 Michael Ference mference@wtwhmedia.com 408.769.1188 @mrference David Geltman dgeltman@wtwhmedia.com 516.510.6514 @wtwh_david Jim Powers jpowers@wtwhmedia.com 312.925.7793 @jpowers_media Tom Lazar tlazar@wtwhmedia.com 408.701.7944 @wtwh_Tom Courtney Seel cseel@wtwhmedia.com 440.523.1685 @wtwh_CSeel

Accumold..................................................... 48 AIM Plastics.................................................. 53 All Motion....................................................... 7 Asahi Intecc.................................................. 96 Atlas Vac....................................................... 84 B. Braun....................................................... BC Bal Seal Engineering................................... 60 Bansbach Easylift......................................... 74 Bay Associates Wire Technologies Corp... 55 Binder USA................................................... 69 Bird Precision............................................... 95 Branson ........................................................ 35 Cadence Inc................................................. 49 Carlisle Medical Technologies.................... 43 Chieftek Precision........................................ 44 Cicoil............................................................. 93 Clippard........................................................ 11 Colder Products Company......................... 57 COMSOL, Inc............................................... 91 DATA IMAGE Corporation.......................... 26 Del-Tron........................................................ 56 Donatelle...................................................... 34 Dunkermotoren........................................... 37 Eagle Stainless Tube.................................... 70 ElectroCraft.................................................. 83 Emerson....................................................... 15 Fabco-Air...................................................... 65 Fischer Connectors...................................... 66 Fluid Metering Inc....................................... 21

Freudenberg................................................ 61 Haydon Kerk Pittman.................................. 28 HP 3D Printing............................................. 63 igus............................................................... 81 IKO International Inc................................... 51 Integer.......................................................... 88 Interpower.................................................... 54 Introtek International................................... 62 IXYS............................................................... 92 J.W. Winco, Inc............................................ 89 John Evans' Sons, Inc.................................. 76 Keystone Electronics Corp............................ 5 LEMO USA, Inc............................................ 80 Lin Engineering............................................ 97 LINEMASTER Switch Corporation............. 41 Master Bond................................................. 87 maxon precision motors........... cover/corner maxon precision motors.................... INSERT MEAN WELL................................................ 77 MedBio......................................................... 64 MEDEFAB..................................................... 72 Memory Protection Devices......................... 9 MicroMo....................................................... 71 Model Solution............................................ 89 MW Medical Solutions................................ 82 Nelipak Healthcare Packaging................... 88 New England Tubing Technologies............. 2 Nitto Kohki USA, Inc.................................... 87 NSK Precision............................................... 18

Okay Industries............................................ 19 OKW USA..................................................... 39 Orchid Orthopedic Solutions....................... 3 Parker Fluidics.............................................. 22 PBC Linear.............................................. 32, 33 PTI Engineered Plastics............................... 29 Qosina.......................................................... 40 Resonetics.................................................. IFC SAT Plating................................................... 23 Schott North America, Inc............................ 4 SDP/SI-Stock Drive Product........................ 26 Signal Transformer (Bel Fuse)..................... 73 SMAC Moving Coil Actuators.................... 16 Smalley Steel Ring....................................... 13 Smart Products USA, Inc............................... 1 Sorbothane.................................................. 52 Spartan Scientific......................................... 68 STEUTE Meditech, Inc................................. 25 Sunrise Labs................................................. 95 Tech-Etch, Inc............................................... 50 Tegra Medical............................................ IBC Teleflex Medical OEM................................. 31 The Arthur G. Russell Co., Inc..................... 27 The Lee Company....................................... 85 Triangle Manufacturing............................... 78 Universal Robots USA, Inc........................... 45 VALTRONIC.................................................. 38 Wabash MPI................................................. 14 Zeus.............................................................. 75

2018 MEDTECH LEADERSHIP

Haydon Kerk Pittman................................ 126 HP 3D Printing........................................... 127 igus............................................................. 128 IKO International, Inc................................ 129 Integer........................................................ 130 Interpower.................................................. 131 Introtek International................................. 132 IXYS............................................................. 133 J.W. Winco, Inc.......................................... 134 John Evans' Sons, Inc................................ 135 Keystone Electronics................................. 136 LEMO USA, Inc.......................................... 137 Lin Engineering.......................................... 138 LINEMASTER Switch Corp........................ 139 Master Bond............................................... 140 maxon precision motors........................... 141 MEAN WELL.............................................. 142 Medbio....................................................... 143 MEDEFAB................................................... 144 Memory Protection Devices..................... 145 MICROMO................................................. 146 Model Solution.......................................... 147 MW Medical Solutions.............................. 148 Nelipak Healthcare Packaging................. 149 New England Tubing Technologies......... 150 New England Wire Technologies............. 151 Nitto Kohki USA......................................... 152 Norman Noble........................................... 153 NSK Precision............................................. 154

Okay Industries.......................................... 155 OKW USA................................................... 156 Onshape..................................................... 157 Orchid Orthopedic Solutions................... 158 PTI Engineered Plastics............................. 159 Qosina........................................................ 160 Resonetics.................................................. 161 SAT Plating................................................. 162 SCHOTT Electronic Packaging................. 163 SDP/SI-Stock Drive Product...................... 164 Signal Transformer (Bel Fuse)................... 165 SMAC MCA................................................ 166 Smalley Steel Ring..................................... 167 Smart Products USA.................................. 168 Sorbothane................................................ 169 Spartan Scientific....................................... 170 Spectrum Plastics ...................................... 171 STEUTE Meditech Inc................................ 172 Sunrise Labs............................................... 173 Tech-Etch, Inc............................................. 174 Tegra Medical............................................ 175 Teleflex Medical OEM............................... 176 The Arthur G. Russell Co., Inc................... 177 The Lee Company..................................... 178 Triangle Manufacturing............................. 179 Universal Robots USA, Inc......................... 180 VALTRONIC................................................ 181 Wabash MPI............................................... 182 Zeus............................................................ 183

Accumold..................................................... 99 AIM Plastics................................................ 100 All Motion................................................... 101 Neel Gleason ngleason@wtwhmedia.com Atlas Vac..................................................... 102 312.882.9867 B.Braun....................................................... 103 @wtwh_ngleason Bal Seal Engineering................................. 104 Bansbach Easylift....................................... 105 Jessica East Bay Associates Wire Technologies........... 106 jeast@wtwhmedia.com binder USA................................................. 107 330.319.1253 Bird Precision............................................. 108 @wtwh_MsMedia Branson Ultrasonics................................... 109 Mary Ann Cooke Cadence Inc. ............................................. 110 mcooke@wtwhmedia.com Carlisle Medical Technologies.................. 111 781.710.4659 CGI.............................................................. 112 Chieftek Precision...................................... 113 Mike Francesconi mfrancesconi@wtwhmedia.com Cicoil........................................................... 114 Clippard...................................................... 115 630.488.9029 COMSOL.................................................... 116 CPC-Colder Products Company.............. 117 Michelle Flando DATA IMAGE Corporation........................ 118 mflando@wtwhmedia.com Donatelle.................................................... 119 440.670.4772 Dunkermotoren......................................... 120 @mflando Eagle Stainless Tube.................................. 121 ElectroCraft................................................ 122 Garrett Cona Fabco-Air.................................................... 123 gcona@wtwhmedia.com Fischer Connectors.................................... 124 213.219.5663 Fluid Metering Inc..................................... 125 @wtwh_gcona LEADERSHIP TEAM Publisher Brian Johnson bjohnson@wtwhmedia.com 617.905.6116

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Managing Director Scott McCafferty smccafferty@wtwhmedia.com 310.279.3844 @SMMcCafferty

Medical Design & Outsourcing

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VP of Sales Mike Emich memich@wtwhmedia.com 508.446.1823 @wtwh_memich

1 â&#x20AC;¢ 2018

EVP Marshall Matheson mmatheson@wtwhmedia.com 805.895.3609 @mmatheson

CONNECTWITH US! Follow the whole team on twitter @WTWH_Medical

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1/25/18 9:29 PM

CMY

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You can try to juggle many vendors.

Or just call us.

Don't waste time & money dealing with multiple vendors when all you really need is one partner. B. Braun OEM has all the capabilities to get your product from drawing board to market. Project management, design and prototyping, engineering, quality systems, sterilization and regulatory guidance, to name a few. The best part of having all these capabilities under one roof is that they come with decades of expertise we can’t wait to share. Choose B. Braun OEM—your true outsourcing partner.

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