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Medical Design & OUTSOURCING medicaldesignandoutsourcing.com ∞ January 2019 ∞ Vol5 No1

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HERE’S WHAT WE SEE

The one secret that all great leaders know

I

’ve spoken with a lot of leaders over my nearly two decades as a journalist: politicians, CEOs and much more. A few were truly great. Many unfortunately weren’t.

Those who were outstanding seemed to get an important truth: that life is more than about money or fulfilling personal needs.

People need to care about something greater than themselves. Show them a cause worth working and fighting for, and they will follow.

Medtronic co-founder Earl Bakken, who passed away late last year, grasped that insight early on. Each of Medtronic’s 86,000 employees still receives a medallion that encapsulates the mission statement Bakken wrote nearly 60 years ago: “Contributing to human welfare by the application of biomedical engineering to alleviate pain, restore health and extend life.”

"[Leaders] who were outstanding seemed to get an important truth: that life is more than about money or fulfilling personal needs."

Bakken also knew the importance of a related corollary: walking the walk.

When Medtronic recalled its Fidelis defibrillator leads – used in hundreds of thousands of U.S. patients – the company’s stock took a hit. Reva Medical CEO Reggie Groves, then charged with running Medtronic's regulatory & quality business, recalled that a phone call from Bakken assured her that the company did the right thing.

"Earl Bakken called us that day. He was probably the single biggest loser of value that day, but he thanked us for doing the right thing for the patients," Groves said at our DeviceTalks West event in December.

“He led by example,” said former Medtronic CEO William Hawkins at a recent company ceremony honoring Bakken. “Earl lived his whole life dedicated to improving the human condition.”

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Chris Newmarker Managing Editor Medical Design & Outsourcing cnewmarker@wtwhm e di a .c o m

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“He remained a quiet leader who never really left the company,” Collins said. “Whether as a board member or simply in his founder role, Earl’s presence was always felt and appreciated by employees, physicians and the patients we all served.”

I’ve been lucky enough to meet a few CEOs over the years that demonstrated similar qualities, but perhaps no one exemplified it more than Bakken.

The medical device industry was lucky to have such a founding father. M

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CONTRIBUTORS

DAVÉ

DIKER

PAPPAN

8

PRAKASH

MAXSON

WALTON

WARFEL

NACH DAVÉ is VP of global regulatory affairs at Premier Research. He oversees the company’s regulatory affairs service offerings in rare diseases and across its broad range of therapeutic focus areas, bringing to the position more than 20 years of experience in the pharmaceutical and contract research industries.

JOHN PAPPAN is a director of regulatory affairs, medical device and business strategy at Premier Research. He focuses primarily in project management and regulatory compliance within the medical device, pharmaceutical and healthcare industries.

MIKE DIKER serves as Emerson’s applications development supervisor, leading a team of engineers who specialize in plastic and metal joining services utilizing Branson ultrasonic welding technologies. He holds a bachelor of science degree in mechanical engineering from the University of New Haven.

DEEPAK PRAKASH is senior director of global marketing at Vancive Medical Technologies, an Avery Dennison business.

TIM GEE is principal at Medical Connectivity Consulting, which advises medical device vendors, startups and providers on their connectivity options and strategies to improve workflow, provide access to their data and integrate their information with EMR systems. It is based in Beaverton, Ore.

TARICK WALTON is global product manager for Emerson and leads the company’s launch of the Branson GSX ultrasonic welding platform.

Additionally, he provides strategic support for performance and quality assurance across the Branson ultrasonic portfolio. Walton holds a bachelor of science degree from MIT and master of science of business and administration degree from Georgetown University.

STEVE MAXSON is VP of sales, vascular technologies for Spectrum Plastics Group. The company is a global manufacturer of medical polymer components and subassemblies, including multi-layer catheter tubing and thin-walled, gel-free balloon tubing.

MELONIE WARFEL is VP of medical devices & diagnostics at Veeva Systems. She has a track record of building profitable businesses across vertical industries including life sciences, healthcare, manufacturing and government.

Medical Design & Outsourcing

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CONTENTS

medicaldesignandoutsourcing.com ∞ January 2019 ∞ Vol5 No1

60

COLUMNS 6

HERE’S WHAT WE SEE

8

CONTRIBUTORS

12

MEDTECH TRENDS

18

CYBERSECURITY

ON THE COVER MEDTRONIC FOUNDER EARL BAKKEN KNEW HOW TO INSPIRE HIS EMPLOYEES

The one secret that all great leaders know

The late Earl Bakken led Medtronic for 40 years. His greatest gift to the company was arguably its mission.

Here are 5 medtech industry trends you need to know Growing cyber threats to medtech

24 MATERIALS

How to address common challenges affecting extended device wear time

28 MANUFACTURING & MACHINING

5 tips for ultrasonic plastic welding success

34 PRODUCT

FEATURES

DEVELOPMENT

What you need to consider when adding connectivity to a medical device

41

68 MONTERIS MEDICAL HAD A SERIOUS RECALL:

HERE’S WHAT THEIR CEO DID

REGULATORY

How technology can ensure MDR compliance – and better business performance

44 TUBING TALKS

48 MD&M WEST

Here are some MD&M West exhibitors

80 MEDTECH VETERAN REGGIE GROVES

ON LEADING WITH ‘PATIENTS FIRST’

86 PRODUCT WORLD 94 LEADERSHIP IN MEDICAL TECHNOLOGY 176 AD INDEX Medical Design & Outsourcing

TOC_JANUARY 2019_Vs3.indd 10

74 WHAT SHOULD THE MANN FOUNDATION DO NEXT?

Dr. Robert Greenberg, the Mann Foundation’s new executive chairman, has ideas about where to take one of medtech’s top research and development outfits. He explained more at DeviceTalks West in December.

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Soon after Marty Emerson took over as CEO of Monteris Medical, he and other company officials realized that the company’s robotassisted brain surgery device had a serious overheating problem.

Here’s how he led the company through the crisis.

1 • 2019

In guiding Medtronic through the Fidelis lead recall, medtech veteran Reggie Groves always took a “patients first” perspective. At DeviceTalks West 2018, Groves explained how her time at Medtronic influenced her as a leader and how she has brought those lessons into her role as CEO of Reva Medical. www.medicaldesignandoutsourcing.com

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MEDTECH TRENDS

Here are 5 medtech industry trends you need to know Whether it’s the slew of mergers and acquisitions or tighter regulation, developments of recent years are having some surprising effects on the medtech industry, according to experts.

M

oney’s tight, large strategics are merging and it’s hard to see where regulation is going – medtech insiders have heard about these trends for years. But a hot topics panel sponsored by law firm Greenberg Traurig at our DeviceTalks West event in December made it clear that they’re producing unexpected effects.

Here are five game-changing medtech trends:

Chris Newmarker | Managing Editor |

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Medical Design & Outsourcing

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1. More reliance on grants by young companies “My experience has been that money's very tight and maybe getting tighter,” said Eric Geismar, a consultant who works with trade association SoCalBio to advise young medtech companies.

When it comes to winning investments from large, legacy medical device companies, accounting law changes mean that strategics have to put a value

1 • 2019

on their equity investments at the end of every year, Geismar said. That means that medtech players that used to invest in startups just to make contact get on their boards face a higher bar.

“Now it's tougher for them and they really want to see results before they'll put significant money in – mostly human results. Animal results might not even be enough,” he said.

There are also simply fewer strategics to approach after a yearslong consolidation spree that produced mega-deals running into the hundreds of millions of dollars.

Startups looking to bridge the gap between seed financing and Series A rounds or corporate investment are increasingly turning to grants, according to Richard Yoon, senior director of intellectual property at Terumo’s MicroVention – especially the highly competitive Small Business Innovation Research grants doled out by the U.S. Small Business Administration. “[SBIRs] actually look good because you have third-party review to take a look at your science,” Yoon explained. “That gives you a little more of the, ‘Wow, there must be something here.’”

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MEDTECH TRENDS

2. More incubation in academia Early financing via academic research grants is also increasingly common, the panelists agreed. But it comes with a hitch: Companies need ties to academia for access to the grants.

“The best research happens at the universities,” Yoon said. “Unfortunately, the development is a little behind, but some of the great ideas start there.”

Interestingly enough, Yoon has noticed that universities are increasingly evaluating tenure-seeking professors on how much technology they’re licensing out.

Those deals can be lucrative for professors, according to Greenberg Traurig patent attorney Roman Fayerberg. “In a lot of these colleges, the agreements that they have at the technology transfer office, they get a certain royalty from licensing deals,” Fayerberg said.

3. Valuation in an uncertain regulatory environment Regulatory uncertainty on both sides of the Atlantic is making valuation increasingly tough, according to the panel.

Major media sensations – such as the International Consortium of Investigative Journalists’ “Implant Files” series and the Netflix documentary “Bleeding Edge” – have increased public scrutiny of the FDA’s 510(k) clearance process. And there’s a push at FDA to move away from predicate devices more than 10 years old and creating a 510(k) alternative based on objective safety and performance criteria, noted Ginger Pigott, vice chair of pharmaceutical, medical device & health care litigation at Greenberg Traurig,who moderated the panel.

“There's certainly been a lot of criticism in media and elsewhere about whether or not the 510(k) process indeed is a safety review, as we understand it to be, or just a substantial-equivalence stamp as some have been arguing, and what does that mean,” Pigott said. “It has impact on what I do, litigation, but it has even more of an impact in terms of what companies are doing and how easy or challenging it is to get that clearance through a process that will continue to change as FDA considers the proposals for evolution of the 510(k) pathway.”

In Europe, scrutiny of medical devices is also increasing as the new Medical Device Regulation goes into effect. “Previously, a U.S.-based medical device company could get an approval and start selling products 14

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MEDTECH TRENDS

in Europe much faster than in the U.S., which provided additional funding, but it's going to take longer to get to the market in Europe as well,” Fayerberg noted.

“The conundrum is that the [regulatory] path is getting harder, but companies want to see an approval before they invest,” Geismar added.

4. The union of medtech and high tech Cooperation between medical device and consumer technology companies is increasing as more products roll out to monitor people’s health and catch problems early, according to Geismar.

“You see Google and Apple working with a lot of device companies now in trying to enhance their own products as well as develop new ones for device companies,” he said.

Those partnerships could have medical device companies marketing products not only to doctors and health providers but also over-the-counter to the general public.

"The best research happens at the universities. Unfortunately, the development is a little behind, but some of the great ideas start there."

5. Rapid changes in the intellectual property landscape The move toward more connected medical devices has a major effect on one of the most important considerations for nascent medical device firms: intellectual property.

Patent attorneys have worked to protect IP for products such as catheters and stents for a long time; the strategy is to find out what’s different in a crowded market.

That’s changing now thanks to supplemental technologies such as connected functions, software, augmented reality and artificial intelligence, Fayerberg said.

“Because you’re dealing with software, it raises different questions than just dealing with the device itself,” he explained.

Expect more guidance from the U.S. Patent & Trademark Office about what a medical device company is able to patent in terms of such supplemental technologies, according to Fayerberg.

“It’s very important to have that strategy,” he said. “How do you protect your core product, and how do you build a fence around it?” M

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CYBERSECURITY

What you need to know about growing cyber threats to medtech Medical devices are an especially rich cybersecurity target for malicious activity by those seeking commercial gain or just trying to wreak havoc.

Although data theft is a serious threat, the risks posed by hacks involving networked medical devices is especially menacing.

I

n 2015, the FDA warned that a networked infusion pump was vulnerable to being accessed and controlled by unauthorized users.

Concerned that attackers could harm patients by altering their medication dosing, the agency warned healthcare facilities to discontinue its use. Years earlier, before hacking of these devices was on most people’s radar, doctors for former Vice President Dick Cheney ordered that his heart defibrillator’s wireless capability be turned off to prevent tampering by terrorists.

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18

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The motivation behind medtech hacking Software-enabled devices have expanded exponentially and their function has evolved from one-way vendor monitoring to fully networked equipment with bi-directional connectivity. That has opened the door to wide-ranging exploitation of device data.

The most obvious motivation is mining data for information that can be used to target customers. A company that sells products and services to diabetics, for example, could benefit from locating patients who use insulin pumps.

It may extend beyond patients to include family members: A genetic testing company might appeal to relatives of diabetics interested in knowing their own risk, or to purveyors of exercise equipment promoting the importance of fitness in diabetes prevention.

But there’s more than reaching consumers. If you’re considering building a hospital in a remote part of Africa, access to data from patients’ devices in that region could help you decide whether to proceed. There 1 • 2019

are also many nefarious uses for stolen data. For example, a device maker could monitor the performance of its competitors’ products and use the information to modify its own offerings and exploit a competing product’s shortcomings in its marketing.

There are many other examples of less-than-altruistic uses of device data.

A company whose drugs treat common chronic conditions might learn that a competitor is developing an implantable device that would give patients a concentrated form of treatment that cuts cost by reducing the required dosage.

Stolen data about the device could be manipulated to call its safety into question.

Networked devices also can provide wide-ranging biometric patient information such as blood pressure, respiration and blood enzyme levels. Companies that issue individual life insurance policies often purchase this information, repackaged by

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CYBERSECURITY

These threats change constantly and are becoming ever more sinister – and thus harder to defend against. A 2015 KPMG cybersecurity survey of providers and health plans reported that four in five healthcare organizations had been attacked in the preceding two years.

Only half felt adequately prepared to fend off a future assault.

third parties to appear to be of legitimate origin, to evaluate clients for insurability and to set premiums.

And then there are those who would use this data to truly nefariou purpose, including intellectual property theft, spoof emails and fake websites to obtain login credentials or install malware and intentional disruption of care to harm or even kill.

Managing risk Two years after that survey, KPMG reported a dramatic rise in computer system breaches and data compromises.

Still, by 2017 43% of respondents had not increased their cybersecurity spending. Just as concerning:

How the threats are evolving These risks will continue to multiply with the proliferation of unregulated devices such as personal fitness trackers and as the Internet of Things becomes a bigger part of everyday life. IBM predicts that the burgeoning web of hardware, software, electronics and sensors will encompass 50 billion devices by 2020, or more than 60 pieces of connected hardware for every person on Earth. The National Institutes of Health say 40% of IoT-linked devices will be health-related -- more than any other category.

• 53% said they were relying on cyber insurance to protect their organizations in the event of an attack.

• 42% did not plan to increase their cybersecurity spending in the coming year.

• 34% had not invested in information security at all in the preceding 12 months.

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CYBERSECURITY

“The value of digital assets across healthcare is skyrocketing, as are the risks and costs of regulatory noncompliance, reputational damage and related cyber and privacy breaches,” according to the 2017 report. Organizations that ignore this reality “are opening themselves up to unfathomable damage to their reputations, their finances, and even their viability,” according to KPMG. The regulatory response In September 2018, the U.S. Dept. of Health & Human Services issued its own warning on medtech security.

Specifically, HHS recommended that device makers and the FDA conduct presubmission meetings to better address cybersecurity-related questions, that the safety agency include cybersecurity questions in 510(k) submissions and that it begin requiring cybersecurity documentation on its refuse-to-accept checklists.

The FDA also recommends that manufacturers include the following in their submissions for networked devices: • A hazard analysis listing the cybersecurity risks considered and the cybersecurity controls incorporated into the device.

• A traceability matrix linking the actual cybersecurity controls to the risks that were considered.

• The manufacturer’s plans for validating and updating device software.

• A description of controls in the software supply chain.

Much of the thinking and guidance on the security of networked medical devices is relatively recent and still evolving. FDA reviewers increasingly request additional cybersecurity documentation from manufacturers when performing premarket reviews and the agency works extensively with manufacturers to address deficiencies in cybersecurity information. M

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Medical Design & Outsourcing 23

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MATERIALS

How to address common challenges affecting extended device wear time

Deepak Prakash | Va n c i v e M e d i c a l Te c h n o l o g i e s

As they look to enhance patient comfort, convenience and clinical outcomes with longer wear times, device makers must manage factors such as bodily fluids, skin regeneration, movement and friction. Luckily, there are material and device design solutions.

A

mid demand to deliver better care more efficiently, the healthcare industry is looking for longer wear times for some medical devices, from wound care dressings to wearables. It’s a challenging but not insurmountable objective, given some fundamental factors that are a natural part of living and healing.

Long-term wear, or extended wear, is defined differently for various medical device applications and patient profiles.

For example, a wearable patch delivering contraceptive medication might be worn for one week and then replaced.

A patch for monitoring glucose in the interstitial fluid might be worn continuously for two weeks. Another monitor may be worn for up to a month. Some wound dressings may need to be changed every two to three days; others once per week.

Whatever the initial baseline, there is a push to extend wear time. Why?

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Medical Design & Outsourcing

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1 • 2019

• Quality of life. Patients value independence, freedom of movement, discretion and comfort— all possible when a medical device can be worn for longer periods.

• Clinical outcomes. There are advantages to not disturbing a wound bed as frequently, gathering more data to aid in accurate diagnosis and treatment, improving medication compliance, etc.

• Costs. Longer wear time and remote monitoring require fewer resources, from the number of devices purchased to the labor and overhead to administer care.

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MATERIALS

Moisture and skin regeneration One of the greatest impediments to longterm wear is moisture. Bodies perspire.

Skin gets oily and continually sheds dead cells, or slough, even under healthy conditions. When wounded, there’s more slough. Healing wounds exudate (sometimes quite a lot). Fluids contacting skin-worn medical devices might come from incontinence or bathing. To make matters more difficult, different body parts (an arm vs. the abdomen vs. the back, etc.) generate fluid at different rates.

There is no one-size-fits-all approach to extended-wear moisture management.

That’s why it is important for device OEMs, materials suppliers, converters and healthcare providers to partner in the development of next-generation skinworn wearables and advanced wound care dressings. Because these devices must accommodate myriad variabilities, multidisciplinary expertise is essential.

For example, by working together on

wearable device development, material suppliers and OEMs can ensure the moisture-management method of choice (vapor transmission or absorption) is compatible between skin-contact and construction-layer materials.

When it comes to wound dressings, healthcare providers have many options and can weigh wear time with various healing properties. Will the patient do best with an odor- and fluid-absorbing hydrocolloid dressing or a breathable thin transparent film dressing, both of which can be engineered to promote autolytic debridement? Would a soft silicone adhesive be an ideal extended-wear option given a patient’s fragile skin? Or is a dressing impregnated with medicalgrade Manuka honey needed to help slough away necrotic tissue and support re-epithelialization?

Movement and friction Like bodily fluids, the movement of daily activity adds to the challenge of achieving longer wear times in skin-worn medical devices. But this too can be addressed with the latest advances in materials and device design. Thin foams and other highly conformable materials can be applied to bendable body joints and contoured body areas such as the sacrum. Materials can be engineered with just the right amount of static shear to allow for the body’s twists and turns. A wearable device or wound dressing can be constructed with a water-resistant top layer to give it staying power through regular showering. Medical adhesives can be formulated to have enough peel adherence to resist various levels of friction, from the repeated rub of a wheelchair armrest to the jostle of a rambunctious child’s embrace – whatever a patient’s lifestyle demands. M

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MANUFACTURING & MACHINING

5 tips for ultrasonic plastic welding success Medical device manufacturers can make smart choices about when and how to apply ultrasonic plastic welding to produce attractive, innovative and high-quality products.

Ta r i c k W a l t o n | Branson Ultrasonics at Emerson |

U

ltrasonic plastic welding is an effective, repeatable and reliable joining method for a range of thermoplastic materials. It is used in an everincreasing number of applications worldwide, for everything from medical devices and implants to consumer products.

But like any other joining or product assembly technology, it is essential to get the basics right to avoid pitfalls or unexpected difficulties. Fortunately, the benefits and the potential pitfalls of this still-growing technology are wellunderstood and can be easily avoided by thinking ahead and working closely with your ultrasonics supplier to address five key considerations:

Mike Diker | Branson Ultrasonics at Emerson |

1. Part design (e.g. geometry, joint design, wall thickness) Avoid design pitfalls by engaging early with application experts about the details of part design. Among the most critical aspects of design for ultrasonically welded parts are part geometry and joint style. For example, if hermetic sealing is essential for product performance, consider using tongue-and-groove joints rather than chisel-step or other joints. Adding texturing or â&#x20AC;&#x153;energy directorsâ&#x20AC;? on part surfaces further enhances joint reliability and manufactured part quality.

A chisel-step joint allows for thinner walls than a standard energy director and is good for structural welds.

Image courtesy of Emerson Automation Solutions

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2. Material selection Ultrasonic welding works extremely well with a range of thermoplastics, but some are incompatible with each other or with the process, so choose with care. Once you’ve selected material types for part design, ensure that your supply chain can manufacture (e.g. injection mold) tighttolerance parts consistently. In the event that a material is adapted or changed, it’s good to reevaluate the process with the help of your ultrasonic supplier, since weld parameter changes or even equipment changes may be required. Because weld quality and strength tie closely to part design and materials, recognize that even small changes can have significant effects on the joining process.

3. Actuation technology Next, select the right actuation technology based on your application needs, production targets and budget.

This selection is especially important for medical or electronics manufacturers whose product designs use delicate or miniaturized components with high regulatory and traceability requirements. Conventional pneumatic actuation technology relies on relatively high levels of downforce to actuate the welding process and can be too strong for thin-walled or delicate parts. They need a technology that offers much more sensitive resolution at low levels of actuation and weld force.

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4. Equipment adaptability To keep pace with evolving production requirements, choose a welder that offers modularity and adaptability.

Emphasize modular systems available with short lead times that can be manually operated on a benchtop or fully automated when increased production speeds are required.

Demand easy and intuitive controls that can establish and maintain consistent process quality, automatically adjust to manage minor variations, and collect the required part and traceability data.

5. Global support Finally, look for global support, including advice and recommendations that help shape your product design, reduce labor costs for training and production, minimize downtime and maintenance requirements, and enable you to adapt when supply chain, vendors or manufacturing requirements change. M

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PRODUCT DEVELOPMENT

6 things you need to consider when adding connectivity to a medical device Adding connectivity is a major trend in the medical device industry. Those taking the leap need to ensure that the product and their ability to support it are in alignment.

A

Tim Gee | Medical Connectivity Consulting |

manufacturer who wants to add connectivity to an embedded medical device must make some obvious technology changes, such as networking, wireless radios and, often, application software and systems integration with EMRs and other systems.

The less obvious impact is on company operations, or the business delivery system. This includes all of the resources, services, policies and procedures used to design and manufacture product, generate sales, and install, service and support the company’s systems. Companies planning a connectivity product development project should make sure that both the product and the company’s ability to deliver and support that product are in alignment.

Here’s a quick description of the most common areas of a company affected by connectivity features.

1. Finance Most companies have a model to evaluate the financial potential of new product development efforts. The factory margin in a conventional embedded system design is often 80%. This is a realistic objective when the company manufactures the

34

Medical Design & Outsourcing

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1 • 2019

entire product. Many connectivity features require that manufacturers resell off-theshelf computing equipment to offer the whole product solution demanded by most customers. The margins on this equipment are almost nonexistent and can hurt a project’s factory margin. For this and a few other reasons, a somewhat different set of financial metrics is needed for connectivity related projects.

2. Engineering Many manufacturers rarely develop new products. Their engineers focus on the company’s core technology, such as beamforming and image processing for a diagnostic ultrasound manufacturer.

Connectivity features require expertise in different areas: TCP/IP networking, IT and medical data communications standards, application software development and systems integration, to name a few.

And like expertise in beamformers, this expertise in connectivity related technology and processes is not something you just “pick up” while doing a project. The manufacturer must identify the skills required for its connectivity design project, identify the gaps and plans to fill them.

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PRODUCT DEVELOPMENT

3. Regulatory affairs In some ways, the embedded system device is a black box that is tightly controlled by the manufacturer.

Companies tend to devise the most efficient regulatory strategy to ensure FDA compliance, but applying that same regulatory strategy to a device with connectivity features often results in higher sustaining engineering costs. The main culprit here is the off-the-shelf IT equipment that is part of any connectivity feature. These are products that are out of the control of the manufacturer and can change every 12 to 18 months. Device manufacturers need a regulatory strategy that can accommodate that change while minimizing required verification and validation testing – in other words, a different regulatory strategy.

4. Marketing The value proposition of an embedded system device is often concentrated on the inherent capabilities of the device

itself. To continue with the ultrasound example, the focus is image quality for specific diagnostic applications. When connectivity features are introduced, the value proposition expands to include workflow automation that connectivity enables. Workflow automation’s value propositions are different from and more varied than those for image quality.

Buyers of new connectivity solutions may also be inexperienced in purchasing this kind of capability and will require education during the sales process – another new marketing requirement.

5. Sales Connectivity expands the sales process from selling the box, i.e., the distinguishing characteristic of the core function of the embedded system device, to include workflow automation that the connectivity features enable. This transforms the selling process into one that is consultative, rather than focused on core functions like image quality.

Connected features also introduce new decision makers, the buyer’s IT department. IT will have concerns and questions that must be addressed, as will the questions from clinical buyers. The sales department will need a different selling process, sales tools and training to meet these new challenges.

6. Installation, service and support Most embedded system devices are simply connected to a power source and the patient. The installation process is often little more than removing the device from shipping packaging and attaching a few accessories. Service and support focus on the internal operation of the embedded system device and can rely on engineering for complex problems or potential latent defects. Connected devices must be integrated with the customer’s enterprise network; application software must be installed on customer computers and/or computers sold by the manufacturer; and systems integration

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must be completed to ensure that data between the embedded system device and other customer systems such as the EMR, PACS or other systems.

Routine installations tend not to require a lot of additional training or skills. But the inevitable problematic installations will require technician- or engineer-level skills. Best practice for service and support for connectivity features is to use remote access to diagnose and often fix customer problems. Establishing remote access and having those resources for connectivity service and support requires enterprise IT acumen in addition to product knowledge.

Depending on the nature of your connectivity features, the impacts described here may over- or understate your needs. Regardless of the specifics, it is clear that there are operational impacts that come with connectivity features.

The ability to support those connectivity features will have a big impact on product quality and customer satisfaction. The keys to good execution are a needs assessment and gap analysis. This will drive an operational plan that must be synced up with product development and the availability of the new product. M

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A blog for technology enthusiasts Get inspired and improve your knowledge of drive systems. Learn about the latest applications in medical, robotics, aerospace and more.

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12/18/18 10:52 AM

REGULATORY

How technology can ensure MDR compliance – and better business performance The mid-2020 deadline for MDR compliance is getting closer. Here’s how companies can use technology to ensure compliance.

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s we enter 2019, the mid2020 deadline for the Medical Device Regulation is getting closer. MDR will change the rules for medical device manufacturers and distributors operating in Europe, replacing the current Medical Devices Directive. Under the MDR, companies will be responsible for ensuring that all their products meet general safety and performance requirements. This now includes cosmetic devices and medical device software for the first time.

Melonie Warfel | Ve e v a S y s t e m s |

Meeting requirements of the MDR Compliance requires companies to fully understand the legislation and what it means for their businesses, and then put in place the software and systems to ensure provisions are met. However, a recent survey found that less than one-third of organizations have a strong understanding of the MDR.

Given the short time until enforcement begins, medical device companies face compliance risks if they are not ready. They should, therefore, look to put appropriate measures in place to guarantee business continuity and minimize risk, as well as ensure they have all the necessary data and documentation to achieve compliance across their products.

Putting evidence at the heart of compliance The MDR has a much greater focus on clinical evaluations than previous legislation.

This means manufacturers and distributors will need to demonstrate clinical evidence regarding the safety of every Class III device in their portfolios, no matter when it was introduced. This "no grandfathering" clause will particularly affect older devices for which manufacturers may have little, or no, clinical information available. Additionally, more products are likely to be designated as Class III, which will add to compliance workloads.

Manufacturers also need to take a whole-lifecycle approach – achieving compliance will not be a single, one-off event. Companies will have to maintain systems and documentation in permanent compliance throughout the device lifecycle.

Accomplishing this requires various fields, including risk management, clinical evaluation, post-market surveillance and clinical studies, to work together closely.

A trigger for technology change The increased requirements for clinical evidence under the MDR will have a major impact on medical device businesses.

Running more trials will require larger investments as well as produce a corresponding need to ensure that data is stored and available in a way that can be used easily and transparently to demonstrate compliance.

www.medicaldesignandoutsourcing.com

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REGULATORY

That means companies should start by evaluating their existing systems and processes. When manufacturers do this, many are likely to find that the technology they use will struggle in the post-MDR world. This is because up until now, many medical device manufacturers have been able to operate through a combination of inflexible on-premise legacy systems and email for information sharing.

On the positive side, this means the MDR can be a catalyst that pushes companies to upgrade and improve their systems. Companies can look to update legacy systems and processes, transforming their technology landscapes by adopting newer and more efficient cloud-based solutions.

This newer technology provides the framework for more collaborative and transparent document and data management across all functions. It removes silos between departments, increasing transparency into workflows and document lifecycles. Using cloud technology enables easier communication and collaboration with external organizations, whether those are outsourcing partners (such as contract research organizations) or regulatory authorities. Employees can operate from

www.medicaldesignandoutsourcing.com

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wherever they are â&#x20AC;&#x201C; whether home or investigative sites, updating the system directly in real time.

Achieving MDR compliance will be considerably simpler once companies have implemented new technology. It allows tasks to be documented through the entire product lifecycle, creating an audit trail across the lifecycle of the record. Everyone involved can receive automatic status updates via clear dashboards. Built-in metrics enable companies to generate reports for both internal and external use and capture valuable insight into performance.

Paper and paper-based processes are removed, which increases efficiency and productivity and reduces administration.

Moving beyond the MDR The MDR will come into force in 2019 and transform the compliance requirements of device manufacturers and distributors.

Clinical-testing workloads will increase, putting a strain on existing processes and inflexible systems. Homegrown legacy solutions are unlikely to be able to achieve effective, efficient compliance.

Now is the time for manufacturers to look at modernizing their technology, which will benefit the overall business while ensuring MDR compliance. M

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1/8/19 5:44 PM

TUBING TALKS

How to ensure the structural integrity of multi-layer polymer tubing The final physical properties of the polymers used are not the only factor when designing a co-extruded multi-layer tube for an intravascular application.

Image courtesy of Spectrum Plastics Group

M

ulti-layer extrusion technology is a process in which two or more polymers are extruded and simultaneously joined in a co-extrusion die to form tubing with multiple layers. Running two or three extruders into a co-extrusion die head produces a single, multi-layered, extruded tube from a combination of materials with different physical properties, friction coefficients and bonding characteristics.

So what does a medical device creator need to know when it comes to multi-layer coextrusion of dissimilar and similar polymers?

Co-extruding dissimilar polymers Multilayer coextrusion poses some challenges, particularly in creating uniform wall thickness.

Differences in the viscosities, velocities and melt temperatures of dissimilar polymers may cause problems, including delamination.

Dissimilar polymers have different chemistries with low levels of interlayer adhesion and are subject to interfacial instability. This is compounded when polymers with low surface energies are used in the multi-layer structures. As a result of the chemical incompatibility, these different grades of polymers do not form strong bonds with each other, even upon coextrusion. Tubing made of layers of dissimilar materials tends to delaminate.

Steve Maxson | Spectrum Plastics Group |

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Medical device and co-extrusion polymer selection Multi-layer tubing suitable for percutaneous transluminal catheters used to deliver an angioplasty balloon may require an inner layer of a lubricious polymer such as HDPE to enable the catheter to advance over the guidewire. The adhesive middle layer could be made of a modified LLDPE, and the outside may be a soft, “bondable” layer such as PEBA for bonding a PA12 angioplasty balloon to the catheter shaft.

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1/8/19 10:36 PM

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TUBING TALKS

Using adhesive to bond the balloon to the catheter shaft is not optimal because the adhesive may fail, and because the adhesive adds to the overall profile of the catheter.

Percutaneous transluminal catheter tubing contains very thin wall thickness down to 25 microns with internal diameters designed to support 0.014in., 0.018-in. and 0.035-in. delivery platforms.

Viscosity and velocity From an extrusion standpoint, viscosity is the most important flow property in multi-layer polymer selection. Typically, the inner layer has the highest viscosity, and the outer layer has the lowest viscosity, as the low-viscosity melt can encapsulate the high-viscosity melt while flowing through the die head and tooling channels.

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Polymers with compatible glass transition temperatures (Tg) and melt temperatures (Tm) should also be chosen for consistent layer distribution.

The glass transition temperature of each polymer layer should be between 85% and 115% of the glass transition temperature of the adjacent layer polymer(s).

Multi-layer tubing die flow channels are typically designed to provide uniform velocity of each polymer flow at the die exit, assuming uniform incoming melt temperatures. When a highervelocity polymer layer merges with a lower-velocity layer, the high-velocity layer slows down, causing wave-like flow instabilities at the interface. Interfacial instabilities result in intermixing of the layers, decreased performance or delamination, and poor aesthetics in catheter tubing.

www.medicaldesignandoutsourcing.com

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Non-uniform melt temperature also affects polymer velocity going into and through the die. In a multilayer coextrusion process, such melt temperature gradients can indiscriminately affect individual layer uniformities.

Extrusion processing conditions can be optimized to avoid the occurrence of interfacial instabilities by controlling the melt temperatures and thereby the velocity ratios of each melt stream.

Adhesive (tie) layers used in multi-layer co-extrusion of dissimilar polymers An adhesive polymer acts as a bonding layer and a stress reliever at the interface of hard-to-bond polymers. It promotes uniform wall thickness and discourages delamination during coextrusion as well as under normal and extreme operating conditions, such as high balloon pressures.

Co-extruding similar polymers High-pressure balloon tubing may have a wall with at least three adjacent coextruded layers of similar polymers such as PA12, with varying durometer ranges for each layer. After the trilayer tubing or preform is reheated and formed into a balloon, the noncompliant, tri-layer dilatation or stent delivery balloon can have a burst pressure of at least 30atm (440psi).

Dual or tri-layer balloon tubing has structural integrity and reduces the standard deviation significantly from balloon to balloon when completing burst performance. The reduction in standard deviation allows the balloon to be rated at a higher pressure. A defect in one layer of a tri-layer tube made of the same material doesnâ&#x20AC;&#x2122;t affect the second or third layer or vice versa. M

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MD&M West

exhibitors you need to know More than 20,000 engineers and executives are expected to gather and network for the annual MD&M West – one

MD&M West takes place at the Anaheim Convention Center in Anaheim, Calif., Feb. 5–7,

and houses an array of industry suppliers showcasing their latest technologies and manufacturing advancements. Think medical device packaging, silicones, ultrasonic assembly and much more.

Here are some of the companies touting medical device manufacturing technologies at this year’s MD&M West.

Emerson

of the largest annual medical device manufacturing events.

Image courtesy of Emerson

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Emerson (St. Louis) is touting its Branson GSX-E1 ultrasonic welding platform at MD&M West this year.

The platform assists in the assembly process of smaller and more complex plastic components. It helps create precise welds by using an advanced electro-mechanical actuation system that gives the user control and position accuracy while applying low trigger force, according to the company. www.emerson.com/enus/automation/branson

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MD&M WEST

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Accumold (Ankeny, Iowa) is touting its contract manufacturing capabilities at this year's MD&M West. Technologies include injection molding, molds and dies, and plastics and polymers.

Accumold manufactures precision micro molded plastic components with part geometries of 5 cm to less than 1 mm in size. The company uses materials including PEEK, Ultem, LCP and most engineered thermoplastics. www.accu-mold.com

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MD&M WEST

Booth #2413 Freudenberg Medical

FlexSeal inducer sheath from Freudenberg Medical Image courtesy of Freudenberg Medical

Freudenberg Medical (Carpinteria, Calif.) is showcasing its contract manufacturing and assembly for medical devices. The company's offerings also include design services, extrusion medical, injection molding, materials and medical device component manufacturing.

Freudenberg Medical has 11 manufacturing operations and employs more than 1,500 people worldwide. Its manufacturing capabilities also include high-precision silicone, thermoplastic components, medical tubing, drug coatings, hypotubes, finished devices and subassemblies for catheters and minimallyinvasive devices. www.freudenbergmedical.com

IRP Medical IRP Medical (San Clemente, Calif.) is touting its contract manufacturing, injection molding and prototyping capabilities at MD&M West this year.

The company specializes in custom molding of liquid silicone rubber, organics and polyisoprene elastomeric materials for the medical device industry. It also offers overloading, assembly and packaging services.

IRP Medical is ISO 13485:2003, ISO 9001:2008 and ITAR certified. It also manufactures all of its LIM products in an ISO Class 8 cleanroom. http://www.irpmedical.com/

Booth #1439 Image from IRP Medical

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MD&M WEST

Booth #2248

Raumedic syringe plungers

Raumedic

Image courtesy of Raumedic

Raumedic (Mills River, N.C.) is showcasing its full-service contract manufacturing for the medical device industry, as well as its medical device assemblies, extrusion medical, injection molding and medical device components.

The company processes a variety of thermoplastics, including nylons, polyurethanes, high-performance plastics like PEEK and PSU and fluoropolymers like FEP and PTFE. Raumedic's other capabilities include single and multi-lumen tubing, jacketing of fine wires, co-extrusion, micro molding, insert molding, silicone pump segments, automated assembly solutions and custom compounding of polymers. www.raumedic.com

Donatelle Donatelle is showcasing its device assemblies, fullservice contract manufacturing for medical devices, injection molding, precision machining, and tooling capabilities at MD&M West this year.

Donatelle provides product design, product development, toolmaking, rapid prototyping, thermoplastic injection molding, liquid silicone molding, micromolding, micro-MIM, precision machining, micro machining, component and device assembly, packaging and process validation. www.donatellemedical.com

Booth #2421 Donatelle clean room Image from Donatelle

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Booth #2404 GW Plastics GW Plastics (Bethel, Vt.) is touting its assembly, contract manufacturing, injection molding, medical device components, product design and development and tooling capabilities at this year's MD&M West.

The company also offers concept-to-market contract manufacturing services. It specializes in medical-surgical components, assemblies and single-use consumable healthcare products – and has in-house tool building capabilities. GW Plastics has precision injection molding capabilities of thermoplastic and liquid silicone rubber.

All of the company's products are manufactured in an ISO 13485 cleanroom, with facilities in the U.S., Mexico, China and Ireland. www.gwplastics.com

In addition to offering thousands of standard catalog products, we take great pride in designing and developing customized solutions for your application needs.

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MD&M WEST

Maxon Precision Motors Maxon Precision Motors (Fall River, Mass.) is showcasing its control systems, controllers, motion control and motors and drives at MD&M West.

Maxon Precision Motors is a supplier of highprecision DC brush and brushless motors and drives that range in sizes from 4 mm to 90 mm.

Booth #3054

www.maxonmotorusa.com

Maxon Motor DC brushed (left) and brushless motors Image courtesy of Mason Precision Motors

Zeus Zeus (Orangeburg, S.C.) is touting its extrusion medical, medical device components, plastics and polymers, R&D, tube processing and tubing types capabilities at MD&M West this year.

The company also offers polymer extrusion technologies for the medical device industry.

Zeus LCP monofilament Image courtesy of Zeus

www.zeusinc.com

Booth #3113

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MD&M WEST

STANDARD AND CUSTOM MOTION CONTROL PRODUCTS FOR DRUG DELIVERY & LIQUID HANDLING

Booth #1847 New England Wire Technologies New England Wire Technologies (Lisbon, N.H.) is touting its cables and wires, electronics components, extrusion medical, medical device components and tubing types at this year's MD&M West.

The company designs and manufactures specialty wire and cables, which includes Litz wire, miniature/microminiature cables and custom hybrid cable configurations for the medical device industry. The company also offers extrusion expertise and wire processing capabilities.

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1/8/19 11:24 PM

HIS EMPLOYEES The late Earl Bakken led Medtronic for 40 years.

His greatest gift to the company was arguably its mission.

EARL BAKKEN made history when he

invented the battery-powered, wearable cardiac pacemaker in 1957 in a Minneapolis garage. But three years later, the company he co-founded was foundering and desperately needed cash.

To show the board of directors that the $200,000 they raised would be put to good use, Bakken wrote a mission statement for the company. Nearly 60 years later, that mission statement continues to guide Medtronic and inspire its 86,000 employees. Each receives a medallion that encapsulates the mission statement’s six tenets: “Contributing to human welfare by the application of biomedical engineering to alleviate pain, restore health and extend life.”

Bakken, who died at his Hawaii home on Oct. 21, 2018, at the age of 94, spent 40 years at the helm of Medtronic, now the world’s largest medtech company. His successors as chief executive, and other executives past and present, extolled Bakken for his leadership, vision and drive to invent and teach, during an event last December in Minneapolis.

The roots of Bakken’s leadership were spiritual, according to Mary Jo Kreitzer, a registered nurse and founder & director of the Earl E. Bakken Center for Spirituality & Healing at the University of Minnesota.

Medtronic founder

EARL BAKKEN N A N C Y C R OT TI S E N I O R E D ITO R

knew how to inspire his employees

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Earl Bakken images courtesy of Medtronic

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EARL BAKKEN

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When Bakken was a shy youngster studying for confirmation – and simultaneously inventing an electronic device to zap bullies – his pastor suggested applying his scientific and electrical interests to helping people, Kreitzer said.

As a young man leading Medtronic, another pastor challenged Bakken to mount a moral defense for implanting electronic devices in the human body.

“He replied, ‘God has given us the ability to develop such devices for the good of humankind and to help restore patients’ lives. Surely that’s a worthy activity in the eyes of God,’” added former Medtronic chairman & CEO Bill George.

"God has given us the ability to develop such devices for the good of humankind and to help restore patients' lives.

Surely that's a worthy activity in the eyes of God." Bakken and his brother-in-law, Palmer Hermundslie, launched Medtronic in 1949 as an electronic medical equipment repair service. Dr. Walton Lillehei – who pioneered open heart surgery at the University of Minnesota’s hospital – asked Bakken to build a battery-powered pacemaker after a baby who was connected to an AC-powered pacemaker died during a 1957 power failure. Thus came what many consider to be the founding of the medical device industry.

In receiving a lifetime achievement award in 2014 from the medtech trade group AdvaMed, Bakken described visiting the hospital and seeing his pacemaker attached to wires in a young boy’s chest.

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EARL BAKKEN

“It was a marvelous feeling to see something we had made keeping this child alive,” he said. “I learned then that this was a wonderful business to be in and supply these miracles for people’s lives.”

An unconventional CEO, Bakken instituted an annual holiday party at which patients tell employees how Medtronic devices changed their lives.

He encouraged patients to use their “extended lives” to help others and was a champion of promoting women to leadership. George and former Medtronic chairman & CEO Art Collins described their job interviews as sessions in which Bakken spoke about the Medtronic mission for nearly an hour and asked no questions of them. Former chairman & CEO William Hawkins described Bakken as a social leader who exhibited extraordinary empathy, humility and confidence.

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EARL BAKKEN

Signal Transformer is a global leader in custom design and manufacturing of Linear Transformers, High Frequency Magnetics & smd Power Inductors.

“Earl taught us a lot about confident leadership [with] his passion for innovation, his relentless focus on the patient and his belief that everyone makes a difference,” Hawkins said. “He led by example. Earl lived his whole life dedicated to improving the human condition.”

Bakken also loved science and never stopped teaching. In 1975, he established the Bakken Museum in Minneapolis to

60 Years of Experience

share his passion for innovation via science, technology and the humanities. The Smithsonian-affiliated museum maintains a collection of historic, scientific and medical instruments as well as books, journals and manuscripts. Thousands of schoolchildren visit the Bakken Museum each year.

A 1948 electrical engineering graduate, Bakken maintained a close relationship with the University of Minnesota. He worked closely with scientists, engineers and healthcare providers at the university and supported it throughout his life. In 2007, the university gave Bakken an honorary medical degree.

Ten years later, the university renamed both its Center for Spirituality & Healing and its Medical Devices Center after him.

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EARL BAKKEN

Bakken inspired many medtech leaders to take risks and to build their companies to help address unmet medical needs, according to Hawkins. After retiring from Medtronic in 1989, he moved to Hawaii in the early 1990s where he spearheaded the establishment of a community hospital, making sure that it provided patients with plenty of natural light and views of the outdoors to promote healing.

Bakken had a unique capability that few company founders display, according to Collins.

“He recognized what he was good at and when it was time to step aside and let others run the day-to-day operations,” Collins explained. “He remained a quiet leader who never really left the company. Whether as a board member or simply in his founder role, Earl’s presence was always felt and

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appreciated by employees, physicians and the patients we all served.”

“He was a good guy,” added Hawkins.

“He cared about patients. He cared for the physicians. He cared for the employees, and he cared for their families.”

Earl Bakken didn’t think he was doing anything out of the ordinary when he built the first battery-powered wearable pacemaker or when he composed the mission statement, according to current CEO Omar Ishrak.

Ishrak called that statement Bakken’s greatest gift to the company.

“When I wrote that mission, I never realized what an impact it would have on the future of our company,” Bakken once said to employees. “I ask you to keep those words in your mind and take them into your heart. I want you to live by it every day.” M

"He cared about patients. He cared for the physicians.

He cared for the employees and he cared for their families."

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Monteris Medical had a serious recall: Here's what their

did

C H R IS NEW M A R K ER MA NA G ING ED ITO R

Soon after Marty Emerson took over as CEO of Monteris Medical, he and other company officials realized that the company’s robot-assisted brain surgery device had a serious overheating problem.

Here’s how he led the company through the crisis.

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arty Emerson became CEO of Monteris Medical (Plymouth, Minn.) in July 2016. Within a month, the first report came in of a problem: The probe tip of the company’s NeuroBlate robot-assisted brain surgery device unintentionally heated up during the MRI-assisted procedure.

That discovery would eventually turn into a recall designated as Class I by U.S. FDA – Emerson’s first in his roughly 30 years in medtech.

Understanding and solving the problem would consume Emerson and dozens of Monteris employees over the next two years.

“Almost every emerging technology at some point or another in its maturation process has to go through one of those trials by fire, if you will, where you’re really getting into the core of your science and technology,” Emerson told Medical Design & Outsourcing. www.medicaldesignandoutsourcing.com

1/8/19 11:37 PM

Monteris Medical CEO Marty Emerson demonstrates the company’s NeuroBlate robot-assisted brain surgery device.

Image courtesy of Monteris Medical

Some regulatory experts said that although the company’s response to the problem wasn’t perfect, it appears to be out of the woods. In October 2018, Monteris won FDA clearance for a laser probe with fiberoptic-controlled cooling for NeuroBlate. The fiberoptic part replaced a metal thermocouple inside the laser probe, enabling Monteris to lift MR scan restrictions.

All patient-contacting components are now non-metallic.

In late 2018, Monteris also announced that more than 2,000 patients have been treated with NeuroBlate since its release in 2013; the company also won reimbursement from Aetna and Anthem. Emerson is optimistic that the roughly $10 million a year company

– which had seen annual revenue growth of 40% before 2018 – is set to grow again as it turns its focus to sales and marketing.

NeuroBlate uses a robot-guided laser to ablate brain tissue during MRI scans. Some brain surgeons find NeuroBlate a useful surgical option for certain epilepsy and brain cancer patients who don’t have many other alternatives, according to Emerson.

Monteris ticked off a lot of boxes for Emerson after he left the top spot at Galil Medical, the Arden Hills, Minn.–based interventional oncology cryoablation technology company he led until its 2016 acquisition by London-based BTG for up to $110 million.

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MONTERIS MEDICAL

A stint as a general manager for Boston Scientific in Singapore in the late 1990s, after joining Baxter in a finance role right out of college in 1985, was Emerson’s first foray into a management career that eventually led to the corner office at Minnetonka, Minn.-based American Medical Systems. (AMS’s male urology portfolio is now part of Boston Sci, and its women’s health portfolio is now Astora Women’s Health.)

Although his sales background and communication skills were what initially landed him at AMS, then- CEO Doug Kohrs told us, Emerson’s level-headed and numbers-oriented approach soon became apparent. Kohrs said he considered those unusual traits for a salesperson and eventually promoted Emerson to COO and groomed him for the top job.

“Marty took a very pragmatic approach to solving problems,” Kohrs recalled. “He wasn’t a sky-is-falling kind

"Almost every emerging technology at some point or another in its maturation process has to go through one of those trials by fire, if you will, where you're really getting into the core of your science and technology."

of guy. He just saw what was going on, and then he got the resources that he needed, and he fixed it.”

Frank Jaskulke, VP of intelligence at Minnesota’s Medical Alley Assn., described Emerson as among the most respected leaders in the state because of his work growing AMS, Galil and now Monteris.

He would need all of his skills after learning of the first unintended probe heating incident in August 2016.

“It became the No. 1 priority,” Emerson told MDO. “We viewed this as an incredibly important initiative that had, at its core, a need to be intensely focused on the science and technology that supports our company.”

Company officials quickly determined the problem involved a coated metal thermocouple that helped measure temperature inside the probe.

As Emerson explained it, the connector from the back of the probe to the system

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1 • 2019

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MONTERIS MEDICAL

had sometimes moved too close to the bore of the MRI magnet, picking up energy that was transmitted down the probe and heating the tip.

The problem only occurred inside particular MRI systems running specific scan types, leading the Monteris team to test more than 20 permutations and combinations from companies including Philips, Siemens and GE. In December 2016, as the company’s investigation progressed, another probe tipheating case surfaced; two more incidents occurred shortly before Monteris alerted the FDA in September 2017. In one, a patient died of a brain bleed a few days after the procedure, although it wasn’t conclusive that the probe tip heating was responsible, according to the FDA. Emerson said that Monteris came to FDA with a thorough understanding of the problem, data from testing the 20 MR equipment permutations, updated instructions for use designed to mitigate the issue and a product development plan to permanently resolve the problem.

Communication and transparency among the Monteris team, with the FDA and with physicians were front-of-mind for Emerson during this process, he told us, recalling a number of late nights when executives and regulatory experts jointly edited responses to the FDA. An accountant by training, he also tried to stay mindful of what he didn’t know.

“I'm not an FDA expert,” he explained. “I relied heavily on the scientists and the technologists and the engineers and the experts on my team to get us through this process.”

e

s.

This illustration shows the laser probe in Monteris Medical’s NeuroBlate robot-assisted brain surgery system.

Image courtesy of Monteris Medical

on

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Did Monteris do enough?

Although Monteris appears to have done many things right and appears to have succeeded in eliminating the problem, according to regulatory experts, there are lessons to be learned for companies facing similar problems.

"We viewed this as an incredibly important initiative that had, at its core, a need to be intensely focused on the science and technology that supports our company."

Former FDA analyst Madris Tomes, now CEO of medtech safety software company Device Events, said she was especially impressed that out of the 342

adverse event reports she counted for the company since 2010, about half came from Monteris’ salespeople – a much better record than the industry as a whole.

“I’ve seen a lot of things handled much worse than this,” Tomes added.

Michael Drues, a Southern Californiabased regulatory consultant, questioned why more than a year elapsed between Monteris learning of the problem and alerting the FDA. “Unfortunately, there is no regulation that requires this for a 510(k) yet – there is for PMAs – but a company does have an obligation, in my opinion, to let FDA know what is going on ASAP. This was a Class I recall, which has potential for serious injury and death.”

“There was never any suggestion from FDA that we didn’t move fast enough,” Emerson told us when asked about the time gap. “We were doing an immense amount of testing along the way.”

There were only two instances of probe tip overheating over the course of 12 months, he added. After Monteris issued updated instructions for use in early October 2017, the company received no reports of unintended heating for the year preceding FDA approval of its new technology, Emerson said.

As of press time, representatives for the FDA had not responded to a request for comment on the Monteris recall.

Monteris emphasizes thorough and complete adverse event reporting, Emerson said, adding that he strives to remember that the company puts its tools in physicians’ hands to help patients.

“The vast majority of the patients … are really well served by the technology that we've provided to those physicians,” Emerson said. “I can't let an unfortunate outcome stop us.” M

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What should the DR. ROBERT GREENBERG, THE MANN FOUNDATION’S NEW EXECUTIVE CHAIRMAN, HAS IDEAS

Mann Foundation ABOUT WHERE TO TAKE ONE OF MEDTECH’S TOP RESEARCH AND DEVELOPMENT OUTFITS.

do next?

NANCY CROTTI SENIOR EDITOR

HE EXPLAINED MORE AT DEVICETALKS WEST IN DECEMBER.

The new executive chairman of the Alfred E. Mann

Foundation for Scientific Research sees the organization continuing its mission of developing devices for unmet medical needs. The foundation for the first time is also inviting outside companies to use its resources.

Founded in 1985, Valencia-Calif.–based AMF launched several innovative companies, including Second Sight Medical Products, which makes devices for the visually impaired; cochlear implant manufacturer Advanced Bionics, now a subsidiary of Sonova; and MiniMed, developer of a hybrid closed-loop insulin delivery system that’s now part of Medtronic.

“It was essentially an incubator before the term ‘incubator’ even existed,” explained Dr. Robert Greenberg, who took over as executive chairman in June 2018 after serving as non-executive chairman since 2004. (John Petrovich leads AMF as its CEO.)

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Brad Perriello, executive editor – Medical at WTWH Media (left), interviews Dr. Robert Greenberg of the Alfred Mann Foundation at DeviceTalks West in Costa Mesa, Calif.

Image by WTWH videographer Graham Smith

www.medicaldesignandoutsourcing.com

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MANN FOUNDATION

“This infrastructure of laboratory space and technical talent and equipment and expertise – regulatory and quality in the manufacturing of these devices – the core expertise ended up being leveraged each time a new company was developed. A lot of that built-up knowledge has really benefited each new startup,” Greenberg said.

Greenberg was chairman & CEO at Second Sight from its inception in 1998 through 2015, leading the development of an implantable retinal prosthesis, the Argus II, to restore vision to patients blinded by retinitis pigmentosa. He also oversaw the successful development and human implantation of a wireless cortical visual prosthesis, the Orion, which the company says has the potential to eliminate nearly all forms of blindness.

Every project the foundation undertakes must be designed for a high

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unmet medical need, either to help a large number of people or to provide a high impact for a small group of people, such as amputees. Deciding which projects to take on remains one of its biggest challenges.

“We look at IP, what patents we might have or might be able to license, as well as freedom to operate,” Greenberg said. “We’ll look at market size, reimbursement, team ability to access folks with expertise in the area – all the factors that you would look at for a startup.”

In his new role, Greenberg wants to incubate local companies in addition to internal projects. He likes to think of the foundation as a research institution with a commercialization focus. Greenberg shares the belief of the foundation’s founder, the late Al Mann, that unless the products actually make it to a company, they won’t benefit patients.

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MANN FOUNDATION

3” and 4” ROUND TFTs WITH CAP Touch Panels “One of the realizations that I had about a year ago was that this infrastructure can be super-helpful to startups that might only have half a dozen people,” he said. “We started working with local companies, providing them access to the labs, to the personnel, and to the infrastructure in general.

As far as picking those companies, our criteria are similar to picking our own internal projects.”

They include BiVacor, a Houston, Texas startup that’s developing a completely artificial heart using two centrifugal impellers placed on a single rotor to provide perfusion to the left and right sides of the body. The device uses magnetic levitation to provide precise, stable operation with no mechanical wear. It is currently being tested in animal trials.

“Although our ultimate goal is to help these individuals and patients with these various diseases, we feel really strongly that these products ultimately need to find a home in a company so that they can be distributed for the benefit of patients,” Greenberg said.

The foundation’s financial resources and accumulated knowledge enable it to stick with projects for the long term, allowing the companies it develops to be more capital-efficient and make fewer mistakes, Greenberg said.

Mann was a leader in the aerospace industry when he made a donation to Johns Hopkins University’s applied physics laboratory to develop a rechargeable pacemaker in 1968.

The following year, at the university’s request, Mann took over the product’s development, cofounding Pacesetter Systems with Johns Hopkins researcher Robert Fischell.

Pacesetter was purchased by Siemens in 1985 (and later, by St. Jude Medical); Mann used some of the proceeds to start a foundation, aiming to convert university-based research into products that filled unmet and poorly-met medical needs.

A more recent foundation-based startup, Axonics Modulation Technologies, went public in October, raising $138 million in its IPO. The Irvine, Calif.–based company is developing an implantable sacral nerve stimulator to treat patients with urinary and bowel dysfunction disorders, with hopes that the platform will be expandable into other clinical indications in the future.

Axonics’ r-SNM device won CE Mark approval in the European Union in June 2016; an external trial module won an FDA nod in July 2017. It’s approved for market in Canada and Australia and expects to file a pre-market approval bid with the FDA during the first quarter of 2019.

"One of the realizations that I had about a year ago was that this infrastructure can be super-helpful to startups that might only have half a dozen people."

1 • 2019

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MANN FOUNDATION

"Although our ultimate goal is to help these individuals and patients with these various diseases, we feel really strongly that these products ultimately need to find a home in a company so that they can be distributed for the benefit of patients."

Now the foundation is working on an implantable myoelectric sensor, a matchstick-sized device designed to transmit electrochemical signals from muscles in the residual limb of an amputee to intuitively move a prosthesis. A controller interprets the signals and commands the prosthesis to perform a particular movement, such as opening and closing the hand, rotating the wrist 360º and laterally moving the thumb.

Combining these three movements enables several grasps that are invaluable for performing everyday tasks. Veterans at the Walter Reed National Military Medical Center are participating in a clinical trial of the sensor, and the foundation expects to transfer the technology to a corporation in 2019, Greenberg said.

“I think medtech is one of the most exciting areas that you can go into in engineering in general,” Greenberg said. “We’re looking a lot more at digital health solutions.

We’re looking at how artificial intelligence and data can play a role in medical devices. It’s something that, historically, we had a lot of implants that were generating data but we weren’t necessarily using that data. We’re spending a lot more time now looking at, particularly (with) our implants, we’re thinking a lot more about the data and how that can be leveraged for the benefit of patients.” M

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Medtech veteran Reggie Groves on leading with ‘patients first’ In guiding Medtronic through the Fidelis lead recall, medtech veteran Reggie Groves always took a “patients first” perspective. At DeviceTalks West 2018, Groves explained how her time at Medtronic influenced her as a leader and how she has brought those lessons into her role as CEO of Reva Medical.

SARAH FAULKN ER | ASSOCI AT E EDI TOR

Once the world's most popular defibrillator lead, Medtronic's Fidelis leads were in hundreds of

thousands of patients in the U.S. So when the device began delivering random, painful shocks to people about a decade ago, Medtronic officials were worried.

That included Reggie Groves, who was charged with running Medtronic's regulatory and quality business.

"It was in so many patients that even a very, very low rate of failure was pretty visible," Groves told the attendees at DeviceTalks West, held December 2018 in Orange County, Calif.

“The challenge was that we had a lead that wasn’t statistically any different, but the failure mechanism was worse. So what do you do? If you want to stop selling and you want to take something off the shelves in the hospital, you must recall it.”

A recall concerned Groves, who was worried that physicians would misinterpret the recall and put patients through the dangerous procedure of extracting leads. But she also understood that the company needed to act.

“Ultimately we made the decision that we didn’t want anybody else implanted with it until we knew for certain whether the lead was going to have a higher ultimate failure rate or not. So we did the recall,” she said.

Groves was asked to testify in front of a congressional committee. She was called to speak to the FDA. Doctors and folks within the industry challenged Groves, telling her that she should have pushed for a recall sooner.

Medtronic lost billions in market cap after it declared a recall for Fidelis, Groves said. But one phone call from Medtronic founder Earl Bakken assured her that she did the right thing.

www.medicaldesignandoutsourcing.com

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REGGIE GROVES

"Earl Bakken called us that day. He was probably the single biggest loser of value that day, but he thanked us for doing the right thing for the patients," Groves said.

"Patients come first," she added. "If you think what you're doing is better for patients, whatever roadblock, whatever challenge comes in front of you, it's easy."

Reva Medicalâ&#x20AC;&#x2122;s Fantom Encore drugeluting, bioresorbable coronary scaffold

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The challenges of bioresorbable tech With years of experience at the world's top medtech firm under her belt, Groves now serves as CEO of Reva Medical â&#x20AC;&#x201C; a publiclytraded, commercial-stage company that makes bioresorbable devices.

The firm touts its proprietary Tyrocore polymer as the only bioresorbable, X-ray visible product on the market. This year, Reva launched its third-generation coronary scaffold, Fantom Encore. The company also has CE Mark clearance for a bioresorbable device for below-the-knee peripheral artery disease. Groves noted at DeviceTalks West

1/8/19 11:52 PM

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THE ORIGINAL MEDICAL PUSH-PULL CONNECTOR

REGGIE GROVES

that the company is also moving forward with bioresorbable, X-ray visible embolic beads to treat vascularized tumors.

While drug-eluting stents remain the gold standard in interventional cardiology, studies have shown that leaving a permanent metal stent inside

After Abbott's stumble with Absorb, European Union regulators wrote new guidelines encouraging doctors to limit the use of bioresorbable devices to clinical trials.

"My view is that Abbott correctly saw that bioresorbable scaffolds are a major disruption to the coronary space

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"Patients come first. If you think what you're doing is better for patients, whatever roadblock, whatever challenge comes in front of you, it's easy." the body presents its own challenges, according to Groves. It would be ideal to create a product that delivered an adequate dose of drugs to a patient, kept the patient’s vessel open throughout the healing process and then dissolved away, she said.

Companies around the world have tried to tackle bioresorbable devices, and many have failed. Most notably, Abbott pulled its bioresorbable Absorb device off the market in 2017, reportedly due to low commercial sales. But long-term trial results have indicated that Absorb had an increased risk of target lesion failure and scaffold thrombosis compared to Abbott's Xience everolimus-eluting stent.

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and are the right thing for patients," Groves said. “I think the mistake Abbott made was to believe that first mover advantage was what was important."

Reva's chief executive said that Abbott's challenges represent an obstacle to convincing doctors and potential investors to buy into bioresorbable technology. But winning the hearts and minds of clinicians is all about showing them the value of Reva's devices with solid clinical data, she added.

"The average interventional cardiologist understands completely that bioresorbable, if we can get one that does as well as metal while it's there, is going to beat metal when it's gone. And so they want it. Now the question is, 'Can I get it through my hospital administration? Can I get it through my chief? Will the payer pay for it because of these guidelines?'

We have a series of headwinds that are certainly a challenge," she said.

"The good news is we don't have a lot of competition."

Having the patience for disruption Whether it was managing the Fidelis lead recall or navigating the challenges of a technology's bruised reputation, Groves has learned to endure through challenging work environments.

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REGGIE GROVES

"Disruption takes time," she said.

"You're probably going to fail. There are very few technologies that the first iteration is going to be a home run."

"So be prepared for the fact that it isn't going to work the first time out of the gate.

Don't drink your own Kool-Aid about how perfect you are and how perfect the technology is and how it's going to change the world in 60 days," she added.

For people just breaking into the medical device industry, Groves advised that they lean into difficult situations and try to take the road less traveled. She also noted that young people, particularly women, who are working to advance their careers shouldn't underestimate the power of speaking up.

"Make sure that you are reaching out and networking with folks who can help your career. I didn't do that.

I thought if I did my job well, I'll be noticed. Don't believe that,” Groves said. “That's just not true. You've got to speak up. I remember one time, while

"Disruption takes time. You're probably going to fail. There are very few technologies that the first iteration is going to be a home run."

I was in a smaller company, I went to my boss and said, 'I think all my male peers are making more money than I'm getting.' I got a $100,000 raise. Gee. You think I was making less money?" M

www.medicaldesignandoutsourcing.com

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PRODUCT WORLD

All Sensors adds pressure ranges to its compact sensor series All Sensors has introduced additional pressure ranges to its BLC series. Applications for the series include medical devices, medical instruments and portable/hand held devices. The series now includes high-pressure ranges from 5 psi to 150 psi, offering design engineers performance for pressure ranges of ±1 inH2O through ±30 inH2O, and now 5 psi to 150 psi gauge and differential and 15 psi to 150 psi absolute. The BLC series basic low-pressure compact sensors provide a high output signal at a low operating voltage, maintaining comparable output levels to traditional equivalent basic sensing elements, according to the company. This lower supply voltage gives rise to improved warm-up shift while the company’s CoBeam technology reduces package stress susceptibility, resulting in improved overall long-term stability. The technology also improves position sensitivity compared with conventional single die devices, All Sensors said. –NC All Sensors Morgan Hill, Calif. allsensors.com

KNF touts new compact high-flow gas pump KNF has launched its new micro gas pump, the NMP830 HP, for its OEM customers. The diaphragm pump offers high flow, pressure and suction in its compact size, making it ideal for medical therapy, monitoring and reprographic applications, KNF announced in November 2018. The NMP830 HP measures 31mm in width and produces free flow up to 5.5 L/min using a single head design and up to 10 L/min with a dual head. The pump is also able to produce pressure up to 3.0 bar g and vacuum down to 50 mbar absolute. The pump is an extension of the company’s NMP series. It offers a 33-44% increase in size-to-flow ratio compared to other pumps that KNF offers. The vacuum and pressure performance are also improved with its smaller size and weight. –DK KNF Neuberger Trenton, N.J. www.knfusa.com

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Micromo launches miniature gearheads with integrated leadscrews for linear actuation Micromo has launched a new series of linear actuators that feature standard gearheads with an integrated leadscrew that allow for any rotary motor to produce linear micro motion. The company suggests that the gearheads with integrated leadscrew offer a cost advantage to engineers and provide a more compact motion solution when compared to conventional configuration methods. Micromo’s new micro linear actuators are available in 6 mm, 8 mm and 10 mm diameter with a variety of reduction ratios offered. Each linear actuator comes in a high-speed or high-thrust version and can be used with any motor technology, including stepper motors and brushless dc motors. The lead screw length can quickly and easily be customized to fit specific applications, according to the company. –DK Micromo Clearwater, Fla. www.micromo.com

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DOWNLOAD: - Product Specifications - 3D CAD Models REQUEST A QUOTE

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SHACEY PETROVIC President & CEO; INSULET

2019 CO-LOCATED EVENT S U M M I T

&

E X P O

SAVE THE DATE:

JUNE 5-6, 2019

Boston

Seaport World Trade Center presented by:

boston.devicetalks.com

@DeviceTalks

Sponsorship opportunities are available for future DeviceTalks programs.

For more information, contact Mary Ann Cooke. 781.710.4659 | maryann@massdevice.com

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PRODUCT WORLD

Steinmeyer makes a move Steinmeyer has moved to Woburn, Mass.

The U.S. subsidiary of a German company that makes precision ball screws, Steinmeyer now has a warehouse with 25% more capacity. The larger quarters will allow the company to broaden its stocking program, which allows customers who place blanket orders to have stock on hand in the U.S., ready for immediate shipment. The move has also enabled Steinmeyer to expand its offerings of miniature ball screws and nuts to engineers working on prototype development. The expanded shipping and receiving area allows for handling ball screws of any length and the loading dock can accommodate a larger range of truck sizes, accelerating the delivery process. Designed and manufactured in Germany, Steinmeyer’s products are used globally in precision positioning for medical devices, lab instruments, optics and other mechatronic applications. –NC Steinmeyer Woburn, Mass. www.steinmeyer.com

Precision Welding For Critical Plastic Components

The Branson GSX Ultrasonic Welding Platform meets the growing demand for the assembly of smaller and more complex plastic components. Precise welds are achieved utilizing an advanced electro-mechanical actuation system that provides unprecedented control and position accuracy, while applying the industry’s lowest trigger force. The Branson GSX can also weld across multiple parameters, monitored in real-time to ensure quality. This is possible with a wide range of input materials and best-in-class repeatability across multiple Branson GSX welders.

See us at MD&M West – Booth #3201

For product information: Emerson.com/Branson

The Emerson logo is a trademark and a service mark of Emerson Electric Co. © 2018 Emerson Electric Co.

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S U M M I T

&

E X P O

The International Design and Development Event for Robotics and Intelligent Systems The Robotics Summit & Expo emphasizes the design and development of commercially viable robotics and intelligent systems products â&#x20AC;&#x201C; wholly new products and services that are to be used outside of laboratory environments and sold at a profit.

Dedicated tracks provide professionals with the information they need to develop the next generation of commercial class robotics and intelligent systems products and services.

Robotics Summit Tracks Technologies, Tools and Platforms Design and Development Manufacturability, Business Models and Business Development Workforce Engagement and Development

2019ATED C CO-LO T E EV N nce onfere c g n i ad ch The ler the medte . y t fo i n u comm

june 4-6, 2019

SEAPORT WORLD TRADE CENTER BOSTO N , M A

ro b o t i c s s u m m i t . co m EXHIBIT AND SPONSORSHIP OPPORTUNITIES For more information, contact Mike Emich 508.446.1823, memich@wtwhmedia.com, P RESE NT E D BY:

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ST R AT EGI C PAR NER :

P ROD U CED BY:

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PRODUCT WORLD

TE Connectivity touts electromagnetic interference filters for MRI rooms TE Connectivity has launched its electromagnetic interference (EMI) filters that are designed to be used in magnetic resonance imaging rooms where Class II drivers are used for powering LED lighting, the company announced in November 2018. The TE filters are part of the company’s Corcom products that are highlyengineered, sales assemblies of electrical filtering components. They are designed to eliminate unwanted electrical magnetic interference. Using the new filters in LED lighting in MRI rooms, room light manufacturers are able to offer highefficiency, patient-centric lighting while reducing electrical interference risk to MRI equipment functionality. “The filters are compatible with 40V, 3A drivers and are an excellent choice for high-noise drivers and their compact size supports OEMs and installers in their drive to minimize the size and weight of their equipment,” Jose Diaz, global product manager at TE Connectivity, said in a press release. –DK TE Connectivity Schaffhausen, Switzerland www.te.com

www.medicaldesignandoutsourcing.com

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PRODUCT WORLD

Synopsys releases new version of Simpleware Synopsys has released a new version of its Simpleware 3D data visualization software, which is used in both life science and advanced materials and manufacturing applications. Improvements in the new Simpleware (Version O-2018.12) include: • An intelligent number formatting system for better clarity of measurements and statistics; • Refreshed icons for more efficient navigation of the user interface and identifying individual tools; • A new welcome page with a streamlined image import workflow; • The ability to add 2D and 3D view annotations to anatomical models to improve collaboration among colleagues; • Scripting auto-completion to enable fast development of automated workflows and plugins; • Better segmentation, with a new local surface correction filter to improve mask accuracy, and interactive segmentation inspection with automatic fixes prior to model generation; • Enhanced dataset processing with new surface object editing tools and intuitive triangle painting selection, and a registration tool that can automatically position any combination of images, masks and surfaces in a single operation. –NC Synopsys Mountain View, Calif. www.synopsys.com

TTP Ventus introduces XP series of micropumps TTP Ventus in October 2018 introduced its new XP series, the latest addition to the Disc Pump range of micropumps. The XP series is meant to provide enhanced performance and efficiency, as well as a wide operational temperature range, to support more applications across the medical, life sciences, environmental and defense sectors, according to TTP Ventus.

The XP series boasts an up to 50% increase in peak efficiency, up to 30% increase in pressure and flow, and enhanced stability across a wider operating temperature range of –25 to 55 °C. TTP Ventus officials say they achieved the improvements through a combination of design alterations, new materials and manufacturing process development. The XP series was expected to start shipping in January 2019, with parts exclusively available to beta-test partners beforehand. –CN TTP Ventus Cambridge, U.K. www.ttpventus.com

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Replace your metal bearings...

...in all applications and environments

iglide® Q2: high strength, dirt and corrosion resistant

iglide® A181: FDA compliant, resistant against washdowns

iglide® P: high load capacity, very low moisture absorption

iglide® J: vibration dampening, reliable and long-lasting

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www.igus.com 1.800.521.2747

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HIP IN ME DT

H

LE

D

S ER

2018

EC

A

LEADERSHIP IN MEDICAL TECHNOLOGY

CONGRATULATIONS PRESENTED BY

20

Medical Design & OUTSOURCING

18

LEA

DERSHIP

WIN

NE

RS

A D VA N CED MATERIA L S Medical Design & Outsourcing is excited to release the

CA B L ES CO N TRA CT MA N U FA CTU RIN G

winners of our annual

CO U PL IN G S

Leadership in Medical Technology program. Since we announced the nominees in our January 2018 issue and online, our user community has voted on what companies they feel best exemplify medical

D ESIG N SERVI CES D I G I TA L MA N U FA CTU RI N G EL ECTRI CA L FA STEN I N G & JO I N IN G

technology leadership in 12 categories. We are happy to celebrate the winners here.

F L U I D PO W ER MA CH I N IN G MO TI O N CO N TRO L

Thank you for your innovation!

Your accomplishments are what drive gigawatts and create jobs.

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PRO D U CT D EVEL O PMEN T www.medicaldesignandoutsourcing.com

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Easy | Locking For Medical Applications

12 Contacts

> 5,000 Mating Cycles

IP54 Rated Protection

www.binder-connector.us

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MEDICAL CONNECTIVITY SOLUTIONS ■

■

FISCHER CORE SERIES PLASTIC

■ ■

Sterilizable Corrosion resistance

DISPOSABLE AND STERILIZABLE ASSEMBLED SOLUTIONS: SILICONE AND THERMOPLASTIC

FISCHER CORE SERIES DISPOSABLE

■ ■

Cost-effective single use plugs Modular or turnkey solution

FISCHER MINIMAX™ SERIES

■ ■

Signal & power High speed data – Ethernet & USB 3.0

fischerconnectors.com

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2019

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 more 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.

www.medicaldesignandoutsourcing.com

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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

2019

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.

over the years the basic principals have remained the same and so has our commitment to micro-injection molding technologies.

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.

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

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.

Accumold 1711 S.E. Oralabor Road Ankeny, IA 50021

Facilities

P: 1.515.964.5741

Accumold is an ISO 13485:2003, 9001:2015 and 14001:2015 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.

F: 1.515.964.5742 accu-mold.com

VOTE

ONLINE

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

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LEADERSHIP IN MEDICAL TECHNOLOGY

2019

About Advanced Energy Advanced Energy (AE) has devoted more than three decades to perfecting power for its global customers. AE designs and manufactures highly engineered, precision power conversion, measurement and control solutions for mission-critical applications and

Precision performance for your POWERful ideas.

Put our power to work for you – across all your demanding applications.

processes.

AE’s power solutions enable customer innovation in complex semiconductor and industrial thin film plasma manufacturing processes, demanding high and low voltage applications, and temperature-critical thermal processes.

Plasma Power

Enable advanced plasma processes control via highly accurate power delivery, frequency tuning and multi-level pulsing.

With deep applications know-how and responsive service and support across the globe, AE builds collaborative partnerships to meet rapid technological developments, propel growth for its customers and power the future of technology.

High Voltage

Access highly efficient control for thousands of mission-critical applications with standard and custom-built high voltage power supplies.

Low Voltage

Advanced Energy | Precision.

Power. Performance.

Benefit from efficient, low-profile power supplies applicable to a variety of markets, including industrial, medical, communications and military.

Contact Us advancedenergy.com info@aei.com

VOTE

Thermal

ONLINE

Equip yourself with unmatched accuracy and consistency via advanced optical pyrometers and SCR power controllers built for demanding conditions.

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

2019

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. 22264 Starks Drive

Scientific Processes / Quality Validation

Clinton Township, MI 48036

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.

586.954.2553 Rfq@aimplastics aimplastics.com

Pad Printing

VOTE

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.

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LEADERSHIP IN MEDICAL TECHNOLOGY

2019

AllMotion Inc. develops and manu-factures miniature high-performance stepper and servo drives for the medical, scientific, optical and general automation markets. Their mission 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 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 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.

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

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.

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.

Command Set for details.

All Motion, Inc. 30097 Ahern Avenue

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.)

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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LEADERSHIP IN MEDICAL TECHNOLOGY

2019

An industry leader in motion control solutions.

AMETEK 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, Transportation and Semiconductor markets for over 85 years.

For more than 85 years, Haydon Kerk Pittman has been reliably solving our customersâ&#x20AC;&#x2122; 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 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.

With our experience, talent and technology, we are committed to putting your challenging ideas into motion.

1500 Meriden Road Waterbury, CT 06705 haydonkerkpittman.com

Let us show you how.

VOTE

ONLINE

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LEADERSHIP IN MEDICAL TECHNOLOGY

2019

Leading the way with a focused technology…

Anomet Products has focused exclusively on manufacturing innovative clad-metal wire composite solutions that deliver optimized performance for the most demanding applications and extreme environments. Our goal has always been to provide superior material quality, product value and customer satisfaction through service and support that far exceed expectations. We’re proud that this unwavering commitment has fostered strong, collaborative partnerships with leading OEMs and design engineers across an extremely diverse range of business sectors not only including the electronics and medical device industries but also, aerospace & defense, automotive, oil & gas, superconductors, and electrochemical industries.

Customized Metal Wire.

Optimized Metal Performance.

Clad metal medical wire such as…

• • • • •

For over 40 years, Anomet Products has been designing and manufacturing clad metal wire used in electronics and medical devices throughout the world. As a pioneer in clad composite wire, our team of highly skilled experienced material engineers has been on the leading edge of many of the following areas during this time.

Anomet Products, Inc. 830 Boston Turnpike Shrewsbury, MA 01545 Direct: 857-302-2523 info@anometproducts.com www.anometproducts.com ISO 9001:2015 Certified

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ONLINE

Pt Clad Ti (Cost Effective Light Weight Platinum) Pt-Ir Cored MP35N (Fatigue Resistant Conductor) Ta Cored 316L (Radiopaque Stainless Steel) Pt Clad Ta (High Strength Sensor Electrode) Au Clad NiTi (Conductive Radiopaque Nitinol)

Medical Device Applications • • • • •

Cardiac Rhythm Management Neuromodulation Vascular Therapy Biosensors and Monitors Marker Band Alternatives

Combine two or more metals into a clad metal wire “system” that acts as one.

Typical Properties

Typical Metals and Alloys

• • • • • • • • • • •

• • • • • • • • • • • • •

High Strength High Conductivity Biocompatibility Radiopacity Corrosion Resistance Wear Resistance Contact Resistance Shape Memory Ductility / Formability Solderability Cost Effectiveness

Copper Gold Molybdenum MP35N Nickel Niobium Nitinol Platinum Tantalum Titanium Silver Stainless Steel Customer Specified Alloys

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

2019

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. 824 Twelfth Avenue Bethlehem, PA 18018

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.

1.866.8.BBRAUN (1.866.822.7286) us.bbraunoem.com

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ONLINE

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.

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LEADERSHIP IN MEDICAL TECHNOLOGY

2019

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 dampers, large industrial shock absorbers, mini shock absorbers, wire rope isolators, micro-hydraulics and linear actuators.

Industries served are: Aerospace, Medical, Defense and Industrial.

Bansbach Easylift® is known for quality.

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.

Advantages of Bansbach Gas Springs:

Bansbach Easylift®

www.bansbach.com

1.800.225.4498

VOTE

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.

•

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.

•

Minimal friction for the production of lowest extension forces.

Customer Service - Our dedicated staff is

50 West Drive Melbourne, FL 32904

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

•

Best lifecycles.

•

Protection against vibration and light side forces.

•

Integrated grease chamber.

•

Low break away forces.

•

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.

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

2019

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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2019

LEADERSHIP IN MEDICAL TECHNOLOGY About binder USA binder USA is a subsidiary of Franz Binder GmbH & Co., a family-owned business and a market leader in the area of circular connectors. For over

Expert 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.

55 years binder has been a technical leader and innovator serving the automation and medical industries. A combined total of 1,700 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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www.medicaldesignandoutsourcing.com

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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

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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.

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

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

Bird Precision has recently introduced our new

Golden Orifices with .0001” total spread for those most demanding applications.

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.

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

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LEADERSHIP IN MEDICAL TECHNOLOGY

2019

BMP Medical provides plastic contract

manufacturing services to leading medical device and diagnostic OEMs in need of injection molding, injection blow, twoshot (2-shot), and insert molding contract manufacturing services. We help customers in the Medical & Diagnostic markets bridge their capability gaps and accelerate their go-to-market success. We foster strong trust-driven relationships to develop inventive solutions tailored to customers and end-user needs. From concept through commercialization, BMP offers in-depth problem solving backed by deep industry knowledge and operational excellences. https://www.bmpmedical.com/

16 Chocksett Road Sterling, MA 01564 Phone: 978-632-2555; toll-free: 800-253-3684 Fax: 978-632-2524 E-mail: sales@bmpmedical.com Web: www.bmpmedical.com

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What makes BMP Medical different from other companies?

A culture that promotes continuous improvement, respect for humanity, and an optimal results-driven approach – all of which benefits leading medical device and diagnostic OEMs, the employees, and the company. This commitment to continuous improvement can be seen in BMP Medical’s most recent purchase of and relocation into a newly expanded 80,000 square foot manufacturing facility, further expanding capacity and capabilities for future growth.

In 2017, BMP proudly became the first plastic injection-molding company to receive MedAccred accreditation. MedAccred is quickly becoming the new standard for quality control & risk mitigation.

Services:

BMP Medical is a global contract manufacturer servicing the Medical Device and Medical Diagnostic markets in all areas, including, but not limited to, IVD, IV access, sample-preparation devices, and lateral-flow technologies. Headquartered in Sterling, MA, and with global manufacturing capabilities in both Massachusetts and Asia, BMP Medical can service partner requirements on a worldwide basis.

Quality Systems: • ISO 13485:2003 • ISO 9001:2008 • FDA 21CFR820 • MedAccred Accredited

• Custom Injection Molding • Custom Injection Blow Molding (IBM) • Custom 2-Shot Molding • Custom Insert Molding • Clean Room Manufacturing (Class 8) • Clean Room Packaging and Assembly (Class8) • Product Development Services • Sterilization Services • Custom Packaging • Pad Printing • DNase- and RNase-free manufacturing • FDA Registered Facility

Capabilities: • Design Consultation • Engineering Consultation • R&D Tooling • CAD Design • Statistical Process Control

www.medicaldesignandoutsourcing.com

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Markets Served:

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LEADERSHIP IN MEDICAL TECHNOLOGY

2019

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-in-class 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 Neurology Biopsy Dianostics Endoscopy Pharmaceutical Orthopedics General Surgery Minimally Invasive Surgery Opthalmology

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.

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

• Design Services

• EDM – Wire, Ram, & Sink

• Rapid Prototyping

• Nitinol Shape Setting

• Certified Cleanroom Manufacturing

• Custom Automation

• Finished Device Assembly

• IncisionLab™

• Complete Supply Chain Management

Cadence, Inc.

• Final Packaging and Labeling

9 Technology Drive

• Sterilization Management

Staunton, VA 24401 sales@cadenceinc.com

We also provide a very broad set of core

Tel: 540.248.2200

capabilities that are competitive and

Fax: 540.248.4400

differentiated in the marketplace. Unlike

cadenceinc.com

most contract manufacturers, we also have significant metals and plastics expertise; making new products a reality.

Plastics Expertise: • 3D Printing • PEEK Machining • Cleanroom Molding • Engineered Resins Expertise • Sharps Molding & Handling • Reel-to-Reel Molding • Plastic Injection Molding • Insert Molding • Micro Molding

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• PEEK Molding

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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.

CGI, Inc. 3400 Arrowhead Drive Carson City, NV 89706 775.882.3422 Toll free: 1.800.568.GEAR (4327) F: 775-882-9599

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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.

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.

cgimotion.com

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LEADERSHIP IN MEDICAL TECHNOLOGY

2019

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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LEADERSHIP IN MEDICAL TECHNOLOGY Leonard Clippard 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.

The complete line includes over 5,000 standard parts. Some of the many products offered include electronic valves, pinch valves, isolation valves, manual valves, flow controls, precision regulators, cylinders, FRLs, pre-piped manifolds and more. Clippard’s expertise is not limited to standard products, but also offers a unique advantage by providing custom products and value-added assemblies for OEM applications.

Excellence in design, materials and workmanship is the Clippard difference that assures your satisfaction.

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

Miniature Pneumatic 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

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.

Catalog 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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LEADERSHIP IN MEDICAL TECHNOLOGY

2019

COMSOL is a global provider of simulation software for product design and research

Fluid-structure interaction analysis of an idealized heart valve, including contact modeling and nonlinear material modeling. Deformation, von Mises stress, and velocity magnitude are shown.

to technical enterprises, research labs, and universities. Its COMSOL Multiphysics® product is an integrated software environment for creating physics-based models and simulation applications. A particular strength is its ability to account for coupled or multiphysics phenomena. Add-on products expand the simulation platform for electromagnetics, structural, acoustics, fluid flow, heat transfer, and chemical applications.

Interfacing tools enable the integration of COMSOL Multiphysics® simulations with all major technical computing and CAD tools on the CAE market. Simulation experts rely on COMSOL Compiler™ and COMSOL Server™ to deploy applications to their design teams, manufacturing departments, test laboratories, and customers throughout the world.

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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The COMSOL Multiphysics® software is widely used for medical device design and bioengineering. Applications include modeling and simulation of ablation systems, hearing aids, stents, hematology analysis, MRI, implantable devices, glucose sensors, ultrasound imaging products, peristaltic pumps, electrical sensors, piezoelectric valves, and more.

Simulation specialists can turn their multiphysics models into simulation applications with the Application Builder tool available in COMSOL Multiphysics®.

This provides a new way for teams of engineers and scientists to bring the use of simulation to non-specialists. With COMSOL Server™ simulation applications can be deployed and administrated via a web interface. With COMSOL Compiler™ simulation specialists can compile an application into a single executable file for unlimited use and distribution. Standalone executable applications provide simulation specialists with an unprecedented level of freedom in distributing their work to their design teams, manufacturing departments, test laboratories, and customers throughout the world.

Visualization of the motion of bacteria particles in a room with a displacement ventilation system.

www.comsol.com

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LEADERSHIP IN MEDICAL TECHNOLOGY

2019

Colder Products Company (CPC) is a leading

provider of quick disconnect couplings, fittings and connectors for plastic tubing. Our solutions improve the design and functionality of your medical equipment and processes, making connections cleaner, faster and safer.

When you work with us, you can choose from our standard product options or we can work together to customize a solution for your needs. 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.

While CPC quick disconnect couplings are a small part of a medical device, they play a crucial role. From patient therapy and surgical devices to in vitro diagnostics and 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 fluid 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.

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

2019

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 make Data Image a leader.

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LEADERSHIP IN MEDICAL TECHNOLOGY

2019

DATA MODUL is a worldwide “Visual Solutions” manufacturer and premier partner in display, touch, embedded, monitor and panel PC system solutions for industrial and professional applications.

We have established ourselves as a leading distributor with top manufacturers in the display field. Customers benefit from our technical and technological expertise to bring ideas and concepts into products for mass production.

Our products are found in medicine, healthcare, automation, portable applications, signage, gaming, transportation and maritime. We can deliver both components or complete application solutions.

Displays

We focus our attention on in-house product development and maintain ISO 9001, 14001 and 13485 certifications, making us equipped to provide customized solutions and value-added services across a wide range of sectors.

Monitor Solutions

DATA MODUL is a franchised distributor for leading display manufacturers, offering longterm product availability and professional PCN/EOL processes covering customized solutions, TFT, monochrome OLED and touch displays.

Our Modular Product Concept allows for development and implementation of standard monitor, panel PC and OEM solutions.

In-house services, ISO-certifications and comprehensive knowledge allow us to provide successful lifecycle support for your project.

Touch 275 Marcus Blvd.

Hauppauge, NY 11788 Phone: East Coast +1 631-951-0800 West Coast +1 503-885-1165 Fax +1-631-951-2121 Email: info.us@data-modul.com www.DATA-MODUL.com

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Our optical bonding solutions include PCAP touch screens with cover lens production and complete touch display solutions with in–house bonding technologies. We are a module partner of major IC manufacturers; ensuring superior touch-screen performance for multi-touch, water and glove operations, and palm suppressions.

Embedded

We are dedicated to developing customized products like Computer on Modules, carrier boards, single-board computers, baseboards, LCD controller boards, X86 and ARM embedded solutions and embedded box PCs. We offer in-house software and hardware development and kits for easy design solutions.

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LEADERSHIP IN MEDICAL TECHNOLOGY

2019

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 a supplier of choice for off-the-shelf stainless steel products and fabricated stainless steel products.

With “Eagle Eye Quality” you are assured: 100% parts made to your specifications. 100% on time delivery. 100% traceable certified material.

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.

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.

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.

Eagle Stainless Tube & Fabrication, Inc.

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!

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

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Custom shaped tubing in sizes from .040” to 1.00” to lengths to 17 ft.

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• Round • Triangular • and more!

• 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 Emerson offers comprehensive ASCO™ fluid automation solutions for a wide range of industry-focused applications within the analytical and medical instrumentation market segments. ASCO products include: liquid isolation valves, general service gas valves, pinch valves, proportional valves, linear indicators, cylinders, grippers, FRL’s, as well as complete fluidic assemblies, and

Series MSV12 Cartridge Valve The MSV12 micro solenoid valve is ideal for high-density control applications, such as medical devices and analytical instruments.

For example, the MSV12 is optimized for the Feed-Waste function on portable Oxygen concentrators. The MSV12 has a compact design, high flow (capable of over 300 L/min), and includes an energy saving solenoid for portable devices. It features grease free construction, no sliding seal, and an economic screw-in cartridge mount. The valve has a very long life, as the solenoid is isolated from the contaminated waste air.

manifold modules. For more information about ASCO products, visit Series 624 Medical Regulator The ASCO™ Series 624 non-relieving regulator is designed to control system pressure to a constant maximum set point. Its lightweight, compact manifold mount interface provides easy installation and maintenance. The Series 624 is suitable for use in a wide variety of gas applications, such as oxygen concentrators and ventilators, and is an excellent choice for use with 95% concentrated oxygen.

www.Emerson.com/ASCO.

Emerson 160 Park Avenue Florham Park, New Jersey 07932 973.966. 2000 www.Emerson.com/ASCO

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Series RB General Service The ASCO™ Series RB is a line of miniature solenoid valves designed for use with air and inert gases. Their compact, lightweight architecture, and low power consumption make them ideal for portable medical devices. The valves’ exceptional service lifetime of over 500 million cycles significantly increases OEM instrument reliability. Medical applications that benefit from the Series RB include: respiratory therapy instruments, patient monitoring equipment, compression therapy (DVT), and robotic pharmacy dispensing.

Series 202 Preciflow IPC The ASCO™ 202 Series Preciflow solenoid valves are designed to precisely control the flow rates of gases in medical equipment and analytical instrumentation. They proportionally control the flow of air and inert gases by varying the electrical input signal to the coil. The compact, ultra-reliable valves are suitable for applications, such as gas chromatography, mass flow controllers, dental equipment, and blood pressure monitoring instruments.

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LEADERSHIP IN MEDICAL TECHNOLOGY Emerson leads the medical global assembly technology market offering Branson technology of advanced plastics joining, ultrasonic metal welding and precision 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. 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.

2019

Meet Project Timelines, Ensure Product Quality and Deliver Expected Return on Investment.

Recently launched, the Branson GSX Series Ultrasonic Welding Platform will make its mark in the industry through its groundbreaking capabilities. Its design stems as a new generation of ultrasonic welders to support the growing demand for the assembly of smaller and more complex plastic components. The latest Emerson welding platform is an advanced and intuitive flexible joining solution, designed to optimize and ensure quality welds, while helping manufacturers meet project timelines and deliver expected return on investments. The Branson GSX Ultrasonic Welding Platform is a highly configurable, modular welding solution for executing precise, repeatable welds across a wide variety of smaller plastic parts and applications. At the heart of the Branson GSX Platform is a new Electro-Mechanical Advanced Actuation System. This combines Emerson’s application experience, a servo-mechanism, software optimization and Branson proprietary dynamic follow-through to ensure weld precision and control.

Branson Laser Welding Systems feature our patented Simultaneous Through-Transmission Infrared (STTIr) technology to provide ultra-fast, 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.

www.Emerson.com/Branson

Americas: 203.796.0400

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

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

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LEADERSHIP IN MEDICAL TECHNOLOGY

2019

Evonik is one of the world leaders in specialty

chemicals. The focus on more specialty businesses, customer-oriented innovative prowess and a trustful and performanceoriented corporate culture form the heart of Evonik’s corporate strategy. Evonik is active in over 100 countries around the world with more than 36,000 employees. In fiscal 2017, the enterprise generated sales of €14.4 billion and an operating profit (adjusted EBITDA) of €2.36 billion.

As one of the technology leaders in materials design and with more than forty years of experience, Evonik offers customized products for the medical sector. The product portfolio includes special polymers for medical technology and biomaterials for long- and short-term implants as well as nonimplants applications.

CYROLITE® acrylic-based compounds: innovative products for medical applications Evonik Cyro LLC 299 Jefferson Road Parsippany, NJ 07054 www.evonik.com www.cyrolite.com

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CYROLITE® compounds are the world’s most advanced medical acrylics. All grades meet the requirements of: USP Class VI, Tripartite, ISO 10993-1 and FDA. They are gamma and EtO stable, lipid resistant and provide good impact, clarity and light transmission.

Due to a broad range of special characteristics CYROLITE® compounds will help medical devices to be the best they can be. All grades of this material are transparent and tough they offer gamma and ETO sterilization resistance, and they are easy to process and weld easily to PVC. The available grades differ in melt flow, color change after gamma exposure and in lipid and alcohol resistance.

CYROLITE® MD compounds offer exceptional ultra-violet light transmittance (UVT) and optical clarity while providing maximum flow characteristics and high dimensional stability. Meeting the stringent performance and regulatory compliance requirements of medical designs, CYROLITE® MD polymers are well suited for diagnostic applications, including cuvettes, test packs, rotors, and crystallography trays.

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

2019

Delivering interchangeable air cylinders in 3 to 5 days

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

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

Pancake® Air Cylinders out-perform the

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

entire field of compact air cylinders. Rugged construction provides unequalled strength, rigidity, and piston rod support maintaining perpendicularity and concentricity for locating, mounting and making attachments to the rod. Heavy wall prevents damage to the bore.

Yes, get to know us. We’ll stand on our

• 8 bore sizes 1/2" to 4"; strokes to 4".

• All with 3 to 5 day delivery

reliability.

F Series & H Series Cylinders Fabco-Air has purchased the Humphrey Stainless Steel Disposable Cylinder line, adding to our existing F-Series products.

Get delivery of all drop-in interchanges within 3 to 5 days.

• Bores from 5/16" to 3" • Strokes to 12".

heads for you. It’s what we do.

Global Series™ Cylinders Feature hard anodized aluminum extrusions, oversized hard chrome plated stainless steel piston rods, and non-lube service to 150 psi.

Fabco-Air, Inc.

Pancake II Air Cylinders – Here’s direct interchangeability with performance superior to Brand B. High strength composite cylinder barrel is self-lubricating and impact resistant. Rod bearing, captive in cylinder head, has higher load capacity, lower friction, zero slip-stick.

• Bores ½" to 4" • Stroke to 4" • 3 to 5 day standard delivery ®

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

• Bores 12-100mm. Strokes 5-150mm • Ports NPT, BSP Parallel, or BSP Tapered • Magnetic piston sensing, & more!

• Shipping within 3 to 5 days

OEM-Priced NFPA Air Cylinders

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incorporate important no-cost options.

Standard features: Multi-Power® Pancakes® deliver forces equivalent to low pressure hydraulic systems.

They can produce forces as high as 4300 pounds at 90 psi. Cylinders shipping within 3 to 5 days.

• See Catalog #PAN2-2 or contact factory for sizing guide and output force tables.

• Adjustable air cushions both ends • Magnetic pistons • 303 Hard chrome plated piston shaft • Stainless steel tie rods • Special rod bushings provide self lubrication of piston rods • Anodized aluminum end caps • Factory lubricated with Magnalube-G® • Shipping within 3 to 5 days.

www.medicaldesignandoutsourcing.com

1/9/19 11:10 AM

LEADERSHIP IN MEDICAL TECHNOLOGY

2019

Reimagining Connectivity, Together.

For more than 60 years, the people of Fischer Connectors have been reimagining connectivity. Every day, over 500 employees in 10 countries work to create innovative connectivity solutions that help design engineers around the world turn ambitious ideas into success stories.

The five series of rugged connectors from disposables to up to 10,000 mating cycles. Our products are manufactured according to rigorous and controlled processes - ensuring the highest standards of quality, every single time.

From the first push-pull connector in 1954 to our current range of five product series, we draw on our history of innovation to help shape the solutions of the future. We partner with customers in a variety of industries, including medical, solving their connectivity challenges to co-create reliable, high-performance devices.

Our global headquarters are in Saint-Prex, Switzerland, along with our R&D center and modern manufacturing facilities. Our North American headquarters is located near Atlanta, GA, and is home to our assembled solutions engineering team, cable assembly teams, customer support, and services. It is ISO 13485 certified and ITAR registered. We also have cable assembly sites in EMEA and Asia, eight local subsidiaries and a wide network of distributors and agents all over the world.

Here at Fischer Connectors, we believe that even a connector company can change the world.

It may sound ambitious. But together with our customers, we’re already pushing the boundaries of connectivity. Our vision, mission and values put into words who we are, what we do, and why and how we do it. They’re a map for our future, as well as a reflection of our history. They are the way we see the world and the change we want to make in it.

We believe that to make a difference, we mjust see things differently. We know from experience that the best ideas begin with asking, “What if?”

Our vision is to reimagine connectivity, helping turn ambitious ideas into solutions that shape the future.

Our mission is to make our customers’ lives easier with a collaborative approach, tailored connectivity solutions and passionate employees who turn challenges into success.

The values are a behavioral compass, guiding the way we work, the decisions we make and the way we treat others. Collaboration. Longevity. Entrepreneurial Spirit. Innovation. Respect. Excellence. They aren’t just words, they’re instructions for action.

Fischer Connectors, Inc. 1735 Founders Parkway Alpharetta, GA 30009 678.393.5400

|

800.551.0121

mail@fisherconnectors.com

As a family company, we put human relationships at the heart of everything we do. Our experts around the world are passionate about making our customers’ lives easier through close collaboration, both internally and externally.

fischerconnectors.com

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The Fisher Freedom™ Series offers easy mating, easy cleaning and easy integration into fixed or wearable devices for any market. Its breakthrough connectivity technology maximizes efficiency, usability and performance while facilitating integration and optimized cable management.

www.medicaldesignandoutsourcing.com

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LEADERSHIP IN MEDICAL TECHNOLOGY

2019

Herrmann Ultrasonics, the technology leader for ultrasonic welding technology, is a solution provider for industrial ultrasonic technology and your ideal partner for welding thermoplastic materials with ultrasonic vibrations.

Ultrasonic welding is used whenever two plastic parts have to be joined permanently: i.e. surgical tools, luer adaptors, connectors, membranes but also medical infusion collectors, fluid containers and hermetic housings.

More common applications include: medical packaging for disposable syringes, heat patches and inhalers. Laminating and embossing of nonwoven materials such as surgical facial masks or the production of incontinence products.

Visit our Tech-Center West Coast in Irvine, CA with increased lab capabilities!

The experts at Herrmann Ultrasonics assist you through every phase of your project and lead you to a great weld result in just 7 steps: 1: Application consulting

• Analysis of the part design and application quality requirements

• Review of the technological advantages of ultrasonic welding 2: Feasibility of ultrasonic weldability

• Assessment of the material to determine if ultrasonics is suitable

• Estimate of development and / or integration costs 3: Sonotrode Design

• Design of the ultrasonic tools

• Sophisticated sonotrode manufacturing and superior amplitude distribution 4: Weld Process Development

• Determination of all essential ultrasonic welding parameters

• Extensive product testing capabilities in our modern laboratory 5: Additional benefits and unique solutions

• Customized solutions & data evaluation

• Prototype production is now possible

Herrmann Ultrasonics, Inc. 1261 Hardt Circle Bartlett, IL 60103 Phone: +1 630-626-1626 E-mail: info@herrmannultrasonics.com Website: www.herrmannultrasonics.com

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6: After Sales Service

• On-site start-up & calibration

• Evaluation and optimization of your production 7: Knowledge transfer

• Principles of ultrasonics are explained in practice-oriented seminars

• The advantages and knowledge of ultrasonic technology are conveyed

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www.medicaldesignandoutsourcing.com

1/9/19 11:16 AM

LEADERSHIP IN MEDICAL TECHNOLOGY

2019

Who is Humphrey Products?

We have been manufacturing for more than 117 years from Kalamazoo, Michigan, and today, as a leading producer of pneumatic and fluid control products. These products are proudly built by loyal and dedicated Humphrey employees, of whom the average service is 15 years. Our valve products are produced with 96% of our suppliers from the Great Lakes region of America.

Industries utilizing our products and engineered solutions include medical device, healthcare rehabilitation, analytical equipment, test and measurement, material handling, general industry and factory automation. Our subsidiary, South Haven Coil, manufactures coils and other electrical components for industry. And since 1962, we have enjoyed an alliance with Japan-based Koganei Corp, one of the premier pneumatic automation companies in the world.

Our quality management system has been assessed and registered by Intertek Testing Services NA, Inc. as conforming to the requirements of ISO 9001:2015.

Visit www.humphrey-products.com Navigate to a final valve selection via our Online Catalog • View and Download CAD Models • Access pdfs of Literature, Catalogs and Engineered Solutions Case Histories • Find Product Specifications • Request a Quote Find one of more than 50 Humphrey Distributors Worldwide Or contact customer service at 1-800-477-8707

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Humphrey designs and manufacturers pneumatic and fluid control components – specifically valves and valve systems – for a variety of applications, including medical devices, analytical instrumentation, factory automation, package conveyor systems and many more.

Our expertise in a wide range of industries is based on technologies proven in our standard products, enabling us to create engineered solutions for critical commercial and industrial applications.

We work to solve not only your fluid control challenges, but also to improve the ease and efficiency of your manufacturing process. This comprehensive approach offers you tremendous outsourcing advantages, significantly reducing your product development cycle and creating vital cost efficiencies. You gain access to our advanced manufacturing technologies, reduced time-to-market, and the ability to leverage critical resources to focus on your core competencies.

Our Standard Products • Solenoid Valves • Proportional Flow Control Solenoid Valves and Electronic Pressure Regulators • Air Piloted Valves • Manual and Mechanical Operated Valves • Cartridge Valves • Quick Exhaust Valves • Pneumatic Auxiliary Components The Humphrey tradition of innovation continues as our family-owned company introduces three new valve technologies: New additions to ProControl Proportional Solenoid Valve Series; Cartridge Style Solenoid Valves and Inert Isolation Valves suitable for aggressive media.

Our Engineered Solutions We are an innovative company of pneumatic and fluid handling experts. We develop Engineered Solutions for customers with unique and challenging needs, where standard components fall short. Drawing from our years of experience and unique valve designs, we tailor “best solutions” for the difficult customer problems.

www.medicaldesignandoutsourcing.com

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LEADERSHIP IN MEDICAL TECHNOLOGY

2019

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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www.medicaldesignandoutsourcing.com

1/9/19 11:21 AM

LEADERSHIP IN MEDICAL TECHNOLOGY

2019

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.

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

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.

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 91 Walsh Drive Parsippany, NJ 07054 United States www.ikont.com

Smooth. In medical applications, an important functional requirements is smoothness.

Maintenance-free. The cost of maintenance, particularly lubrication needs, can drive up the cost of ownership for many types of motion equipment. Medical and lab automation machines are no exception.

At IKO, our solution to this maintenance problem is our proprietary “C-Lube” technology. With C-Lube, our linear guides have been tested to run maintenance-free for 12,500 miles and more, without the need to replenish the lubricant.

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

Smoothness can also translate into less noise, and quiet motion components are strongly preferred in any medical machine or diagnostic system that is used in proximity to patients.

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www.medicaldesignandoutsourcing.com

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LEADERSHIP IN MEDICAL TECHNOLOGY

2019

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®

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.

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.

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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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

1/9/19 11:23 AM

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 Point Level Sensor or vibration, which would normally cause false air alarms.

These sensors are designed to meet OEM form, fit and functional specifications.

Sensors are available with integral or remote circuitry and panel mount or self-standing designs.

Drip Detect Sensor

www.medicaldesignandoutsourcing.com

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Introtek’s line of Noninvasive 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 IntroFlow™ non-invasive flow detection devices incorporate the latest ultrasonic technology for flow measurement. The nonIntroFlowTM invasive concept provides a platform for non-contact measurement where safety, hygiene and cleaning are of concern. This free-entry sensor is designed for easy tube installation and can be accommodated for various tube sizes. Fully integrated electronics yield the smallest footprint with simple interface to medical and industrial applications. The standard configuration outputs a voltage frequency that is proportional to liquid flow velocity. Absent tube and air detection are fault outputs for added value.

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.

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LEADERSHIP IN MEDICAL TECHNOLOGY HELPING ENGINEERS SUCCEED

Medical Design & Outsourcing

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.

Standard parts are extremely versatile in their application and therefore can offer great opportunities.

An increased use of standard parts greatly reduces the costs of product development and in turn, provides the engineer with more time to devote on larger project requirements. The engineers can concentrate on the actual machine or equipment design, as standard parts can cost-effectively be procured externally. The wheel does not have to be re-invented, and the creativity in developing can be the focus again.

JW Winco offers catalogs or digital part libraries that users can access quickly. Along with an extensive selection of high quality parts, JW Winco strives to make an engineer’s job easier. The company’s mobile-responsive website at www.jwwinco.com is dedicated to providing the customer with modern navigation and usability that also allows visitors to see product availability.

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 and free CAD download in all common 2D and 3D CAD formats. Customers can not only check product availability and pricing online, they can 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.

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GN 1580 Hygienic Design Screws and Nuts Maximum hygiene is one of the absolutely basic prerequisites wherever food is produced. However, hygiene also plays a major role in other sectors – from medical technology and the pharmaceutical industry to manufacturers of dispersion paints.

JW Winco has now expanded its Hygienic Design range to include the new GN 1580 Screws and Nuts that are intended for use in hygienic applications and certified according to EHEDG standards. The sealed flange surface enables components to be mounted without dead spaces.

The high quality finish as well as the large corner radii and closed surfaces prevent adherence of dirt and facilitate cleaning. JW Winco also offers the suitable sealing rings as spare parts under GN 7600. Find out more at www.jwwinco.com.

GN 256 Silicone Vibration / Shock Absorption Mounts with Stainless Steel Components Available with either an AISI 304 stainless steel tapped insert or a threaded stud, GN 256 Silicone Vibration / Shock Absorption Mounts are

2019

frequently used as end-stop bumpers or leveling mounts for machines and systems, e.g. for sanitary conveyors.

The silicone rubber material absorbs vibrations, has a dampening effect, is age-resistant, and has an increased working temperature range, resistant up to 392 °F (200 °C). Thanks to the material purity, it is possible to use the FDA compliant mounts in the food or medical industry. They are available in a number of thread sizes, inch or metric, and combinations that opens up the range of applications these mounts can be used in. Find out more at www.jwwinco.com.

GN 426 / GN 565 Cabinet “U” Handles with Antimicrobial Coating

GN 426 and GN 565 Cabinet “U” Handles are manufactured from a bent aluminum profile and have excellent stability and ergonomic design. The manufacturing process allows the production of special designs in relatively small quantities. In addition to the standard finishes, these cabinet “U” handles are also available with an antimicrobial plastic coating. This coating demonstrably reduces the growth of viruses, bacteria, and fungi.

Standard parts with antimicrobial plastic coating are primarily used in the medical and health care sector as well as in public buildings, such as airports, train stations, and stadiums. Find out more at www.jwwinco.com.

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800-877-8351 fax 800-472-0670 sales@jwwinco.com jwwinco.com

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www.medicaldesignandoutsourcing.com

1/9/19 11:26 AM

LEADERSHIP IN MEDICAL TECHNOLOGY Spring Design & Manufacturing Excellence John Evans’ Sons, is the international leader in the design and manufacturing of constant force springs, constant force

2019

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.

springs for the medical device industry.

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:

We are a trusted medical device industry

• World class surgical robots

spring supplier, as evident by our

• Surgical staplers

commitment to manufacturing excellence.

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

spring assemblies and precision specialty

All of our products align with strict quality standards. We are ISO 9001 and ISO 13485 certified.

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.

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

Spiral Torsion Springs • Develops high torque John Evans’ Sons, Inc. 1 Spring Ave. Lansdale, PA 19446 www.springcompany.com

• Rotation in two directions • Compact, easily mounts in many designs

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 spring products.

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LEADERSHIP IN MEDICAL TECHNOLOGY

2019

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-9001:2015 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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www.medicaldesignandoutsourcing.com

1/9/19 11:32 AM

LEADERSHIP IN MEDICAL TECHNOLOGY

2019

Laser Light Technologies is focused on improving the lives of both clients and community with advanced laser micromachining technology. We’re a trusted resource for life sciences, medical device and microelectronics companies, bringing decades of experience to precision laser services and systems.

We serve industries making a real difference for people: medical devices, life sciences, and microelectronics. The parts we manufacture are used in lifesaving surgeries, sophisticated medical treatments, and much more. We’re proud to contribute to making lives better, from the clients we partner with to the individuals who benefit from devices using the parts we make.

Laser Light Technologies 5 Danuser Drive Hermann, MO 65041 https://laserlight.com

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Our Client Success Team unites sales, marketing and customer service to build success at every stage of a project.

Additionally, our engineering team offers world-class expertise in research and development, processes, quality, mechanics, design and software. These two teams deliver the best possible client service.

We use precision laser systems to manufacture microscopic part features, down to 3 microns in size. We specialize in cutting, drilling, ablation and coating removal, product research and development, and design for manufacturability. We also assist clients moving to in-house manufacturing in developing custom laser systems.

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LEADERSHIP IN MEDICAL TECHNOLOGY

2019

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

The Original Push-Pull Connector

www.lemo.com

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.

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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

market.

www.medicaldesignandoutsourcing.com

1/9/19 11:33 AM

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.

Lin Engineering 16245 Vineyard Blvd

2019

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

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

2019

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.

TM

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

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www.medicaldesignandoutsourcing.com

1/9/19 11:38 AM

LEADERSHIP IN MEDICAL TECHNOLOGY

2019

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

Master Bond 154 Hobart Street Hackensack, NJ 07601

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.

Tel: 201-343-8983 Fax: 201-343-2132

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

www.masterbond.com technical@masterbond.com

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LEADERSHIP IN MEDICAL TECHNOLOGY

2019

maxon drives set the world in motion. maxon motor combines electric motors, gears and DC motor controls into highprecision, intelligent drive systems that

Offering solutions that fit your customized needs maxon precision motors focuses on comprehensive solutions optimized through a diversified product range and client consultation.

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.

maxon motor manufactures small, highquality brush and brushless DC motors ranging in size from 4 mm to 90 mm. maxonâ&#x20AC;&#x2122;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.

maxon X drives Extremely powerful drives that 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 high-precision, robust drive system ideal for any application requiring 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.

Visit xdrives.maxonmotorusa.com.

With over 50 years of experience, hightech innovations and superior product quality, maxon is the reliable partner in drive technology. Individual, customized drive solutions are our greatest strength.

maxon precision motors, inc.

101 Waldron Road Fall River, MA 02720 508.677.0520 info@maxonmotorusa.com maxonmotorusa.com

Visit us online and discover the digital maxon world.

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On our website, you can find the latest information on our products and services as well as an integrated online catalog, the selection program and the maxon online configurator.

Go to www.maxonmotorusa.com

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www.medicaldesignandoutsourcing.com

1/9/19 11:37 AM

LEADERSHIP IN MEDICAL TECHNOLOGY

2019

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 9,500 standard models widely used in Industrial Automation, Communication, LED & Horticultural 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

2019

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 • Two-shot 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.

• 90,000 Total Sq Ft • 37,000 Sq Ft of Clean Room

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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www.medicaldesignandoutsourcing.com

1/9/19 11:40 AM

LEADERSHIP IN MEDICAL TECHNOLOGY

2019

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 multi-color, long length and 360 degree wraps. Hot stamping services and polyolefin marker bands, produced on custom equipment is also available. Complete turn-key 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.

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

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LEADERSHIP IN MEDICAL TECHNOLOGY

2019

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 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 Fax: 631-249-0002

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.

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 !!

memoryprotectiondevices.com

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www.medicaldesignandoutsourcing.com

1/9/19 11:42 AM

LEADERSHIP IN MEDICAL TECHNOLOGY

2019

Complete Medical Devices & Assemblies MICRO is a full-service contract manufacturer of complete medical devices, insert/ plastic moldings and custom fabricated tube assemblies. This includes product development & design assistance—from prototyping and validation to full-scale production. Our own tube mill for raw material, combined with our laser cutting technology and automated work cells, allow us to drastically reduce tubing costs on high volume, single-use disposable instruments.

Tubing capabilities include: flaring, flanging, expansions & reductions, piercing, slotting, sharpening, electropolishing and laser welding, cutting & marking. Our modern facilities are cGMP-QSR compliant and ISO9001, ISO-13485 & ISO-14001 certified and we maintain an ISO Class 8 clean room for surgical instrument assembly.

MICRO 140 Belmont Drive Somerset, NJ 08873 732-302-0800 sales@micro-co.com www.micro-co.com

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A Tradition of Manufacturing Excellence

MICRO is a full-service contract manufacturer that draws on over 70 years of experience in medical device assembly, precision metal stamping, insert/ injection molding, machining, sharpening, and finishing—delivering the highest quality products to customers in the medical device industry. Utilizing modern manufacturing techniques and innovative engineering solutions, we manufacture and distribute our products to customers all around the world.

We are the world’s largest manufacturer of titanium and stainless steel ligation clips – class-critical implant devices shipped directly to inventory. We also produce a wide variety of blades, scissors, stapling and biopsy devices, as well as laparoscopic, endoscopic and arthroscopic minimally invasive surgical instruments.

Program Management

We strive to develop and manufacture the best possible products at the best possible

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price, while providing a supply-anddistribution chain that allows our customers to operate at optimum efficiency and ease.

To achieve these ends, we offer full-service project and supply-chain management platforms consisting of cost containment/ quality-enhancement programs, inventory consignment, just-in-time delivery, and local warehousing.

Design Engineering

At its heart, MICRO is an engineering company, staffed by experienced, innovative design engineers driven to help customers achieve their goals in a timely, cost-effective manner.

Critical to our success is our ability to design, produce and maintain the dies, molds and associated tooling used to produce customer parts. From prototyping to mass production, we are eminently capable of generating engineering designs that take advantage of our team’s unique ability to translate our customers’ needs into practical, reliable solutions.

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LEADERSHIP IN MEDICAL TECHNOLOGY Microlumen has been a leading manufacturer of high performance medical products since 1987. Our high performance medical tubing is used in a wide range of minimally invasive, critical OEM applications such as cardiovascular catheters, stent delivery systems, urological retrieval devices and drug delivery.

Primary materials include Polyimide, PTFE, Pebax®, Nylon, Polyurethane and various polymers specifically designed to provide exceptional mechanical, thermal and chemical properties. Our proprietary process delivers significantly tighter tolerances for our medical and surgical tubing than conventionally extruded products.

MicroLumen offers innovative solutions and aids engineers in the design of extremely specialized medical devices. Our diversified medical product line and secondary operations include; custom laser machining, etching, composite constructions, assembly, braid / coil reinforced shafts - all that solve specific tasks. Contact our engineering team for possibilities.

MicroLumen, Inc., is registered to ISO 13485:2003.

Exceptional Products & Customer Service

MicroLumen is committed to providing high performance medical and surgical tubing of unparalleled quality and function. Our dedication to technical excellence ensures that our surgical tubing products will always be at the cutting edge of what’s possible, while maintaining the highest standards of consistency and quality. Our goals are simple. To help you, our client: •

Improve patient care

•

Reduce recovery times

•

Reduce the overall cost of health care

We invite you to experience the best in high performance medical tubing products. Our products include polyimide tubing, braid reinforced tubing, PTFE/composite tubes, and laser machined medical tubing.

Capabilities

We design and produce the highest quality medical and surgical tubing available, on time and at a competitive price. Our cutting-edge processes ensure exceptional consistency and product performance, while also providing the flexibility to create new solutions that meet your specific needs.

In our state-of-the-art manufacturing plant, our tubing is manufactured with tighter tolerances than conventionally extruded plastic tubing.

High Performance Medical Tubing

Microlumen

MicroLumen provides tubing with exceptional mechanical, thermal and chemical properties for use in a wide range of minimally invasive, critical OEM applications such as cardiovascular catheters, stent delivery systems, urological retrieval devices and drug delivery.

One Microlumen Way Oldsmar, FL 34677 T: 813-886-1200

Our innovative manufacturing process allows us to deliver significantly tighter tolerances than conventionally extruded tubing. We offer Polyimide, PTFE, Nylon, Pebax®, Polyurethane, and various polymer products. Our secondary operations, including custom laser machining, etching, composite constructions, assembly, and braid/coil reinforced shafts enable us to develop customized solutions for your exact requirements.

www.microlumen.com

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1/9/19 11:45 AM

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

2019

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 valueadded 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 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 and ISO 13485 certified as well as 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.

www.medicaldesignandoutsourcing.com

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LEADERSHIP IN MEDICAL TECHNOLOGY

2019

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 strength lies within our coalition of five industry leading brands: BellowsTech, FL; Economy Spring, CT; LaVezzi Precision, IL; Helical Products, CA and Servometer, NJ. It’s our expertise in the science of precision metal components and the competency of our engineering teams that enable us to deliver a unique set of specialty products in drug, delivery, orthopedic implants, medical equipment and robotic instrumentation.

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

Trusted Partner.

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.

• Heat Treating • Micro-Machining • Laser Swiss Machining • Packaging • EDM • 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 Rosemont, IL 60018

• ISO 9001:2015 • ISO 13485 • ISO 8, Class 100,000 Clean Room

mwmedicalsolutions.com

• FDA Registered Facility • REACH

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

• RoHS

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Applications:

• Laparoscopic Devices • Home Dialysis Pumps

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• Orthopedic Implants • Robotic Instrumentation

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LEADERSHIP IN MEDICAL TECHNOLOGY

2019

Healthcare-Focused Custom Packaging Solutions With facilities in Cranston, RI; Phoenix, AZ; Whitehall, PA; Venray, the Netherlands; Galway, Ireland; 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 trays, custom built sealing machines and other value added services.

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.

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 Healthcare Packaging 21 Amflex Drive Cranston, RI 02921 www.nelipak.com

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.

Waste and Cost Reduction through Design

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

2019

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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www.medicaldesignandoutsourcing.com

1/9/19 11:49 AM

LEADERSHIP IN MEDICAL TECHNOLOGY

2019

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.

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 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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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

2019

Nippon Pulse is a global manufacturer and Tier 1 supplier of precision motion control products for original equipment manufacturers. For more than 60 years, Nippon Pulse has built state-of-the-art rotary and linear motion control solutions, including the innovative Linear Shaft Motor, industry-leading stepper motors, linear stages and controllers. Our high-quality products can be utilized in an extensive number of applications and industries, and can be customized to meet individual customer specifications.

Nippon Pulse America is a wholly owned subsidiary of Nippon Pulse Motor Co. Ltd.

At Nippon Pulse, we want to provide exceptional customer service and support for OEMs. Our application engineers have extensive product knowledge and can help determine the best solution for your unique motion control application. Our thorough approach to each new application allows us to make recommendations from an overall project standpoint, and we take the time to learn about your requirements, limitations and desired functionality, which enables us to make specific recommendations for the best mechatronic solutions – even if it means suggesting products with different capabilities than we can provide.

Nippon Pulse America Inc. 4 Corporate Drive Radford, Virginia 24141 www.nipponpulse.com

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Nippon Pulse is a leading supplier for medical manufacturers because of our product lifetime guarantee and the consistency in quality of our motion control products over that lifetime. For every custom solution we manufacture, we keep meticulous records for each aspect, so we can continue to re-manufacture your motor to the identical specifications and requirements – forever! You can count on Nippon Pulse’s reliability over the lifetime of your equipment, and you can trust that you will always be able to get the parts you need.

It’s about building trust with customers: we want to impress you, not just satisfy you. As one long-time customer says, “NPM gives us the best of both worlds: excellent quality and highly engineered Japanese products with exceptional American service and customer engagement.”

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LEADERSHIP IN MEDICAL TECHNOLOGY

2019

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 USA, Inc. 46 Chancellor Drive

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.

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.

Roselle, IL 60172 www.nittokohki.com

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LEADERSHIP IN MEDICAL TECHNOLOGY

2019

NSK is a manufacturer of motion and control products. Founded in 1916, NSK has proven to be an industry leader backed by superior quality, engineering support and technical innovation.

NSK manufactures and distributes a wide range of rolling bearings, linear motion, mechatronics and automotive components. NSK brings innovation and new products and technologies to the industry.

Operating in the Americas, NSK Corporation is a member of the NSK Ltd. Group and is headquartered in Ann Arbor, Michigan. NSK

Providing 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.

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.

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 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

NSK Americas

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.

4200 Goss Road Ann Arbor, MI 48105

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

1-800-255-4773 info@nsk-corp.com nskamericas.com

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LEADERSHIP IN MEDICAL TECHNOLOGY

2019

Engineering expertise and solution-oriented innovation are in every aspect of our contract manufacturing services. OKAY Industries is recognized by the world’s leading medical companies for our ability to meet the most demanding challenges, with quality-driven processes and a detailed understanding of the requirements of medical device component and subassembly markets. Our combination of multi-discipline engineering teams, state-of-the-art technologies and advanced production systems helps customers get to market on-time, exceeding expectations at every step.

Okay Industries Headquarters 200 Ellis Street New Britain, CT 06051 Phone: (860) 225-8707 Fax: (860) 225-7047 info@okayind.com www.okayind.com

Your Partner in Success

The OKAY Industries team brings more than 100 years of manufacturing expertise to every project, combining our legacy tool and die experience with advanced machining, quality inspection and automated robotic technologies. With processes customdeveloped for your exact order specifications, we combine an array of manufacturing systems including precision stamping, Swisstype and CNC turning, CNC milling, laser tube cutting, laser welding, laser marking and surface treatments, finishing and assembly operations. Our technologies and equipment are optimized by OKAY’s engineering and manufacturing expertise. From design through total product life cycle, our team collaborates with you every step of the way to improve outcomes, lower costs and meet production objectives.

OKAY is a contract manufacturer and design for manufacturability partner for leading medical device OEMs around the world. We produce medical and surgical components and subassemblies for a variety of precision applications including: • Laparoscopic, Endoscopic and Arthroscopic Devices

• Surgical Stapling, Cutting Blades/Knives and Scissors

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We operate with three facilities located in New Britain, CT; Berlin, CT; and Alajuela, Costa Rica, totaling more than 182,000 sq. ft. of manufacturing space. Our processes are 13485:2016 and ISO 9001:2015 certified, FDA registered, and comply with a wide variety of medical quality standards.

Medical Expertise

• Cardiac and Neurostimulator Implantable Devices

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182,000+ Square Feet of Manufacturing Excellence

• Ligation Instrument Components and Assemblies

Right From The Start

From our custom-designed prototyping processes to the expertise that comes from delivering millions of precision components, OKAY Industries is ready to help you make your medical components, Right From The Start.

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www.medicaldesignandoutsourcing.com

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LEADERSHIP IN MEDICAL TECHNOLOGY Award-Winning Electronic Enclosures

2019

OKW manufactures advanced enclosures for today’s electronics equipment.

OKW Enclosures, Inc. is a specialist manufacturer of enclosures for OEM electronics. The company’s extensive and award winning program includes pocket-size,

The enclosures can be supplied fully customized to customer specifications.

handheld, desktop, portable, wall mount and

The range includes the following popular versions:

DIN rail enclosures, plus accessories and a

Handheld Enclosures

large range of tuning knobs.

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

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

much more.

Free samples are available for evaluation.

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

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.

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

www.okwenclosures.com

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2019

LEADERSHIP IN MEDICAL TECHNOLOGY Leader in 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.

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.

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 www.orchid-ortho.com

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Enhance product development realization through Orchid’s expertise in product design, regulatory submission and design transfer process. Generating new ideas and developing solutions to challenging design problems is at the core of Orchid Design’s capabilities. Whether it is an idea, a partially developed product, or even a clinical problem, we can provide a full range of design and development services from initial ideation to final Design for Manufacturing (DFM) and verification testing to help deliver innovative products to the market. Orchid Design helps customers overcome complex and challenging processes related to product design and development. And, by utilizing Orchid’s design-to-manufacturing, customers get the benefit of leveraging Orchid’s manufacturing expertise across our global network.

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Major Markets Served: Orchid specializes in implants, instruments and innovative technologies for the following markets: •

Joint reconstruction

•

Spine

•

Trauma

•

Sports Medicine

•

Extremities

•

Dental

•

Cardiovascular

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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 volume, simple to complex, prototype to production, PTI has delivered quality end products for 35 years.

Certifications PTI is FDA, UL, and ITAR registered and ISO 13485, ISO 9001, ISO 16949, and AC8160 certified

2019

State of the art tool room The PTI Tool Room has a fully-integrated network, 23 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.

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 more than 5,000 OEM single-use components to the medical and pharmaceutical industries.

We offer free samples, low minimum order requirements, just-in-time delivery, modification of existing molds, and new

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 Component Inventory

product design and development.

Applicators, Swabs & Brushes Bags Caps Chambers Clamps & Clips Containers Connectors Dilators & Introducer Sheaths Dispensers Drapes, Towels & Bandages ENFit™ Extension Lines Filters Guide Wire & Catheter Accessories Injection & Sampling Ports Needles NRFit™ O-Rings Ports & Flanges Scoops & Spoons Spikes Sterilization Supplies Stopcocks Syringes Tools Tubing Valves

Qosina is ISO 9001, ISO 13485 and ISO 14001 certified, and operates in a 95,000 square-foot, climate-controlled facility that includes an ISO Class 8 Clean Room. Our Qosmedix subsidiary serves the cosmetic, skin care and spa industries.

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

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Our Services • • • • • • • •

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 Connect with us:

https://www.linkedin.com/company/qosina https://twitter.com/qosina https://instagram.com/qosina https://www.facebook.com/Qosina-Corp-153031621400995

www.medicaldesignandoutsourcing.com

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2019

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LEADERSHIP IN MEDICAL TECHNOLOGY

2019

Resonetics is the leader in laser micro manufacturing for life sciences. Core competencies are laser processing, nitinol processing, and thin walled Swiss precision tube fabrication. 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 medical device applications.

The company is ISO 13485:2016 certified

Challenging the Limit of Laser Micro Manufacturing

with facilities in the U.S., Costa Rica, Israel and Switzerland.

At Resonetics, we lead through our Lightspeed™ Development Team and the Advanced Technology Group (ATG) that thinks outside the current parameters of laser processing to solve customers’ most challenging technical problems. The team has produced many technical advances in 2018 encompassed by a wide range of next generation capabilities including 3D micro ablation, precision nitinol cutting, fine wire welding, and precision wire stripping.

26 Whipple Street Nashua, NH 03060 800.759.3330

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). 3D micro ablation

sales@resonetics.com resonetics.com

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was developed based on the unmet customer needs in the Neurovascular market, 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. The enhanced precision in cutting greatly improves the post processing consistency and manufacturing yield. Nitinol processing capabilities have been further expanded with the acquisition of STI Laser in Israel and the addition of shape setting and electropolishing capabilities in the Lightspeed Development lab in San Diego.

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2019

LEADERSHIP IN MEDICAL TECHNOLOGY SCHNEEBERGER is a manufacturer of high precision linear bearings: ball, needle and cross roller bearings, miniature linear bearings, slides, spur and helical gear racks, box ways, ball and roller Monorail linear guideways with AMS integrated linear encoder option. SCHNEEBERGER is your turnkey supplier! Designing and manufacturing consistently high quality linear technology, including single to multi-axis linear motion systems, supporting the Machine Tool, Semiconductor, Life Science, Metrology, Photonics, Electronics, Automation and Packaging industries.

Schneeberger Continues to Lead the Way! In 1923 when Schneeberger was first founded, the focus was on manufacturing tool sharpening equipment for the woodworking industry. However, in 1948 its attention turned to the linear motion industry as we first developed and produced linear guideways and roller tables, based on customer drawings.

44 Sixth Road Woburn, Massachusetts 01801 United States 800-854-6333 www.schneeberger.com

Since that time, Schneeberger has been looked upon as an innovator and leader in combination technology, combining linear guideways with integrated encoders and/or precision gear racks, saving our customers assembly & alignment time, and the cost of auxiliary mounting hardware. Schneeberger introduced its first Monorail with integrated linear encoder in 1992. That product is now known as AMS (Advanced Measuring System). A handful of other companies have introduced “me-too” alternatives in the years since, but none come close to our application expertise and installed customer base.

Again in 2005 the first Miniature Rail with an integrated scale (MINISCALE) was introduced and most recently in 2016 the first MINISLIDE (MSQSSCALE) hit the market. All combining accuracy, guidance and space saving advantages in one!

As the company enters it 96th year in business under new leadership, our CEO Mr. Stefan Hanke continues the mission of providing our current customers and perspective customers with the best products and services to build machines that are both economically and technologically advanced. Our goal is to grow sustainably and to shape our future independently!

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LEADERSHIP IN MEDICAL TECHNOLOGY

2019

Manufacturer of innovative motion components and systems

Integrated motors simplify machine building

Schneider Electric Motion leads integrated motor solutions with our MDrive® family of products. Compact and cost effective, MDrive products combine motor and electronics all in one compact motion package for rotary and linear motion applications from factory floor to laboratory bench.

Pioneering the development of integrated motor and electronic products, now globally recognized by the MDrive® brand name, our U.S.-based R&D team continue innovating. Continuing to lead the trend of integrating more components into single units to improve operations while reducing costs and saving energy.

NEW Absolute Encoder for Lexium MDrive products expand product performance without increasing size. A 1000-line absolute encoder continues the trend of integrating more components into single units to improve operations while reducing costs.

Lexium MDrive® These all-in-one motor and electronic products are well suited for industrial automation, incorporating robust design features and performance enhancements. A multi-turn absolute encoder option can increase performance without increasing product size. Products with fully programmable motion controller can be operated in several modes including: closed-loop, torque control, and variable current control for energy savings and reduced heating.

Rotary and linear motor versions are available.

Schneider Electric Motion USA 370 N. Main St. Marlborough, CT 06447 United States https://motion.schneider-electric.com

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MDrive® Plus Integrated rotary and linear motors with electronics are available in a wide range of low cost, extremely compact configurations. MDrivePlus all-inone motion control solutions can reduce system cost, design and assembly time for a large range of motion control applications.

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www.medicaldesignandoutsourcing.com

1/9/19 12:04 PM

LEADERSHIP IN MEDICAL TECHNOLOGY

2019

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

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Stock Drive Products/Sterling Instrument is a Designatronics company, serving customers globally since 1950. ISO 9001:2015 + AS9100D registered.

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

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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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www.medicaldesignandoutsourcing.com

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LEADERSHIP IN MEDICAL TECHNOLOGY

2019

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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www.medicaldesignandoutsourcing.com

1/9/19 12:15 PM

2019

LEADERSHIP IN MEDICAL TECHNOLOGY For over 50 years, innovation, quality, and engineering have been at the core of Smalley’s business. This commitment has led to Smalley becoming the leading manufacturer of wave springs and Spirolox Retaining Rings. Their dedication to service combined with their reputation for on-time delivery has earned Smalley approved supplier status with leading

Quality Parts:

OEM manufacturers around the world.

free design consultations to ensure your

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 16949 certified.

unique application considerations are taken

Small Diameter Products:

Smalley Engineers have specified thousands of parts for nearly every industry. They provide

into account. Standard or custom, Smalley provides you with the right part, in the right material, with No Tooling Costs™

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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Wave Springs:

Wave springs offer up to 50% space savings in comparison to a traditional coil spring.

The smaller spring 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.

Spirolox® Retaining Rings:

Spirolox Retaining Rings come standard in 302 & 316 stainless steel. They have No Ears to Interfere® with mating assembly components. The lack of lugs or “ears” makes these ideal for tight radial applications, and require no special installation or removal tools. They are groove interchangeable with ordinary stamped rings as well.

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:

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

2019

Check Valves, Pumps, & More Smart Products USA designs and manufactures check and pressure relief valves, liquid and air pumps, and related components. Products are compact, customizable, and provide accurate, reliable flow control in advanced, low pressure, low flow systems.

An ISO 9001:2015 Certified Company.

What are modular check valves?

At Smart Products USA, modular valves combine end fittings + check valve into one tamper-and leak-resistant solution. This innovative design is available in our popular Series 300, a miniature version in our Series 500, and additional NPT or metric options in our Series 200.

Here’s What Works Customers choose connection diameters, and depending on the modular series selected, they further customize with mix and match end fitting styles. Or, use the same configuration for both ends. Options by series include: • Series 300: Barb sizes 1/16”, 3/32”, 1/8”, 3/16”, 1/4”, 5/16”, 3/8”, & 1/2”.

NPT sizes in 1/4” & 1/8”. Additional styles in foot/filtering, manual relief, & smooth stem • Series 500: Barb sizes 1/16” & 1/8”. Male Luer & Female Luer Lock • Series 200: NPT sizes 1/8” & 1/4”. Plus, a metric M10 option

The ultimate, easy customization with Smart Products USA In addition to modular valves, we offer standard and specialty cartridge valves in a variety of sizes and styles. All Smart Products USA check / pressure relief valves are customizable by 9+ plastic body and 7+ o-ring materials, as well as opening pressure ranges from 0.09–20 PSI. We also offer customizable liquid and air pumps.

Smart Products USA, Inc. 644 Fanning Fields Road Mills River, North Carolina 28759

We provide a unique and quality product for every customer based on liquids/gasses used, application environment, and intended shelf life. Customers work closely with us to determine the right components and build an application-specific product.

www.smartproducts.com

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www.medicaldesignandoutsourcing.com

1/9/19 12:19 PM

LEADERSHIP IN MEDICAL TECHNOLOGY

2019

Vacuum Heat Treating for the Medical Industry Solar Atmospheres is one of the world’s largest providers of commercial vacuum heat treating services, serving over 18 metal working industries including aerospace, medical, and power generation. Solar’s thermal processing produces bright, scale-free parts with minimal distortion. With over 60 furnaces ranging from lab sized to 48 feet long with a 150,000 pound workload capacity, Solar can efficiently handle any size job.

Solar operates plants in Eastern and Western Pennsylvania, California, and South Carolina. Nadcap, ISO 9001:2015/ AS9100D, ITAR, and MedAccred Certified.

Solar Atmospheres

Lives depend on your medical components, so partner with a heat treater that you can depend on. Solar’s state-of-the-art services include vacuum heat treating, brazing, carburizing, nitriding and advanced processing of raw materials. From annealing to case hardening, we’ll help assure that your parts perform reliably in critical situations.

At Solar Atmospheres, your stringent medical specs get the specialized expertise they deserve. Harness our leading-edge vacuum technology for clean, bright, safe parts. Our world-class equipment and expertise give you precise process control and repeatability for uncompromised quality.

1969 Clearview Road

Solar Atmospheres operates a MedAccred accredited metallurgical testing services laboratory, utilizing Struers Microhardness testers which can read both Knoop and Vickers scales without recalibration. Computerized stage control and indentation measuring systems significantly improve test accuracy, precision, and repeatability.

Souderton, PA 18964 https://solaratm.com

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Solve your toughest thermal processing challenges with innovative, custom process solutions from our brain-trust of metallurgists, chemists and engineers. Our commitment to taking on the challenge of new types of work is evidenced by the R&D we perform for universities and national laboratories.

Get results that exceed your expectations and the responsive service you deserve at Solar Atmospheres.

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LEADERSHIP IN MEDICAL TECHNOLOGY

2019

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 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.

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.

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

Sorbothane Passes the Egg Smash Test https://youtu.be/RVE5b3BzSWQ

www.sorbothane.com

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www.medicaldesignandoutsourcing.com

1/9/19 12:20 PM

LEADERSHIP IN MEDICAL TECHNOLOGY

2019

Spartan Scientific, an American manufacturing facility located in Northeast Ohio, was formed in 1987, with a mission to redefine industrial solenoid valves and related products.

We have developed many core strengths including our ability to react and produce a product quickly, to specification, that incorporates electronics coupled with fluid power.

Spartan implements continuous improvement in every area of our business.

Spartan has effectively reduced installation costs and related setup while reducing retrofits and service times.

Many of the products manufactured by Spartan Scientific are specials, or variations of standard products.

We are known for our high quality media separated valves, electronic shut off valves, air compressor drain valves, condensate drain valves and water drain pump valves and more.

Series 3B23 Isolation Solenoid Valve

Series SSDP Fixed Displacement Solenoid Pump

Series 4BKR Isolation Solenoid Valve Manifold Mounting Option

Spartan Scientific’s Role Within the Medical Industry Spartan Scientific, specializes and builds solenoid valves and dispensing pumps used for controlling air or fluid within a diverse range of industries including medical and analytical device technology.

Spartan Scientific understands the importance of the specific critical requirements within these two industries by continuing to design and manufacture products that combine high-quality materials with superior reliability, that meet design specifications and exceed performance requirements.

Spartan’s isolation solenoid valves, also known as media separated solenoid valves, have been specifically designed to control the flow of a media without allowing any contamination to occur. Spartan also offers dosing pumps for precise, repetitious dispensing of a media in analytical, diagnostic, and therapeutic equipment.

Choosing the right product for an application involves finding the best product that meets design specifications and performance requirements which is why Spartan Scientific offers custom solutions designed for your specific application, in addition to their standard offering.

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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Spartan’s solenoid valves and dosing pumps have been and can be used in applications within these areas of the analytical and medical technology industries: Dialysis, Artificial Respiration, Dental Technology, Endoscopy, Respirators, Injector Pumps, DNA Synthesis, Hematology, Pipette Dispensing, etc.

Custom Solutions Utilizing the technology and processes implemented in our standard industrial product lines, Spartan Scientific has the ability to go a step further and offer custom solutions for any application.

Our engineering and sales staff will work with you to design, fabricate, test, and ship your custom product using the highest quality standards backed by our ISO 9001 design certification.

If you have a special project that requires something not offered in our standard product line, talk to us, our design experts will be more than happy to help build you a solution.

Customer Focus is our Goal •

The customer is the reason Spartan Scientific exists; Customer demand is our passion.

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Spartan strives to deliver excellent service and high quality products. Our customer’s ability to succeed is our top priority. Meeting customer requirements is our primary area of concern.

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Active passion for continuous improvement in all departments all the time.

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Two Ears and One Mouth policy…Listen to our customers.

www.medicaldesignandoutsourcing.com

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LEADERSHIP IN MEDICAL TECHNOLOGY Spectrum Plastics Group is an ISO 13485 registered medical plastics manufacturer of

2019

A trusted partner for medical device components.

extruded, injection-molded, machine-finished, and sub-assembly solutions. The company’s

INJECTION MOLDING

global footprint and medical Class 7 and Class

Our injection molded product solutions are premium, high quality component and fully assembled thermoplastics and silicone.

Products include micro-, insert-, and multi-shot molded components and assemblies. We are a major supplier to orthopedic, dental, sports medicine, surgical and medical device market customers.

Spectrum Plastics Group is a recognized leader in manufacturing and converting engineered, high temperature and performance medical plastics, including implantable and bioresorbable materials.

8 cleanrooms in the United States, Mexico, Costa Rica, Ireland, and Malaysia supply thermoplastic and silicone tubing, catheters and catheter sub-assemblies, injectionmolded components and implantable devices, medical film & packaging, and a variety of value-added and device finishing services.

CATHETER DESIGN, DEVELOPMENT, AND ASSEMBLY Spectrum Plastics Group specializes in providing advanced catheter solutions through the combination of various technologies including precision extrusion, coil/braid reinforced shafts, steerable catheters and secondary operations.

Spectrum Plastic engineers have designed and built some of the most sophisticated catheter sets for the most advanced companies in the medical device world.

Spectrum Plastic Group 2500 Northwinds Pkwy, Suite # 472

VALUE-ADDED ASSEMBLIES & FINISHING SERVICES

Alpharetta GA 30009 Phone: 404-564-8560 Fax: 404-564-8579 www.spectrumplastics.com

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Offering expert capabilities at every step of the manufacturing process – from concept to full scale production, and sterilization – Spectrum Plastics is your trusted partner for medical device components and value-added assemblies. We deliver results to leading medical device companies around the globe.

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www.medicaldesignandoutsourcing.com

1/9/19 12:28 PM

2019

LEADERSHIP IN MEDICAL TECHNOLOGY 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.

Our staff of 300 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.

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.

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.

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. 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.

STEUTE Meditech, Inc. 901 Ethan Allen Highway, Suite 102

Call for a no-obligation design consultation, or a complimentary evaluation sample.

Ridgefield, CT 06877 203.244.6302 Email: info@steutemeditech.com www.steutemeditech.com

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LEADERSHIP IN MEDICAL TECHNOLOGY

2019

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, 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.

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 manufacturing locations in the U.S. and Costa Rica (ISO 13485 and FDA registered, QSR compliant) and have additional sales offices in the U.S. and Europe.

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 www.tegramedical.com

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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.

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Quick Wire and Tubing Store Over two million feet of in-stock wire and hypotubing inventory available for shipping within 24 hours. Secondary processes are also available.

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GENESIS Tech Center is a registered trademark of Tegra Medical.

A member of SFS.

www.medicaldesignandoutsourcing.com

1/9/19 12:30 PM

LEADERSHIP IN MEDICAL TECHNOLOGY

2019

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 innovative solutions for: • Extrusions • Diagnostic and interventional catheters • Balloons and balloon catheters • Introducers • Specialty sutures, braids, and fibers • Bioabsorbable sutures, yarns, and resins

Work With The Experts™ Need a partner? Look no further. Teleflex Medical OEM, a proven leader in the medtech industry, offers you the advantages of: • Extensive capabilities • Decades of experience • Deep expertise • World-class facilities, including our new EPIC Medtec™ Centers for product innovations

Teleflex Medical OEM 1425 Tri-State Parkway Suite 120

Teleflex Medical OEM truly is the end-to-end solution provider offering you everything from raw materials to components to finished devices – all according to your exacting specifications.

Gurnee, Illinois 60031

Let’s get to work on your project.

www.teleflexmedicaloem.com

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Our comprehensive, in-house capabilities bring your device ideas to life: • Product concept development • Engineering • Design for manufacturability • Regulatory services • Material selection and formulation • Prototyping • Testing and validation • Production process development • Custom tooling • Manufacturing • Finishing operations • Assembly • Packaging • Private labeling • Sterilization

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LEADERSHIP IN MEDICAL TECHNOLOGY The Arthur G. Russell Co., Inc. (AGR) develops state-of-the-art automatic assembly equipment for the medical device, consumer

2019

Automatic Assembly Equipment Innovator

and electronics industries. Headquartered in Bristol, Connecticut, AGR is an ISO 9001:2015 registered private company with over 70 years of designing, building, installing, and supporting world-class assembly, test,

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

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.

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.

THE ARTHUR G RUSSELL COMPANY

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.

ARTHUR G. RUSSELL 750 CLARK AVE

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.

BRISTOL, CT 06010 860.583.4109 arthurgrussell.com

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www.medicaldesignandoutsourcing.com

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LEADERSHIP IN MEDICAL TECHNOLOGY Founded in 1948, The Lee Company is a manufacturer of miniature fluid control components for aerospace hydraulic and fuel systems, automated liquid handling in medical and scientific instrumentation, medical disposable applications, oil exploration and production, automotive and off-highway equipment, machine tools, high performance motorsports, and other industries worldwide. The Lee Company employs over 1,000 people and occupies over 1 million square feet of modern manufacturing and office space 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.

Innovation in Miniature ®

The Lee Company The Lee Company 2 Pettipaug Road, P.O. Box 424 Westbrook, CT 06498 Phone: 860.399.6281 Toll Free: 800.533.7584

2019

For over 70 years, The Lee Company has been an industry leader in precision fluid control. Under the premise of economically solving problems where existing hardware is either not immediately available, or is too cumbersome, The Lee Company continues to redefine miniature fluidics through innovations developed at our Technical Centers in Essex and Westbrook, Connecticut.

Products include miniature solenoid valves, high-speed micro-dispense valves, nozzles, dispense pumps, custom manifold systems, inert tubing, Lee Plug® expansion plugs, check valves, shuttle valves, pressure relief valves, directional flow controls, safety screens, flow restrictors and associated fluid handling components.

Quality at The Lee Company is a companywide, management driven commitment. Lee invests heavily in facilities, people, and state-of-the-art equipment, enabling the company to perform all machining, assembly, and testing in-house. Every component is tested prior to shipment to ensure the highest levels of reliability and repeatability. This commitment to end-to-end quality control assures that Lee products will consistently meet and exceed the performance demands of mission-critical applications.

Lee’s unique capabilities in miniaturization and engineering expertise (one of every 7 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.

www.TheLeeCo.com

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LEADERSHIP IN MEDICAL TECHNOLOGY TRACO Electronic AG, is a Swiss company with headquarters in Baar, Switzerland.

TRACO markets its products worldwide under the registered trademark TRACO POWER. As a leading power supply specialist with more than 35 years’ experience we are dedicated to the design and manufacturing of high quality DC/DC and AC/DC power conversion products with an emphasis in medical approved solutions.

The standard product offering in medical grade power solutions includes 5~450 watt AC/DC power supplies in open frame, fully enclosed or encapsulated models and 2~30

2019

Global Leader in Medical Certified Power Solutions TRACO POWER medical products are suitable for B and BF rated equipment. Our safety critical products are globally certified to current Medical regulations and standards and approved to the requirements for applied parts applications with a 2xMOPP rating and are BF compliant. TRACO POWERS’s global manufacturing facilities are certified to ISO 9001/14000.

Our commitment to quality is supported by a full 5 year warranty on our medical products and every standard model has fully regulated output voltages, a reinforced insulation system and a low leakage current.

watt DC/DC converters with PCB mounting.

Additional features include: • Product certification according to IEC/EN/ES 60601-1 3rd edition for 2xMOPP • IEC 60601-1-2 4th Edition Compliance for EMC • Risk management process according to ISO 14971 including risk management file • Acceptance criteria for electronic assemblies according to IPC-A-610 Level 3

Traco Power North America

• Design and production to ISO 13485 quality management system

2025 Gateway Place, Suite 330 San Jose, CA 95110 P: (408) 916-4570

• 5-year product warranty

F: (408) 916-4571 Email: salesusa@tracpower.com www.tracopower.com

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www.medicaldesignandoutsourcing.com

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2019

LEADERSHIP IN MEDICAL TECHNOLOGY Miniaturized & high-precision complex products We innovate and manufacture miniaturized and high-precision complex products for our worldwide medical device partners.

Our customers are leading suppliers of active implants, medical-grade wearables as well as medical and portable medical equipment. For over thirty five years, we have helped hundreds of companies develop and produce Class II & III medical devices as well as advanced miniaturized electronic assemblies. Headquartered in Switzerland, our company spreads over three continents with design, development, industrialization and manufacturing sites in Switzerland, the U.S.A. & Morocco.

Valtronic is an EMS company developing and assembling highly complex printed circuit boards, hybrid circuits, and complete medical devices. With its full scope of expertise, from design and development to industrialization and manufacturing, Valtronic has become the partner of choice for worldwide medical device companies.

Leading The Way In Medical Device Innovation

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

Innovating Tiny Devices With Huge Impact

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.

Medical-Grade Wearables

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

Portables

29200 Fountain Parkway Solon, Ohio 44139 www.valtronic.com info@valtronic.com (440) 349-1239 FDA Registered/ISO 13485:2016

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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.

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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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 Courtney Nagle cseel@wtwhmedia.com 440.523.1685 @wtwh_CSeel

Accumold..................................................... 27 Advanced Energy, Inc.................................. 66 AIM Plastics.................................................. 58 AllMotion........................................................ 7 AMETEK - Haydon Kerk Pittman................ 55 Anomet Products......................................... 76 B.Braun........................................................ BC Bansbach Easylift......................................... 85 Bay Associates Wire Technologies............. 20 binder USA................................................... 95 Bird Precision............................................... 91 BMP Medical................................................ 32 Cadence Inc................................................. 63 CGI Motion.................................................. 15 Chieftek Precision........................................ 71 Clippard........................................................ 49 COMSOL...................................................... 37 CPC-Colder Products Company................ 33 DATA IMAGE Corporation.......................... 77 Data Modul Inc............................................ 29 Eagle Stainless Tube.................................... 30 Emerson ............................................... 23, 89 Evonik Performance Materials...................... 3 Fabco-Air, Inc............................................... 39 Fischer Connectors...................................... 96 Herrmann Ultrasonics.................................... 4

Humphrey Products Company..................... 2 igus Inc......................................................... 93 IKO International......................................... 70 Interpower.................................................... 67 J.W. Winco, Inc............................................ 87 John Evans’ Sons, Inc.................................. 50 Keystone Electronics Corp.......................... 11 Laser Light Technologies............................ 42 LEMO USA, Inc............................................ 84 Lin Engineering............................................ 31 LINEMASTER Switch Corporation............. 73 Master Bond................................................. 91 Maxon Precision Motors........... cover/corner Maxon Precision Motors.................... INSERT MEAN WELL USA, Inc................................. 83 Medbio, Inc.................................................. 82 MEDEFAB..................................................... 51 Memory Protection Devices......................... 9 MICRO Medical........................................... 38 Microlumen............................................ 46, 47 MW Medical Solutions................................ 65 Nelipak......................................................... 78 New England Wire Technologies & New England Tubing Technologies...... 45 Nippon Pulse Americas, Inc........................ 59 Nitto Kohki USA........................................... 77

NSK Precision................................................. 1 Okay Industries............................................ 36 OKW USA..................................................... 43 Orchid Orthopedic Solutions..................... 16 PTI Engineered Plastics............................... 53 Qosina.......................................................... 17 Renishaw....................................................... 57 Resonetics.................................................. IFC Schneider Electric IMS................................ 40 SDP/SI-Stock Drive Product........................ 87 Signal Transformer (Bel Fuse)..................... 64 Smalley Steel Ring....................................... 35 Smart Products USA...................................... 5 Solar Atmospheres...................................... 62 Sorbothane.................................................. 26 Spartan Scientific......................................... 72 Spectrum Plastics Group............................. 25 STEUTE Meditech, Inc................................. 19 Tegra Medical............................................ IBC Teleflex Medical OEM................................. 13 The Arthur G. Russell Co., Inc..................... 79 The Lee Company....................................... 21 Traco Power.................................................. 22 VALTRONIC.................................................. 14

2019 MEDTECH LEADERSHIP

Fischer Connectors.................................... 123 Herrmann Ultrasonics................................ 124 Humphrey Products Company................. 125 igus............................................................. 126 IKO International, Inc................................ 127 Interpower.................................................. 128 Introtek International................................. 129 J.W. Winco, Inc.......................................... 130 John Evans’ Sons, Inc................................ 131 Keystone Electronics................................. 132 Laser Light Technologies.......................... 133 LEMO USA, Inc.......................................... 134 Lin Engineering.......................................... 135 LINEMASTER Switch Corp........................ 136 Master Bond............................................... 137 maxon precision motors........................... 138 MEAN WELL USA, Inc............................... 139 Medbio, Inc................................................ 140 MEDEFAB................................................... 141 Memory Protection Devices..................... 142 MICRO........................................................ 143 Microlumen................................................ 144 MICROMO................................................. 145 MW Medical Solutions.............................. 146 Nelipak Healthcare Packaging................. 147 New England Tubing Technologies......... 148 New England Wire Technologies............. 149

Nippon Pulse Americas, Inc...................... 150 Nitto Kohki USA......................................... 151 NSK Precision............................................. 152 Okay Industries.......................................... 153 OKW USA................................................... 154 Orchid Orthopedic Solutions................... 155 PTI Engineered Plastics............................. 156 Qosina........................................................ 157 Resonetics.................................................. 158 Schneeberger, Inc...................................... 159 Schneider Electric IMS.............................. 160 SDP/SI-Stock Drive Product...................... 161 Signal Transformer (Bel Fuse)................... 162 Smalley Steel Ring..................................... 163 Smart Products USA.................................. 164 Solar Atmospheres.................................... 165 Sorbothane................................................ 166 Spartan Scientific....................................... 167 Spectrum Plastics ...................................... 168 STEUTE Meditech Inc................................ 169 Tegra Medical............................................ 170 Teleflex Medical OEM............................... 171 The Arthur G. Russell Co., Inc................... 172 The Lee Company..................................... 173 Traco Power................................................ 174 VALTRONIC................................................ 175

Neel Gleason ngleason@wtwhmedia.com 312.882.9867 @wtwh_ngleason

Accumold..................................................... 98 Advanced Energy, Inc.................................. 99 AIM Plastics................................................ 100 AllMotion.................................................... 101 AMETEK Haydon Kerk Pittman................ 102 Mary Ann Cooke Anomet Products, Inc................................ 103 mcooke@wtwhmedia.com B.Braun....................................................... 104 781.710.4659 Bansbach Easylift....................................... 105 Mike Francesconi Bay Associates Wire Technologies........... 106 mfrancesconi@wtwhmedia.com binder USA................................................. 107 630.488.9029 Bird Precision............................................. 108 BMP Medical.............................................. 109 Garrett Cona Cadence Inc. ............................................. 110 gcona@wtwhmedia.com CGI Motion................................................ 111 213.219.5663 Chieftek Precision...................................... 112 @wtwh_gcona Clippard...................................................... 113 Ashley N. Burk COMSOL.................................................... 114 737.615.8452 CPC-Colder Products Company.............. 115 aburk@wtwhmedia.com DATA IMAGE Corporation........................ 116 Data Modul Inc.......................................... 117 Jami Brownlee 224.760.1055 Eagle Stainless Tube.................................. 118 jbrownlee@wtwhmedia.com Emerson..................................................... 119 Emerson..................................................... 120 Bill Crowley Evonik Performance Materials.................. 121 610.420.2433 Fabco-Air.................................................... 122 bcrowley@wtwhmedia.com

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

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

Medical Design & Outsourcing

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EVP Marshall Matheson mmatheson@wtwhmedia.com 805.895.3609 @mmatheson

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CONNECTWITH US! Follow the whole team on twitter @MedTechDaily

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1/9/19 1:27 PM

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It‘s not a component.

It‘s a starting point.

B. Braun’s OEM Division. The only outsourcing partner you’ll ever need.

Start with B. Braun OEM’s deep product catalog. Add in some serious design and engineering skills.

It means we can create a device, set or kit tailored to your exact specifications. Once we’ve finished designing, we’ll handle everything from project management and manufacturing to packaging, sterilization and regulatory approval. With endless products and a full suite of capabilities, we’re the ideal choice to speed your project to market.

B. Braun Medical | OEM Division | USA | us.bbraunoem.com | 1-800-359-2439 ©2018 B. Braun Medical Inc. Bethlehem, PA. All rights reserved. OEM 16-5563 11/17 LMN

MEDICAL56DESIGN & OUTSOURCING | FULL PAGE | BRN2024 B Braun 9-18.indd

1/8/19 2:54 PM