Medical Design & Outsourcing – JANUARY 2020

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www.medicaldesignandoutsourcing.com JANUARY 2020

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KEEPING HIS EDGE CVRx CEO NADIM YARED HAS EMERGED AS A FEARLESS, OUTSPOKEN LEADER IN MEDTECH. THE 10 GREATEST MEDTECH ADVANCES OF THE 2010s I’M A MEDTECH EXPERT WHO SURVIVED A TUMOR IN MY HEAD INDUSTRY VETERAN GIVES A GLIMPSE OF LIFE ON THE OTHER SIDE OF THE SCALPEL.

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E D I T O R I A L EDITORIAL Executive Editor Chris Newmarker cnewmarker@wtwhmedia.com @newmarker Managing Editor Nancy Crotti ncrotti@wtwhmedia.com Senior Editor Danielle Kirsh dkirsh@wtwhmedia.com Assistant Editor Sean Whooley swhooley@wtwhmedia.com Editorial Director DeviceTalks Tom Salemi tsalemi@wtwhmedia.com

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HERE’S WHAT WE SEE

The next Roaring '20s

T

he medtech industry received one of the best holiday gifts it could have hoped for just before Congress adjourned for its year-end break: the repeal of the 2.3% medical device excise tax.

The tax was part of the Affordable Care Act of 2010 and was one of a number of funding mechanisms meant to help pay for the health reform. But the medtech industry argued that the tax limited jobs and innovation.

The tax on the sale of most medical technologies applied to medtech companies’ revenues, not profits. Device companies over the years achieved temporary suspensions of the tax through Congress — but never an outright repeal, until now.

One clear spark for that growth is leadership, the theme of this month’s issue of Medical Design & Outsourcing. We profile Miles White, 64, who will step down as CEO and chairman of Abbott in March after 21 years at the helm.

Abbott was a very different company when White took over in 1999, focusing more on pharmaceuticals than medical devices.

White made some bold moves to change that focus, spinning

"[The repeal of the 2.3% medical device excise tax was] a huge win for the industry. The medtech industry directly accounts for well over 300,000 jobs in the United States, according to the U.S. Department of Commerce."

It’s a huge win for the industry. The medtech industry directly accounts for well over 300,000 jobs in the United States, according to the U.S. Department of Commerce. More than 80% of medical device companies in the United States consist of fewer than 50 employees. If the tax was reactivated, it would lead to a loss of 21,390 full-time equivalent jobs and a reduction in of $1.7 billion in the gross domestic product, according to a recent Tax Foundation estimate.

With the specter of the tax lifted, medtech can concentrate on its continued growth. The global medical devices market size was valued at $425.5 billion in 2018 and is expected to reach $612.7 billion by 2025, according to a report released last month by Fortune Business Insights.

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www.medicaldesignandoutsourcing.com

Nancy Crotti Managing Editor Medical Design & Outsourcing ncrotti @wtwhm e di a .c o m

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off the company’s research-based pharmaceutical business in 2013 and acquiring St. Jude Medical four years later in one of the biggest deals in medtech history. Our profile offers insights into White’s achievements and leadership style.

Also featured this month, we talk with Nadim Yared, CEO of CVRx, which this year received FDA premarket approval for its Barostim Neo, the first neurostimulation device that can treat heart failure patients who are not indicated for cardiac resynchronization therapy. Yared, who recently served as chairman of the medical device trade group AdvaMed, shares the leadership philosophy that brought him to CVRx and reveals the traits he looks for in budding medtech leaders.

Finally, I’ve been writing and editing for Medical Design & Outsourcing since May 2018, and took over as managing editor in November. (Former managing editor Chris Newmarker moved up to executive editor of Life Sciences.) I look forward to interacting with many more of our readers and contributors, and to providing the news on the latest in medtech.

Miles White

Nadim Yared

"With the specter of the tax lifted, medtech can concentrate on its continued growth."

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Medical Design & Outsourcing 7

CONTRIBUTORS

SPEER

FINN

MCGUIRE

JON SPEER is founder and VP of quality assurance and regulatory affairs at quality management software company Greenlight Guru (Indianapolis). A graduate of the RoseHulman Institute of Technology, he has more than 20 years of medical device experience, including product development, project management, quality and regulatory affairs.

DENIS FINN is a product development engineer at Guill Tool & Engineering (West Warwick, R.I.). Guill designs and manufactures extrusion tooling for various thermoplastic and elastomeric applications.

ANN MCGUIRE is product marketing manager for Arena Solutions (Foster City, Calif.). She has held consulting, sales and marketing positions in the product lifecycle management (PLM) and quality management systems (QMS) industry for the past 25 years. Prior to working in PLM, McGuire was an engineer in the semiconductor acquisition and test group for a major computer company.

ZOLDY

JOHN ZOLDY is manager of new business development at Metallon (Thomaston, Conn.), where he has worked for more than 18 years. The company has expertise in engineering, tooling, die building and automated assembly.

BILL BETTEN is the president of Betten Systems Solutions, a product development realization consulting organization based in Minneapolis-St. Paul.

Betten utilizes his years of experience in the medical industry to advance device product developments into the medical and life sciences industries, helping clients to develop innovative medical devices and adapt to a changing environment. Betten most recently served as director of business solutions for Devicix/Nortech Systems, a contract design and manufacturing ďŹ rm.

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CONTENTS

medicaldesignandoutsourcing.com ∞ January 2020 ∞ Vol6 No1

50

COLUMNS 6

HERE’S WHAT WE SEE

8

CONTRIBUTORS

12

DRUG DELIVERY

16

MACHINING

• • • • • THE LEADERSHIP IN MEDTECH ISSUE

ON THE COVER MILES WHITE’S FEARLESS STRATEGY FOR GROWING ABBOTT

The next Roaring ‘20s

Twenty years after becoming Abbott CEO, Miles White is retiring. Here’s how he transformed the company.

Human factors and drug-delivery devices Precision stamping for disposable medical components: Here are the basics

20 MEDTECH TRENDS

4 medical device industry trends affecting innovation

25 REGULATORY

Good design controls are critical to avoid FDA issues

FEATURES

28 STANDARDS

Top 4 mistakes when implementing ISO 13485

60 KEEPING HIS EDGE

Nadim Yared’s outspoken style helped grow CDRx and help the medtech industry.

32 TUBING TALKS

How do flow dynamics work with extrusion tooling?

66 THE 10 GREATEST MEDTECH ADVANCES OF THE 2010S

The medical device industry changed significantly in the last decade, setting the stage for a fast-growing future.

36 MD&M WEST PREVIEW 95 LEADERSHIP IN

MEDTECH 2020

184 AD INDEX

84 I’M A MEDTECH EXPERT WHO SURVIVED

A TUMOR IN MY HEAD

Industry veteran gives a glimpse of life on the other side of the scalpel.

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DRUG DELIVERY

How human factors created a new generation of drug-delivery devices

Left to right, generations I through III of West Pharmaceutical Services’ SmartDose drug-delivery platform.

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Human-factor testing is beneficial early on in the design process, rather than as a confirmation at the end. Here’s how testing for usability and desirability helped spark three generations of drug-delivery devices.

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Medical Design & Outsourcing

est Pharmaceutical Services has multiple generations of its SmartDose products under its belt since it started working on the drug-delivery devices in 2012. Human factors played a major role in the iterations.

The SmartDose Gen I device was initially used in clinical studies.

From those studies, West received data from the returned devices to see what happened during drug delivery – whether it went as planned, if there were any mechanical issues or use errors.

The goal was to better develop new generations of the device.

“It’s one thing to get a written report on what happened in a clinical trial, but we actually got the returned units,” Eric Resnick, VP and CTO at West Pharmaceutical Services told Medical Design & Outsourcing. “The SmartDose technology stores all the data on the circuit board. We can read the units and just see how did the program sequence through from the start of injection or not started, when the unit gets activated, when the dose was completed or when it stopped dosing and may have alarmed.”

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It was the type of human factors research that has informed West through three generations of SmartDose. How the company harnessed human factors provides some important lessons for drug-delivery device developers in general.

From the human factor data, West Pharmaceuticals built a database to see if the device triggered certain error codes frequently and the possible cause of the error code. The forensics from the device’s software show how it performs, and, along with the mechanical view, feeds into making the platform better in subsequent releases.

“It could be use. It could be design,” Resnick said. “What can we do to prevent that from happening? It could be a destructive process to take something apart to see if something went wrong internally in the mechanisms.

We are able to develop and deploy CT scanning to give us an image inside the device to see if something breaks or if something is out of place.”

Gen I of the SmartDose is a combination product that offers a prefilled, wearable, subcutaneous injector with a drug-delivery system.

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DRUG DELIVERY

The patient-centric wearable injector is a user-loaded, subcutaneous, selfadministation device that delivers high-volume and high-viscosity drug products, according to the company.

“We knew we weren’t looking at a one-off product. We were trying to build a platform,” Resnick said. “When that launch got approved three years ago, we were already moving down a number of paths.”

The second generation of the SmartDose technology is similar to Gen I in that it is user-loaded. When ready to inject, the user inserts a separate prtefilled cartridge into the device, which starts the process of the workflow to get ready to self-administer, Resnick explained. The second-generation device has expanded and improved software to be used with more viscous drugs, dosages up to 10 ml and faster injections. It also offers multiple programmable parameter options, can run multiple programs and handle

any number of dosing regimens from minutes to hours.

“So, on the user-loaded device, what we realize is it’s one thing to have people get trained on how to use devices. It’s better to eliminate the possibility of misuse or someone doing something out of order,” Resnick said.

“So, what we built into it is, through our own user research, mechanical checks along the workflow.”

For example, a user won’t be able to close the door on a SmartDose device unless the cartridge is completely seated. Users can’t initiate an injection by pressing the button until the adhesive is removed and firmly attached to the body.

“We basically just put locks in place that would prevent out-of-step or out-of-sequence activation from happening,” Resnick said. “We also just made it almost impossible for the device to be mishandled in preparation of administration.”

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We knew we weren't looking at a one-off product. We were trying to build a platform. When that launch got approved three years ago, we were already moving down a number of paths.

The Gen III SmartDose technology has some of the same benefits as Gen II in terms of improved software, electronics and power management.

The difference between it and other generations is that a patient would only have to open the package and remove from the blister and the device would be ready for use. The cartridge is preloaded in the device, an idea inspired by human factor data from its previous iterations.

“That addresses partner needs where they want the patient to have to do as few steps as possible in the workflow and readying themselves for selfadministration,” Resnick said. “You can see how that would be beneficial with more drugs going to less-frequent dosing.”

Through each new generation of SmartDose devices, West Pharmaceutical Services takes into account usability elements of human factors — incorporating in the desirability that comes out of user research. The company uses ethnographic research to look at the environment in which people are administering the drug or preparing themselves for selfadministration. Observations and follow-up questions provide an understanding of

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Medical Design & Outsourcing

1 • 2020

SmartDose Gen I. 3.5 mL Drug Delivery Platform Image courtesy West Pharmaceutical Services

how users feel and what they think when handling the device.

However, controlled environments are not always indicators of the real world, Resnick said. It is important to see how people are using it in the home or wherever they are self-administering, because the physical environment and other activities, such as preparing dinner and talking on the phone, can affect how a patient uses the device.

“What it has taught us over the last several years is the importance of that research, using human factors as well, as a confirmation or validation of your design,” Resnick said. “We can compile design inputs from the user view that are as important as our traditional performance inputs of delivering the doses in X minutes.”

Resnick said conducting multiple human factors studies throughout the early stages of development is more important than using human factors as a confirmation at the end when arriving at the design validation. Early use of human factors can show more than feasibility — it can also show desirability and if people will use the technology according to a prescribed regimen.

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Medical Design & Outsourcing

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MACHINING

Precision stamping was used to produce this disposable stainless steel surgical scissor.

Image from Metallon

Precision stamping for disposable medical components: Here are the basics Careful planning enables cost-effective production of high-quality products.

F

rom surgical devices to onetime-use tools, disposables are increasingly important in medical applications.

Precision stamping can be an optimal choice to achieve cost, compliance and process flexibility requirements. Designers should work with their manufacturing vendor during development to ensure success.

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Medical Design & Outsourcing

Start with a design partnership The cost to design and produce machining tools and stamping dies can be significant when manufacturing a new product. The concern about these expenses increases when manufacturing disposal components.

While a large-volume run can spread tool-and-die costs over many thousands of pieces, in short runs and prototyping, OEMs must partner closely with their manufacturer to ensure the right tooling is produced from the beginning.

One effective approach is to identify opportunities for standardized dies and tools. This often occurs in a product that has different configurations or options.

Typically, the majority of the product’s form will be the same — or similar enough to be modified during the design stage — so that all parts can use the same die set. The standardized die could be part of a first production pass, which is followed by a 1 • 2020

second production pass with unique tools and dies. Alternatively, one production run can be performed, using the standardized die throughout and changing select tooling when quantities are met.

For example, Metallon recently developed a disposable medical scissor.

The scissor’s handle, shank and pivot point were all manufactured using one standardized die and a single stamping process. The scissor was available with three different blade tip options: a sharp tip, a Littauer with a hook, and a blunt tip, which could each be created with a simple tooling change. This reduced overall tooling costs as well as set-up time.

Tool & die optimizations Optimizing material usage is critical, especially in today’s volatile metals market. When designing a stamping die, engineers typically look to reduce waste and capture scrap. In disposables, where weight and durability can be important, engineers must also design products with the end user in mind.

In the case of the disposable scissor, designers tested different bend types for the scissor handle to maximize strength, comfort and resistance to deformity. Designers also performed less quantifiable testing, working to create a scissor that would be

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The importance of material selection When producing disposables, engineers should carefully evaluate material costs. The designer and the manufacturer should work together to identify materials with the best manufacturability, the lowest cost and the best performance for the end application.

Disposables are often subjected to a wide range of conditions before use. During production, parts are formed, cleaned, bagged and stored, experiencing chemical exposure and different handling processes. When used in the end application, they are exposed to a second set of conditions. Engineers must work to ensure the material selected will function, without issue, in a potentially critical situation.

Automation processes High-volume production runs and projects with precision requirements can benefit from automation processes, which can lower costs and improve quality. In medical applications, this can help ensure compliant machining and stamping, while also streamlining production.

As disposable surgical instruments and medical components continue to gain market share, precision stamping can be a cost-effective solution that meets quality, performance and cost targets. Designers should work with their manufacturing partner in the early stages of development to help reduce tool and die costs, optimize material and manufacturing costs, and ultimately produce a part that meets performance goals.

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MEDTECH TRENDS

4 medical device industry trends affecting innovation Major medical device companies are increasingly outsourcing their innovation. Here’s what that means.

The medtech trends panel at DeviceTalks West in December included (left to right) Ginger Pigott, vice chair of Greenberg Traurig’s Pharmaceutical, Medical Device & Health Care Litigation Practice; Marlon Housman, senior legal director at Medtronic Vascular; Casper de Clercq, a general partner at Norwest Venture Partners; and Roman Fayerberg, a shareholder and registered patent attorney at Greenberg Traurig.

Image courtesy of WTWH Media videographer Derek Little

T Chris Newmarker | Executive Editor |

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Medical Design & Outsourcing

he medical device industry is increasingly relying on small, young companies to provide innovations, but the early-stage medtech companies are mostly relying on angel investors.

It’s also more important than ever to protect intellectual property and mitigate exposure to litigation.

Those were some of the big takeaways from a Greenberg Traurig– sponsored panel on medtech M&A, IP and product liability trends — held at DeviceTalks West in December.

Panelists included Marlon Housman, senior legal director at Medtronic Vascular; Casper de Clercq, a general partner at Norwest Venture Partners; Roman Fayerberg, a shareholder and registered patent attorney at Greenberg

1 • 2019

Traurig; and Ginger Pigott, vice chair of Greenberg Traurig’s Pharmaceutical, Medical Device & Health Care Litigation Practice.

Here are four medical device industry trends affecting innovation: 1. Innovation through acquisition For the legacy medical device companies, there’s less opportunity for big, game-changing, strategic acquisitions than there used to be.

Instead, the focus is more on the smaller acquisitions that can add products to the companies’ lineup, said Housman of Medtronic Vascular.

“R&D budgets are shrinking. There’s a lot more pressure. So as a result, we do look elsewhere for developmental technologies,” Housman said.

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MEDTECH TRENDS

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In the pharmaceutical industry, innovation is already mostly outsourced, according to de Clercq at Norwest Venture Partners.

“I think that’s probably where large medtech is going… Looking outside for innovation,” de Clercq said.

2. Partnering with academia in a way that protects IP Academia is also a great source of inventions for medical device companies, but medtech outfits need to take care to protect their IP, said Fayerberg of Greenberg Traurig.

“It’s a great way to get the foundational IP fast and some data behind it, but you have to be careful with the license and agreements. That usually comes up during the due diligence: who owns what part of the IP and how important is the foundational IP,” Fayerberg said.

It’s also worth noting that research institutions often work together. So a license from university A may not be enough if university B and C are also involved.

“It’s definitely something to look at during due diligence,” Fayerberg said.

Housman urged caution.

"R&D budgets are shrinking. There's a lot more pressure.

So as a result, we do look elsewhere for developmental technologies."

“I’ve heard of experiences of companies doing deals with academia and finding out that, basically, all of the IP and resources they’ve developed in this collaboration with the academic institution by contract ends up being owned by the institution,” Housman said.

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3. VC is still for more advanced companies Venture capital outfits still appear to be focused on funding medical device companies that have already achieved a few milestones.

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“We typically seek out FDA-cleared devices… We want to see clinical data, ideally,” said de Clercq.

Much of the funding for early-stage companies currently comes from angel investors, according to de Clercq, who said it is relatively easy to secure an investment in the $1 million to $3 million range.

4. Medical device litigation is here to stay Media reports have affected the public’s perception of the medical device industry and garnered some attention from plaintiff lawyers — and that attention in turn has increased the potential for litigation, according to Pigott of Greenberg Traurig.

Medical device companies need to not only think about regulatory compliance, but also about mitigating litigation risks, Pigott said. “Medical device litigation is here to stay.”

I've heard of experiences of companies doing deals with academia and finding out that, basically, all of the IP and resources they've developed in this collaboration with the academic institution by contract ends up being owned by the institution.

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REGULATORY

Good design controls are critical to avoid FDA issues No medtech company wants to run afoul of the FDA. Implementing good design controls can keep regulatory issues at bay.

Ann McGuire | Arena Solutions |

M

edical device companies recognize that using design controls helps to assure good design and engineering practices that yield high-quality solutions.

This is critical when considering FDA validation and design compliance.

Companies need to know which elements to incorporate in design controls before creating formal plans to implement them.

Why use design controls?

In addition to achieving better practices and designs, sound design controls can prevent FDA inspection observations and notices (Form 483s) — which can be very costly and even derail product launches.

Form 483s and FDA warning letters are similar in nature and serve to inform all affected parties about issues that require corrective action. The Form 483, also called “Inspectional Observations,” conveys conditions or practices that indicate a potential violation of FDA requirements.

The warning letter is typically an escalation from insufficient follow-up on a 483.

Controls or consequences Approximately 90% of 2018 FDA 483s cite quality system regulation issues (21 CFR 820), which are very concerning. The accompanying pie chart shows that 14% are design control issues (CFR 820.30) as well as corrective and preventive actions (CAPA). The consequences to affected companies are significant. Medical device manufacturers avoid being listed on the FDA website, as this kind of visibility can harm sales and profitability and may lead patients and physicians to lose confidence in the device. Medical device makers are also at risk from competitors who can exploit the information. Lastly, management and other resources can be pulled from priorities to address these issues, which can be quite disruptive to business operations.

A solid design controls foundation simplifies FDA compliance, so companies can pass audits without a finding.

What goes into design controls?

Design and development planning are the first elements in the design control process. The plan includes activities, dates and responsible people. It is documented and updated as it evolves. This leads to the next element, design input.

Design input comes from users, patients, physicians and other stakeholders.

The design process results in design output, which is documentation describing

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Medical Design & Outsourcing

25

REGULATORY

the product. Design reviews occur throughout design development to check the design results and identify issues.

Verification ensures that the design outputs completely and unambiguously match the design input. During verification, personnel should be able to answer questions like:

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Do we have all the documentation we need?

Who has approved it and when?

What’s missing?

Design transfer is the process of providing manufacturing with the design output they need, including bills of materials, drawings and assembly instructions. Although design transfer is not frequently cited in 483s, it can cause delays and errors when companies transfer information manually from engineering to operations.

The next element is validation — testing to make sure the manufactured product meets the users’ needs.

All these tests and results must be documented. Validation is the most commonly referenced sub-part of the design controls 483s.

Design changes Design changes are the second-most cited issue under design controls. After releasing the first revision, updating enterprise system planning software and other downstream systems can be tricky. Many aspects of the design may have changed, which makes it essential to understand what has changed as well as whether components were added or removed. It’s also important to ensure that supporting documents have been updated. Change processes can have many variables making documenting and following those processes more difficult.

Keeping track Finally, the design history file (DHF) is the compilation of a company’s product design documentation and its evolution. This is an administration-heavy element that can be cumbersome to maintain and use.

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Traditional, document-centric quality management system (QMS) solutions can help simplify some of these processes.

However, a product-centric QMS solution uses a single system to manage the foundational product record in context with all related quality processes. This connected product record includes a relational bill of materials (BOM), approved manufacturers list (AML), and changes (ECOs). Managing the quality processes in the same system creates better visibility of issues and faster resolution with connected quality records like complaints and CAPAs that can drive ECOs to correct any design issues.

Ultimately, having a productcentric QMS helps companies with design transfer and design change processes as well as the FDA-required ďŹ le management. This also helps medical device companies establish solid design controls to avoid FDA warnings that can result in lost revenue, patient health issues, or, in some cases, death.

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Medical Design & Outsourcing

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STANDARDS

Top 4 mistakes when implementing ISO 13485 ISO 13485 provides quality management system (QMS) guidelines for the production of safe and effective medical devices, but it’s easy to get tripped up.

I

SO does not publish reports on manufacturer violations found during audits, making it difficult to learn from others’ mistakes.

Here are the four most common mistakes that manufacturers make in their attempts to comply with ISO 13485:

Jon Speer | Greenlight Guru |

1. Treating processes as checkboxes Oftentimes, contract manufacturers will achieve their ISO 13485 certification as a competitive advantage to secure business, instead of doing it because they believe in the benefits of the framework. ISO 13485 activities are not just “checkboxes,” or must-do items for compliance.

Implementing ISO 13485 should involve a holistic approach with an emphasis on quality from the outset.

The process should promote a culture of quality across the entire organization that extends beyond the initial execution of the standard’s processes.

Companies that adopt a qualityfirst mindset when implementing ISO 13485 will find it a value-add exercise, rather than just an effort to comply with regulations.

Many companies have ineffective CAPA processes that can cause mistakes to snowball. It's critical to fully understand the differences between "corrective action" and "preventive action."

2. CAPA overload Many companies have ineffective CAPA processes that can cause mistakes to snowball.

It’s critical to fully understand the differences between 28

Medical Design & Outsourcing

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“corrective action” and “preventive action.” According to ISO 13485, a corrective action eliminates the cause of nonconformities in order to prevent a recurrence. A preventive action eliminates the causes of potential nonconformities in order to prevent their occurrence.

CAPA overload can quickly occur when a company’s poor processes inhibit the ability to eliminate and prevent nonconformities, or the company is overburdened by managing excess CAPA events.

Auditors are likely to dig deeply into a company’s CAPA processes to gain a better understanding of how root causes were identified. ISO auditors are also interested in the efficiency of your QMS processes. Effective CAPA procedures within your QMS are among the first things an auditor looks at and considers in their findings. Don’t skip this important step!

3. Management reviews Management reviews are required under ISO 13485 and FDA 21 CFR Part 820 to ensure companies are properly executing and following procedures.

Companies often make mistakes during implementation due to the amount of time and paperwork involved.

Management teams often see reviews as a last-minute checkbox activity. This pressure of feeling “under the gun” only compounds the work needed to be done, creating unnecessary stress.

Section 5.6.2 of the standard offers a list of things companies should consider during management reviews: • • • • •

Results of audits.

Customer feedback.

Process performance.

Product conformance.

Status of corrective and preventive actions.

www.medicaldesignandoutsourcing.com

EXPERIENCE. PRECISION.

STANDARDS

• • • •

Follow-up to previous reviews.

Improvements.

New regulatory requirements.

Changes that could affect quality systems.

Ineffective systems make it challenging to keep information up-to-date, and records may be easily lost. This leads to poor management reviews that reinforce a poor-quality culture within an organization. Effective management reviews are opportunities to assess how your QMS and internal processes are functioning, in order to be proactive and control CAPA management.

4. Risk-based processes ISO 13485:2016 frequently mentions riskbased processes, encouraging companies to assess risk after completing a process or task. This, too, is often carried out as a checkbox activity.

Companies should document each risk assessment with its corresponding

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risk management file to be managed and scored. This is a process that cannot be done in haste.

When managing supplier risk, riskbased processes should be directly proportional to the supplier’s role with your device. One effective way is to assess how the component interacts with patients. The more contact it has with patients, the higher the risk score it should receive.

A risk-based approach is also critical for handling complaints. Without one, your processes can become cumbersome and lead to the CAPA overload scenario.

Prevention is key Manufacturers can avoid common pitfalls associated with ISO 13485 by using their QMS to bring safe, effective medical devices to market. This is the overall intended purpose of the standard.

A focus on quality can help manufacturers achieve and maintain compliance as a natural byproduct.

Reinforced by an effective QMS, companies can gain valuable insights to prevent issues from happening later.

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TUBING TALKS

How do flow dynamics work with extrusion tooling?

Medical tubing makers need to carefully control and tune their extrusion tooling to very tight tolerances in a cost-efficient manner.

Flow channel geometry plays a critical role.

Extrusion tooling users can encounter dead spots that prevent the material from flowing freely. If this is not corrected, the material can become completely degraded.

Image courtesy of Guill Tool & Engineering

T Denis Finn | G u i l l To o l & Engineering |

he extrusion process presents several challenges, and a frontrunner is product quality, especially when it comes to extruded medical products.

Medical tubing and jacketed products must be produced to conform to very tight tolerances. It’s often necessary to inspect wall thicknesses and diameters to tolerances lower than 0.0004 in./.01 mm.

Polymers used in the medical industry may also be extremely expensive. Medical tubing makers must carefully control and tune extrusion systems to produce demanding products in a cost-efficient manner. This is especially important for multi-layer and/or multi-lumen constructions.

In overly large channels, the polymer’s exposure time to processing temperatures could cause degradation. A too-restrictive geometry may make the system run at high pressures and limit production speeds. Users may also encounter dead spots that prevent the material from flowing freely. If this is not corrected, the material can become completely degraded.

While flow channel geometry challenges can occur with all polymers, this becomes a serious problem in the medical industry due to the use of expensive materials. Also, medical products commonly use barium sulfate, a radiopaque substance that allows the finished product to be visible on X-ray scans.

When barium sulfate is co-extruded with

While flow channel geometry challenges can occur with all polymers, this becomes a serious problem in the medical industry due to the usage of expensive materials.

The flow channel geometry that the polymer flows through is a critical component of a well-designed extrusion system. Residence time, or the amount of time the polymer takes to flow through the die assembly, should be considered to avoid burning and stagnation issues.

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high-temperature materials like fluoropolymers, the flow channels must be engineered to ensure the barium sulfate does not degrade.

Dead spots and high residence time will cause the barium sulfate to yellow and ruin the product.

www.medicaldesignandoutsourcing.com

TUBING TALKS

The sensors and feedback the system provides should be checked and double-checked to ensure the polymer is properly processed. The temperature of the polymer flowing through the die cavity could differ greatly from the thermocouple reading. As we know, the thermocouple is a sensor that measures the temperature of the die assembly. In most cases, the sensor does not directly read the temperature of the polymer but is installed on the outside housing of a die assembly. A considerable thermal gradient can occur between the polymer and the thermocouple, giving false confidence that the polymer is being properly processed. Since the polymer temperature could actually be colder or hotter than what is indicated, it is imperative to take physical measurements from the melt stream when working with fragile materials or establishing recipes for the line. To do this, you should take the measurements while at production speed.

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www.medicaldesignandoutsourcing.com

As the polymer begins to travel through the restrictive flow channels, it will develop heat from viscous dissipation. The faster you go, the more heat the polymer’s flow will contribute to the system, if everything else stays the same. Close monitoring is critical for many thermally sensitive materials like ethylene vinyl alcohol (EVOH), in which gels and other degradation may develop. For example, you might look at the thermocouple and see 300 ºC but measure the direct temperature and get 330 ºC. In this case, you need to adjust the thermocouple settings to get the right melt temperatures.

Materials may also be prone to melt fracture, a phenomenon that produces an unsatisfactory surface finish on the product. Using proper tooling sizes and processing parameters will avoid these troublesome issues.

According to Guill national sales manager Bill Conley, if the extruder is running very slowly, we can also offer

dual, triple or quadruple output dies.

Instead of getting another line, you are effectively doubling the extrusion system to double or even quadruple your production. In this way, you save a lot of money on equipment and processing personnel.

Image courtesy of Guill Tool & Engineering

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Medical Design & Outsourcing

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&M MD WEST N A N C Y C R OTTI M A N A G ING ED ITO R

EXHIBITORS YOU NEED TO KNOW

DA N IELLE K IR SH S E N IO R ED ITO R

M

D&M West — set for Feb. 11-13, 2020 — is billed as the largest medical device manufacturing event in the world.

Now in its 35th year, it showcases hundreds of industry suppliers and attracts thousands of medical device industry insiders. Strolling around the show floor at the Anaheim Convention Center, in Anaheim, Calif., visitors will see an array of industry suppliers showcasing their latest technologies and manufacturing advancements. Twelve educational tracks will include information on medtech design and manufacturing, smart manufacturing and 3D printing.

Here are some of the companies touting medical device manufacturing technologies at the upcoming MD&M West.

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www.medicaldesignandoutsourcing.com

MEDICAL CONNECTIVITY SOLUTIONS ■

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MD&M WEST PREVIEW

FREUDENBERG MEDICAL BOOTH #2413

Freudenberg Medical (Carpinteria, Calif.) will exhibit at MD&M West alongside joint venture partners VistaMed, Cambus Medical, Hemoteq, and Freudenberg Performance Materials. Freudenberg plans to tout several new products, including: •

•

• Freudenberg Medical's HelixTwist multi-lumen tubing Image from Freudenberg Medical

HelixTwist multi-lumen tubing, designed to provide an equal balance of stress across the inner and outer lumens as the tube bends for use in pacemakers, breathing tubes and other applications that require navigation through tortuous pathways within the human body.

Helix iMC technology to continuously measure the inner geometry of silicone tubes, designed to increase product quality for high-precision applications while reducing material usage and process time.

Velona custom and specialty needles (Cambus Medical), design and product development support, manufacturing

• High Performance • Tight Tolerance • Component Solutions You can from Spectrum Plastics Group. Providing some of the most invasive medical device products with high performance, tight tolerance plastic solutions. From structural heart to orthopedics, from Apollo™ PEEK multilumen extrusions to injection molded bioresorbable composites to Adam Spence® braided tubing, Spectrum Plastics brings to market some of the most advanced component manufacturing technologies that enable your next generation devices and products.

Visit spectrumplastics.com for more information.

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www.medicaldesignandoutsourcing.com

•

•

•

and final assembly for needle devices in the clinical areas of fine-needle aspiration/fine-needle biopsy, minimally invasive delivery systems and structural heart applications.

Tri-Layer tubing (VistaMed), a single lumen tube comprised of three discrete layers available in a wide range of multi-layer material combinations.

Next-generation products from Freudenberg Medical's minimally invasive solutions group, including the Composer Epic and Composer Toccata catheter handle platforms, and the HyperSeal Mini hemostasis valve.

New hydrophilic debridement foam for wound cleansing (Freudenberg Performance Materials) for cleansing deep and hard-to-reach wounds; foams with direct coating of silicone adhesive, and components for advanced wound care, traditional wound care, and stoma care. –NC

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MD&M WEST PREVIEW

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Quality – The standard of something as measured against other things of similar kind, the degree of excellence of something.

At Fabco, our machine centers make Quality parts for pneumatic cylinders.

Every item Fabco manufactures refl ects the highest standards of quality. Working in unison, our team takes every measure necessary to assure that our parts adhere to these standards. Only after they have passed our critical quality checks at every step of their production will they be deemed ready for our customers.

If quality and reliably high performance in your pneumatic automation applications matter to you as much as they do to us, then Fabco’s pneumatic cylinders are your only choice.

Trelleborg (Trelleborg, Sweden) will highlight its custom silicone and thermoplastic molding capabilities at MD&M West. Specific types of products on display will include: • • •

Micro-molded parts, parts with complex geometries and multi-component parts.

Silicone sheeting and tubing capabilities, as well as the company's medical silicone tubes for long-term implants.

Specialty tubing and hoses, designed jointly with customers to meet their individual application needs.

Examples include multi-lumen, flexible, kink-resistant and silicone tubing with a plastic core for minimally invasive instruments, catheters and probes.

Trelleborg's GeoTrans technology, designed to enable a significantly greater variation in the geometry of tubing, supporting unique, customer-specific designs. For example, it's possible to separate one lumen into two lumens (or two into one) during the extrusion process, eliminating the need for a molded component between the different segments. Lumens can be stopped and restarted, or the dimensions of the tubing can be changed, which is often necessary for wound drains. –NC

Technical support Ph: (352) 373-3578 Fx: (352) 375-8024 service@fabco-air.com Fabco-Air, Inc. 3716 N.E. 49th Avenue Gainesville, FL 32609-1699 www.fabco-air.com 40

Medical Design & Outsourcing

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CO.56 Pro ultrasonic sensor series, which readings and can be easily clamped free-hanging on the nvasive Clamp-on FlowBubble Sensors

w measurement and air bubble detection tubing. The accuracy of the SONOFLOW CO.56 Pro is up to compact unit. The integrated electronics two percent and the repeatability is as low as one percent, operate up to twelve independent sensors depending on where the sensor is mounted and which kind ntrol unit guarantee the world’s smallest of liquid is measured. Additionally to the measurement of EM flow and bubble detector to be used in sensors flow conditions, the sensor ementary The non-invasive ultrasonic operate without any is able to detect air bubbles as small as one third of the inner diameter of the tube. ementary The non-invasive ultrasonic sensors operate without any eveloped media contact, they quickly perform bi-directional flow

eveloped es, which es, which detection detection ectronics tectronics sensors t smallest sensors esmallest used in e used in

RES

SONOFLOW CO.56 Pro Flow Bubble Sensor

media quicklyclamped performfree-hanging bi-directionalonflthe ow readingscontact, and canthey be easily readings and can beofeasily clamped free-hanging tubing. The accuracy the SONOFLOW CO.56 Pro ison upthe to tubing.

The accuracy of the SONOFLOW CO.56 Pro percent, is up to two percent and the repeatability is as low as one two percenton and the repeatability as low as one percent, depending where the sensor is is mounted and which kind depending on where the sensor is and which of liquid is measured.

In addition tomounted the measurement of kind flow of liquid is the measured.

Inable addition to the of flow conditions sensor is to detect airmeasurement bubbles as small as conditions sensor able to detect bubbles as small as one third ofthe the inner is diameter of the air tube. one third of the inner diameter of the tube.

MD&M WEST PREVIEW

MICROCARE MEDICAL BOOTH #2343, 616

See us at MD&M West in Anaheim, CA February 11-13 Booth# 2190

Non-Invasive Clamp-On Sensor Can be Freely Suspended measurement & bubble detection

MicroCare Medical (New Britain, Conn.) plans to show off products to improve the medtech manufacturing process, including:

The new Opteon SF80 specialty fluid for use in Combined Flow Measurement r for non-invasive measurement vapor degreasers. It is a high& Bubble Detection solvency, nonflammable and & lightweight sensor design HARDWARE ATTRIBUTES environmentally sustainable Integrated ElectronicsOne-channel architecture | Fail-Safe d cleaning fluid with a low global Cyclical selftest warming potential.

Watchdog nics & data processing TECHNICAL SAFETY FEATURES • Carrier fluids used for the safe TECHNICAL SAFETY FEATURES and effective deposition of sitivity SOFTWARE ATTRIBUTES silicone, PTFE lubricant and other Initial test procedure HARDWARE ADVANTAGES onal flow measurement pharmaceutical coatings onto HARDWARE ADVANTAGES One-channel architecture medical devices. These nonarchitecture & highly preciseOne-channel Fail-Safe flammable, fast-drying fluids are Fail-Safe Watchdog typical medical Watchdog grade IV tubing REGULATORY SAFETY STANDARDS designed as replacements for nPB Cyclical self test and TCE, which are being phased Cyclical self test out for environmental, health or MEDICAL SAFETY safety reasons.

TECHNICAL SAFETY FEATURES

•

•

Duraglide dry lubricant, designed to lubricate assemblies that slide, pivot or twist, eliminating "stiction" and improving actuation.

Applications include catheters, cutting tools, staplers and hypo tubes. –NC

IEC 60601-1 IEC 60601-1-2 (4th edition) – EMC

REGULATORY SAFETY STANDARDS ACOUSTIC EMISSION REGULATORY SAFETY STANDARDS

Opteon SF80 specialty degreasing fluid Image from MicroCare Medical

IEC 61157

MEDICAL SAFETY MEDICAL IEC 60601-1 SAFETY IEC IEC 60601-1 60601-1-2 (4 edition) – EMC IEC 60601-1-2 (4th edition) – EMC th

RoHS COMPLIANCE RoHs directive 011 / 65 / EU

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C2Dx's STIC pressure monitor

Image from Keystone Solutions Group

42

Medical Design & Outsourcing

Keystone Solutions Group (Kalamazoo, Mich.) plans to exhibit the STIC Intra-Compartmental pressure monitor system supplied by its client company, C2Dx. TIC is a hand-held pressure monitor with built-in microchip technology and a pre-filled syringe, designed to provide an immediate or continuous reading of compartment pressure in critical care settings. –NC

1 • 2020

t es W 13 M 24 & D th M oo B

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DONATELLE BOOTH #2951 Donatelle (New Brighton, Minn.) is touting device assemblies, full-service contract manufacturing for medical devices, injection molding, precision machining and tooling capabilities.

The company offers product design, product development, toolmaking, rapid prototyping, thermoplastic injection molding, liquid silicone molding, micromolding, micro-MIM, precision machining, micromachining, component and device assembly, packaging and process validation. –DK Image from Donatelle

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BOOTH #3058 Raumedic (Mills River, N.C.) is showcasing medical device full-service contract manufacturing, assemblies, extrusion, injection molding and medical device components.The company processes a number of thermoplastics, such as nylons, polyurethanes, high-performance plastics like PEEK and PSU and fluoropolymers like FEP and PTFE. Raumedic’s other capabilities include multi-lumen tubing, jacketing of fine wires, co-extrusion, micromolding, insert molding, silicone pump segments, automated assembly solutions and custom compounding of polymers. –DK

Raumedic officials think PVC-free disposable plastic products such as this infusion kit will become common in the future.

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Medical Design & Outsourcing

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MD&M WEST PREVIEW

ZEUS BOOTH #3113

Zeus (Orangeburg, S.C.) is touting extrusion molding, medical device components, plastics and polymers, tube processing and more.

The company’s capabilities include polymer extrusion and minimally invasive medical devices within vascular, non-vascular, urology, cosmetic surgery, neuromodulation, drug delivery and women’s health markets. –DK

TEGRA MEDICAL BOOTH #2930, 2933 Tegra Medical (Franklin, Mass.) will be at MD&M West to show examples of its expertise in manufacturing of components and of complete, finished medical devices, particularly those with intricate tolerances or that require combining non-traditional with common technologies.

Tegra Medical’s products are used for procedures such as arthroscopy, endoscopy, joint reconstruction, biopsies, and drug delivery in the areas of orthopedics, cardiac care, women’s and men’s health, neurology, ophthalmology, radiology, pain management, diabetes and other medical specialties.

The company also offers wire and hypotube, either off-theshelf or with custom finishing treatments such as cutting, grit blasting, centerless grinding, end treatments, custom mandrels and coating. –DK

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Resonetics (Nashua, N.H.) is touting its medical device assembly, cutting, components, metal fabrication and wire processing at MD&M West this year.

The company is a laser micro manufacturer that provides contract manufacturing services to the medical device and life sciences industry. It also manufactures thin-wall, stainless steel tubing and precious metal radiopaque marker bands and provides nitinol processing with precision grinding, forming and machining of tight tolerance components and subassemblies. –DK

MasterControl (Salt Lake City) is showcasing control systems, quality and compliance, regulatory affairs, software and supply chain management and logistics capabilities at MD&M West .

The company provides cloud-based quality and compliance software for the life sciences industry. Its platform can help digitize, automate and connect quality and compliance processes at every step of the production process.

The types of devices include instruments for soft tissue removal, retractors, spreaders, implants, suturing devices, needles, cannulae and catheters. –DK

Miles White’s

fearless strategy for growing

Abbott

With strong leadership and a taste for risk-taking, outgoing CEO Miles White left no stone unturned as he grew Abbott into one of the world's largest medical device companies.

N A N CY C R OTTI M A N AG ING ED ITO R

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F

ew medical device companies have seen the growth and transformation that Abbott has seen under the leadership of Miles White.

During his two decades as Abbott’s CEO, White has more than doubled the Abbott Park, Ill.– based company’s annual revenue — to more than $30 billion. What was more of a pharmaceutical company when White took over now has more than a third of its sales coming from medical devices, placing Abbott among the world’s largest medtech companies.

White, 64, will step down from the CEO position on March 31 after 21 years at the helm, but will remain with the company as executive chairman.

Robert Ford, currently Abbott’s president and COO, will become the 13th CEO in the company’s history.

Abbott’s medical device market strategy under White included getting into continuous glucose monitoring with its popular FreeStyle Libre, which eliminates the need for finger sticks. It pioneered transcatheter mitral valve repair with its MitraClip device and also sells connected cardiac monitors, a rechargefree, implantable spinal-cord stimulator, and a group of diagnostic instruments, generic medicines and nutritional products.

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MILES WHITE

Abbott’s two decades of transformation under Miles White 1999 • Miles white takes over as Abbott chairman and CEO. The company has customers in 130 countries, approximately 57,000 employees, sales of $12.5 billion — more than 60% in the U.S. — and a market capitalization of $75 billion.

• Acquires Perclose, providing the foundation for building the company’s cardiovascular business.

2000 • Begins public-private partnership in Tanzania to strengthen the country’s healthcare system, investing more than $130 million during the next two decades.

Abbott’s MitraClip

Abbott went all-in into the medical device market in 2017, when it acquired St. Jude Medical for a whopping $25 billion. The company meanwhile spun off its research-based pharma business and its blockbuster drug, Humira, into a separate company, AbbVie, in 2013.

Less celebrated were Abbott’s $2.8 billion acquisition of Advanced Medical Optics in 2009 and its contentious $5.3 billion purchase of Alere in 2017. Abbott sold the renamed Abbott Medical Optics to Johnson & Johnson for $4.33 billion that same year.

So how did White do it? Analysts who follow Abbott credited White’s strong managerial style and operational culture.

“He’s known for being pretty demanding and kind of leaves no stone unturned,” said Matthew Taylor, a UBS analyst who has covered Abbott for five years. “I think there’s really no place to hide at Abbott. You need to hit your goals and be ahead of the market or

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MILES WHITE

Abbott’s two decades of transformation under Miles White (continued) 2001 • Acquires Knoll Pharmaceuticals.

Develops and launches Humira, which would become the world’s best-selling drug.

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2003 • Establishes point-of-care business, enabling rapid, near-patient testing, with the acquisition of i-STAT.

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2004 • Spins off the hospital products business as Hospira, an independent, publicly traded company. Pfizer buys Hospira for $17 billion in 2015.

• Acquires TheraSense, a bloodglucose monitoring business, setting the stage for its diabetes care business.

• Clean Room Assembly • Custom Tubing Solutions • MIM (Metal Injection Molding)

2005 • Earns place on the Dow Jones Sustainability Index, remaining on the list for 15 years and leading the healthcare industry for the past seven years.

• Precision Machining • Insert/Injection Molding • Precision Metal Stamping

2006 • Acquires Guidant’s vascular business, including the Xience drug-eluting stent.

• Creates fully integrated global nutrition business.

2010 • Acquires Solvay’s pharmaceutical business.

• Forms a stand-alone “established pharmaceuticals” business focused on providing branded generic drugs to emerging markets.

• Acquires Piramal’s Healthcare Solutions business in India.

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MILES WHITE Abbott Freestyle Precision Neo blood glucose meter

you’re going to be on the hot seat. He really keeps people accountable.”

That said, Taylor believes that Abbott has good leaders in all of its divisions and long-serving staff. “A lot of people work at Abbott for their entire career, and that’s kind of a rare thing,” he said.

Taylor also credited White with doing a “tremendous job” in growing value over the last 20 years. “He’s been fairly creative around portfolio-shaping,”

especially in the medical device division, the analyst said.

“When you look at where their growth has come and will come from, medical devices is growing the fastest of any of the divisions, and we expect it to grow double-digit over the next few years when the market is growing single-digit,” Taylor added.

Analyst Vijay Kumar, managing director of Evercore ISI, characterized White as a “very, very strong leader” who was not afraid to take “big, bold steps” such as the pharma divestment and the St. Jude acquisition.

“He has been right when he’s taken big, bold steps,” Kumar said. “Sometimes for people to take big actions like that, you need the buy-in from key stakeholders, and Miles had it.”

"I think there's really no place to hide at Abbott.

You need to hit your goals and be ahead of the market or you're going to be on the hot seat.

He really keeps people accountable."

Abbott's Freestyle Libre continuous glucose monitor and its patient app

www.medicaldesignandoutsourcing.com

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MILES WHITE

Abbott’s two decades of transformation under Miles White (continued) 2013 • Separates its research-based pharmaceutical business into a new public company called AbbVie. Today, the combined market capitalization of the companies has risen 167% to $277 billion.

2014 • The FreeStyle Libre, the first continuous glucose-monitoring system to eliminate fingersticks, is approved in Europe. It was later approved for use in the U.S. and remains the best-selling CGM in the world.

In a Q&A interview provided exclusively to Medical Design & Outsourcing, White reflected on his tenure and the direction of the company. The interview was edited for length and clarity.

Q: How do you feel about the growth potential of Abbott?

MW: Abbott’s growth potential today is the best I’ve seen in my 35 years with the company. We’ve built the company very deliberately, through a multi-year process, to do just that and, consequently, to deliver superior results for years to come. We’ve shaped our businesses to align with where the future of healthcare is going to be. We’ve also greatly expanded our internal R&D capability. As a result, we have one of our strongest product portfolios ever.

Q: Is your confidence based more in the lineup of forthcoming products and services or in your acquisitions or talent development?

MW: They’re all interlinked, but the primary factor for any company to grow is to innovate: to be in the right place with the right products.

Q: How has Abbott’s approach to innovation changed during your 20year tenure?

MW: When I became CEO, our largest and most profitable business was pharmaceuticals. This became even more true after we introduced Humira, the world’s best-selling drug. In 2013, we made a big move, creating AbbVie. That proved extremely successful. We’re now a technology and market leader across a range of medical-device businesses. These products, and others in our pipeline, are

MEDICAL DEVICEwww.arthurgrussell.com ASSEMBLY

MILES WHITE

focused on some of the world’s greatest healthcare concerns. Non-communicable diseases – such as diabetes and heart disease – are chronic and long-lasting, and they’re drastically increasing in prevalence around the world.

Abbott’s two decades of transformation under Miles White (continued) 2014 • Expands established pharma business with the acquisitions of CFR Pharmaceuticals in Latin America and Veropharm in Russia.

Q: You have said that Abbott has a strong performance and servantleadership culture. How have you been able to maintain those aspects over the many reinventions of the company?

MW: A strong culture tends to be selfperpetuating. It draws people who are attracted by it, it identifies people who share its values, and it reinforces those values through countless actions and interactions every day.

2016 • Launches Alinity diagnostics systems across all of Abbott’s laboratory testing segments.

2017 • Acquires St. Jude Medical for $25 billion, boosting its position in the cardiovascular and neuromodulation markets.

• Acquires Alere and its point-ofcare diagnostics business for $5.3 billion.

Abbott Infinity deepbrain stimulation device

2019 • Ranks No. 1 in its industry among Fortune’s Most Admired companies for the sixth straight year.

• Abbott’s stock reaches all-time high. Shareholder value reaches $220 billion, with a total return of 575% (which includes the combined $294 billion market capitalization of Abbott, AbbVie and Hospira), well ahead of the Dow Jones Industrial Average (393%) and S&P 500 (274%) over the same timeframe.

• Abbott’s sales reach $30.6 billion with 65% in international markets and a market cap of $149 billion (excluding AbbVie and Hospira). The company now has 103,000 employees in more than 160 countries.

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TOM SALEMI EDI TORI AL DI RECTOR, DEVI CETALK S CVRx CEO NADIM YARED has emerged as a fearless, outspoken leader in medtech.

G N I EP

KE

T

EDGE

hroughout his career, Nadim Yared — the CEO of surging neurostimulation company CVRx — has pushed to assume new responsibilities and duties.

However, during one moment in 2006, Yared adamantly refused to discuss leaving Medtronic to become CEO of the Minneapolis-area startup.

The executive recruiter representing CVRx’s investors refused to take no for an answer. "Nadim, I know," Yared recalls him shouting over the cell phone.

“Every single CEO say it’s not the time.

But let me tell you....”

Yared cut him off. “Trust me, this is not the time.”

Yared’s unusual reluctance didn’t come from within. At the time of the call, he’d been standing knee-deep in ocean water. His 3-year-old daughter sat

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his

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on his shoulders. Two helicopters circled above, and several Zodiac rescue boats buzzed about, carrying the U.S. Marines who had just pulled his vacationing family out of Lebanon at the start of the 2006 war between Israel and Hezbollah.

Yared eventually took the call and the job. Over the past 13 years, he’s led a young company that is developing neurostimulation devices to treat chronic diseases, including hypertension and heart failure. He’s also emerged as a leader in the medtech industry. As chairman of the industry group AdvaMed, he argued for FDA reform and against the now-repealed medical device tax imposed by the Affordable Care Act. Although AdvaMed leaders typically come from larger companies — like this year’s chairman, Kevin Lobo of Stryker — Yared’s CVRx didn’t even sell a product at the time.

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In a recent interview, Yared shared the details of a career that started with an internship at GE in France. In 1992, GE was developing a console for its CT scanners. Yared helped create a development environment for the engineers to test their software, but the software he developed worked so well it was built into the final console. Yared had a full-time job with GE before he graduated in 1993.

Yared quickly was appointed to be an engineering manager, with three engineers reporting to him. He attributed his rapid rise to being “outspoken” while possessing “big ideas.” He looks for these qualities in employees.

CVRx scored a success last summer when it secured premarket approval to market its Barostim Neo device for heart failure in the United States.

Image courtesy of CVRx

“I love people with an edge,” he said.

“I mentored a lot of the high-potential students who were hired by GE or recruited into their leadership program. These are people who don’t stop for obstacles, who think they can change the world and many of them do end up changing the world.

Many of those young engineers I coached over the years became CEOs in either medical or other industries.”

Yared said he’d like to see more engineers with edge, but he concedes the industry doesn’t always value edge or overconfidence.

“Many managers feel threatened by engineers who have edge,” he said. “They also feel threatened by engineers who have a lot of passion. Also, taking risks in larger organizations and larger teams sometimes is discouraged by some middle managers.”

Yared believes that young engineers should try to work with businesses that value edginess, values and creativity.

NADIM YARED

GE Healthcare’s X-ray business was lagging in Europe when Yared took over. Trailing competitors OEC Medical, Philips and Siemens wouldn’t do under legendary GE CEO Jack Welch, who required GE businesses to be either first or second in their space. If that couldn’t be achieved, they were sold off or closed.

“I wanted to fix it,'’ Yared recalled.

He moved manufacturing from Belgium to India and changed the sales distribution. Sales rose by 45% but his group was still stuck in fourth, so he opted to grow through acquisition by buying OEC Medical and attempting to acquire Medtronic’s surgical navigation portfolio.

Medtronic ultimately decided not to sell. Instead it recruited Yared to join the company as vice president and general manager of the navigation business.

"Many managers feel threatened by engineers who have edge. They also feel threatened by engineers who have a lot of passion."

Four years later, Yared got the call from the executive recruiter from CVRx. The company had support from blue-chip investors, and early animal data demonstrating that stimulating the baroreceptors could help hypertension and heart-failure patients.

“That was a no-brainer,” he said. “I jumped into this. I really convinced the board that I’m the right CEO for this with absolutely no hesitation or fears.”

Fear would have been justified. Founded in 2001, CVRx initially set out to lower blood pressure, but the space became crowded with startups trying to treat hypertension by ablating nerves in the kidney.

Yared said he knew CVRx’s 1 • 2020

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NADIM YARED

approach was more effective, but he recognized the overflow of competition could only damage the company. If renal denervation succeeded it would eat into CVRx’s market, and if it didn’t, it would poison the public’s view of deviceoriented treatment for hypertension.

Yared steered CVRx into heart failure, which the company initially abandoned for fear it couldn’t compete with cardiac resynchronization therapies being developed by larger medtech companies.

Those treatments turned out to not be as effective in treating heart failure as CVRx executives — prior to Yared’s joining — had initially feared.

Over its 18 years, CVRx has raised more than $340 million from venture capital investors and corporations, including New Enterprise Associates and Johnson & Johnson. The company recorded a major success last summer when it secured premarket approval to

CVRx’s Barostim Neo works by electrically activating the baroreceptors, the body’s natural blood pressure sensors that regulate cardiovascular function.

Image courtesy of CVRx

market its Barostim Neo device for heart failure in the United States.

Yared is credited with strong leadership at AdvaMed and the Medical Device Innovation Consortium, a publicprivate advocacy program that he currently chairs.

The greater contribution to medtech might have been CVRx’s work with the FDA to develop its Expedited Access Pathway

guidance. CVRx, according to Yared, served as the regulatory track’s test subject.

“I think the experience has helped the FDA set the stage and tone for how they [establish] approval trial designs for breakthrough devices,” he said.

Now, CVRx is prepared to go commercial. And, once again, thanks partly to Yared’s efforts, it won’t be paying a medical device tax.

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rom disposable endoscopes to TAVR to robotic surgery, there's a whole host of medtech advances widely available now that weren't around much 10 years ago.

"In terms of technological advances, I would put this past decade as one of the most important for medical technology. From connected devices and robotics, to advances in material sciences and biologics, the technological leaps our industry made over the past 10 years are astounding," Brian Johnson, president of medtech trade group MassMEDIC, told Medical Design & Outsourcing.

Shaye Mandle, CEO of the Minnesota-based Medical Alley Association, thinks the 2010s set the stage for a healthcare revolution. "Due to this decade of innovation, the 2020s promise to redefine health innovation and care, providing new opportunities for collaboration, patientcentric design and unique health consumer experiences.

This is just the beginning of what’s possible," Mandle said.

The editorial team at MDO and MassDevice polled some top experts on how medtech improved over the 2010s.

Read on to discover our top 10 list.

Managing editor Nancy Crotti and senior editor Danielle Kirsh contributed to this article.

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In terms of technological advances, I would put this past decade as one of the most important for medical technology. From connected devices and robotics, to advances in material sciences and biologics, the technological leaps our industry made over the past 10 years are astounding 10. Neurostimulation for everything Medical device companies already had a few devices out in the early 2000s that used pacemaker technology to treat brain and nervous system disorders such as Parkinson’s. But the 2010s were the decade when they sought to harness neurostimulation or neuromodulation to treat a whole host of conditions.

Here’s just a sample of how it’s being used:

www.medicaldesignandoutsourcing.com

GREATEST MEDTECH ADVANCES OF THE

10s •

•

•

• •

How important were the 2010s for medtech innovation?

Read on.

In 2018, FDA approved the Medtronic Deep Brain Stimulation for Epilepsy. Medtronic says the system can reduce the frequency of seizures in adults with medically refractory partial-onset epilepsy.

Silcon Valley–based NeuroPace, meanwhile, touts its RNS System as the only closed-loop brain-responsive neurostimulation system designed to prevent epileptic seizures. The company is studying whether the system might also help treat binge eating in certain people.

CVRx (Brooklyn Park, Minn.) scored a success last summer when it secured premarket approval to market its Barostim Neo device for heart failure in the United States.

Nevro has developed and commercialized the Senza spinal cord stimulation (SCS) system for chronic pain treatment.

SPR Therapeutics launched its Sprint peripheral nerve stimulation (PNS) system in November 2018, with indications for treating both acute and chronic pain. – CN

NeuroPace's RNS System is a closed-loop brain-responsive neurostimulation system designed to prevent epileptic seizures.

Image courtesy of NeuroPace

www.medicaldesignandoutsourcing.com

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MEDTECH ADVANCES IN 2010s

9. Disposable endoscopes The 2010s saw the rise of endoscopes that were inexpensive enough that they could be used once on a person and then thrown away — avoiding the reprocessing challenges and related infection risks that come with reusing scopes. The global market for disposable scopes reached $515.7 million in 2017, and it’s expected to grow to $3.1 billion by 2026, according to Acumen Research and Consulting.

Leaders in the space include Boston Scientific, Hillrom and Ambu. – CN

FDA in December cleared the first fully disposable duodenoscope: the Exalt Model D made by Boston Scientific.

Image courtesy of Boston Scientific

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MEDTECH ADVANCES IN 2010s

8. Advances in treating hearing and sight loss Thanks to biotech advances, device miniaturization and better computing power, the past decade has also seen potentially disruptive advances in treating the loss of hearing and sight.

Rising stars include Frequency Therapeutics, which priced an $84 million IPO in 2019. Frequency’s hearing loss treatment drug FX-322 is meant to activate progenitor cells — mature stem cells that can proliferate into different types of cells. A health provider injects the drug into the middle ear in a slowrelease gel.

Early in 2019, Second Sight Medical announced the first trial implantation of its Orion cortical visual prosthesis system. The implanted Orion system converts images captured by a miniature video camera mounted on glasses into a series of small electrical pulses delivered to the brain — bypassing diseased or injured eyes.

“This is the first time that we’ve had a completely implantable device that people can go home with and use in their own living conditions without having to be plugged into an external device,” ULCA Health neurosurgeon Dr. Nader Pouratian said in a news release. “It helps them recognize, for example, where a doorway is, where the sidewalk begins or ends or where the crosswalk is. These are all extremely meaningful events that can help improve their quality of life.” – CN

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Second Sight Medical’s implanted Orion system converts images captured by a miniature video camera mounted on glasses into a series of small electrical pulses delivered to the brain — bypassing diseased or injured eyes.

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Medtronic’s Micra leadless pacing system Image courtesy of Medtronic

7. Tiny pacemakers Medtronic scored a major advance in pacemaker innovation in 2016 when it achieved FDA approval of its Micra transcatheter pacing system, which is about the size of a vitamin pill. Implanted via catheter into the heart’s right ventricle, it delivers single-chamber pacing without the need for the wires and leads that have proved challenging for pacemaker manufacturers.

St. Jude Medical recalled its leadless pacemaker, Nanostim, in October 2017.

Now part of Abbott, it’s competing with Medtronic to produce a leadless dualchamber pacemaker. – CN

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6. Brain-computer interfacing People who have lost the ability to move or their sense of touch got a boost in March when the FDA released draft guidance to help developers of brain/computer interface (BCI) devices to pass regulatory hurdles on their way to investigational device exemptions.

The FDA defines (BCI) devices as neuroprostheses that interface with the central or peripheral nervous system to restore lost motor or sensory capabilities. Examples of these devices are being developed worldwide.

Companies including NeuroSky and Emotiv have developed EEG headsets that not only work for gaming, but help people recovering from a stroke or who have neurodegenerative diseases such as amyotrophic lateral sclerosis (ALS) to regain their independence.

Researchers at Battelle and The Ohio State University Wexner Medical Center worked together to develop a BCI called NeuroLife that helps paralyzed people to regain conscious control of their fingers, hand and wrist.

A Swedish woman with a hand amputation recently became the first recipient of an osseo-neuromuscular implant to control a dexterous hand prosthesis. In 2017, an international research team developed a BCI that can read brain chemistry to enable communication in patients who are paralyzed and unable to talk. The FDA has put a particular focus on helping paralyzed military veterans and those who have amputations to regain physical function.

Having clear direction early in the process may help device developers in this rapidly evolving field save money and reduce risk, then-FDA Commissioner Dr. Scott Gottlieb said in March.

“There are many ways we identify these areas,” Gottlieb added. “Once we do, we work to ensure that the tools are in place to advance the development of these new technologies, by providing clarity and direction to medical device developers to help reduce the barriers of bringing new treatments to patients.” – NC 74

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Carbon's 3D printing technology in action

Image courtesy of Carbon

5. 3D printing 3D printing, or additive manufacturing, has been around for decades. But it was only in the 2010s that medical device designers truly embraced it as an effective prototyping tool. Now it holds the promise to also enable the creation of customized medical devices.

3D printing company Carbon, for example, has a business partnership with Johnson & Johnson to develop “digitally printed material that serves a mechanical function in the body, but after a few months it’s fully bioabsorbed and transitions to your own tissue,” Carbon co-founder and executive chairman Joseph DeSimone told CNBC in November.

More than 100,000 hip cups have been made in Arcam printers and implanted in patients, according to GE Additive’s Arcam business. Smith & Nephew for the past few years has had its 3D-printed titanium Redapt revision acetabular fully porous cup with Conceloc technology. Stryker has invested heavily in 3D printing research, with the technology supporting its Trident II hip cup and much more.

"Next-generation approaches include Tissium's high-resolution 3D printing platform that harnesses fully synthetic, biomorphic and programmable polymers to create implantable devices that can guide tissue growth," said serial medtech entrepreneur Jeff Karp, a professor of medicine at Brigham and Women's Hospital and Harvard Medical School.

On top of customized medical devices, 3D-printed models are becoming an important presurgical planning tool.

At Mayo Clinic, for example, the health provider's Anatomical Modeling Lab makes thousands of models a year to help surgeons prepare, as well as educate the people who need the operations. – CN

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4. Digital health — and AI hype More than a decade after the launch of the iPhone and Amazon Web Services, the greater access to ever-increasing computer power is rapidly transforming medtech. A cell phone with a camera has the potential to replace a bulky diagnostic machine. Health providers are also increasingly embracing telehealth.

"Hospital systems are setting up telehealth departments and reimbursement codes are being added and refined. The next decade will see us all receiving healthcare over our mobile devices," said Scott Thielman, CTO at Product Creation Studio (Seattle).

It’s little wonder that this year's CES has companies touting 546 digital health and 635 wearable devices.

Traditional medical device companies are also seeking ways to package sensors into a host of implantable medical

devices in order to glean insights. Boston Scientific, for example, has its HeartLogic heart failure diagnostic sensors packaged into implantable CRT-Ds and ICDs. Next on the horizon is artificial intelligence — with the open question of whether AI can deliver on what companies are promising when it comes to improving healthcare. – CN Boston Scientific has its HeartLogic heart failure diagnostic sensors packaged into implantable CRT-Ds and ICDs, including the Resonate X4 CRT-D shown here.

Image courtesy of Boston Scientific

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3. Getting closer to an ‘artificial pancreas’ Researchers in the field of diabetes management have been working to create a closed-loop system that can measure glucose and inject insulin as needed. The idea is to have the system work as an “artificial pancreas” for people with diabetes, using a combined glucose sensor, control algorithm and an insulin infusion device.

The FDA describes an artificial pancreas as a system of devices that mimics the glucose-regulating the function of a healthy pancreas. Computer-controlled algorithms connect the CGM and insulin infusion pumps to enable continuous communication between the two devices. The system can monitor glucose levels in the body while adjusting insulin delivery to reduce high blood-glucose levels and reduce low blood glucose without the need for patient interference.

Medtronic was one of the first companies to win approval for a hybrid closed-loop system back in 2016. The MiniMed 670G system was the first system of its kind to win clearance globally. While it wasn't a fully standalone artificial pancreas, the system was one step closer toward developing a fully capable closed-loop system.

Companies in the race to make the first artificial pancreas include Bigfoot Medical, which has a partnership with Abbott.

Other companies include Tandem Diabetes, Insulet, Beta Bionics and more.

However, with the hype of closed-loop systems, some people have taken on the task of hacking and DIY-ing their own diabetes devices. The FDA warned in 2019 against using unauthorized devices for diabetes management as it could lead to incorrect insulin dosing, which can be fatal.

There's also a rise in continuous glucose monitor clearances. Continuous glucose monitors, like the implantable Eversense system, could replace the tedious fingersticks diabetics are tasked with to measure blood glucose levels.

Abbott has already seen success with its FreeStyle Libre glucose monitoring system; the company in early 2019 touted real-world data showing reduced prolonged hypoglycemia and better glucose control among system users. – DK

Image courtesy of Medtronic

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The procedure was initially used as a last-chance option for people with severe aortic disease, but the procedure saw ever-expanding indications through the 2010s. Recent studies suggest TAVR overall could be a safe alternative to traditional surgery. The FDA in August 2019 cleared heart valves made by Medtronic and Edwards Lifesciences for use in patients at low risk from openheart surgery.

The success of TAVR has sparked a race to commercialize transcatheter mitral valve replacement devices. – DK

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EPOXY SYSTEM UV15DC80Med 1. Robotic surgery expands Pioneered by Intuitive Surgical through the early 2000s, robot-assisted surgery became a hot medtech area in recent years, with a host of major medtech companies seeking to break into the space.

"The 2010s served as validation of the robotic surgery hypothesis: Providers, payers and patients will embrace an expensive platform technology that effectively gives the surgeon superpowers in the operating room. The stage is set for a battle over platforms among the big players and a myriad of procedure-specific systems from smaller innovators," said Thielman at Product Creation Studio.

Medtronic in 2019 unveiled its much-awaited Hugo RAS system — which the medical device giant touted as more flexible and cost-effective than systems currently on the market.

Johnson & Johnson closed the year by announcing its purchase of the remaining stake in Verb Surgical, following what J&J described as a successful strategic collaboration with the Alphabet life sciences unit Verily. J&J’s Ethicon subsidiary in February inked a $3.4 billion deal to pick up surgical robotics pioneer Dr. Fred Moll’s newest robotic surgical play, Auris Health, and its FDA-cleared Monarch platform.

Intuitive, meanwhile, continues to innovate when it comes to robot-assisted soft-tissue surgery. Its da Vinci SP robot for single-port surgery has a tube that is about an inch wide and delivers fully articulating instruments: three that can manipulate things and one that’s a steerable endoscope. The robot is in the process of launching in the United States.

Robots are also hot in the orthopedic surgery space. More than six years after spending $1.7 billion to acquire Mako Surgical, Stryker is leading the way. Big competitors including Johnson & Johnson’s DePuy Synthes business, Zimmer Biomet and Smith & Nephew have either launched or are preparing to launch their own robots.

In December 2018, Medtronic closed on its $1.7 billion purchase of Mazor Robotics and its robot-assisted surgery platform for the spine. A month later, Medtronic launched its Mazor X Stealth robotic-assisted spinal surgical platform in the U.S. –CN

The da Vinci SP in action

Image courtesy of Intuitive Surgical

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I'm a medtech expert who survived a tumor in my head More than eight months into a successful recovery from surgery to remove a golfball-sized meningioma, medtech industry veteran Bill Betten reflects on lessons learned.

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BI LL BET T EN BET T EN SYST EMS S O LU TI O N S

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neurosurgeon walks into the room and says, “So you’re the interesting case.” Not exactly words one wants to hear, but the scientist and engineer inside me waited to hear the punch line. I had recently been informed that I had a brain tumor a bit larger than a golf ball in my head, and I was here to discuss options.

Fast forward to today, and I’m eight months into a successful recovery from surgery that removed what turned out to be a benign tumor. I have a very interesting scar now healed on my head. I’m still waiting for my new superpower to show up now that I’ve got the extra room in my brain, but perhaps my personal journey will be the reward in itself.

While my observations certainly aren’t going to reform health care, the process

be a patient or user of many of the products and services on which I’d worked over the years.

certainly gave me a different view than my usual product development or technology role, and I hope you gain a new perspective as well.

Just to tell you more about myself, I’m a physicist and an electrical engineer who’s had the great pleasure of working for decades on product development for some of the world’s largest companies as well as startups. While much of my career was spent in and out of hospitals working for medical device development companies, that experience did little to prepare me to www.medicaldesignandoutsourcing.com

The discovery My earliest medical experiences went back to my time at 3M in the late 1980s. I worked on hearing aids, blood perfusion systems, and surgical systems among other things, and in the 90’s I was an interface program manager figuring out the early days of connected medical devices, teleradiology, and the DICOM interface that was supposed to ensure that expensive imaging systems play together.

Our work included collaborating with imaging modality partners to send digital X-ray images from the USS George Washington aircraft carrier to Bethesda Naval Hospital and Walter Reed Army Medical Center.

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I ultimately migrated to the world of much smaller monitoring devices, but MRI has always fascinated me. I’ve been honored over the years to speak with leaders in the field including Dr. Raymond Vahan Damadian, the inventor of the first MRI and founder/CEO of Fonar, and Doug Dietz, innovation architect at GE Healthcare. I also recently worked for a company that provides much of the internal precision cabling and connectivity within MRI systems for major manufacturers.

Little did I anticipate, however, that I would one day land myself inside the confining tube of an MRI — the result of finally checking up on a left leg that would “go to sleep” for minutes with a pins and needles sensation. My general physician in February had forwarded me to a neurologist who was heading toward the same diagnosis: pinched nerve. I thought the steroids I was already taking

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were causing some low-grade headaches, but I mentioned the headaches anyway.

The neurologist listened and told me that headaches in someone over age 40 with vision issues typically suggested an MRI. I asked when, was told that there had been a cancellation, and 10 minutes later was having my first MRI ever.

It's been there a decade at least — growing.

The MRI whirred, banged and clicked its way through the 45-minute process of flipping my molecules with a magnetic field and then reading the results for a look inside my head. I knew that the inside of an MRI was truly confining and full of strange noises, but it’s another thing to actually experience. All my memories about MRI flashed through my head as I lay in the tube, staring up, listing to late ‘70s rock music as I wondered what was

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going to happen with me.

I got dressed and saw the neurologist coming in right away to speak with me — not a normal situation. She said it was a “probably” non-malignant type of tumor called a meningioma that forms on membranes that cover

the brain and spinal cord just inside the skull. Technically it isn’t a brain tumor as it doesn’t usually engage the brain directly; it is just a tumor that is in the head. At that particular point in time, however, that wasn’t much of a distinction. The words “head” and “tumor” are still pretty scary when used together. You go, “Wow, what does this all mean?”

“It’s been there a decade at least — growing,” the neurologist said.

Finding the right surgeon The diagnosis immediately sent me into an information-gathering mode, looking up the details of meningiomas and starting down the path of figuring out what to do next. Fortunately, health insurance was not an issue as one of the benefits of being married to a retired teacher is the ability to continue benefits, albeit at a rather stiff price. I needed to ensure at a minimum that both the surgeon and facility were covered, but our premium coverage made it likely they would be.

My immediate focus was on contacting neurosurgeons. Living in Minnesota certainly facilitates — or perhaps confuses — the process since we have excellent internationally recognized facilities. After compiling a list of about 10 surgeons I decided that I wanted to get at least two opinions. Arranging the appointments included the frustrating experience of just how much the healthcare system still lacks interoperability. I’ve been promoting the virtues of telemedicine for over 25 years, but here I was filling out transfer forms, listing FAX numbers because email was unacceptable, and even picking up a disk of images from the exam myself as a backup.

The first surgeon with whom I met made the interesting comment that started this article. Upon my inquiry (and a good laugh), he pointed out that my symptoms were a bit atypical for this size of the tumor 86

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as I did not show any expected signs of “left-side weakness” that would have been expected based on the size and location of the tumor. We discussed the MRI, medical technology, and some common people we knew at the Mayo Clinic where he had trained years before. He generally walked me through the options. It’s one thing to have a dispassionate conversation about medical technology as a developer, but a very different process when you’re the subject of the conversation. We discussed some timing concerns, but his recommendation was certainly surgery, and he recommended getting it relatively soon. He was calm, collected, and very engaging in the conversation. When we walked out my wife commented that “he really thought of you as a person.” He further demonstrated this when I got a call from him after hours the next night as I had left a message with a few questions for his nurse. He knew that I was getting another opinion, but his message was that getting treatment at all was more important than whether he did the surgery. Spending an extra 20 minutes of his “off-time” answering my questions was greatly appreciated.

Two days later I met with surgeon No. 2, a very experienced surgeon who had probably done 10 times the procedures of the first and was undoubtedly qualified. The visit was professional, factual and addressed my questions. When I inquired about going down the road to the Mayo Clinic, where I have been doing collaborative work for decades, or the University of Minnesota hospital where I’m engaged on a pediatric board, he noted that my case simply wasn’t that interesting nor was it necessary. He’d trained in a research institution and pointed out that this was relatively straightforward and would likely go as a training case for a resident. He saw no need to go to those lengths as this just wasn’t that challenging.

His words were reassuring in their own way, but on the other hand, I’m not sure there is such a thing as “minor” brain surgery unless perhaps it is being done on someone else.

So, which of these two qualified surgeons did I choose? When it came down to it, we decided to go with the first surgeon, the one who viewed me as a “person, not just a patient.”

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location, a pre-op physical, and scheduling of surgery was basically a 3-week exercise in controlled chaos, coordination, canceled plans, and new ones coming into being.

With surgery scheduled, it was now time to begin the pre-medications and particularly the three days of anti-bacterial showers, clean towels, and clean linens in an attempt to limit any infection sources at home, leaving me to only be concerned about the opportunity for hospital-acquired infections — a major concern in the industry.

On the day of surgery, I arrived for a pre-operative MRI at 5 a.m. in order to prepare for surgery tentatively scheduled for 7:30 a.m. This MRI was a bit different from my diagnostic scan as this involved the placement of interesting little targets all over my head in strategic locations, providing a “GPS” system for precise mapping of the tumor location. At this point I was marked up with a pen, shaved, then adhesive waypoints fastened

to my head making me look a bit like Frankenstein’s monster. Another 45-minute MRI and a trip back to my pre-op site later, and I’ve got the surgical team walking in to say hello and introduce themselves. I took particular care to make sure that they knew who I was, even mentioning the somewhat macabre experience of doing some final device development work at a Mayo Clinic cadaver lab the day before surgery and pointing out that I was very eager to come out of this surgery in a positive fashion.

The anesthesiologist must have done a great job of prep as the last thing I remember was being wheeled around the corner following the team and that was it.

I woke up eight hours later. I came out of anesthesia “hangover” free and relatively coherent, certainly much different than my only previous surgical procedure more than 20 years ago. To make a long story short, the surgery went well, taking a long time due to tumor consistency being that of an

eraser and a bit challenging to remove. The good news was that they removed almost 98% of the tumor, with some need to only heat treat the remainder due to its proximity to a large vein in the brain.

ICU and recovery The protocol for brain surgery patients is to begin monitoring in the ICU, so I found myself wheeled in there. The care staff came in, introduced themselves, and started hooking up the various connections. First the ever-present pulse oximeter finger clip. I was quite familiar with these instruments having served as head of product development for a leading manufacturer of the devices, but no, it wasn’t the Nonin Medical brand. Then the blood pressure cuff, heart monitoring, and the leg massagers to prevent blood clots were attached. I was now prepared to be a very monitored patient. Finally, the IV connections were re-done, with at least

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two ports designed to provide access for either testing (glucose, various other blood levels) or input in case of infection or need to treat something.

The ICU is definitely not designed for ease of recovery. The staff poked, prodded and tested me every hour during the night. In addition, since I used to be a fairly consistent runner, my natural resting heart rate tends to be in the 50’s, sometimes dropping into the high 40’s when asleep, so the alert went off every time that happened. The only saving grace was that being fully hooked up meant I was connected via a catheter, so at least I didn’t have to worry about going to the bathroom. I thought back to all of the meetings I had over the years with remote monitoring companies discussing all kinds of devices for monitoring and how it would revolutionize health care. Years later, we’re still being poked and prodded, including the thermometer under the tongue and a blood pressure cuff blowing up every hour for measurements. After a night of this, I resolved to do everything I can to facilitate the evolution to wireless www.medicaldesignandoutsourcing.com

wearables and more friendly sensors.

After that “interesting” night in ICU, the discussion focused on whether I could transfer to the med/surgical unit, where I’d likely only need to be monitored every two hours. They’d let me eat some real food, too.

In order for that move to happen, I had to go through both a cognitive assessment and a physical evaluation. Less than 24 hours after surgery, I was nervously going through an evaluation of my mental capabilities — a scary proposition because who knows what transpired while I was operated on. Was I the same person coming out as the one going in? But I passed the test and got a larger room with a great view and even a bathroom.

Prior to surgery I was told to expect to stay in the hospital for a total of four to five days, depending upon any complications, infections, mobility issues, etc. However, my surgeon called me Saturday morning after the second night in the hospital, asked how I was feeling, and mentioned that the initial assessments seemed to be very positive. He asked if I would be interested in departing the hospital that day, less than 48 hours after surgery. While a bit concerned about the rapid exit, I recognized that recovery at home is less costly and more conducive to rest — as long as there’s an appropriate support system and precautions. Healthcare experts, in fact, know that a more relaxing home treatment and recovery has substantial benefits, providing both a decrease in cost and an increase in quality of life. My wife, and my “alpha” sister who had come to town, were a bit panicked at the news because they had expected a bit more time to set up the new “recovery” room in our first floor sunroom so I wouldn’t have to climb stairs. But 48 hours after surgery I was on my way home to my personal recovery room.

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2.25”

- brushed or bldc motors - 5 amps per axis - 16 analog inputs - 16 on/off drivers - home and limit in - live tech support - made in the USA See the

EZQUAD SERVO in action!

WWW.ALLMOTION.COM

(510) 471-4000 30097 Ahern Avenue Union City, CA 94587 Te c h n i c a l S u p p o r t

(408) 460-1345

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Reflections While the journey through the system was complex, arduous, and a bit scary as a participant rather than an observer, I was impressed by the people in the system. I am a technology person and have been involved in many of the technological improvements that proved to be valuable in my care. However, I was reminded at every step — from help identifying potential surgeons, the interviews, and the care in ICU and the med/surgical floor — that it is still about the people, not just the technology.

While I’m not naming the individuals involved, I have the utmost of respect and thanks to the doctors, staff, and facilities at Regions Hospital in St. Paul. They uniformly made me feel like a person not an object. Perhaps I went out of my way to connect with them as well given my background, but

it made me miss that care environment just a bit, particularly when I got the follow-up welcome home card signed by them. People do make a difference.

As for me, I’m going back to work on medical technology, working with partners to develop tools to ease pain and suffering. Technology is the great enabler, and I believe it will continue to ease care for chronic illnesses, elder care and assisted living, and perhaps even one day the various maladies afflicting us. My trip through the health care system certainly gave me a much better appreciation of the medical system not just as a developer but as a person.

Postscript: Eight months after surgery I have only a little residual numbness in my left foot with the expectation that it might continue to improve over the first year after surgery — certainly a positive outcome.

4.5”

Tray & blister sealers with features preferred by packaging engineers.

NEW

All Electric Tray Sealers!

4.875”

Superiority in Packaging! atlas vac machine www.atlasvac.com

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Made Your Way & Made in the U.S.A. Advocate, Support, and Empower Good Health Since every day can be critical in a medical setting, it is crucial to design and use quality hospital-grade cords. Interpower® can make hospital-grade power cords and cord sets to your specifications and have them to you fast with a 1-week U.S. manufacturing lead-time on non-stock Interpower products.

These cords are available in a variety of lengths and colors. Value-added options can be added, such as specialized labeling and packaging. If you have questions, Interpower offers free technical support.

When designing, building, and maintaining hospital-grade products to be used in worldwide markets it is important to know some countries have medical requirements, while others have recommendations. In addition, some select hospitals have requirements that they choose to follow specific to their facility. Special consideration is needed for products to be used in Australia, Canada, Denmark, Japan, and the United States.

Contact Customer Service for More Information • Made in U.S.A. • 1-week U.S. manufacturing lead-time on non-stock Interpower products • Same day shipping on in-stock products • Blanket or schedupled orders available • No minimum order or dollar requirements • Value-added options

®

Order Online! www.interpower.com

®

Business Hours: 7 a.m.–6 p.m. Central Time

INTERPOWER | P.O. Box 115 | 100 Interpower Ave | Oskaloosa, IA 52577 | Toll-Free Phone: (800) 662-2290 | Toll-Free Fax: (800) 645-5360 | sales@interpower.com

Design inspiring products, faster

"Onshape makes it easier to collaborate with the peace of mind that you remain in full control over who can view or edit your designs."

- Nicolas Perrin, Founder at PERRINN

Onshape is the only SaaS product development platform www.onshape.com/trial

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.

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ONLINE

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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

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 microsized 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, 9001 and 14001 certified company with a state of-the-art, 130,000 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 six 100K clean rooms and three 10K clean rooms for micro-electronics and medical applications.

F: 1.515.964.5742 accu-mold.com

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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

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ALTECH - COMPONENTS FOR MEDICAL DEVICE DESIGNS Serving automation and control industries since 1984, Altech’s products meet UL and international standards and all are RoHS and REACH compliant. Altech’s commitment to quality have been recognized since May 27, 1999 when they were awarded the prestigious honor of ISO 9001 certification and maintains a ISO 9001:2000 certification today.

Product lines include miniature circuit breakers, busbars, DC-UPS devices, digital panel meters, terminal blocks, enclosures, contactors, many types of relays including safety relays, motor disconnect switches, strain reliefs, receptacles, foot switches, push buttons and pilot lights. Many other products are also available.

Altech provides many services. This begins with its product managers, providing technical support and partner with customers in design assistance, ensuring the best solutions.

The Customer Service Department ensures that customers are informed with complete order information.

The versatile assembly department provides manufacturing, value added or customization services to expedite delivery. The marketing department has been highly recognized for its catalogs, advertising and website, while the sales department motivates over 25 manufacturer representative companies throughout North America, ensuring product information is complete.

The product line includes miniature circuit breakers, busbars, DC-UPS devices, panel meters, terminal blocks, contactors, motor discon¬nect switches, pin & sleeves, receptacles, foot switches, many types of relays, push buttons & pilot lights. Also available are metal detection systems, ferrules, marking & engraving systems, fuses, power distribution blocks, tubing, liquid tight strain reliefs, timers, test & measurement, LED panel lights, thermostats, panel filters, tower lights & wire ducts. Altech’s products meet UL and many international standards and all are RoHS compliant.

Altech 35 Royal Rd. Flemington, NJ 08822 www.altechcorp.com

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Altech Corporation is an established USA supplier of components and devices used in industrial control, instrumentation and automation. It is an ISO 9001:2000 certified manufacturer and distributor of electrical, electronic and electromechanical components.

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Industry leader in linear motion solutions AMETEK Haydon Kerk Pittman is a leading technology and global manufacturer of stepper-based linear actuators, rotary motors and customized motion control solutions.

Worldwide manufacturing facilities and sales offices have been serving customers in the Industrial Automation, Medical Equipment, Lab Instrumentation, Business Machines, Transportation and Semiconductor markets for more than 85 years.

Haydon Kerk Pittman has been reliably solving the most complex motion control and automation design challenges by providing strong technical support, superior quality and rapid service.

With strict quality and engineering standards, Haydon Kerk Pittman designs and builds a broad portfolio of linear, rotary and customized linear motion control solutions.

Whether used in a robotic surgical application that requires precise linear motion to meet lifesaving 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.

With experience, talent and technology, Haydon Kerk Pittman is proud of their reputation as a global expert in motion control customization, innovative designs and manufacturing quality.

Introducing the new easy to integrate MiniSlide Series. Small size, big power simplifies engineering in small lab and automation equipment.

1500 Meriden Road Waterbury, CT 06705 haydonkerkpittman.com

The IDEA Motor enables distributed control without the use of a costly PLC or external motion controller. Compact, high-torque precision servo motor and IDEA Drive.

And coming soon, the Z-Theta provides linear (Z) and rotary (Theta) motion in one assembly.

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AMETEK Specialty Metal Products (SMP) is

a leading global manufacturer of advanced metallurgical powder, tube and strip products for the most critical applications.

As a division of AMETEK, Inc., AMETEK SMP has six manufacturing facilities in the UK and the USA. Reading Alloys, Fine Tubes, Superior Tube, Hamilton Precision Metals and AMETEK SMP Wallingford are known for their metallurgical and engineering expertise in manufacturing specialty metal products for the medical industry in which quality and performance are paramount.

Precision Tubes

High quality tubes are critical components for heart valves, pacemakers, vascular stents, trauma and orthopedic implants as well as endoscopic surgical instruments and spinal cages.

Key alloys include medical-grade stainless steels and titanium alloys including Ti grade 5 and specialty alloys MP35N and 316V.

Our advanced metallurgical products are custom-made in a range of high-

Precision Strip and Foil

performance alloys that offer excellent strength-to-weight ratios, biocompatibility and corrosion resistance for critical medical implants and devices.

These high purity materials are used in implantable enclosures, surgical instruments, stents, PCBs, electronics and more. Alloys include CP and Titanium alloys, as well as Stainless Steels 316LS & SS420 and MP35N® for stents and spring connectors, resistance alloys for medical diagnostics as well as high purity Nickel strip for battery applications. Titanium strip products for implantable devices are produced with fine grain size for drawability, superior surface finish, and short lead-times. We can now also produce grades 9 and 23 to facilitate the external charging of implant device batteries.

The titanium strip and foil products can be reduced to ultra-thin gauges with low roughness or high roughness for electrode, cathode and antenna applications.

AMETEK Specialty Metal Products 3900 Germantown Pike Collegeville, PA 19426-3112

Shaped Wire

www.ametekmetals.com

Our specialty shaped wire products are used for orthodontic brackets, toothbrush staples and superconductors used in MRI scanners.

Hydride-Dehydride Titanium Powders

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For biocompatible implant coatings used in total joint replacement devices including hip, knee, spinal, shoulder and maxillofacial implants.

Our metallurgical expertise enables us to engineer customized titanium morphologies - blocky and angular, spongey, or equiaxed morphology to promote osseointegration. Other advantages include custom particle sizes and conformance to ASTM F67 and F1580. Ti grades include CP Ti, Ti 6A/4V and Magnesium & Sodium reduced Ti Sponge.

www.medicaldesignandoutsourcing.com

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.

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.

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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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)

ONLINE

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.

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Atlas Vac is the industry standard recognized for technical excellence in the design and manufacture of medical device tray sealers used in cleanroom production.

Their knowledgeable staff is comprised totally of engineers and technicians who know their product and your issues when it comes to tray sealing.

Atlas Vac is the only manufacturer worldwide offering an All Electric Tray sealer for extreme accuracy, Light Curtain Safety Systems, UDI barcode input and

Atlas Vac Machine’s core expertise is the design and manufacture of tray sealing equipment for medical device packaging clean room applications.

Whether you require a tray sealer, tooling nests or field service, the engineers and technicians at Atlas Vac Machine are considered some of the most knowledgeable in the industry.

audit trail data, Direct Force Sensing for digital down-force readings, Electric Shuttle Technology for ultra-smooth

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

movement as well as the heaviest cross section heater design for even heat distribution and anodized single piece CNC precision tooling nests.

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

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

Atlas Vac Machine, LLC 9150 Reading Rd. Cincinnati, OH 45215 www.atlasvac.com

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Atlas Vac recently included, as a standard feature, Data Logging for a complete Audit Trail of not only the dynamic sealing cycle data but also Operator ID’s & PW, sign-ins, PW changes, recipe changes, alarms, date, time and odometer reading all on a standard 10” color touch screen. Entry by bar code of recipe input, tool ID matching and UDI input for lot tracking is also a standard feature.

New for 2020, an optional Enterprise Integration Solution (EIS) was created as a simplified interface between corporate ERP systems and the tray sealer for bi-directional exchange of set-ups and resulting production sealing performance.

www.medicaldesignandoutsourcing.com

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’s OEM Division B. Braun Medical Inc. 861 Marcon Boulevard Allentown, PA 18109

For more than 175 years, B. Braun has worked to protect and improve the health of people around the world. With thousands of pioneering achievements in medical device and pharmaceuticals, the family owned company remains at the forefront of 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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Propelled by our philosophy of Sharing Expertise®, B. Braun Medical Inc. is a leader in infusion therapy, pain mangement technology, and support services that meet the highest standards for quality, safety, sustainability, and efficiency.

Every day, over 64,000 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.

The B. Braun Group of Companies has global headquarters in Melsungen, Germany and operations in 64 countries.

In the U.S., B. Braun Medical’s corporate headquarters is located in Bethlehem, Pennsylvania with manufacturing facilities in Allentown, Pennsylvania, Irvine, California, Daytona Beach, Florida, and the Dominican Republic.

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

www.medicaldesignandoutsourcing.com

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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

•

Custom Connector Design

BAYCABLE delivers unparalleled engineering expertise “an integrated solutions partner” that can help skillfully create the optimal interconnect system for your application.

MARKETS: •

Medical

•

Industrial

•

Automotive

•

Audio

•

Defense

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.

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.

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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www.medicaldesignandoutsourcing.com

At BihlerMed, our continuing mission

BihlerMed is your partner in the journey to either create your new device or to maintain & automate the production of your current device.

BihlerMed partners with clients and works with OEMs to provide unique customer-specific solutions from the genesis of the strategy through the legal and regulatory reviews, into the market, and post-market support.

The Bihler Group of Companies can provide many services as well as offer complete turn-key systems on German-built Bihler Vari-Slide assembly system technology and equipment.

is to design, develop, and produce advanced medical devices and ergonomic lighting solutions. Through our innovative devices, we offer surgeons the opportunity to perform procedures more quickly, more safely, and with better patient outcomes. BihlerMed, part of the Bihler Group of Companies,

Services offered: • Product Design • Product Testing • Research and Development • Testing & Inspection • Cleanroom Assembly • Laser Welding • Automation • Precision Metal Stamping, Forming & Automated Assembly • Ultra Sonic Welding

has over 40 years of experience offering customers tailored partnerships.

Commitments to safety, quality, and engineering design have resulted in an advanced portfolio of products, including Scintillant®, our patented, handheld instrumentation lighting technology, and SurgiLight, the hands-free illumination system by View Medical.

Certifications: ISO 13485:2016.

Capabilities: • R&D Tooling • CAD Design • Engineering consultation • Prototyping & 3D Printing • Plastic Injection Molding • CNC Machining & Turning

BihlerMed 85 Industrial Drive, Bldg. B Phillipsburg, NJ 08865 908.329.9123 bihlermed.com

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Major Markets: • Medical Device Assemblies • Surgical Lighting & Instruments • Ligation and blade products • General & Specialty Surgical tools • Laparoscopic, endoscopic & Arthoscopic

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Expert

About binder USA binder USA is a subsidiary of Franz

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.

Binder GmbH & Co., a family-owned business and a market leader in the area of circular connectors. For over 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

Reliability, quality, responsibility

805.437.9925 www.binder-usa.com

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

Bird sapphire and ruby orifices are scientifically designed to insure repeatable flow control of both liquids and gas.

As technology continues to demand precision and smaller tolerances, engineers are turning to Bird Precision micro-drilled 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.

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

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’s unique manufacturing process 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 sales@birdprecision.com birdprecision.com

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

Bird Precision has recently introduced our new

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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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BMP Medical provides plastic contract

manufacturing services to leading medical device and diagnostic OEMs in need of injection molding, injection blow molding, two-shot (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

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 benefit leading medical device and diagnostic OEMs, the employees, and the company. Our continuous improvement approach can be seen in our expanded capabilities within our 80,000-square-foot manufacturing facility and in our commitment to implementing internal training programs with an eye to benefiting our valued customers. BMP proudly became the first plastic injection-molding company to receive MedAccred accreditation. MedAccred is quickly becoming the new standard for quality control and risk mitigation.

operational excellences. https://www.bmpmedical.com/

Services: BMP Medical 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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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, samplepreparation 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 13485:2016 • FDA 21CFR820

• 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 Design & Development Services • Sterilization Services • Custom Packaging • Pad Printing • DNase- and RNase-free manufacturing • FDA Registered Facility • Class 7 Assembly

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

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Markets Served:

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• MedAccred Accredited

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 575 people with headquarters in Staunton, VA and other locations in Connecticut, 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 Metals Expertise: to make finished devices as a single, turnkey • Advanced Welding Lab™ manufacturing partner for medical OEMs. • Micro Machining & Swiss Machining Cadence offers complete services that range from initial design through manufacturing and full supply chain management for single use and disposable medical devices.

Staunton, VA 24401

• EDM – Wire, Ram, & Sink

• Certified Cleanroom Manufacturing

• Nitinol Shape Setting

• Finished Device Assembly

• Custom Automation

• Complete Supply Chain Management

• IncisionLab™

capabilities that are competitive and

Tel: 540.248.2200

differentiated in the marketplace. Unlike

Fax: 540.248.4400

most contract manufacturers, we also have

cadenceinc.com

• Precision Metal Stamping

• Rapid Prototyping

We also provide a very broad set of core

sales@cadenceinc.com

• Sharps – Specialty Blades & Needles • Microstamping & Multi-slide Stamping

• Sterilization Management

9 Technology Drive

• Tube Fabrication including LaserSwiss

• Design Services

• Final Packaging and Labeling

Cadence, Inc.

• Laser Welding, Cutting, & Marking

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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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.

Advanced Products for Medical Applications Our core business is manufacturing precision motion control solutions. CGI’s diverse customer base and wide range of applications have earned us a reputation for quality, reliability, and flexibility. Our leadership in the market features a careful blend of cutting edge technology and renowned reliability.

With CGI you can count on us to provide the highest levels of manufacturing acumen and expertise while delivering it with the customer service you deserve. Our goal is to be the most trusted partner in your supply chain.

Whether it’s an improvement on a current design or groundbreaking new designs, CGI has the know-how and team to enable design excellence.

Our team is renowned for being able to provide complex precision machined component parts of high quality and hold tolerances as tight as 2.5 microns (.0001”).

These parts are machined from diverse metals, and involve a variety of hardness, surface treatment, heat-treating and plating requirements. One of the distinct competitive advantages we are able to provide our customers with is an engineering team that is knowledgeable and easy to work with.

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

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

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

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LARGEST MINIATURE-GUIDES SUPPLIER IN THE WORLD Chieftek Precision USA of 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 first-rate service to American customers — offering German quality with Taiwanese flexibility, prompt delivery, and

Chieftek Precision USA of Chieftek Precision Co. Ltd. (cpc) supplies linear guides, direct-drive tables, linear motors, feedback components, and servo drives backed by a team of managers, engineers, and technicians dedicated to the R&D and manufacture of top-quality linear-motion components.

competitive pricing.

Chieftek MR Series linear guides excel in precision measurement and inspection applications; ARC guides are widely used in machine tools; HRC and ERC guides complete heavily loaded axes; and RR linear guides with roller bearings deliver top performance in general motion designs.

Chieftek P Series ironless linear motors have the highest thrust density and efficiency of their kind. C Series iron-core linear motors deliver high thrust with low cogging. For users familiar with belt and ballscrew-driven systems, Chieftek packages its linear motors into CLS/CLMS compact linear stages that integrate linear motor, guide, and positioning.

Engineers can also source servo drives from Chieftek. The Will1 Series features high power density, easy-to-use autotuning, and advanced features to let machine builders create breakthrough products. The low-voltage Chieftek Will1-D accepts 48-Vdc input to 30 A continuous. It features an ultra-small size and high power density — and is suitable for AGVs, drones, and robot applications; Will1-B drives support all standard encoder formats.

Chieftek Precision Co., Ltd (cpc) www.chieftek.com

Most recently, Chieftek introduced the UF-30-09 ultra miniature linear-motor stage. With thickness to 9 mm and acceleration to 3.5 g, the stage excels in electronics assembly (SMT), medical pipetting, and other multi-head applications where space is limited.

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CLIPPARD PRECISION FLUID CONTROL PRODUCTS & SOLUTIONS

Clippard provides thousands of standard and special precision flow control products to design engineers and manufacturers around the world. Clippard’s expertise is not limited to providing over 5,000 standard products, but also offers a unique advantage by providing custom products and value added assemblies for hundreds of applications.

Products include: • Electronic Pressure Controls • Electronic valves, standard and proportional isolation • PTFE Isolation valves and pneumatic or electronic pinch valves • Precision flow controls • 7, 8, 10 and 15 mm electronic valves • Cylinders and fittings • Value-added custom assemblies • Special components and systems designed for customer’s OEM applications For over 75 years Clippard has been manufacturing and providing products and solutions to design engineers and manufacturers in a wide variety of industries including drug dispensing, laboratory equipment, medical devices, material handling, analytical, chemical analysis, sampling, life science/biotech, genetic research, gas chromatography, spectrometry, DNA synthesizing, blood analyzing, printing, diagnostic equipment, fermentation, packaging, water treatment and more.

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

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

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Components Corporation is the global leader in the design, manufacture and engineering of precision printed circuit test points, wireform interconnect and testing solutions, printed circuit card edge connectors, preform jumpers and hardware, and battery contacts.

We remain committed to solving the industry’s most demanding wireform interconnect and testing challenges with

Components Corporation: Your Trusted Leader in Innovative Interconnect Solutions

high-quality and innovative products for the broadest range of mission-critical

At Components Corporation, throughout our years we’ve focused on providing innovative, essential solutions to the most challenging problems faced by board designers, builders and technicians worldwide. Much of our skill in board-level product improvement and application technology can be traced to our strong history in successful research and development.

applications. Our industrial, military, commercial and consumer customer base have come to rely on Components Corporation to ensure the excellence

Now concentrating strictly on boardlevel hardware, our early challenges in developing solutions in space flight, aviation, medical and fledging electronics applications have given Components Corporation a talent for anticipating that every new product has to be smaller, faster, less costly and more functional on rapidly shrinking board real estate.

and economy of products regardless of the quantity required. Our products are marketed through a worldwide network of sales representatives and distributors.

CC ®

With a dedicated “no failure” policy, Components Corporation remains the leading manufacturer in Printed Circuit Wireform Interconnect Products.

We’ve earned our reputation as being the driving, innovative force in the development of circuit board hardware technology

COMPONENTS CORPORATION

Components Corporation

COMPONENTS C C 866-426-6726 ®

CORPORATION

And at Components Corporation, custom manufacturing is our standard.

Given basic requirements or dimensions, Components Corporation is able to deliver an economical, perfectly functioning part from prototype to production run. A unique feature of both our custom wireform and standard products is their ability to function in extremely harsh conditions.

All of our products are RoHS and REACH compliant (Directive 2015/863/EU RoHS and EU Regulation EC 1907/2006).

www.componentscorp.com

www.componentscorp.com / (888) 401 7490

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Our in-house capabilities allow us to partner with each customer to design and develop the best custom products for any PCB design requirement, incorporating compliant materials to stringently meet industry directives.

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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.

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.

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.

ONLINE

www.comsol.com

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

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

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.

4202 Metric Drive Winter Park, FL 32792 407-478-4064 www.dataimagelcd.com

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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.

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.

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

Touch

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.

275 Marcus Blvd.

Hauppauge, NY 11788 Phone: East Coast +1 631-951-0800 West Coast +1 503-885-1165

Embedded

Fax +1-631-951-2121

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 inhouse software and hardware development and kits for easy design solutions.

Email: info.us@data-modul.com www.DATA-MODUL.com

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EXPERTS FOR PHARMA AND MEDICAL DEVICE TESTING DDL is an ISO 17025 accredited testing lab that provides package, product and materials testing to the medical device and pharmaceutical industries. DDL’s team of engineers, technical and quality experts is devoted to helping customers worldwide succeed by taking an independent, involved and informed approach to ensuring regulatory compliance. DDL’s commitment to customer service is supported by an upfront approach, unmatched technical

DDL has provided package, product and materials testing for the medical device, pharmaceutical, and consumer goods industry since 1990.

expertise, a robust quality system and scalable capacity. All of our testing services

We offer full service package testing in Eden Prairie, MN and Irvine, CA, and select package testing capabilities in Edison, NJ. The Eden Prairie laboratory also offers medical device, combination products and materials testing services. Select device and combination product testing services are now offered at the Irvine laboratory. All our DDL laboratories work one on one with clients providing technical expertise, readily available capacity and individualized, easy to understand, comprehensive quotes.

are delivered with integrity, professionalism and a commitment to meeting our customers’ timing needs.

Our laboratories house over 125 continuously monitored environmental chambers providing accelerated aging, real time aging, stability testing, thermal shock, thermal performance and environmental testing services.

Temperature ranges from -65C to 120C and humidity ranges from 5% to 95% RH are available.

Cryogenic temperatures can also be accommodated.

DDL, Inc. 10200 Valley View Road, Suite 101

Equipped with dynamic and mechanical test systems for shock, vibration, tensile and compression testing, our labs perform distribution simulation testing per ASTM D4169 as well as the sterile barrier system testing for seal strength and integrity per ISO 11607.

Eden Prairie, MN 55344 www.ddltesting.com

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Testing of medical devices such as Luer fittings, syringes, needles, catheters, guidewires, cannulae and tracheal tubes, along with combination products is done at the Eden Prairie, MN and Irvine, CA locations.

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

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Delivering stainless steel, high nickel alloy and 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:

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.

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!

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

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-theart machinery supply uniformly smooth bends - meeting the tightest customer specifications.

Eagle Stainless Tube & Fabrication, Inc.

Flaring and reductions Flaring and end reduction of tubing is an every day precision process at Eagle.

Special tools and procedures have been developed to insure repeatability for proper mating of flared and end-reduced tubes.

Call us. We are ready to help with any of your metal needs!

Phone: 800.528.8650 Fax: 800.520.1954 www.eagletube.com

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

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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.

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State-of-the-art tube bending

Emerson leads the medical global assembly

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

technology market offering Branson technology of advanced plastics joining, ultrasonic metal welding and precision cleaning systems. Our in-depth medical industry experience insures customers

Branson GSX Series Ultrasonic Welding Platform offers a new generation of ultrasonic welders to support the growing demand for the assembly of smaller and more complex plastic components. The newest 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

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

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 servomechanism, software optimization and Branson proprietary dynamic follow-through to ensure weld precision and control.

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.

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.

And with the new GLX Micro delicate parts are safe with clamp forces as low as 1N.

www.Emerson.com/Branson

Branson 41 Eagle Road Danbury, CT 06810 203.796.0400 Branson.Info@emerson.com

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

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Eurofins Medical Device Testing Your Global Testing Partner From our testing lab...to the operating room.

It’s where experience, quality and accuracy matter the most.

With a strategic focus on quality and personal service, we help our clients ensure the safety and efficacy of their products by delivering unparalleled testing services with complete, compliant and accurate data.

As a trusted partner for over 40 years, let our experience and global reach work for you.

From implants and instruments, to single-use and combination products, as well as active electronic devices, Eurofins Medical Device Testing provides the optimal strategy for all types of medical devices and delivers rapid turnaround times with the highest level of service and most advanced technologies.

With extensive knowledge of the commercialization process, regulatory requirements and scientific trends in the Medical Device Industry, our scientists and engineers have been assisting companies, large and small, with developmental testing and regulatory submissions for more than 40 years.

Our >20 state-of-the-art facilities throughout North America, Europe and Asia Pacific offer extensive capacity and the highest level of instrument technology, enabling us to provide the full scope of testing services required by the Medical Device Industry, including:

Eurofins Medical Device Testing 2425 New Holland Pike

•

Analytical Chemistry - Our chemistry laboratories are equipped with nearly 400 HPLCs and 100 GCs with more than 600 detectors.

•

Microbiology - We offer validations for terminal sterilization, as well as for reprocessing of reusable devices and environmental monitoring to support your clean manufacturing facilities.

•

Biocompatibility - Our global biocompatibility team includes a vast group of certified veterinarians, pathologists and toxicologists.

•

Electrical & Mechanical - We perform testing of active medical devices for compliance to electrical requirements of ISO 60601.

•

Package Testing - We provide the full range of testing required to assess every aspect of product packaging, from sterile seal integrity through pallet-level transit testing, as well as label durability and UDI compliance.

•

Stability Testing & Storage - Over 187,000 cubic feet of environmental chamber space for accelerated and real-time stability and aging studies.

Lancaster, PA 17601 717-656-2300 medical-device@eurofins.com www.Eurofins.com/medical-device

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Eurofins Medical Device Testing can help develop and execute your test plans and navigate the regulatory pathway to market anywhere in the world. Our laboratories maintain quality systems compliant with cGMP, GLP, and ISO 17025, and conducts testing in accordance with ISO, ASTM, ANSI, AAMI standards, as well as custom test methodologies to meet the unique needs of our customers.

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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

Pancake® Air Cylinders out-perform the 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.

• 8 bore sizes 1/2" to 4"; strokes to 4" • All with 3 to 5 day delivery

products with proven performance and reliability.

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

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

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.

FABCO-AIR

A member of Festo Group 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

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

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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

www.medicaldesignandoutsourcing.com

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

• 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 incorporate important no-cost options.

Standard features: • 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

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

We’re proud to offer the broadest range of high precision, high performance products for micro motion applications in the medical market.

FAULHABER MICROMO brings together the highest quality motion technologies and value-added services in North America plus global engineering, sourcing, and manufacturing to deliver the best micro motion solutions. FAULHABER MICROMO partners with customers to deliver quality, innovative solutions faster and better every time. Contact our team today.

FAULHABER 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 FAULHABER 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.

EXCELLENCE IN MICRO MOTION SOLUTIONS

Since 1961, FAULHABER 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

FAULHABER 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

FAULHABER MICROMO is ISO 9001 and ISO 13485 certified as well as RoHS compliant. With the FAULHABER Group’s ISO 14001 certification, FAULHABER 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, FAULHABER MICROMO is the premier provider of micro motion control systems. FAULHABER’s product line includes fractional horsepower DC coreless motors, 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.

FAULHABER MICROMO 14881 Evergreen Ave. Clearwater, FL 33762 T: (800) 807-9166 www.faulhaberUSA.com

IT’S ALL HERE IN NORTH AMERICA

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From concept to delivery, FAULHABER 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 our strength. FAULHABER MICROMO’s operations include a state-of-the-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. FAULHABER 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 through FAULHABER MICROMO’s product configurator & motion system tool, many products can be delivered in three days or less to meet immediate design and testing requirements.

www.medicaldesignandoutsourcing.com

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.

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.

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

|

800.551.0121

mail@fisherconnectors.com fischerconnectors.com

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Precision metal fabrication for med-tech companies.

Celebrating 50 years, Fotofab is committed to supplying high quality, custom etchedmetal components to a wide range of leaders in the aerospace, defense, medical, industrial, and electronics industries. We are ISO 9001:2015 and AS9100 certified. Our commitment doesn’t stop with our products.

We also take pride in our high levels of customer service and satisfaction.

From our design services to rapid prototyping to production, the Fotofab team is committed to collaborating with our customers to find the best solutions to their project challenges; completed on-time and with the professionalism which our customers have come to expect.

Located on Chicago’s Northwest side, our main plant houses multiple etching lines, a thoroughly equipped CAE/CAD department and modern inspection/testing capabilities. Our tooling, forming, and stamping facility is located in Elk Grove Village, a short drive from our main facility and very close to O’Hare airport.

Delivering the Highest Quality Custom EtchedMetal Components, since 1967 Fotofab provides a wide range of high precision metal fabrication services to produce standard and custom components with geometries from simple to very complex. From RF Shields to Encoders to Springs to Electrical Components Fotofab has the capability. Whether the mission is a quick turn prototype to a high-volume production run, Fotofab has been satisfying

Fotofab LLC 3758 W. Belmont Ave. Chicago, Illinois 60618 773.463.6211 www.fotofab.com

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engineers for five decades. While our core competency has not changed over that time, the technology of our production tools continues to evolve. As we look to our next decade, we see opportunities for our customers to benefit from our unrivaled experience, while knowing that their parts will be produced with state of- the art production methodologies and uncompromising quality standards.

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

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As a leader in the chemical etching industry, not only do we offer a variety of services such as stamping, cutting, forming and plating we also work with exotic metals.

From Aluminum to Titanium, Fotofab can deliver etched parts from almost any metal or alloy. Be it medical, aerospace, electronics or any other market, Fotofab has the experience and resources to meet and exceed customer expectations.

Freudenberg Medical is a global partner for the design, development and manufacture of innovative medical devices, components, and minimally invasive product solutions.

With 11 manufacturing operations and more than 1,500 associates worldwide, Freudenberg Medical offers a wide range of capabilities from high precision silicone and thermoplastic components and tubing to coatings, hypotubes, specialty needles, and subassemblies for catheters and minimally invasive devices.

Freudenberg Medical has the experience and expertise to simplify your supply chain and get product to market faster. A global network of R&D and manufacturing facilities supports customers from material selection and design optimization to prototyping and mass production of components and finished devices.

Freudenberg Medical has introduced a number of pioneering process and product innovations over the past 6 months. These include: Helix iMC™, a groundbreaking new technology to continuously measure the inner geometry of silicone tubes. Unique to the industry, it increases product quality for critical applications and dramatically reduces material waste and process time.

HelixTwist™, unique multi-lumen tubing designed to provide an equal balance of stress across the inner and outer lumens as the tube bends. Ideal for pacemakers, breathing tubes, and other applications which require navigation through tortuous pathways within the body.

As a materials specialist, Freudenberg Medical has developed a proprietary conductive silicone compound used for smart therapeutic devices that deliver electrical currents also to shield sensitive electronics.

Freudenberg Medical California • Indiana • Massachusetts Minnesota • Costa Rica • Germany Ireland • China info@freudenbergmedical.com www.freudenbergmedical.com

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Freudenberg Medical holds 5 patents for minimally invasive technologies, these include the Composer® Catheter Handle Platform, hemostasis valves with variable diameter seals, and expandable introducer sheaths. Three next generation Product Solutions were just added to the portfolio – Composer® EPIC and Composer® Toccata Catheter Handle Platforms, and the HyperSeal® Mini hemostasis valve. Designed for medical device companies looking to accelerate time to market with commercialization-ready solutions.

And announcing the latest in needles devices from Cambus Medical, Velona® Custom & Specialty Needles for fine needle aspiration, fine needle biopsy, minimally invasive delivery systems, and structural heart applications.

www.medicaldesignandoutsourcing.com

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Halkey-Roberts is a leading supplier of plastic components and subassemblies used for fluid and gas management in disposable medical devices. We supply all of the major OEM medical device and Life Science companies worldwide. We are ISO 13485 certified and manufacture to GMP standards.

Our standard and customized medical valves include those used as substitutes for needle ports in IV and drug delivery applications, catheter balloon inflation valves, tubing clamps, tubing flanges, fill and drain closures, hand pumps and pressure relief valves.

Our comprehensive line of high flow, split septum swabable valves feature a unique and innovative patented design that allow the valves to be used in a wide variety of demanding applications where high flow and a closed system are a must.

We have the technical and financial resources to invest in new product development and the automation it takes to produce high-quality products at the lowest possible price point. We understand the value of providing an economical solution that solves a problem and addresses a need in the market.

Our design and manufacturing groups work hand-in-hand utilizing concurrent engineering methodologies to minimize the product development cycle. Our vertical integration, meaning we mold and assemble most everything in the same facility, demonstrates our expertise in the vast array of engineering disciplines from mold building, automation, machine vision and materials.

Halkey Roberts Corporation 2700 Halkey Roberts Place North St. Petersburg, Florida 33716 www.halkeyroberts.com

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Halkey-Roberts has supplied high quality products for over 75 years. We pioneered the use of plastics in the medical device industry when we introduced the Roberts’ tubing clamp decades ago. We continue to provide innovative solutions to the Medical Device and Life Science markets worldwide.

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We also understand the concept of mass customization. We combine your idea with our in-depth product knowledge and expertise in flexible automation to provide a custom product at a low unit production cost. This helps our customers differentiate their end products and provide their clients with truly custom solutions.

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Precision Metal Components for Medical Devices Hobson & Motzer’s world-class facilities offer the most advanced technology in metal transformation and assembly. With more than 100 years of precision manufacturing experience, we have the capabilities and infrastructure to deliver on critical projects.

Our commitment to lean and continuous improvement results in superior quality, as well as exceptional supply chain performance and customer satisfaction. Our extensive tool design and engineering expertise drives repeatability and efficient production. We offer precision rapid prototyping and projectbased support, from concept to completion.

Medical device components include endomechanical, electro-surgical, pharmaceutical, ophthalmic blade blanks, custom electrical contacts, and more.

Improving Lives.

Advancing Technology.

Transforming Metal.

Performance When It Counts As a trusted supplier to OEMs, we drive the latest thinking in manufacturing through innovation and technology. We are often relied upon to make the impossible possible—or pick up where others have failed.

Our company is vertically integrated with key competencies in metal stamping, and 3-, 4-, and 5-axis high-speed CNC machining, PECM, laser cutting, welding, and assembly services. We also perform a wide range of secondary operations, all in house: pad printing, PTFE coating, metal finishing, electro polishing, and more. We have an extensive team of toolmakers and a highly equipped tool room—all supported by industryleading design engineers and skilled project managers.

Our plants are highly automated, featuring robotic automation technology that is engineered, designed, built, and supported in house.

Hobson & Motzer 30 Airline Road Durham, CT 06422 1-860-349-1756 www.hobsonmotzer.com

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Vertical integration is a solid strategy—but listening to the needs of our customers has truly been the driving force behind our manufacturing depth. We invest in the right equipment, resources, and people to successfully develop in-house expertise. This ensures the highest quality end-to-end, so medical device OEMs can have confidence in our precision, our consistent quality, and a robust supply chain.

www.medicaldesignandoutsourcing.com

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Do you have a challenging project that you need to deliver on?

Your odds for success improve with a call to HOBSON & MOTZER

1-800-476-5111

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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.

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

IKO International 91 Walsh Drive Parsippany, NJ 07054

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

United States www.ikont.com

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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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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.

IPE is your total solution provider!

International Polymer Engineering (IPE) provides high-quality design, engineering, and manufacturing services for many different industries through custom profile extrusions made from FluoroFlex ePTFE and a variety of melt thermoplastic materials. We also manufacture a variety of other products such as sutures, biopsy channels, light guide covers, and CO2 sensor covers. The mission of IPE is to provide our customers with innovative, consistent, high-quality products and services that consistently exceed the expectations of our customers. This is accomplished through continually examining International Polymer Engineering (IPE) is one of the only companies worldwide that engineers custom FluoroFlex ePTFE and thermoplastic extrusion solutions for the most demanding applications. IPE utilizes advanced engineering solutions, creativity, and experience to provide the best possible solutions to our customer’s specific requirements and specifications across a wide variety of industries. We accurately control the function and form of ePTFE to meet almost any porosity, density, barrier, instrument delivery, and bending section for applications such as filtration, medical device covers, implants, and dental components, among others.

We also specialize in the bonding of ePTFE to other materials (metal, plastic, etc). We are experts in providing the best solutions for lubricity, caustic chemical resistance, flexibility, low profiles, and the shift away from ferrous materials. We use the latest in polymer technology, equipment, and technique to offer a wide range of fabricating capabilities, reduce costs, and shorten lead times for the manufacture of all of our tubing, rods, and sheets. IPE is an ISO 13485:2016 certified company. Our testing and analysis procedures ensure that all of our products meet the stringent quality standards that our customers require.

We constantly inspect for any particulate matter that may limit performance in your application. Our Class 10,000 clean rooms assure you of our attention to detail and minimizing particulate contamination.

and reviewing our existing products and researching and developing new materials and technologies.

International Polymer Engineering, Inc. (IPE) 2445 West Medtronic Way Tempe, Arizona 8528 www.ipeweb.com

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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.

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.

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.

As the premier supplier of AC power system components, Interpower hospitalgrade 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.

®

®

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

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.

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.

sales@interpower.com www.interpower.com

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

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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 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

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.

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

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.

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® 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.

www.medicaldesignandoutsourcing.com

Drip Detect Sensor

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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HELPING ENGINEERS SUCCEED JW Winco, Inc. A Ganter Company, is a leading supplier of Standard Industrial Machine Components and Assembly Hardware that also specializes in offering value-added services to engineers. 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 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 frequently used as endstop bumpers or leveling mounts for machines and systems, e.g. for sanitary conveyors. The silicone rubber material absorbs vibrations, has a damping 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 open up the range of applications these mounts can be used in.

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.

GN 717 Indexing Plungers GN 717 indexing plungers are characterized by their small dimensions. They are universally suitable due to their prevention of misalignments and positioning errors of mating indexing bores. The lock-out type is used for applications where the plunger pin needs to stay in its retracted position. To achieve this, the knob is rotated by 90 degrees after being retracted. A notch keeps the plunger in the retracted position. These indexing plungers are available either with a plastic knob, with a pull ring, or with a wire loop.

ONLINE 800-877-8351

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fax 800-472-0670

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sales@jwwinco.com

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jwwinco.com

www.medicaldesignandoutsourcing.com

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.

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

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.

standards. We are ISO 9001 and ISO 13485 certified.

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

Spiral Torsion Springs • Develops high torque • Rotation in two directions • Compact, easily mounts in many designs

Spring Powered Reels • Wide range of forces, cable lengths, & travel

John Evans’ Sons, Inc.

• Mounts quickly & easily

1 Spring Ave.

• Metal and plastic available

Lansdale, PA 19446 www.springcompany.com

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

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Quality Interconnect Components and Electronic Hardware Leading–edge technology and precision manufacturing have defined Keystone’s performance as a world-class manufacturer of precision, electronic interconnect components and hardware since 1950.

Keystone Manufactures precision stampings and specializes in progressive dies, four slides, wire forming, in-die tapping, and high-speed blanking. Assembly procedures include eyeleting, riveting, staking, swaging, inserting, crimping and screw insertion to assemble components into finished products.

Our Product Design Guide M70 features products for OEM Designers and Engineers who create/develop state-of-the-art electronic products/instruments/systems. Our Custom Manufacturing Division provides modifications and custom fabrications and is fully integrated with in-house, precision tool and die shop that utilizes the latest CAD/CAM and 3D modeling software to provide close tolerance Stamping, Machining and Assembly services.

Keystone is ISO 9001:2015 certified and RoHS/ REACH compliant with USA headquarters and offices in Canada, Europe, Australia and Asia. Visit our website for our Dynamic Catalog of Products or to request our New Product Design Guide M70.

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.

Test Points & Terminals

Low profile and limited board space drive today’s PCB connectivity designs. Keystone is the right fit with UL Recognized Quick-fit Male and Female PCB terminals, Snap-on, Snap-Fit and PCB Screw Terminals as well as SMT and THM Test points and Jumpers and more.

Fuse Clips & Holders

Fuse connectivity products for Electronics, Datacom, Telecom, Automotive and Solar use.

Keystone offers Surface Mount, Thru-Hole and Rivet Mount products for Cylindrical, Automotive and Subminiature fuses.

Spacers, Standoffs/Supports

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.

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

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Pins, Plugs, Jacks & Sockets

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.

www.medicaldesignandoutsourcing.com

Multipurpose and Panel Hardware

Check out the diverse selection of Panel and Mounting hardware Keystone is well known for. Fan Filters & Guards, LED Lens Caps, Holders & Spacer Mounts, Jack Screws and Connector Hardware, Instrumentation Handles, Cable Clamps, Knobs and more.

YOUR IDEA REALIZED Keystone Solutions Group is a West Michigan-based product development and medical device contract manufacturing company. In operation for more than 20 years, we collaborate with customers around the world in the medical device industry to design, develop, test, and manufacture a wide range of products. Keystone’s operation is FDA registered and ISO13485:2016 certified and provides assembly, kitting, packaging, and sterilization management services for single-use disposable and reusable medical products.

Complete end-to-end solutions from concept through approval and production; values and a culture that aren’t just taglines. These attributes make Keystone a leader in the medical device industry and ensure a successful, long-term, collaborative journey.

Taking it beyond the core contract development and contract manufacturing services, Keystone provides unique pathways to product launch through a truly collaborative approach with clients. Regulatory, IP, and other commercial challenges are tackled utilizing solutions that break the mold of typical OEM/CM relationships.

Keystone Solutions Group

Whether clients are starting with a napkin sketch or looking to transfer the

6387 Technology Ave, Suite B

manufacturing of a mature product, the Keystone team can drive the solution

Kalamazoo, Michigan 49009

across the finish line. Àla carte or turnkey, we help clients solve challenges and launch successful device programs across the globe.

www.keystone-pd.com Amy DiPiazza Business Development Manager Amy.DiPiazza@keystone-pd.com

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Founded in 1918, Lee Spring is headquartered in New York, with multiple locations in the United States, Mexico, Europe, India and China. The Lee Spring brand sets the standard for excellence through bold product innovations, quality manufacturing and responsive customer care.

Lee Spring takes pride in creating solutiondriven responses. The Lee Spring Sales Team, Engineering Team and Manufacturing Team collaborate to develop application specific resolutions.

Lee Spring manufactures and distributes mechanical springs, wire forms, stampings and fourslide parts worldwide. Our extensive print and online catalog offers over 25,000 inventoried products in a variety of materials. From 10 springs to 10 million springs, Lee Spring is a premier global source for stock catalog and custom designed mechanical springs and related products.

Lee Spring continues to respond to the voice of the customer with advanced Custom capabilities and unique Stock products such as LeeP™ Plastic Springs, Bantam™ Mini Springs, Lite™ Pressure Springs and our latest expansion of Stainless Steel 316 springs. All stock products are available through our website or our print catalog.

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We make it easy - exceptional personal attention

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We have it - over 25,000 catalog products

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We can design it - engineering expertise

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We can make it - extensive custom manufacturing capabilities

Lee Spring understands the value of our customers for well qualified engineering support. Lee Spring engineers can offer assistance from design conception through project completion. Extensive expertise in spring design and mechanical engineering complement our customers’ design teams.

Lee Spring’s expanding global presence and in-depth knowledge of the worldwide marketplace puts Lee Spring at the leading edge of creating market specific solutions for customers’ needs.

www.leespring.com

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STOCK SPRINGS

Over 25,000 Stock Springs Online CAD Downloads Free Ground Shipping Options Available •

Over 25,000 Stock Imperial and Metric Designs

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Free CAD Downloads

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Pull/Kanban Capabilities

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CAD Assisted Product Design, Drawing & Modeling

Live Engineering Support

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Live Engineering Support

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Free Ground Shipping in Continental U.S.

•

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Free Passivation on Stainless Steel Springs

In-House Prototype Production Services

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Free Plating on Music Wire Springs

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Free Material & Chemical Certification

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Free Grinding on Standard Compression Springs

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Free Certificates of Compliance

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In-House Tooling Production Including EDM

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Governmental and Industrial Regulatory Expertise

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Global Supply Chain Network

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Long or Short Runs

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Proprietary Quality Control System

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Free Certificates of Compliance

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Guaranteed RoHS & Reach Compliance

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Online or Phone Ordering

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Inch and Metric Designs

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Wire Forms, Stampings and Springs Prototypes to Production Runs Turning Ideas Into Reality •

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CUSTOM SPRINGS

www.medicaldesignandoutsourcing.com

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 self-latching 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 707-206-3700 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.

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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 over-designing while keeping in mind future developments and improvements.

LIN ENGINEERING

MOTOR SPECIALISTS IN MOTION A

COMPANY

Lin Engineering

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.

16245 Vineyard Blvd Morgan Hill, CA 95037 www.LinEngineering.com

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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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Advanced CNC and Additive Manufacturing From small runs to full-scale production, Marox partners with you to deliver innovative solutions that push the boundaries of contract machining. As a proven leader in medical device contract manufacturing, we leverage our expertise to serve many industries and remain as one of the top manufacturing companies in Massachusetts and beyond. Driven by leadership and experience, we have the capabilities that allow us to meet the rigorous challenges of the medical device industry. Precision, quality, and efďŹ ciency enable us to meet tight tolerance requirements. Our expertise includes spine, orthopedic, extremity, endoscopy, and dental components.

Marox

Marox uses its extensive contract manufacturing expertise and resources to become an extension of your business. Whether you require speciďŹ c machining assistance or are interested in a more comprehensive program, including engineering support and inventory management, our insightful suggestions and concurrent process adjustments are aimed at improving the bottom line without compromising quality and delivery. Our state-ofthe-art facility gives us the ability to manage numerous production runs simultaneously by housing an array of the most sophisticated multi-axis CNC machines and additive technologies on-site. In addition, we have extensive manufacturing experience in a broad range of materials.

373 Whitney Avenue Holyoke, MA 01040 413.536.1300 www.marox.com

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Marshall is a Medical Device Contract Manufacturer Marshall Manufacturing Company is a contract manufacturer serving medical device OEM’s throughout the world. We’re located in the heart of “Medical Alley”. We are 13485 registered since 2010.

Marshall Manufacturing Company is a World Leader in the art of

CNC Swiss & Mirco-Swiss: We provide our customers micro-parts by utilizing CNC microSwiss machines.

CNC 3D Bending. Our capabilities

Laser & EDM: Other methods of precision material removal at Marshall include CNC Laser Tube Cutting and CNC Wire EDM.

OEM’s in the manufacturing of their

in bending small diameter premachined wire and pre-laser cut tubing serve many medical device medical products. Marshall provides Swiss machining, micro-Swiss machining, laser tube cutting and

Wire & Tube Bending: CNC 3D Bending of pre-machined small diameter wire and tubing remains one of Marshall’s specialty services.

3D-bending services to customers throughout the United States, Europe and Asia.

Laser Welding: For the permanent assembly of small machined and laser cut components, Marshall offers CNC Laser Welding.

Supplying our customers with medium to high volume production quantities, Marshall offers solutions

Automation: Marshall is constantly automating processes.

to complex bending of precision machined wire and tubing. Utilizing laser alignment, proximity sensors or probes, we have the ability to orient specific bend radiuses to machined and laser cut features. The robotic arm of our CNC bending machine can then orient these features into

Marshall Manufacturing Company

their appropriate position within the bending operation.

3820 Chandler Dr Minneapolis, MN 55421 612-788-9621 www.marshallmfg.com

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Master Bond is celebrating 40 years of formulating cutting edge adhesives, sealants, coatings and potting/encapsulation systems for challenging medical device applications.

High Performance Adhesives, Sealants & Coatings Our expansive line of epoxies, silicones, UV curable and LED curable compounds can be customized to meet a myriad of property requirements including: • • • • • • •

High/low temperature resistance Electrical conductivity/insulation Thermal conductivity Sterilization resistance High/low viscosity Flexibility and toughness Optical clarity

Developed to withstand harsh environmental conditions, our products feature superior longterm durability. They are used in a variety of industries and are designed to meet stringent industry standards and are certified for: • • • • •

USP Class VI ISO 10993-5 NASA low outgassing FDA CFR 175.300 & FDA CFR 175.105 UL 94V-0 & UL 94V-1

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

MasterSil 912Med: Biocompatible Silicone Passes USP Class VI Testing

MasterSil 912Med is a single component silicone with a paste viscosity offering a non-corrosive, neutral cure. Complying with USP Class VI and ISO 10993-5 specifications, it resists many kinds of sterilization including gamma radiation, EtO and some types of liquid sterilants. MasterSil 912Med withstands rigorous thermal cycling as well as thermal and mechanical shock.

UV15DC80Med: Features Superior Sterilization Resistance

Master Bond UV15DC80Med is a special dual cure epoxy based system that offers a primary cure using UV light along with a secondary heat curing mechanism. This enables the adhesive to cure areas on parts that do not allow UV light curing because of “shadowing” issues. It also meets USP Class VI specifications and passes ISO 10993-5 cytotoxicity testing.

Master Bond 154 Hobart Street Hackensack, NJ 07601

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

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

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maxon drives set the world in motion.

Offering solutions that fit your customized needs

maxon combines electric motors, gears and DC motor controls into high-precision, intelligent drive systems that can be

At maxon, we focus on comprehensive solutions optimized through a diversified product range and client consultation.

custom-made to fit the specific needs of customer applications. maxon helps

maxon manufactures small, high-quality brush and brushless DC motors ranging in size from 4 mm to 90 mm. maxon’s rhombic wound ironless rotor motors provide exceptionally high efficiency, low EMI emissions, fast acceleration, no preferred rotor position, torque constants and long service life. The drive components are assembled and designed according to your individual needs. Our modular system includes planetary, spur and special gearheads as well as encoders and control electronics.

provide innovative solutions at competitive prices for numerous applications in various markets, such as industrial automation, medical, robotics and aerospace.

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 highprecision, 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.maxongroup.us

With over 50 years of experience, high-tech innovations and superior product quality, maxon is the reliable partner in drive technology.

Individual, customized drive solutions are our greatest strength.

maxon precision motors, inc.

125 Dever Drive Taunton, MA 02780 508.677.0520 info.us@maxongroup.com maxongroup.us

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ONLINE

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.maxongroup.us

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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.

9000 Standard Models

MEAN WELL USA, Inc. 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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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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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

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.

southern NH’s best kept secret.

Services Offered 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 Come Visit Us at: in house. Strict control over the MD&M manufacturing process results Minneapolis, MN in high quality components and devices.

MD&M

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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Anaheim, CA

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BIOMEDevice Boston, MA BIOMEDevice San Jose, CA

medicaldesignandoutsourcing.com/leadership

888-MEDEFAB 81 Turnpike Rd. Jaffrey, NH 03452

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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.

A Tradition of Manufacturing Excellence To achieve these ends, we offer full-service MICRO is a full-service contract manufacturer that draws on over 75 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.

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

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We are the world’s largest manufacturer of titanium and stainless steel ligation clips – classcritical 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 price, while providing a supply-and-distribution chain that allows our customers to operate at optimum efficiency and ease.

www.medicaldesignandoutsourcing.com

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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MicroCare Medical is an ISO 9001:2015 registered company specializing in cleaning, coating and lubricating fluids used in the manufacture of a broad range of medical devices. Since 1983 MicroCare Medical has pioneered hundreds of environmentally progressive and sustainable products in response to the medical device industry’s evolving cleaning and coating needs.

Duraglide™ Dry Lubricant

MicroCare operates with three production facilities, four logistics centers, three critical cleaning labs and a distribution network spanning 47 countries. The superior MicroCare chemistries, and the depth of applications technical expertise have earned them the loyalty of customers around the globe.

forces up to 25%. Duraglide™ is non-

Duraglide™ Dry Lubricant is used on a variety of devices with complex movements including catheters, cutting tools, staplers and hypo tubes. It features a proprietary micro dispersion PTFE technology to lubricate assemblies that slide, pivot or twist eliminating ‘stiction’ and reducing actuation migrating, fast-drying and leaves a smooth, slippery and uniform coating on any surface.

It is hostile to bioburden and is compatible with all commercial sterilization processes.

Duraglide™ is ISO 10993 tested and certified for easy validation.

Universal Carrier Fluid

MicroCare provides both off-the-shelf and customized formulas engineered to meet the specialized needs and processes for successful device manufacturing while ensuring compliance and safety.

The non-aqueous, nonflammable Universal Carrier Fluid for silicones dissolves and carries medical grade silicone lubricants and deposits them onto medical devices. Dip, brush or spray onto parts. Hostile to bioburden, the carrier fluid quickly evaporates, leaving a thin, uniform film of silicone on the surface of the treated part. The process is fast, safe, easy and delivers excellent coating consistency on treated components.

MicroCare Medical can tailor the carrier fluid to better manage materials compatibility, dispensing challenges and coating concentration.

Cleaning and Binder Extraction Fluid

MicroCare Medical 595 John Downey Drive New Britain, CT 06051 Phone: 860-827-0626 Fax: 860-893-1930 www.microcaremed.com

Tergo™ Metal Cleaning Fluid (MCF) is a highly effective precision cleaning fluid for vapor degreasing. It is an aggressive, nonflammable fluid that cleans heavy hydrocarbons, greases, flux residue, waxes and silicone soils. It also serves as an effective 3D/MIM parts debinder prior to sintering. Tergo™ MCF has a broad

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range of material compatibility, is non-pyrogenic and meets stringent environmental and worker safety regulations. It is a drop-in replacement for traditional solvents like nPB, TCE and PERC.

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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.

Exceptional Products & Customer Service

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 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.

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.

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.

Microlumen One Microlumen Way Oldsmar, FL 34677 T: 813-886-1200 www.microlumen.com

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High Performance Medical Tubing

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.

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.medicaldesignandoutsourcing.com

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Total solution for steel strip spring application Ming Tai Industrial Co., Ltd. is one of leading manufacturer of steel strip springs for medical device application, including Constant Force Spring, Constant Torque Spring, Power Spring and Pre-stressed Power Spring, Variable Force Torque Spring, Variable Torque Spring and SpringStrip Tube.

With ISO 9001: 2015 and RoHs certificated, Ming Tai is capable of serving customer from the technical support in develop procedure, prototype, to trial run, mass production, spring mounting and assembly.

Each manufacturing procedure, including steel strip slitting, heat treatment, edge trimming, forming process is consistent production and completed in-house to ensure highest quality requirement.

Ming Tai Industrial Company expects to be your best engineering consultant for steel strip spring application with enthusiasm. Recently Ming Tai has been helping lots of customers to develop medical devices which apply steel strip spring successfully. All innovative products include pen-type drug injector, high adjustable monitor and keyboard integrated medical workstation, high adjustable trapeze for patient bed, and patient bedside table, Bowden cable for endoscope, draw wire encoder for MRT machine. Both performance of Ming Tai’s steel strip springs and manufacturing service are gain lots of praise and appreciation from customers.

Attached figure 1, it explain that variable force torque spring exerts constant force to keep injecting drug with fixed flow, to prevent patient from feeling uncomfortable.

Variable force torque spring also features stretch force in the end the stroke that ensure pen type drug injector dose drug entirely.

Figures 3, you can find constant force spring features counterbalance. These can be applied to high adjustment application, such as patient bedside table.

FIGURE 1

Since there are a number of different spring design possibilities for a given application, you are welcome to contact us in the early design phase to create an optimized spring solution for your demand. Along with high quality production, prompt delivery and competitive pricing. Ming Tai is your best partner to win the market.

FIGURE 3

Ming Tai Industrial Co., Ltd. No. 250, Sing Jhong Road, Tamsui New Taipei City, Taiwan 251 Taiwan 886(2)26228651 www.powerspring.com.tw

FIGURE 2

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MTD Micro Molding is a micro medical manufacturer of ultra- precision molded components that meet the exact requirements of the medical device industry. While many companies dabble in micromolding components for the medical market, MTD focuses 100% on medical micromolding.

MTD is an ISO 13485 certified and FDA registered micro molding contract manufacturer with in-house tooling,

MTD Micro Molding is built for high performance in one area: the micro molding of advanced medical implants and products. Every part of the manufacturing process, from design through packaging, is carried out by people whose sole focus is medical micromolding. Our team of designers and engineers work together under one roof to solve complex challenges to help our partners bring higher quality medical devices components to market before their competitors.

Key medical markets for bioabsorbable micromolding include Orthopedic and Drug Delivery.

Other markets served include: Biomed Pharma, Bronchoscopy, Diabetes Care, Endoscopy, ENT, Gastrointestinal, Gynecology, Interventional Cardiology, Neuromodulation, Oncology, Peripheral Medicine, Urology, Vascular, and other areas to help improve life.

unparalleled bioabsorbable molding expertise, assembly services and state-ofthe-art equipment—all under one roof. Our focus on problem solving for medical devices ensures successful delivery of complex custom products that nobody else can produce.

BIOABSORBABLE EXPERTISE: As a globally recognized leader in bioabsorbable polymer molding, MTD achieves bioabsorbable micromolding success with tools like runner optimization, robust validation, and in-house testing. MTD utilizes a proven process that results in bioabsorbable products with superior post-mold mechanical and functional properties, consistent and minimal post-mold IV loss, and highly capable critical dimensions.

SPEED TO MARKET: From mold fabrication to manufacturing to testing and inspection, all micro molding processes take place at our headquarters, which means faster turnaround times and better quality control.

MTD Micro Molding 15 Trolley Crossing Road

SUPERIOR TECHNOLOGY: Our breakthrough micro molding technology permits sharper edges and tighter feature tolerances. In a field where precision is paramount, MTD Micro Molding delivers the highest quality solutions possible, which leads to more efficient, reliable, and betterfunctioning products, less invasive implants, and healthier patients.

Charlton, MA 01507 1-800-998-5549 info@mtdmicromolding.com mtdmicromolding.com

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FASTER, BETTER PROBLEM SOLVERS: By refining a micro design for improved manufacturability and consulting on materials, our specialized team of engineers helps bring your new cutting-edge micro products to market faster. A staggering 20% of new projects come to us as “rescues”—failed attempts by others. Our success rate? 100%.

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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 seven industry leading brands: BellowsTech, FL; Economy Spring, CT; LaVezzi Precision, IL; Helical Products, CA; Marox, MA; Sussex Wire, PA and Servometer, NJ. It’s our expertise in the science of precision metal components

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.

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.

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 mwmedicalsolutions.com

• ISO 9001:2015

Applications:

• ISO 13485

• Fluid Delivery

• ISO 8, Class 100,000 Clean Room

• Dispensing Tips

• FDA Registered Facility

• Specialty Needles

• REACH

• Cannula and Assembly Products

• RoHS

• Catheters • Laparoscopic Devices • Home Dialysis Pumps

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• Robotic Instrumentation

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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.

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 T E C H N O LO G I E S

New England Tubing Technologies 132 North Main Street

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.

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 valueadded services. Let us help you dream beyond today’s technology and achieve the impossible!

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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

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!

603.838.6624 www.newenglandwire.com

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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.

Nitto Kohki leads through exceptional product design and execution, with pumps that meet the rigorous demands of today's medical device industry.

WHY DESIGNERS CHOOSE NITTO KOHKI

Nitto Kohki pumps feature a unique, patentawarded 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.

• World class manufacturing expertise ensures consistent product quality

• Exceptionally reliable performance for critical applications

• Clean, simple design maximizes performance, minimizes maintenance — adding value over the integrated product lifecycle.

46 Chancellor Drive Roselle, IL 60172 www.nittokohki.com

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Novotechnik is a world leader in the development and manufacture of a wide spectrum of touchless, noncontact, and potentiometric rotary and linear position sensors for motion control in industrial, automotive, aerospace, robotic, and medical equipment applications.

These applications include the Segway personal transporter, where Novotechnik engineers worked with the customer to develop a critical application-specific steering sensor.

Novotechnik owes its success to superior engineering and the development of leading technologies resulting in new application capabilities with proven product reliability and accuracy enabling the company to provide its customers with the clear and comprehensive specifications needed by design engineers. These capabilities include linear non-contact, linear inductive and single-turn rotary noncontact using Novostrictive®, Indres®, NOVOPAD™, NovoFoil™, Novohall™, PsP, and Vert-X® proprietary technologies.

Products include Novotechnik’s touchless rotary sensors with no moving parts and a maximum angular resolution of 0.022°.

Novotechnik is ISO 9001 certified and was one of the first companies to achieve ISO/TS 16949 certification worldwide.

Novotechnik angle and position sensors are integral parts of complex industrial feedback loop applications, and other, motion systems including: Chicago’s Willis Tower, the London Eye, forklifts and even a NASA space probe.

Touchless rotary angle sensors utilize some of many new technologies found in Novotechnik products. Novotechnik’s Novohall technology enables angle sensors to measure without any mechanical wear and through solid and non-solid materials. A magnetic marker attaches to an application’s rotating part and a sensing part with NovoHall technology detects the position of the magnet and converts the detected angle to a usable voltage output. One product family this technology is used in is the RFD4000 Series and enables 12-bit resolution and repeatability of 0.1° or better.

Novotechnik is enhancing its magnetoresistive technology introduced a few years ago by combining it with Hall effect technology. This combined technology give engineers a magnetic

Novotechnik U.S., Inc. Southborough, MA 01772 Toll free: 800-667-7492 Ph: 508-485-2244 www.novotechnik.com

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Novotechnik’s combined non-contacting technology is utilized in their RMB3600 Series of magnetic encoders. This series measures up to 16 turns as well as the precise angle within a turn. Once power is applied, the RMB3600 Series is able to measure and to retain turns and angle even during a loss of power. For applications with a need for precision, these sensors deliver 16-bit resolution and linearity of 0.13%. They also provide various analog output options and one or two channels.

Combining new industry leading position sensing technologies and capabilities, Novotechnik continues its history of engineering leadership, and brings products with new abilities and features to market that empower motion control engineers to design solutions that were impossible a short time ago.

155 Northboro Road

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encoder which continues to measure rotations after power fails or is removed, all without batteries. This information is stored for years—even without power.

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Headquartered in Ann Arbor, Michigan, NSK Americas consists of United States,

NSK: Engineering Innovation In Medical Technology

Canada, Mexico, Latin America and Brazil operations. Seven manufacturing facilities

Customer Challenge

are located in the USA, including a linear

An OEM customer developing a next generation syringe pump was seeking a compact linear motion system with high accuracy, repeatability and reliability, to smoothly and quietly position the plunger for extremely precise fluid dispense.

Previously, the customer had used lead screws – or sliding screws – which generate particles from the sliding motion.

precision components facility in Franklin, Indiana. Certified to ISO 9001:2015 and ISO 14001: 2015 standards, this state-of-the-art manufacturing plant ensures shorter lead times and faster turnaround. NSK has a dedicated team of sales, marketing, customer service, and engineering experts that not only serve as your

NSK Solution

personal guide to selecting the right product

• Motorized Ball Screw Actuator (MBSA)

solution but also as a long-term solutions

• Precision ground ball screw directly integrated into a NEMA 17 stepper motor

provider. NSK can assist in domestic repairs and replacement services minimizing potential

• Space-saving design with the elimination of motor coupling

downtime to provide significant cost savings.

• Longer life compared to lead screw due to the higher efficiency, smoother operation, zero backlash and improved rigidity of a precision ground ball screw

www.nskautomation.com

• Configurable encoder pre-assembled to motor • Easy disconnect, simplifying field replacement

Compact, Smooth, Repeatable Accuracy: NSK Motorized Ball Screw Actuator NSK’s MBSA series combines a precision-ground ball screw with an ultra-accurate stepping motor.

It’s the ideal integrated solution for medical devices and laboratory equipment used in diagnostics, syringe pumps, microfluidics, imaging, cancer treatment, and other clinical applications requiring smooth, precise, near-silent motion and maintenance-free long life.

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

www.nskautomation.com/applications

nskamericas.com

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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.

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 custom-developed for your exact order specifications, we combine an array of manufacturing systems including precision stamping, Swiss-type 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.

190,000+ Square Feet of Manufacturing Excellence

We operate with three facilities located in New Britain, CT; Berlin, CT; and Alajuela, Costa Rica, totaling more than 190,000 sq. ft. of manufacturing space. Our processes are 13485 certified and FDA registered, and comply with a wide variety of medical quality standards.

Medical Expertise

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:

Okay Industries Headquarters 200 Ellis Street New Britain, CT 06051 Phone: (860) 225-8707 Fax: (860) 225-7047

• Laparoscopic, Endoscopic and Arthroscopic Devices

info@okayind.com www.okayind.com

• Cardiac and Neurostimulator Implantable Devices • Surgical Stapling, Cutting Blades/Knives and Scissors

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• Ligation Instrument Components and Assemblies

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Part of Something Greater

Our commitment to excellence, innovative approach and unmatched manufacturing expertise help customers improve the health and lives of people around the world. We deliver solutions that are Part of Something Greater.

Award-Winning Electronic Enclosures

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 much more.

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

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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Modern CAD in a Secure Cloud Workspace Onshape is a next-generation Software-as-a-Service (SaaS) design platform that speeds up product development. It’s an all-in-one system that combines CAD, release management, workflow, collaboration, analytics, admin tools, and an API with more than 50 engineering applications. Onshape helps extended design teams work together faster and helps executives make better

Onshape’s SaaS Design Platform Helps Companies Modernize Product Development

business decisions with real-time analytics and unprecedented visibility into their company’s design and manufacturing processes.

Based in Boston, Massachusetts, Onshape is a PTC business.

Ironically, engineers and designers are among the last professions to experience the benefits of digital transformation. While many companies moved most of their business-critical tools online years ago - e.g. HR software, CRM, accounting, marketing, et. - most hardware engineers are still stuck using installed file-based design tools tied to a single work computer.

Onshape is the only Software-as-a-Service (SaaS) product development platform that combines powerful CAD tools with real-time data management, collaboration, and business analytics.

Executives and managers can get up-to-the-minute progress reports on a project’s status and builtin version control prevents costly delays and manufacturing errors. Whenever an engineer makes a design change, everyone else on the team instantly sees it.

Onshape 121 Seaport Boulevard Boston, MA 02210 www.onshape.com

Using a unique cloud database architecture, Onshape:

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•

Enables multiple engineers to simultaneously work on the same design.

•

Requires no downloads, installs or IT support.

•

Provides new team members with instant CAD access.

•

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

•

Automatically upgrades your system every three weeks.

•

Tracks every design change in a comprehensive Edit History, allowing teams to instantly revert back to any prior state.

•

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

Sign up for a free Professional Trial and experience the benefits of cloud-native product design.

www.onshape.com/signup

www.medicaldesignandoutsourcing.com

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 Orchid is driven to success through our customer-focused team, living out our core purpose and values and striving for continuous improvement.

improve our customers’ supply chains through our supply chain solutions.

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.

Major Markets Served:

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

Hip Reconstruction

•

Knee Reconstruction

•

Spine

•

Extremities

•

Trauma

•

Sports Medicine

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PTC unlocks the value created by the convergence of the physical, digital, and human worlds.

PTC brings to market four leading technologies: • • • •

Computer Aided Design Product Lifecycle Management Industrial Internet of Things Augmented Reality

www.ptc.com

PTC unleashes industrial innovation with award-winning, market-proven solutions that enable companies to differentiate their products and services, improve operational excellence, and increase workforce productivity. With PTC, and its partner ecosystem, manufacturers can capitalize on the promise of today’s new technology to drive digital transformation.

Visit www.ptc.com and discover why the most innovative companies partner with PTC.

PTC www.ptc.com

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PTI Engineered Plastics is a custom injection molder and manufacturer of plastic components and assemblies. PTI is a diverse company servicing the medical, automotive, defense, aerospace, consumer products, and electronics industries. Whether it’s low or high volume, simple or complex, prototype or production, PTI can deliver. Our 160,000 sq. ft. facility in Macomb, Michigan offers 4,000 square feet of ISO Class 8 Cleanroom, an array of secondary services and is fully versed in IQ/OQ/PQ validation protocol.

Our facility was purposely designed and technically equipped to deliver our customers a comprehensive experience.

Design

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

Tooling

The PTI Tool Room has a fully-integrated network, 23 high-speed 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. We also offer plunge EDM machining and wire EDM capabilities. PTI uses an array of materials from aluminum, mild steel, hardened steels and stainless. Injection mold types include: unit-mold insert, free standing, shuttle loading, hot runner, single cavity and multiple cavity. PTI’s P3™ Proprietary Process can create ready-for-production prototypes.

Production

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

PTI’s Production floor currently hosts 54 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.

Smart Factory Technology

PTI has 12 Arburg presses that are all equipped with a host computer system. These “smart machines” provide numerous benefits from improved efficiency, safety, security, cost reduction and performance.

Cleanroom Manufacturing

Services within ISO Class 8 Cleanroom include injection molding, assembly, secondary operations and packaging.

PTI Engineered Plastics 50900 Corporate Drive

Secondary Services

Macomb, MI 48044

PTI offers an array of secondary services such as plastic joining, laser marking, and assembly.

586.263.5100 teampti.com

Color Lab

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PTI has added a color management lab to its list of capabilities. With this software, we can achieve the perfect match. This system will reduce lead time, allow for on-site adjustments, and reduce cost with its demand-based system. It’s simple, clean, and fast. This added service will increase speed to market for our customers.

Validation

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

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Qosina is ISO 13485, ISO 9001, ISO 22301 and ISO 14001 certified, and operates in a

Qosina is a leading global supplier of more than 5,000 OEM single-use components to the medical and pharmaceutical industries.

95,000 square-foot, climate-controlled facility that includes an ISO Class 8 Clean Room. Its Qosmedix subsidiary serves the cosmetic,

Our Extensive Component Inventory 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

skin care and spa industries.

Our Services

Qosina

• • • • • • •

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

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Comprehensive print and online catalogs On-hand inventory of 5,000+ SKUs Low minimum orders Free samples of most items Supply chain management Modification of existing molds New product design and development

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

Resonetics is the leader in micro manufacturing

Applications and Advancements for the Medical Device Industry

for life sciences. Core capabilities include laser processing, nitinol processing, metal fabrication and thin wall tube fabrication. Our industry-leading teams, resources and passion

Resonetics has combined advances in laser and motion control to develop a cost-effective tool for high-volume manufacturing of catheter components. This innovative and highspeed laser cutting process is called PRIME™ Laser Cut.

for innovation puts our broad capabilities and absolute customer satisfaction in your hands.

The laser cut tubes (LCT) from the PRIME™ process have many advantages over traditional catheter manufacturing methods (such as braided or coil construction). Below are key benefits of PRIME™ LCT catheter components:

Our speed and best in class customer service enables us to develop strategic R&D teams all while keeping an eye on your manufacturing costs - ensuring delivery of great value on volume production.

Customization: a key benefit of LCT over traditional catheter construction is the ability to completely customize the part geometry to match the clinical demands of the catheter. For example, if designing a catheter requiring significant stiffness on the proximal end but uniaxial flexibility on the distal end, this can be difficult to achieve with a traditional braiding or coiling technique.

Resonetics has claim to many of the industry’s firsts and puts innovation at the forefront of our focus; we heavily 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 with

Torque Transfer: LCT typically employs interrupted cutting which enables flexibility but maintains a monolithic connection from proximal to distal ends of the catheter. This direct connection ensures a good torque response when functioning the device in-vivo.

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

Kink Resistance: an additional advantage of the monolithic aspect is optimized kink resistance. As devices become more flexible, they inherently have a higher risk of kinking upon insertion and propagation through the anatomy. The PRIME™ process enables the design of flexibility and optimization of kink resistance without sacrificing functionality.

26 Whipple Street Nashua, NH 03060 800.759.3330 sales@resonetics.com resonetics.com

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Ovality: a challenge with braided and coiled catheters is flattening or ovality as they move through difficult anatomy. Since LCT is monolithic it does not collapse as it propagates tortuous anatomy. This is critical when passing additional devices through the inner diameter of the catheter.

Low Profile: LCT based catheters can start with a relatively thin-wall tube (down to <0.0005”) while maintaining strength requirements of the catheter. Again, the monolithic benefits of LCT enable a reduced wall thickness of the catheter which opens up space for larger devices passing through the inner diameter.

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

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Established 1950, SDP/SI provides engineering development and manufacturing for many of the most recognized companies in medical, aerospace and robotics today.

The state-of-the-art Hicksville, NY facility

Facing a design challenge?

houses the latest manufacturing, industrial

SDP/SI partners with many Fortune 500

automation, and inspection equipment

companies in new and exciting projects.

available. Employing skilled machinists, CNC

Applying years of experience, product

programmers, inspectors, engineers, and

knowledge, and design acumen our

customer service personnel, we meet and

engineering and manufacturing teams

surpass expectations. Standard catalog

provide innovative solutions through

components can be found and purchased

part selection, modifications, or

online where free 3D CAD models and part

custom design.

specifications can be easily downloaded.

Sometimes the best solution is the simplest. Standard components are a cost-effective Manufacturing capabilities include precision

option and with 87,000 machined and molded components offered, SDP/SI is the

gear cutting, 5-axis milling, 9-axis Swiss turning,

engineer’s preferred source.

and world class quality.

•

Timing Belts and Pulleys

ISO 9001:2015 + AS9100D certified, ITAR,

•

Precision Gears

Reach, and RoHS compliant.

•

Precision Gearboxes

•

Bearings

•

Couplings

•

Hardware

•

Precision Machined Components

•

Molded Components

Stock Drive Products/

•

Mechanical Assemblies

Sterling Instrument

•

Contract Manufacturing

250 Duffy Avenue Hicksville, NY 11801 USA

Celebrating our 70th anniversary this year, we

Web: www.sdp-si.com

continue to grow. Our ability to fully support projects

Email: sdp-sisupport@sdp-si.com

from the development and prototype stage through

Phone: 516-328-3300

the entire life cycle of a product has built a strong

Toll Free: 800-819-8900

and loyal customer base. Our precision gears,

Fax: 516-326-8827

machined parts, molded components, and drive assemblies can be found in high-tech operating rooms, movie sets, military operations, space exploration, and even on Mars. Partnering with

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OEMs around the world we manufacture and manage supply chain of precision components required for medical, surgical robotics, aviation, satellites, defense, automation, and commercial industries. We

medicaldesignandoutsourcing.com/leadership

look forward to working with you.

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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

Wave Springs:

provides you with the right part, in the right

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.

material, with No Tooling Costs™

Wave springs operate as load bearing devices. They take up play and compensate for dimensional variations within assemblies.

A virtually unlimited range of forces can be produced whereby loads build either gradually or abruptly to reach a predetermined working height. This establishes a precise spring rate in which load is proportional to deflection.

Smalley Steel Ring Company

Spirolox® Retaining Rings:

555 Oakwood Road

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.

Lake Zurich, IL 60047 Phone: (866) 478-9757 Email: info@smalley.com expert.smalley.com/MDO/Medical

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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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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. Customers work closely with us to determine the right components based on liquids/ gasses used, application environment, and intended shelf life.

Smart Products USA, Inc. offers endless possibilities with made to order check /

An ISO 9001:2015 Certified Company.

pressure relief valves. Ideal for liquid or gas applications in any industry, valves are fully customizable by 43+ sizes and styles, 9+ plastics, 7+ o-rings, and opening pressure ranges from 0.09 – 20 PSI. Options include cartridge, barbed, NPT, side seal, flanged, Luer, and more. Depending on valve model chosen, the following materials are available: • Plastics: Polypropylene, Nylon, Acrylic, Acetal, PVDF (Kynar), Polycarbonate, Ultem®, ABS, and Radel® • O-rings: Buna-N, EPDM, Viton®, Silicone, Fluorosilicone, Aflas®, and Kalrez® Beyond cartridge valves, you can further customize with modular end fitting options.

Customers mix and match sizes and styles or use the same configuration for both inlet and outlet. Options by series include: • Series 300: Barbed sizes 1/16”, 3/32”, 1/8”, 3/16”, 1/4”, 5/16”, 3/8”, and 1/2”.

Smart Products USA, Inc.

NPT sizes in 1/4” and 1/8”. Additional

644 Fanning Fields Road

styles in foot/filtering, manual relief, and

Mills River, North Carolina 28759

smooth stem

www.smartproducts.com

• Series 500: Barbed sizes 1/16” and 1/8”.

Male Luer and Female Luer Lock • Series 200: NPT sizes 1/8” and 1/4”. Plus, a Metric M10 option In addition to valves, we also offer customizable liquid and air pumps. Smart Products USA provides a quality and application-specific product for every customer.

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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/

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.

AS9100D, ITAR, and MedAccred Certified.

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.

Solar Atmospheres 1969 Clearview Road

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.

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

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

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Medical Design & Outsourcing

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SONOTEC was founding in 1991 by Hans

hines

Munch and Dr. Santar zur Host-Meyer.

Developers of the first human ultrasound, the scientist started their company after the reunification of Germany. The two scientists shifted the company focus in 1995 from level and leak detection to medical applications after being approached by a major dialysis equipment manufacturer. In 1996, SONOTEC along with Fresenius medical filled a joint patent for microbubble detection. SONOTEC has become the number one supplier of dialysis air bubble sensors due to the unique benefits. SONOTEC US was founded by an

Air Bubble Detectors

Engineer Christopher Portelli along with the

SONOTEC’s Air Bubble Detector was developed to meet the highest safety standards.

The ABD05 series is the only known 606014th edition fail safe sensor available and can detect bubbles and output a bubble size. Our advanced software allows for characterization, adjustment, and testing of the sensor. With the future of home medical treatment application on the rise, SONOTEC’s ABD05 also has a unique and long proven self-adjusting intelligent sensor. It’s Self-Adjusting feature allows for changes in the environment such as humidity, tube insertion, and tube variation to keep false bubble detection at the lowest in the industry while ensuring bubbles are detected down to 0.1ul. SONOTEC also offers full documentation packages with information such as 700 bubble test, safety concepts, board layout and history of design process.

parent company SONTOEC GmbH becoming a subsidiary of SONTOEC to service the Americas Market. With over 200 employees SONOTEC is dedicated to the medical sensor market and its advancement for the next generation of smart sensors. SONOTEC has TUV ISO13485, ISO9001, ATEX certifications.

Sonotec US Inc. 190 Blydenburgh Rd, Suite 8

• • • •

Islandia, NY 11749 sales@sonotecusa.com 631-415-4758

Only true Fail-safe sensor available Micro Bubble detection Self-adjusting sensor Software

www.sonotecusa.com

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• • • •

Bubble and Flow measurement Mounted or free hanging design All Electronics inside the probe head Flow down to 20ml/m at 1% repeatability

Along with SONOTEC’s standard sensors, we offer Blood Leak Detectors, Drip Chamber Sensors, and Level Sensors. Blood Leak Detectors are designed to measure even the smallest amounts of blood run in dialysate. The ALD is SONOTEC’s solution to monitoring the liquid level in infusion therapy, dialysis, and parenteral nutrition, without false detection of small foamy bubbles.

The SONOCONTROL 15 is an ideal level switch able to mount onto metal pipes and optionally comes with ATEX certification.

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Medical Design & Outsourcing

The CO.56 Pro series sensors are the newest generation of SONOTEC’s patented integrated solution to flow measurement. This next generation sensor combines our proven technology of measuring flow and bubbles in one sensor while reducing the weight and foot print so the sensor can be freely suspended on tubing without additional mounting hardware.

SONOTEC has miniaturized the electronics know as flow boards and inserted them in the flow probe head allowing for a fully compact design with no need for additional electronics. The flow sensor can detect flows down to 20ml per min at a 1% repeatability while still maintaining a high sensitivity of bubble detection.

Level and Blood Leak Sensors

ALD t 'PS 3FMJBCMF -FWFM %FUFDUJPO BU %SJQ $IBNCFST

170

CO.56 Pro Flow Meter with Bubble Detection

1 • 2020

• Drip Chamber level sensors • Blood Leak sensors • Level sensors for pipes and containers

www.medicaldesignandoutsourcing.com

Proven 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 viscoelastic material that has been specified by engineers worldwide for over three decades. Sorbothane® is a highly damped polymeric solid that “flows” like a liquid under load. Its superior damping and isolation properties have been scientifically and real-world proven. Sorbothane® is ideal for engineering design applications requiring shock absorption, vibration isolation and acoustic damping.

Produced in a durometer range from 25 to 85 Shore 00 scale Sorbothane® is considered a super soft polyurethane.

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

Unique applications call for innovative solutions.

Standard Sorbothane® parts and custom engineered solutions are available to meet individual product objectives.

Sorbothane, Inc. - Innovating Shock & Vibration Solutions

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

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

For over 37 years Sorbothane, Inc. has been - and will continue to be - the innovative and trusted choice of engineers worldwide for developing materials and components that isolate vibration, attenuate shock and damp unwanted noise.

These standard products have been developed over 30 years and are selected for their specific shock absorbing and vibration isolating applications.

The Sorbothane® Standard Products Guide is available at www.sorbothane.com or by contacting Sorbothane, Inc. directly.

2144 State Route 59 Kent, Ohio 44240 Phone: 800.838.3906

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

www.sorbothane.com

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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.

Active passion for continuous improvement in all departments at all times.

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

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

Spartan Scientific Overview Spartan Scientific continues to evolve by expanding our product range and developing key components in today’s medical and analytical technology markets. Fluid Power has remained a fundamental principal of the medical world, and Spartan has recently introduced new products and new solutions specifically focused on meeting critical requirements, exceeding expectations, and creating value for medical providers, practitioners, and patients. Spartan specializes in building isolation valves, diaphragm valves, and dispensing pumps used for controlling medical medias such as water, oxygen, CO2, blood, plasma, dialysate fluid, steam, and disinfectant fluid.

NEW Product Line: APVS Series

APVS 08

Spartan Scientific recently added and developed the new Media Separated, APVS Series designed for automatic control of chemical media & processing, pharmaceutical processing, dialysis systems, artificial respiration, chemical injection systems, deionized water, potable water treatment, and more. Available in sizes ¼”, 3/8”, ½”, ¾”, and 1.0 inch, the APVS greatest strengths are the ability to handle stringent chemical control requirements. APVS Valves are bubble-tight tested and rated from vacuum up to 250 PSI in certain configurations. The APVS’s rugged actuators, pilot assemblies and valve bodies are designed for years of use.

APVS 04

SSDP 15

NEW Product Line: Series SSDP 15, 30, & 60

Spartan Scientific

SSDP 60

8510 Foxwood Court Youngstown, Ohio 44514

Spartan Scientific recently announced the release of our new product family of electro-fluidic solenoid dosing pumps. The SSDP 15 is available now while the SSDP 30 & 60 will be released in the first quarter of 2020. The SSDP Series consists of an environmentally resistant, fully encapsulated solenoid design that offers high-precision at a fixed volume, allowing finite control of fluids, making the SSDP product line the ideal choice for controlling liquids in medical, analytical and scientific applications, such as in vitro diagnostics, dialysis and biotechnology.

Phone: 330-758-8446 Toll Free: 855-629-4648 Email: customerservice@spartanscientific.com www.spartanscientific.com

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

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

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

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

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

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SERVICES OFFERED

Spectrum Plastics Group is an ISO 13485 registered contract manufacturer of extruded,

CATHETER DESIGN, DEVELOPMENT, AND ASSEMBLY

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

Spectrum Plastics Group specializes in providing advanced catheter solutions through the combination of various technologies, including tight tolerance, precision extrusion, coil/braid reinforced shafts, steerable catheters, complex balloons, 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.

footprint across the United States, Mexico, Costa Rica, Ireland, and Malaysia supply thermoplastic and silicone tubing, catheters and catheter sub-assemblies, medical balloons, injection molded components and implantable devices, medical film &packaging, and a variety of value-added and devicefinishing services. Spectrum Plastics is the

INJECTION MOLDING

largest and most comprehensive tubing

Our injection molded product solutions consist of both premium, high quality components and fully assembled devices. 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.

extruder in North America.

VALUE-ADDED ASSEMBLIES & FINISHING SERVICES Offering expert capabilities at every step of the manufacturing process — from concept to full scale production, and sterilization management — 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.

Spectrum Plastic Group 2500 Northwinds Pkwy, Suite #472 Alpharetta, GA 30009 Phone: 404-564-8560 Fax: 404-564-8579

OFFERINGS INCLUDE:

E-mail: marketing@spectrumplastics.com

• • • •

Web: www.spectrumplastics.com; webstore.spectrumplastics.com

•

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• • • • •

Design & Prototyping Development Material Selection Fabrication/Secondary Ops Solvents, UV Adhesives, Radio Frequency, and Ultrasonic welding and Plastic Bonding Automated, and Manual Assembly and Sterile Packaging Product Testing and Sterilization Management Services Quality Controls Manufacturing Transfers 510K & Regulatory Services Scalable Manufacturing

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STEUTE has specialized in designing and

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

STEUTE has been designing and manufacturing medical-grade foot switches expressly for medical device OEMs worldwide since 1952. During that period we have tooled a wide range of platforms/consoles, actuators, detents, carrying handles, and analog and digital output devices.

These components, coupled with the wide array of connectors, cables, strain reliefs and our inhouse graphics capabilities, has enabled us to address an infinite number of medical device OEM foot switch needs with our unique “off-the-shelf-custom” program.

Our staff of 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.

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

With offices in 30 countries, our worldwide team is ready to share our ideas for realizing a human interface that optimizes your device’s performance and market appeal.

• Operator comfort and ease-of-use

Each unit is developed with the following key objectives: • Optimum medical device functionality • 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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Tegra Medical makes products used in a variety of markets including: Tegra Medical provides true end-to-end contract manufacturing solutions, handling all the steps of creating your complete device or component from prototyping to full production. 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.

• 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,

Manufacturing Capabilities Tegra Medical has the expertise to manufacture complete, finished medical devices, particularly those with intricate tolerances or that require combining non-traditional with common technologies. We are renowned for keeping devices sharp throughout the entire manufacturing process. Our vast range of manufacturing technologies includes CNC milling/turning, Swiss machining, wire and sinker EDM, laser processing, CNC grinding, injection molding of various materials, metal forming, Nitinol shape setting, and gundrilling, as well as cleanroom molding and assembly.

cannulas, fixation systems, probes, wires, catheters, stylets, mandrels and many more.

See our website for details.

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

Tegra Medical 9 Forge Park Franklin, MA 02038

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.

info@tegramedical.com T: 508.541.4200 www.tegramedical.com

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ONLINE Where medical devices come to life, Tegra Medical, and GENESIS Tech Center are registered trademarks of Tegra Medical.

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A member of SFS.

www.medicaldesignandoutsourcing.com

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

Automatic Assembly Equipment Innovator

9001:2015 registered private company with over 70 years of designing, building, installing, and supporting world-class assembly, test, inspection, and packaging systems.

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.

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 heavy-duty construction methods and components, cam and servo-driven mechanisms, and state-of-the-art control and inspection systems, are our trademarks.

Through dedication, focus, and experience, AG Russell is able to meet your most demanding automation applications. Providing more than just assembly equipment; we provide you with “the edge” you need to stay competitive in your market.

THE ARTHUR G RUSSELL COMPANY

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

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

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Founded in 1948, The Lee Company is a manufacturer of miniature fluid control 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 for the medical industry include miniature solenoid valves, high-speed microdispense valves, nozzles, dispense pumps, custom manifold systems, inert tubing, check valves, pressure relief valves, safety screens, flow restrictors and associated fluid handling components.

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

Quality at The Lee Company is a company-wide, 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.

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

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.

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

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Tiodize is an advanced technology company specializing in the development, manufacturing and application of products for the prevention of friction, wear and corrosion.

Our products are utilized in an increasing broad spectrum of industries including medical, aerospace, automotive and electronics.

The company was founded in 1966 by Thomas Adams to fill the need for a special coating to reduce galling and its associated effects on titanium parts used in high performance aircraft. This coating and method of application, now widely known as the “TIODIZE PROCESS” , has been specified for the use on practically every major space, military and commercial aircraft program since its introduction.

The experience gained from aerospace and the proven ability of Tiodize to maintain high quality application over time, enabled the TIODIZE PROCESS to become the medical industry standard for titanium anodizing for titanium implants.

The TITANIUM PROCESS for anodizing aluminum has been a staple for over 50 years. Available for either Type II, to enhance biocompatibility, lubricity and anti-galling on implants.

Or, Color Anodizing. This method is primarily used for parts identification in the Operating Room. By identifying the parts by the color, the risk of mistakes is lessened dramatically.

HIGH STRENGTH COMPOSITE FASTENERS PINS • BOLTS • SCREWS • NUTS

Tiodize Co., Inc. 5858 Engineer Drive

Strongest Composite Fasteners Available Today

Huntington Beach, CA 92649 Phone: 714-898-4377

TIODIZE also designs and manufactures composite fasteners and bearings for use in medical equipment used in X-Ray environments. The composites are X-Ray transparent, lightweight and will outlast metal parts. They can also be custom made to your design requirements.

Fax: 714-891-7467 tiodize@tiodize.com www.tiodize.com

CLEANER / DEGREASER FOR USE IN FDA INSPECTED FACILITIES

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• Just apply and rinse away • D99 is being used to replace hazardous solvents • Strong and environmentally safe

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Miniaturized & high-precision complex products

Valtronic is a global full-service contract manufacturer with 35+ years of experience in turnkey devices, microelectronic assemblies, and miniaturization in the medical device industry.

Our customers appreciate the collaboration and passion of our technical experts who understand their business needs and are dedicated to producing high quality devices to achieve product expectations.

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

Leading The Way In Medical Device Innovation

have helped hundreds of companies develop

With more than one 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.

and produce Class II & III medical devices as well as advanced miniaturized electronic assemblies. Headquartered in Switzerland, our company spreads over three continents

Innovating Tiny Devices With Huge Impact

with design, development, industrialization

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.

and manufacturing sites in Switzerland, the U.S.A. & Morocco.

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

By applying expertise in electronic miniaturization technologies and medical product development, Valtronic helps its partners create compact, user-friendly therapeutic components adaptable to many medical applications.

Through engineering, design and development, project management, and manufacturing, the group can help develop turnkey solutions for all of your organization’s portable medical device needs.

29200 Fountain Parkway Solon, Ohio 44139 www.valtronic.com info@valtronic.com (440) 349-1239

Medical Equipment

FDA Registered/ISO 13485:2016

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

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End-to-End Engineering Solutions

Viant is a global strategic manufacturing

partner that helps medical device

Viant is one of the few manufacturing partners in the industry with true end-to-end solutions, from design and development through manufacturing and packaging.

OEMs bring complex medical devices and components to market. Our deep materials expertise, combined with our experience in design & development, manufacturing, assembly, and packaging, allow us to bring our customers’ medical technology solutions to life. With nearly 6,000 associates across 24 locations worldwide, we are a unique combination of big-company scale and small-company attention.

At Viant, we’re 100% focused on medical technology.

Our engineers bring both deep medical device expertise and an understanding of clinical applications.

The result is clinically effective, innovative solutions for customers serving these markets: • • • • •

Surgical Technologies Orthopedics Cardiac & Interventional Bioelectronics Drug Delivery, Diagnostics & Patient Care

Our end-to-end solutions begin with comprehensive design and development (D&D) services. Our team of almost 100 dedicated D&D engineers work with our customers to design products for optimal performance as well as optimal manufacturability.

Our materials engineers offer unparalleled breadth of expertise, including polymers, metals, and industryleading UHMWPE. With a broad understanding of clinical applications and manufacturing processes, they help customers select materials with the characteristics needed to meet performance and cost requirements.

Our production engineers use Lean Product Launch techniques to design and develop manufacturing processes and successfully launch products while minimizing risk, reducing waste, and compressing timelines.

Our team of degreed packaging engineers offers comprehensive services including packaging design and development, process validation, and testing.

Developing packaging solutions allows our customers to streamline their supply chains and optimize product launches.

For more information, visit www.viantmedical.com.

At Viant, we’re in it for life. The strength of our global engineering teams is integral to our success in partnering with customers to bring to market medical devices that positively impact lives.

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Leadership In Waterproof Connectors for Portable & Wearable Medical Applications

Yokowo Medical Connectors — Used All Over the World Headquartered in Tokyo, Japan, Yokowo has been manufacturing connectivity

Yokowo develops smaller, rugged connectors to withstand the everyday environmental hazards found in portable health care equipment. Yokowo springloaded pogo-pin connectors deliver the high reliability performance required in demanding portable, mobile and wearable medical electronic applications.

solutions for nearly 100 years. Specializing in medical connector technologies for advanced devices, Yokowo connectors are also used in the automotive, consumer, industrial and wearable markets. Yokowo’s investment in R&D continually expands its connector product offering that includes

Waterproof receptacle (IPx7)

Environmental Protection Yokowo pogo-pin connectors provide IP-rated protection. In spring-loaded connectors, this is achieved by installing an O-ring between the contact pin and housing for waterproofing. For example, Yokowo S Series designs can offer IP67-, IP68- or IP69K-rated protection against liquids like water, cleaning chemicals and more.

pogo-pin connectors, floating battery connectors, two-piece connectors, mating pads, lead sockets and more. Yokowo offers more than 5000 customization options available with SMD, through-hole, or press fit mounting options. Yokowo’s extensive global network provides support for all the stages in the product development process.

Waterproof pogo-pin (IPx7)

Durability & Reliability Yokowo’s pogo-pin contacts provide a constant mating force and can withstand the shock / vibration common in portable medical equipment. Contacts are electroplated with gold over nickel to achieve high electrical conductivity, increasing durability and corrosion resisistance required by critical clinical equipment. Advanced vaccum-plated pogo-pin contacts offer maximum durability up to 100,000 mating cycles.

Size To meet SWaP requirements, new waterproof pogo connectors can feature narrow terminal pitches of 2.5 mm.

Yokowo America Corporation USA East 3701 Algonquin Road, Suite 560 Rolling Meadows, IL 60008 847-870-1660

Flexibility Saving space and cost, pogo-pin connectors can also mate with a wide variety of surfaces.

USA West 1525 McCarthy Boulevard, Suite 222 Milpitas, CA 95035 408-545-0050

High Current Using advanced insulator technology, Yokowo pogo-pin connectors offer much higher currentcarrying capacity, up to 10A, versus standard ball technology.

www.yokowoconnector.com

S-Series High Speed Waterproof Mating Pads

Visit Yokowo online: http://www.yokowoconnector.com/

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S-Series Waterproof Family

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

AD INDEX

SALES Jami Brownlee jbrownlee@wtwhmedia.com 224-760-1055 Ashley N. Burk 737.615.8452 aburk@wtwhmedia.com Mike Caruso mcaruso@wtwhmedia.com 469.855.7344 Mary Ann Cooke mcooke@wtwhmedia.com 781.710.4659 Bill Crowley 610.420.2433 bcrowley@wtwhmedia.com Michael Ference mference@wtwhmedia.com 408.769.1188 @mrference

Accumold .................................................... 21 AllMotion ..................................................... 91 Altech Corporation ................................... 2, 3 AMETEK Haydon Kerk Pittman ................. 71 Ametek Specialty Metal Products ............. 47 Anomet Products ........................................ 68 Atlas Vac ..................................................... 92 B. Braun ...................................................... BC Bay Associates Wire Technologies, Inc. .... 30 BihlerMed .................................................... 48 binder USA .................................................. 44 Bird Precision .............................................. 83 BMP Medical ............................................... 65 Cadence ..................................................... 27 Canfield Industries Inc. ............................... 86 CGI Inc. ........................................................ 17 Chieftek Precision ......................................... 7 Clippard ....................................................... 77 Components Corporation ......................... 58 COMSOL ..................................................... 61 DATA IMAGE Corporation......................... 45 Data Modul Inc. .......................................... 24 DDL .............................................................. 79 Eagle Stainless Tube................................... 19 Emerson....................................................... 15 Eurofins Medical Device Testing ............... 41 Fabco-Air, Inc. ............................................. 40 FAULHABER MICROMO ............................ 53

Fischer Connectors ..................................... 37 Fotofab ........................................................ 26 Freudenberg Medical................................. 43 Hobson & Motzer ....................................... 75 IKO International, Inc. ................................ 72 International Polymer Engineering ........... 63 Interpower ................................................... 93 Introtek International .................................. 52 J.W. Winco, Inc. .......................................... 80 John Evans’ Sons, Inc. ................................ 62 Keystone Electronics Corp........................... 5 Keystone Solutions Group ......................... 31 Lee Spring Company.................................. 11 LEMO USA .................................................. 46 Lin Engineering ........................................... 69 LINEMASTER Switch Corporation............... 9 Marox ........................................................... 29 Marshall Manufacturing ............................. 74 Master Bond................................................ 83 maxon ........................................ cover/corner maxon ................................................. INSERT MEAN WELL ............................................... 57 Medbio, Inc. ................................................ 88 MEDEFAB .................................................... 81 MICRO ......................................................... 54 MicroCare Corp. ......................................... 49 Microlumen ........................................... 34, 35 Ming Tai Industrial Co., Ltd. ...................... 90

MTD Micromolding ...................................... 4 MW Medical Solutions ............................... 78 New England Wire Technologies & New England Tubing Technologies ..... 33 Nitto Kohki USA .......................................... 22 Novotechnik ................................................ 76 NSK Precision .............................................. 89 Okay Industries ........................................... 64 OKW ............................................................ 55 Onshape ...................................................... 94 Orchid Orthopedic Solutions .................... 18 PTI Engineered Plastics .............................. 73 Qosina ......................................................... 23 Resonetics ................................................. IFC Smart Products USA ..................................... 1 Solar Atmospheres Inc. .............................. 82 SONOTEC US Inc ...................................... 42 Sorbothane.................................................. 14 Spectrum Plastics Group............................ 38 STEUTE Meditech, Inc................................ 59 Stock Drive Products/Sterling Instrument ... 80 Tegra Medical ........................................... IBC The Arthur G. Russell Co., Inc.................... 56 The Lee Company ...................................... 13 Tiodize ......................................................... 39 Valtronic ....................................................... 87 Viant Medical .............................................. 70

2020 MEDTECH LEADERSHIP

Fotofab ...................................................... 124 Freudenberg Medical............................... 125 Halkey Roberts .......................................... 126 Hobson & Motzer ..................................... 127 IKO International, Inc. .............................. 128 International Polymer Engineering ......... 129 Interpower ................................................. 130 Introtek International ................................ 131 J.W. Winco, Inc. ........................................ 132 John Evans’ Sons, Inc. .............................. 133 Keystone Electronics ................................ 134 Keystone Solutions Group ....................... 135 Lee Spring Company................................ 136 LEMO USA, Inc. ........................................ 137 Lin Engineering ......................................... 138 LINEMASTER Switch Corp. ...................... 139 Marox ......................................................... 140 Marshall Manufacturing ........................... 141 Master Bond.............................................. 142 maxon ....................................................... 143 MEAN WELL USA, Inc. ............................. 144 Medbio, Inc. .............................................. 145 MEDEFAB .................................................. 146 MICRO ....................................................... 147 MicroCare Corp. ....................................... 148 Microlumen ............................................... 149 Ming Tai Industrial Co., Ltd. ..................... 150 MTD Micromolding .................................. 151 MW Medical Solutions ............................. 152

New England Tubing Technologies ........ 153 New England Wire Technologies ............ 154 Nitto Kohki USA ........................................ 155 Novotechnik .............................................. 156 NSK Precision ............................................ 157 Okay Industries ......................................... 158 OKW USA .................................................. 159 Onshape .................................................... 160 Orchid Orthopedic Solutions .................. 161 PTC ............................................................ 162 PTI Engineered Plastics ............................ 163 Qosina ....................................................... 164 Resonetics ................................................. 165 SDP/SI-Stock Drive Product ..................... 166 Smalley Steel Ring .................................... 167 Smart Products USA ................................. 168 Solar Atmospheres ................................... 169 SONOTEC ................................................. 170 Sorbothane................................................ 171 Spartan Scientific ...................................... 172 Spectrum Plastics ..................................... 173 STEUTE Meditech Inc............................... 174 Tegra Medical ........................................... 175 The Arthur G. Russell Co., Inc.................. 176 The Lee Company .................................... 177 Tiodize ....................................................... 178 VALTRONIC ............................................... 179 Viant Medical ............................................ 180 Yokowo ...................................................... 181

Accumold .................................................... 96 AllMotion ..................................................... 97 Altech Corporation ..................................... 98 AMETEK Haydon Kerk Pittman ................. 99 Michelle Flando mflando@wtwhmedia.com Ametek Specialty Metal Products ........... 100 440.670.4772 Anomet Products, Inc. .............................. 101 @mflando Atlas Vac .................................................... 102 B.Braun ...................................................... 103 Mike Francesconi mfrancesconi@wtwhmedia.com Bay Associates Wire Technologies, Inc...... 104 BihlerMed .................................................. 105 630.488.9029 binder USA ................................................ 106 Bird Precision ............................................ 107 David Geltman dgeltman@wtwhmedia.com BMP Medical ............................................. 108 516.510.6514 Cadence ................................................... 109 @wtwh_david CGI Inc. ...................................................... 110 Chieftek Precision ..................................... 111 Neel Gleason Clippard ..................................................... 112 ngleason@wtwhmedia.com Components Corporation ....................... 113 312.882.9867 COMSOL ................................................... 114 @wtwh_ngleason DATA IMAGE Corporation....................... 115 Jim Powers Data Modul Inc. ........................................ 116 jpowers@wtwhmedia.com DDL ............................................................ 117 312.925.7793 Eagle Stainless Tube................................. 118 @jpowers_media Emerson-Branson ..................................... 119 Eurofins Medical Device Testing ............. 120 Courtney Seel Fabco-Air, Inc. ........................................... 121 cseel@wtwhmedia.com FAULHABER MICROMO .......................... 122 440.523.1685 Fischer Connectors ................................... 123 @wtwh_CSeel

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

EVP Marshall Matheson mmatheson@wtwhmedia.com 805.895.3609 @mmatheson

1 • 2020

www.medicaldesignandoutsourcing.com

CONNECTWITH US! Follow the whole team on twitter @MedTechDaily

MD&O_FP_nails_01.2020_pdfx1a.pdf 1 12/16/2019 8:25:33 AM

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You can try to juggle many vendors.

Or just call us.

Don’t waste time & money dealing with multiple vendors when all you really need is one partner.

B. Braun OEM has all the capabilities to get your product from drawing board to market.

Project management, design and prototyping, engineering, quality systems, sterilization and regulatory guidance, to name a few. The best part of having all these capabilities under one roof is that they come with decades of expertise we can’t wait to share. Choose B. Braun OEM—your true outsourcing partner.

B. Braun Medical | OEM Division | USA | us.bbraunoem.com | 1-800-359-2439 ©2017 B. Braun Medical Inc. Bethlehem, PA. All rights reserved. OEM 16-5563 9/17 LMN

MEDICAL DESIGN & OUTSOURCING | FULL PAGE | 9" X 10.875" | BRN2023