Medical Design & Outsourcing - JANUARY 2017

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www.medicaldesignandoutsourcing.com JANUARY 2017

Leadership: HOW HOWARD ROOT LED VASCULAR SOLUTIONS TO A $1 BILLION BUYOUT

— and Beat the Justice Dept. Along the Way • Medical Device Enforcement Developments in the Northeast • WOMEN IN MEDTECH: Making Gains, but Not There Yet • Inside the Largest Medical Device Acquisition in History

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medicaldesignandoutsourcing.com ∞ January 2017 ∞ Vol3 No1

E D I T O R I A L EDITORIAL Founding Editor Paul Dvorak pdvorak@wtwhmedia.com @paulonmedical Executive Editor Brad Perriello bperriello@wtwhmedia.com Managing Editor Chris Newmarker cnewmarker@wtwhmedia.com @newmarker Senior Editor Heather Thompson hthompson@wtwhmedia.com Associate Editor Fink Densford fdensford@wtwhmedia.com Assistant Editor Danielle Kirsh dkirsh@wtwhmedia.com

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1 • 2017

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HERE’S WHAT WE SEE

2017: A year of continued change This year was slated to be one of profound change even before it began. The surprise election of Donald Trump is the most obvious example, but 2016 saw its fair share of churn in the C suite. Here are just a few examples: •

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AngioDynamics and Joe DeVivo parted ways last year, with Covidien veteran James Clemmer taking over the corner office.

DeVivo landed at InTouch Health, which is pioneering a telehealth network designed to securely and wirelessly link medical devices.

Titan Medical CEO John Hargrove and clinical & regulatory EVP Dr. Dennis Fowler each stepped down in 2016, as the company struggled to find the cash to fund development of its Sport robot-assisted surgery platform.

ConforMIS replaced founder & CEO Dr. Philipp Lang (who stayed on as a director) with former Integra LifeSciences president Mark Augusti.

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Smith & Nephew CFO Julie Brown moves to luxury apparel maker Burberry; Brown is due to be replaced effective March 1 by Graham Baker, currently the finance chief at generic pharmaceuticals maker Alvogen.

That trend is slated to continue into 2017, as the new administration finalizes its choices for the top spots in government. As of this writing in December, the president-elect had selected several controversial figures for key positions affecting healthcare and medtech in particular. If confirmed by Congress these nominees are likely to initiate profound changes to our healthcare system and economy.

For example, the pick for head of the Health & Human Services Dept., Rep. Tom Price (R-Ga.), an orthopedic surgeon and avowed Obamacare foe, introduced his own legislation to repeal and replace the Affordable Care Act. His plan formed the basis for House Speaker Rep. Paul Ryan’s healthcare proposal and

Brad Perriello Executive Editor Medical Design & Outsourcing bperriello@wtwhmedia.com

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would create fixed tax credits to be used for healthcare, promote health savings accounts and create state-level “high-risk pools” designed for people with existing conditions.

Seema Verma, Trump’s pick to lead the Centers for Medicare & Medicaid Services, is a healthcare consultant with extensive Medicaid experience who worked closely with Vice President-elect Mike Pence in designing the expansion of Indiana’s elderly healthcare program under the ACA. Verma helped design a system which calls for participants to pay a small monthly fee for public health insurance; a missed payment results in a 6-month lockout.

And Trump was said in early December to be considering Jim O’Neill, a Silicon Valley investor with no medical experience, to lead the FDA. O’Neill has said that the federal watchdog should stop considering efficacy when evaluating medical devices and drugs, approving them solely on the basis of their safety.

It remains to be seen how these picks will affect medtech, which is in for more changes related to the election – including the likely repeal of the medical device tax.

Changes are also taking place here at Medical Design & Outsourcing as we close our second year. We’ve expanded our reach considerably this year and will continue to do so in 2017. As part of that growth, I’m happy to write that Managing Editor Nic Abraham has stepped into a new digital marketing role for WTWH Media’s medical division.

My father, who served as a lieutenant in the U.S. Army Corps of Engineers, always said it’s the sergeants who really run the show; Nic, herself an Air Force veteran, is a shining example of that. She’s been a key part of our continued growth here at MDO and we’re so glad to still be working with her as she pursues her passion for marketing.

We’re lucky that Nic’s replacement as managing editor, Chris Newmarker, is himself so accomplished. Chris comes to us from UBM Canon, where he was a senior editor in charge of Qmed. An experienced journalist, Chris brings a wealth of knowledge to bear on the medical device industry. We’re delighted to have Chris aboard as we look ahead to 2017 and its challenges and opportunities. M

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CONTRIBUTORS

NEWMARKER

MERIN

FERRARO

FAULKNER

SCHWANGER

THOMPSON

VAN ACKER

NOVOTNY

TESCHLER

DVORAK DENSFORD

MATT VAN ACKER is an Account Manager at electropolishing specialist Able Electropolishing.

FINK DENSFORD is Associate Editor of Medical Design & Outsourcing. He has a passion for covering science, engineering and tech development and has been engaged in the scientific research world for over 5 years.

PAUL DVORAK is the Founding Editor of Medical Design & Outsourcing. He has more than 27 years of experience writing and editing technical articles and editorials covering a variety of industries.

SARAH FAULKNER is Associate Editor of Medical Design & Outsourcing. After graduating college with a degree in chemistry, Sarah embraced the dynamic world of journalism.

NEIL FERRARO chairs the mechanical technologies practice group at intellectual property law firm Wolf Greenfield, Boston.

ANDREA D. MERIN is an associate in the mechanical technologies practice group at intellectual property law firm Wolf Greenfield, Boston.

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CHRIS NEWMARKER is Managing Editor of Medical Design & Outsourcing. A professional journalist of 15 years, Chris's career has taken him from Ohio to Virginia, New Jersey and, most recently, Minnesota.

DAVID NOVOTNY is Senior Vice President of Novella Clinical’s Medical Device & Diagnostic Division and has more than 18 years of clinical research experience in hospital, CRO, medical device and biopharma environments.

TODD SCHWANGER, a Global Product Manager for Southco Inc, has over 10 years of experience in various roles at the company including engineering and project management.

LEE TESCHLER is the Executive Editor of the Design World network of websites, online resources and print publications.

HEATHER THOMPSON is Senior Editor of Medical Design & Outsourcing. She has more than a decade of experience covering technology, regulatory and business trends in the medical device and diagnostics industry.

www.medicaldesignandoutsourcing.com

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CONTENTS

medicaldesignandoutsourcing.com ∞ January 2017 ∞ Vol3 No1

DEPARTMENTS

ON THE COVER:

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8 CONTRIBUTORS

12 REGULATORY: Value-based healthcare is here to stay, and it will change everything you do

Fresh from a huge win over the U.S. Justice Dept. in a False Claims Act lawsuit, Howard Root guided Vascular Solutions to a $1 billion buyout. Here’s what he learned about leadership along the way.

FEATURES 43

Not all medical power supply makers are ready for new medical safety standards coming into effect within the next two years. The standards spell out tough-to-meet levels of electrical isolation and radiated emissions.

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Vascular Solutions’s Howard Root on leadership

Fresh from a huge legal win over the U.S. Justice Dept., Howard Root guided Vascular Solutions to a $1 billion buyout. Here’s what he learned about leadership along the way.

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PATENT PROTECTION: Three IP issues in outsourcing medical devices

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MANUFACTURING & MACHINING: What applications are best suited for electropolishing?

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THE CATH LAB: Predictions on the future of trancatheter mitral valve replacements

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CONNECTORS CORNER: A touch of the lips adjusts the microscope during brain surgery

30

ENGINEERING 911: Fixing touchscreen drift

36

TUBING TALKS: Flexible co-extrusion can replace glass in blood analysis tubes

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FDA NEW PRODUCTS: The FDA’s clearances and approvals for November 2016

72

DEVICE TALKS: A conversation with Verb Surgical CEO Scott Huennekens

Women in medtech: Making gains, but not there yet

More women are taking leadership positions in medtech, but there’s still a lot of ground to gain. And it’s not just about correcting the gender imbalance, female executives say.

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Inside the largest medical device acquisition in history

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Tougher standards for medical power supplies

Medtronic and Covidien shook the medical technology industry with a merger of unprecedented scale. Here’s an insiders’ view of the deal.

76 PRODUCTS

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HERE’S WHAT WE SEE: 2017 is a year of continued change

1 • 2017

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REGULATORY

Value-based healthcare is here to stay, and it will change everything you do

Heather Thompson | Senior Editor | Medical Design & Outsourcing |

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The Affordable Care Act has received a lot which healthcare providers are selling at a of attention, but there’s a lesser-known and loss. “You have to learn how to add value on equally monumental bit of legislation called the outcomes numerator. This is 10x more the Medicare Access & CHIP Reauthorization powerful that cost cutting, and requires Act (MACRA). It establishes a quality payment investment in innovation. This is new territory.” program that requires physicians and hospitals “Cost cutting alone cannot create value. to participate in a merit-based incentive You cannot drive cost to zero” payment system (MIPS) and an alternativeHowever, if you use a different model by payment models (APM), starting this year and calculating a value score that factors in the continuing through 2020. “avoided costs” and better outcomes, you have The ACA and MACRA have overlapping a model that offers significant value and works quality and value mandates designed to cut in healthcare. “A $1 product that saves $4 in healthcare costs by reducing complications, cost from complications has the same value as increasing patient satisfaction, and replacing buying at an 80% discount. This is powerful.” the “fee-for-service” business model with Kucklick says that more and more, a bundled reimbursement model over a healthcare providers will be asked to provide “continuum of care.” These quality and value transparent pricing along a continuum of mandates come with a blizzard of acronyms, care. Fee for service that pays for re-dos and from ACO to HCAHPS (pronounced “H-Caps”), readmissions is going away. The new model CJR and MACRA. is a bundled reimbursement for an episode Theodore Kucklick, CEO and founder of care, from pre-operative, to the procedure, of Cannuflow and author of “The Medical and recovery. Providers will be expected Device R&D Handbook,” says MACRA, unlike to provide this under an Accountable Care Obamacare, was passed with wide bipartisan Organization (ACO) structure, where the support and ensures that “value purchasing is provider is “at risk,” meaning they profit if here to stay.” they can deliver under budget, but absorb the The evolution of value-based care and costs and losses if additional care is needed, purchasing will be a long process, Kucklick says. and pay penalties for complications.

“According to Michael Leavitt, former HSS Because this is a new model of care, new Secretary under George W. Bush, we are only thinking and design will be needed to achieve five years into a 30-year process.” these goals. The old incremental improvement He warns that the model of attacking cost models won’t work anymore. Examples include alone is too simple and doesn’t make sense in the automated sponge counters acquired last healthcare. “For the past few years, healthcare year by Stryker and Medtronic. Normally these systems focused on costs. The easy wins of would never have gotten traction with physician cost-cutting are gone, and now it will take buyers, says Kucklick. But they do with hospital innovation and imagination to generate value. systems striving to drive down overall costs.

Excessive focus on cost can actually harm value This is the kind of new thinking valuewith worse outcomes.” based healthcare requires. With hospital “The currently accepted formula for consolidation and the ability to collect data, describing value is Michael Porter’s ‘V=O/C,’” outcomes can be tracked reliably for the first he says. What is possible with cutting time. Value can be quantified. Successful costs in the denominator with discounts designs and products will focus on producing is very limited, says Kucklick. There is a these outcomes and real value that reflects business break-even limit and a point at both a cost and an outcomes component. M 1 • 2017

www.medicaldesignandoutsourcing.com

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PATENT PROTECTION

Three IP issues in outsourcing medical devices You’ve developed an idea for a new medical device, and you’ve even found a manufacturer to actually create it. Don’t forget to protect your product from those who might take credit for it or create a competing product. In order to do so, keep the following three issues in mind.

Andrea D. Merin | Associate | Wolf Greenfield |

N e i l P. F e r r a r o | Shareholder | Wolf Greenfield |

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1.) Keep information confidential Whether you are meeting with a potential manufacturer or investor, or have employees working for you, it’s important to maintain confidentiality.

A discussion about your product with a potential manufacturer could be considered a public disclosure that could limit or even prevent you from seeking intellectual property (IP) protection in the future. Worse, a disclosure could spark innovation that could introduce a competing product into the marketplace or block you from access to an improved product.

One way to minimize such risks is to use a nondisclosure agreement (NDA) – sometimes referred to as a confidentiality agreement – in your business practices. (You may also want to incorporate a nondisclosure provision into your employment agreements.)

Such agreements may set out the terms under which information should be kept confidential – for example, any work or discussions relating to the product or future versions of the product, any work or discussion that falls within the scope of a product’s manufacture, or any work or discussion that falls within the scope of one’s employment. The agreement may also dictate the owner of such information, the duration of the term (for example, indefinitely, a set time period after disclosure, during a term of employment, and until the completion of the manufacturing of a product), and 1 • 2017

the consequences of disclosing such confidential information to a third party.

A signed agreement will provide the security of conducting your meetings knowing that the information you disclose is and will remain confidential.

Sometimes, however, even if you have prepared an NDA, a potential manufacturer may refuse to sign the agreement prior to meeting with you. In such instances, you may wish to consider filing for some form of IP protection before conducting any meetings. For example, you could file a provisional patent application, which would keep the invention confidential at the Patent Office and give you a year to decide whether to invest more funds into the product or to seek additional patent protection. In this example, even if your conversations with partners end up being considered public disclosures, or if the manufacturer turns around and repeats what you discussed or makes a competing product, you have already taken steps toward obtaining a patent to eventually block them from copying.

Some innovators do both: they will enter into the appropriate confidentiality agreements with their partners but will have already filed a provisional or even a regular patent application before their meeting. And during that meeting, they will limit the conversation to only that information contained in the patent application.

2.) Choose Your Contract Terms When entering into a manufacturing agreement, it is important to consider the terms of the contract, especially when they pertain to potential IP rights. During the manufacturing process, features on a device will inevitably be changed or added due to costs, availability of

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a particular component, or to improve efficiency or functionality. New versions of the product with additional features may also be developed at a later date with the assistance of the manufacturer.

Unfortunately, if a contract is silent with respect to the ownership of such changes or improvements, or if the contact terms are not clear, there may be confusion as to who owns these improvements and who has rights to commercialize them.

A simple but well-known example illustrates this issue. Suppose you invent a new chair and bring it to your contract manufacturer. They in turn suggest adding rockers to the legs. Who owns the rocking chair idea? The supplier might argue it is theirs, whereas you will argue that it is derived from your chair idea and therefore you should own it.

Further, lack of consideration for this issue at the outset could not only complicate your relationship with the manufacturer, it could also complicate your ability to obtain patent protection for one or more of your products (or product features). To avoid such confusion, consider including a section in your manufacturing contract that outlines the ownership of each product or any product improvement.

For example, a contract could specify that your company owns all of the rights to the product, including improvement rights. Alternatively, there could be shared ownership between your company and the manufacturer regarding any improvements of the product.

Whatever ownership you end up agreeing upon, also consider including contract provisions that include obligations to assign any pertinent ownership rights.

For example, if the ownership of the product, including any improvements, belongs to your company alone, your contract terms should require that the manufacturer and any employees working for the manufacturer be obligated to assign their rights to the product or product improvements to your company.

Under this example, should you decide to seek patent protection, you would be able to list your company as the applicant for the patent (in other words, as owner of the product via an obligation to assign) and make all patent-related decisions.

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3.) When to Seek Patent Protection Securing patent protection to cover your products is one way to protect your investment. For example, a patent may be used to deter or even stop a competitor from entering the marketplace with a product having the inventive features you developed. You may file utility patents to cover the functionality of your product or design patents to cover the appearance of your product. For robust protection, you may even consider obtaining both utility and design patents, or perhaps more than one of each type of patent. For example, you may try to get patents to cover the appearance and functionality of the entire device and also to cover a particular inventive feature of the product. However, your activities during both development and production of your device (for example, outsourcing) may affect your ability to obtain patent protection in the U.S. and internationally. As such, the timing for applying for patent protection is important.

Under current U.S. patent law – that is, since the America Invents Act (AIA) went into effect in 2012 – you are entitled to a patent if your invention is not “in public use, on sale, or otherwise available to the public” before you file your patent application. As mentioned above, since disclosures to a potential manufacturer may be considered public disclosures, you may consider using a confidentiality agreement or filing for IP protection before any such meeting.

With respect to the manufacturing agreement itself, the law had been unfavorable to innovators. Under prior U.S. case law, a manufacturing contract was considered a “sale” of the invention. Fortunately, a recent ruling of the Court of Appeals for the Federal Circuit held that a contract for manufacturing is not considered a public sale of the invention per se, and an innovator’s ability to protect their idea after entering into the manufacturing contract is preserved.

Although this ruling is helpful, you may consider filing for patent protection before engaging in a manufacturing contract to minimize risks. Of course, since the product can change during the manufacturing stage, one path to patent protection may be to file a provisional application before engaging in a manufacturing contract, and thereafter filing a non-provisional application including any additions or changes to the product that may have arisen during manufacturing.

With a full appreciation of these and other issues, you will be well on your way to engaging with partners to manufacture your product innovations – without losing out on the patent protection you deserve. M

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MANUFACTURING & MACHINING

What applications are best suited for electropolishing?

A cutting tool after electropolishing–burrs and displaced metal are dissolved leaving a smooth surface.

A cutting tool with a rough, as machined surface prior to electropolishing.

Medical device manufacturing is highly regulated and so requires the utmost attention to sanitation, safety and biocompatibility. Devices, regardless of whether intended for internal or external use, must be clean, defect-free and burr-free; meet stringent demands from a variety of regulators such as the FDA; and successfully pass biocompatibility testing. A few device-use concerns can be met with the proper application of electropolishing. For example: Common concerns in the medical community:

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enhanced corrosion resistance clean, sanitary, easy-to-clean surface improved microfinish - smoother surface enhanced biocompatibility fatigue life improvement burr-free surface decorative finish consistent/repeatable finish

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MANUFACTURING & MACHINING

How electropolishing works Because it’s electrochemical in nature, electropolishing uses a combination of rectified current and a blended chemical electrolyte bath to remove flaws from the surface of a metal part. Parts are fixtured on a rack and submerged into the electrolytic bath. As the current is applied, the electrolyte acts as a conductor to allow metal ions to be removed from the part. While the ions are drawn toward the cathode, the electrolyte maintains the dissolved metals in the solution. Gassing in the form of oxygen occurs at the metal surface, furthering the cleansing process.

A skilled electropolisher can remove a precise amount of material per customer instructions. Material removal via electropolishing may be as little as 0.0001 in. per surface or up to 0.002 in. per surface depending on what the

application requires. On a stainless steel part, for example, electropolishing removes the embedded contaminants and creates a chromium-rich passive layer that is 30 times more corrosion-resistant than a passivated surface.

Why electropolishing is necessary for finished medical components Although electropolishing is marked by the bright polish left on a surface, more functionality-related benefits include deburring, endurance, microfinish improvement, increased biocompatibility and corrosion resistance, as well as removal of recast layer, discoloration from heat, and other surface flaws. Fabrication processes such as stamping, grinding, machining and heat-treating all are employed to transform a metal bar,

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casting or sheet into a finished part.

As metal is bent, ground, heated and altered, the metal surfaces alter significantly. These alterations take the form of burrs, surface irregularities, scale and embedded particulate, which need to be removed before use in surgery. In many cases, these surface imperfections can be a focal point for infection or metal contamination for the patient. In addition, the imperfections may inhibit the functionality of the component, such as a blade with an edge that doesn’t cut as it should. Sometimes engineers look to coating processes to hide or mask a contaminated surface. The chief weakness of coatings is delamination.

Depending on the application (implant, tissue insertion, multipleuse or single-use surgical tools), chipping, peeling or delaminating coatings pose unique and potentially dangerous conditions for the patient.

While the coating itself may not be dangerous, exposing the poor metal surface underneath can be. Exposed burrs could break off in surgery, microscopic surface irregularities could harbor dangerous bacteria and embedded contamination can cause rust or corrosion under repeated chemical sterilization procedures. Most metalworking processes leave a metal surface porous and spongy, a condition called an “amorphous layer” of smeared metal which can be observed under 100X-300X magnification. This amorphous layer has significant air space that is perfect for trapping bacteria, water and chemicals.

Research in other fields has proven that electropolished surfaces are highly resistant to biofilm production.

Not all electropolishers are the same Electropolishing is not a commodity as some may assume – it’s also typically the last step in a sequence of manufacturing operations, so there is a lot of time and money at stake. The process takes years to master; lots of trial and error and good recordkeeping are required to discover how different part configurations, material 20

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High quality welding – visualized and documented. types and sizes react to the process. Electropolishing is not a one-size-fits-all process: Though it is highly scientific, there is an art to tailoring the process to a specific part – each part is unique and the process needs to be set up for the specific part and the application or engineer’s goals. Some important things to look for when finding an electropolisher you can trust with your medical parts: ISO 9001:2008 and ISO 13485 certification; amount of experience and history electropolishing parts; ability to work with materials or alloys other than the standard 300 series stainless steels including titanium and nitinol; and ability to control the process and hold tight tolerances. Properly electropolished parts will function better as a result of a smoother, more corrosionresistant, burr-free and biocompatible surface that is uniform and in tolerance. M 1 • 2017

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THE CATH LAB

Predictions on the future of transcatheter mitral valve replacements

David Novotny Senior Vice President Medical Device & Diagnostics Novella Clinical

| | | |

The standard of care for moderate and high-risk patients with severe aortic stenosis – transcatheter aortic valve replacement (TAVR) – may soon be matched by transcatheter replacement of a mitral valve, a market potentially four times the size of TAVR.1 Developments for TMVR and upcoming clinical trials should give hope to the millions of people unable to undergo even minimally invasive mitral valve repair.

Significant mitral valve regurgitation (leaking) occurs in 2 to 3% of the general population, affecting more than 176 million people globally, including 7.8 million in the United States.2 However, only about 70,000 mitral repair or replacement surgeries occur in the U.S. each year due to the procedure’s high risk.3 It seemed the solution was on a fast track to approval, but that is not the case. TAVR procedures have become the standard of care for prolonging lives and improving life

next four years, as well as a glimpse at the road that may lead us there.

Future headline #1: Delays in TMVR device development continue How we get there: Let innovation take its course.

Since 2000, at least 30 devices in this space have gone through benchmark and animal testing, and have entered or are ready to start clinical trials.

The setbacks these trials experienced have disappointed stakeholders, but cynics only compare the results with the rapid success of TAVR. The mitral valve has a much more complex structure than the aortic valve. A replacement must anchor a perfect seal in a space that is not a neat circle as is the aortic valve. Instead, it is a much more chaotic space between two physiologically different, beating chambers of the heart. By realistic measures, innovations abound in the TMVR device space. Almost all the

AHEAD OF US WE EXPECT TO SEE A FEW MORE HURDLES AS DEVICE MAKERS EXPLORE NEW WAYS TO ADDRESS THE VARIABILITY IN VALVE STRUCTURE FROM PATIENT TO PATIENT. quality. However, applying that same technology to mitral valves (TMVR), which work just millimeters away from aortic valves, is likely years away from the U.S. market.

Until then, here are three headlines I expect to read over the 22

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devices in clinical trials use different design strategies.

Ahead of us we expect to see a few more hurdles as device makers explore new ways to address the variability in valve structure from patient to patient, particularly

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THE CATH LAB

because the device must serve a larger, more mixed patient population than TAVR technology.

Future headline #2: Wave of TMVR device companies announce PMA submissions How we get there: Secure longterm results with long-term planning At least eight clinical trials are using TMVR devices as of fall 2016. That makes a decent mix of products that could hit the mark in terms of design. But most of these trials are early-stage. Some trials have seen suboptimal short-term mortality rates, while others have stalled from slow enrollment.

Studies will advance as longer-

term outcomes are reported which means device makers and CROs should pay close attention to how they screen participants for long-term implications. In particular, trials should aim at enrolling patients who are on optimal and stable medical regimens.

The Mitral Valve Academic Research Consortium recommends sponsors pre-define the criteria for medication dosing stability before randomization to remove any impact it might have on possible effects of the device and clinical outcomes.

Future headline #3: TMVR devices: Durable and safe in at-risk populations How we get there: Preempt ambiguous results with clearly defined endpoints The Research Consortium has identified

10 clinical endpoints for all TMVR trials: 1. Mortality 2. Hospitalization 3. Neurological events 4. Myocardial infarction 5. Access and vascular complications 6. Bleeding complications 7. Acute kidney injury 8. Arrhythmias and conduction system disturbances 9. Device and procedural success and specific device-related technical failure issues and complications as well as secondary endpoints involving quality-oflife measures 10. Functional performance and echocardiographic assessments including residual mitral valve regurgitation (MR) and perivalvular leaks4

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YOU DESIGN

The complicating factor is that MR can stem from many more pathologies than aortic valve stenosis, and can lead to more comorbidities, which blurs the endpoint data. To that end, the Research Consortium instructs TMVR trials to differentiate and stratify patients between primary and secondary (functional) MR. The success of TAVR has created an opportunity for advancing transcatheter approaches for mitral regurgitation patients. Although the future of TMVR is more complex, we will be scanning headlines for good news and waiting for the data demonstrating that TMVR devices safely reduce mitral regurgitation, prolong patients’ survival, and improve quality of life. A white paper, “Innovations in Heart Valve Technology,” is available here: http:// tinyurl.com/Innovation-in-heart M

For further reading 1. Stuart, M. Percutaneous Mitral Valve Therapy: The Next Decade. STARTUP. February 2012, Vol. 17, No. 2.

Elsevier Business Intelligence.

2. Delling, F. and Vasan, R. Epidemiology and Pathophysiology of Mitral Valve Prolapse. 2014; 129: 2158-2170 doi: 10.1161/ CIRCULATIONAHA.113.006702.

3. Persistence Market Research. Heart Valve Repair and Replacement Market Will Reach $4,712.7 million in 2020, Globally by Persistence Market Research. April 29, 2015.

4. Stone, G. et al. Clinical Trial Design Principles and Endpoint Definitions for Transcatheter Mitral Valve Repair and Replacement: Part 2: Endpoint Definitions: A Consensus Document From the Mitral Valve Academic Research Consortium. J Am Coll Cardiol. 2015 Jul 21; 66(3):308-21. doi: 10.1016/j.jacc.2015.05.049.

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CONNECTORS CORNER

The MARI, named after Dr. Pitskhelauri’s daughter, provides hands-free positioning of the microscope and adjustments to its optic system. The surgeon touches the control unit with his lips to adjust the microscope. The system is manufactured by Tolikety Co., Russia.

A touch of the lips now adjusts the microscope during brain surgery

Chris Newmarker | Managing Editor | Medical Design & Outsourcing |

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Custom cable and connectors from Germany-based ODU played a significant role in the development of a surgical microscope system that brain surgeons can adjust with their lips rather than their hands.

Removing brain tumors can be a tricky business. In Russia, the operation involves looking through a microscope while carefully making small cuts, according to ODU. Surgeons in the past had to frequently adjust the microscope for a clearer view of what they were removing.

Dr. David Pitskhelauri thought there had to be a better way, according to ODU. Pitskhelauri has a lab at Moscow’s Burdenko Neurosurgery Institute in Russia, where he is a respected neurosurgeon specializing in brain tumors and surgical epilepsy therapy.

Pitskhelauri learned over the years that surgical success is about more than knowledge and skills. Patience is also critical, said Pitskhelauri, as related by ODU. Constant manual adjustments to the surgical microscope can cause pauses in operations and suck up valuable time.

The longer the surgery lasts, the more prolonged the anesthesia, which means added stress for the patient. Shorter

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surgeries are the way to go. Pitskhelauri wondered whether it was possible for him to adjust the microscope without taking his hands out of the operational field. The saved time could be critical.

The solution that came from Moscow-based Astratech involved a complex system able to convert lip movements into control signals for the microscope. The system needed a quick response, sensitivity and precision.

Astratech director Nicolay Rozhnin relied on a team with years of experience in electronics and micro-technology.

The new system needed one more critical element, though, and it involved electrical connectors. The surgical microscope system needed cable and connectors able to provide reliable power and signal transmission, free of failure, between the control device and the control system of the surgical microscope. Off-the-shelf versions would not do. Astratech relied on a previous collaborator – subcontractor and connector manufacturer ODU – to provide customized, application-specific designs.

ODU produced cable assemblies for an important part of the overall system.

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The MARI project, as it came to be called, resulted in a somewhat heavy helmet weighing 1,100 g. But because the helmet connects to the microscope and spreads its weight across the head, it’s not a problem for the surgeon, according to ODU. The MARI system contains ODU connectors on each side of the device.

There are also additional ODU MINISNAP push-pull connectors for a total of six different cable assemblies.

The connectors ensure the power supply to the control device and small electromagnets, as well as the signal transmission to the surgical microscope.

The push-pull cable assembly in the MARI is even heated through the eyepieces on the control device to prevent viewing from fogging during surgery.

The MARI system is gaining interest in the neurosurgery world, according to ODU. There are patents for the system in the Russian Federation, the E.U., and the U.S., with surgeons presently using it in Russia and Europe. Here’s a YouTube video of the MARI-5 in action: http:// tinyurl.com/odu-mari-5 M

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ENGINEERING 911

Hold still: Fixing touchscreen drift The latest development in the digitization of healthcare infrastructure is the accelerating migration from traditional computer monitors to touchscreen devices. The transition is from a static device that simply displays information into one that is continually touched, tapped, and swiped.

Different types of touch screens present new equipment design challenges. To provide the most ergonomic user experience, it’s necessary to balance the force required to hold the display screen in position during use, while still letting users easily move and position the screen to individual preferences.

To d d S c h w a n g e r | Global Product Manager | Southco Inc. |

(ABOVE) Constant-torque hinges provide an ergonomic solution for mounting touchscreens to mobile and stationary medical equipment. Infinite positioning makes it easy and intuitive to move the display. The hinge holds the screen in place while a user enters data on the touchscreen interface.

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Design challenges Good ergonomics is important because touchscreens are the device by which critical patient data is entered and updated – whether by nurses using handheld tablets or mobile data entry stations. Data accuracy is critical, so if the hinge mechanisms mounting and supporting the touchscreens are subject to unneeded or accidental motion when used, the staff can make errors or have to repeatedly correct inputs, reducing their efficiency.

Mobility, one design challenge, impacts how touchscreens are integrated into the current generation of medical equipment. The portability of medical equipment means that machines and terminals must accommodate mobility, while still addressing capability. The mobile nurse station provides an example.

First generation models featured a display screen, keyboard, computer and wireless connectivity, all mounted on wheels to move from room to room for interactions with patients. The latest versions of these mobile systems are rapidly incorporating touchscreens to replace or supplement keyboard interfaces.

The screens are often larger than standard desktop computer displays, while some versions are heavier devices that integrate the computer and wireless communications elements into a single, touchscreen-driven system.

The touchscreens, attached to the cart by movable hinges, are usually designed for vertical and horizontal motion. This makes it easier for sharing information with patients, and for collaboration by nursing staff and other patient-care providers. It’s common to see these carts www.medicaldesignandoutsourcing.com

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ENGINEERING 911

being moved in and out of rooms on any hospital or rehab ward at a shift change.

The increasing use of touchscreens is not limited to the mobile nursing station.

For example, ultrasound systems, carts for drug dispensing, and other systems have all become mobile with the goal of reducing the time, effort and risk associated with moving patients from one location to another. In addition, constant usage by many people can create significant demands on the hinge devices holding the touchscreens.

The right hinge devices can help ensure long-term touchscreen operation that is efficient, ergonomic, and reliable.

Constant torque holds every position The technical capabilities of the latest hinge technology provide industrial

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design engineers with new options to better integrate and support the use of touchscreens in healthcare applications.

Positioning hinges make it possible to define the operating effort required to move or position doors, display screens, safety shields and lights, almost any mounted component that is opened, closed, or moved.

For touchscreens on mobile equipment and in static applications, constant torque hinges are a proven positioning technology with multiple advantages. Constant torque hinges provide smooth operation and infinite positioning of touchscreens. This allows for intuitive movement of the screen that holds it at any point throughout a full range of motion when stopped. The amount of effort required to move it is just enough

1 • 2017

Display mounts, such as Southco’s AV-D40 series, contain integrated constant torque positioning technology that makes larger, heavier monitors feel lightweight and easy to position with one-handed operation.

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to respond to deliberate motion, while holding the touchscreen in place for more casual or touch interactions.

Traditionally, this capability is accomplished with clamping or latching mechanisms, which often do not provide the infinite positioning that a constant torque hinge supplies, or the smooth flowing tactile feedback. In addition, a constant torque hinge provides one-handed operation, rather than pushing a button or flipping a lever to move the device.

Multiple users, multiple options Constant torque hinges are available in a range of precisely defined holding strengths, so medical-cart designers can select the one that ergonomically works best for how users are expected to interact with the screen. Constant torque hinges provide an intuitive interaction, which is valuable for equipment with multiple users. It’s easy to figure out how to reposition the screen just by applying the right force, rather than figuring out where to flip a lever or push a button.

State-of-the-art constant torque hinges are also engineered for long service life. With multiple daily users constantly moving and adjusting the touchscreens, this is vital. The hinges provide repeatable and consistent motion that lasts much longer than other hinges that use plastic bearings or wave washers for tension.

Constant torque hinges are also useful in another, emerging application: the handheld tablet holder. Healthcare institutions are equipping medical professionals with handheld mobile devices to streamline on-the-job responsibilities.

Carrying tablets from location to location lets healthcare professionals improve efficiency of daily tasks.

However, it can be cumbersome to carry tablets around for extended periods, so manufacturers are designing devices with special mounts that let the user effortlessly support the tablet in one hand while entering data with the other. In the same way that constant torque hinging improves positioning of stationary displays, handheld tablet mounts designed with constant torque devices let the user easily

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ENGINEERING 911

Positioning hinges provide constant torque in a compact package for smaller display mounting applications, such as mechanisms for handheld tablet operation.

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adjust the tablet to their own unique preference. When not using the handheld feature of the mount, the same mechanism can be used to affix the tablet to patient’s bed or to stand the tablet on its own – on a table for example – letting the user keep both hands free to perform other tasks.

Although most touchscreens are the size of tablets or desktop monitors, some applications are beginning to use larger,

1 • 2017

heavier screens, including systems with the computer and wireless communication hardware integrated into the unit. For these heavier devices, combining constant-torque hinges with a counterbalance can provide a more reliable, ergonomic solution.

Counterbalance hinges incorporate heavy-duty counterbalance springs that store energy and release it when the screen is repositioned. They provide an excellent solution for applications where the element being lifted has significant weight.

Pre-engineered hinge speeds final design Taking advantage of proven, constant-torque technology is a smart way to reduce design risk while saving R&D time and expense. If a design requires that an ultrasound touchscreen tilt with one to two pounds of user effort, the design team has two options: It can spend time on a design that meets the operating specs, or it can simply choose a solution that has this feature designed in.

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Pre-engineered, touchscreen positioning technology designed for the demands of the medical environment offers many advantages: • •

•

•

Their reliability has already been validated by the manufacturer and other companies that have used them.

The components allow for more streamlined designs, imparting a sleek appearance, eliminating protruding parts and reducing labor costs for installation and assembly.

Pre-optimized solutions may be specified to match equipment size, operating effort, operating environment and color, further simplifying the design.

Leading suppliers now offer more compact constant torque hinges engineered to fit more cleanly into thin profile applications

Touchscreen technology is easy and intuitive which is why its use in medical applications will continue to grow. The right hinge and positioning technology can help ensure these devices are efficient and ergonomic, helping healthcare personnel care for patients in the best manner possible. M

Close up of Southco ST-5A Hinge

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TUBING TALKS

While a glass tube (right) may break during routine handling, the LipoTube does not, a significant safety consideration for lab workers.

Flexible co-extrusion can replace glass in blood analysis tubes

Transferring blood samples using a glass capillary tube comes with certain hazards.

Although the tubes work well enough, the glass is brittle, and if it breaks in the hands of a lab technician the contamination calls for a time-consuming clean up. What’s worse than broken glass is that the lab techs handling the tubes now frequently deal with AIDS and other dangerous blood-borne viruses.

Switching to a more flexible alternative material has been a tough nut to crack.

Proposed polymer alternatives made from PETG are more expensive because of their manufacturing complexity. For instance, a polymer substitute requires a plasma treatment to prepare its inside surfaces for the heparin coating, a necessary addition that prevents blood from clotting. The end results were more costly products that were not received well in the market.

Paul Dvorak | Founding Editor | Medical Design & Outsourcing |

A MAJOR CUSTOMER TELLS THAT THE FUNCTION OF THE TUBE IS PERFECT AND THEY ARE NOW DOING A SHELF-LIFE TEST. A recent alternative, LipoPath tube, is said to be a more cost efficient, hydrophilic, glass-clear alternative. “The manufacturing method of LipoPath capillary tubes – a co-extrusion, two layers at once – eliminates the need for drying prior to plasmatreatment or heparinization, and no coating may be needed for some applications,” explains Herman Felix, director of international sales for Natvar Division.

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Precision Components Photo Etched Parts

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TUBING TALKS

The LipoPath tube (right) shows a greater capillary action than the glass tube. Because the new product is co-extruded, the capillary function is embedded in the properties of the plastic used on the inside layer.

The hunt for a less-expensive alternative has been on for many years. Even simple polycarbonate is not transparent enough. “We eventually developed the multilayer coextruded PETG tubing that has a capillary function that allows coating their inside with heparin, but without the plasma treatment,” says Felix. The inside layer gives the tube hydrophilic capability while the outside layer provides transparency and rigidity.

“A major customer tells that the function of the tube is perfect and they are now doing a shelf-life test. So the tube does what it needs to and its price is competitive against glass. And in some cases, the LipoPath tube can be used straight away in applications where the heparin coating is not required,” he says.

It is a significant development because it took years to come up with the right solution, and it is not just the function but also the cost. “The safety issue is most important. One tube bends and the other one breaks,” Felix adds. M

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FDA NEW PRODUCTS

The U.S. Food & Drug Administration’s clearances and approvals for November 2016 The FDA released the lists of devices it cleared via 510(k) and approved via PMA in November 2016:

November 2016 original pre-market approvals: Summary of PMA Originals & Supplements Approved Originals: 1 Supplements: 114

PMA Monthly approvals from 11/1/2016 to 11/30/2016 SUBMISSION NUMBER

FINAL REVIEW DECISION DATE TRACK

TRADE NAME

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P150043 11/09/2016 PMAO- QVCAD QVIEW

PMA Origi SYSTEM MEDICAL, INC.

Approval for the QVCAD System. The QVCAD System is indicated for use as an aid to the reader during screening procedures in searching images of female breasts produced by the somo.v Automated Breast Ultrasound System (screening mammography BI- RADS® Assessment Category 1 or 2, and BI-RADS Composition/Density c or d) to detect mammographyoccult lesions in regions not known to have suspicious findings.

The indicators produced by the QVCAD System are not intended to be used for diagnostic characterization of suspicious findings.

A full list of the original and supplemental approvals granted this period can be accessed via www.massdevice.com/medtech-approvals-fda-releases-november-2016-pma-approvals.

November 2016 510(k) clearances: TOTAL 510(k)s THIS PERIOD: 254 TOTAL WITH SUMMARIES: 241 TOTAL WITH STATEMENTS: 13

READ MORE ONLINE FROM MASS DEVICE

A full list of the 510(k) clearances granted this period can be accessed via www.massdevice.com/fda-releases-november-2016-510k-clearances.

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SAFETY STANDARDS

New medical safety standards coming into effect within the next two years spell out tough-to-meet levels of electrical isolation and radiated emissions. Not all medical power supply makers are ready.

LELAN D TES CH LER EXECUT I VE E D I TO R • DESIGN WORLD

T

he effects of electromagnetic interference on medical gear made headlines in the 1990s when the FDA’s Center for Devices & Radiological Health found that the presence of low-level EMI kept some sleep-apnea monitors from noticing that babies had stopped breathing. EMI was also the culprit in other problems back then, ranging from power wheelchairs that started rolling when EMI caused their brakes to release, to EMI from electrosurgery units that made anesthetic gas monitors stop working.

Fast-forward to today: Design practices to prevent EMI have grown more stringent. But the potential for interference problems have risen with the pervasive use of wireless technology in all manner of medical gear. In particular, the switching power supplies now nearly ubiquitous in medical equipment are getting close scrutiny for RFI problems because of their potential for radiating harmful interference.

Most modern switching supplies internally operate in the range of hundreds of kilohertz to a few megahertz. That means the strongest upper harmonic frequencies they generate tend to

be not much higher than a few tens of megahertz – typically not an interference problem for modern-day wireless gear. But the next generation of new designs for switch-mode power supplies push operating frequencies higher as a way of cramming circuitry into smaller and smaller volumes.

An indication of the trend can be seen in the recently developed Dart power supply from Finsix, a start-up with roots in the Mass. Institute of Technology. The Dart fits in the palm of your hand but puts out 65 W, as much as a conventional brick power supply for laptops. The key to its small size is its switching power supply operating at VHF switching frequencies – around 100 MHz, per company literature. That puts its strongest upper harmonics squarely in the UHF frequency bands occupied by communication gear such as the Global Positioning System and narrowband radio modems used for controlling power distribution networks.

The concern over interference problems is such that the newest version of EN60601-1-2, the International Electrotechnical Commission (IEC) 60601-1-2 safety standard for medical equipment, calls for tougher levels of EMI and RFI (radio frequency interference) performance.

www.medicaldesignandoutsourcing.com

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SAFETY STANDARDS

Problem is, the EMI/RFI provisions in this standard have been handled in a way that has caused confusion among users and makers of power supplies. “The third edition [of EN606011] is still in force for safety requirements. The

Many medical power supplies are no bigger than conventional industrial supplies despite the requirement for lengthier creepage and clearance distances.

An example is the CUS200M series from TDK-Lambda with fits in an industry standard 3 x 5-in. footprint and is suitable for B and BF-rated equipment.

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fourth edition [which contains the new EMI/ RFI requirements] will come into force for some parts of the world in 2017. By end of 2018, it will be required everywhere,” says Kevin Parmenter, VP applications at power supply maker Excelsys Technologies and chair of the Power Sources Manufacturers Assn.’s safety and compliance committee.

“To be compliant, you have to meet both the third-edition and fourth-edition specs now.

Big manufacturers have already done fourthedition compliance because it can take three to five years to get a new design into production.

And meeting the EMI levels spelled out in the fourth edition is challenging because of all the noise a switching supply generates. But power supply makers that use well-defined design methodologies should be in good shape.”

1 • 2017

Power supply makers are also having to make design changes to meet requirements spelled out in the third edition of EN 60601-1-2. For one thing, the third edition calls for more isolation of circuit components. Creepage and clearance allowances have grown. Creepage is the shortest path between two conductive parts (or between a conductive part and the bounding surface of the equipment) measured along the surface of the insulation.

Creepage distance protects against tracking, a process that produces a partially conducting path of localized deterioration on the surface of an insulating material as a result of electric discharges near an insulation surface.

Clearance is the shortest distance between two conductive parts (or between a conductive part and the bounding surface of the equipment) measured through air.

Clearance distance helps prevent dielectric breakdown caused by the ionization of air. The dielectric breakdown level is also influenced by relative humidity, temperature and degree of pollution in the environment.

To make matters a bit more confusing, the creepage and clearance distances spelled out in the third edition of EN 60601-1-2 must be further increased to handle another requirement: Operation at altitudes above 5 km. High-altitude safety is now mandated in China via the Chinese standard GB 4943.1-2011 and is becoming important in Chile, India, Peru and other countries with mountainous terrain. The creepage and clearance distances that are adequate for safety at sea level aren’t acceptable at high altitudes. The reason: Air’s capacity to act as an insulator diminishes with altitude, forcing designers to position conductors farther apart in the interest of safety.

Designers typically plan for high altitudes by employing a printed circuit board layout standard called IPC-2221B, then applying a multiplier to the distances it specifies – usually 1.48 X.

www.medicaldesignandoutsourcing.com

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SAFETY STANDARDS

But not all power supply makers currently meet third-edition requirements.

“Some suppliers who aren’t good at it are still in the second edition, even though the third edition is the current law of the land for safety,” says Parmenter.

“There are probably over 500 suppliers worldwide that market internal power supplies. Probably less than 10 make products you’d want to put in a medical system. Compliance really thins the herd.”

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The third edition of IEC 60601-1 also spells out that equipment exhibit a high degree of isolation between the AC input to the power supply, the internal highvoltage stages, and the DC output. For example, medical supplies that operate from a 240-Vac mains must withstand a dielectric test at 4 kVac for medical applications (compared to 3 kVac for industrial applications).

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Though adherence to the third and fourth edition of IEC/EN 60601-1 is not universal in medical power supplies, some units do meet these new standards. An example is the CUS350M medical and ITE certified 350W power supplies from TDK-Lambda. Input to output isolation is 4 kVac and 1.5 kVac input-toground and output-to-ground.

More stringent as well is the treatment of “touch current.” Touch currents refer to those that may follow leakage paths from an enclosure to a patient or operator. Touch current levels allowed within the third edition of IEC 60601 are no more than 100 μA for normal operation and 500 μA for a single fault condition.

1 • 2017

Medical Design & Outsourcing 45

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SAFETY STANDARDS

Breakdown voltage vs. pressure in air (assuming a 0.1-in. gap)

Touch current differs from the total patient leakage current. The total patient leakage current test measures the leakage current when all parts of the medical device that touch the patient are, in fact, in contact with the patient. The test is designed to ensure the patient is protected when there are multiple connections and leakage paths.

The distances between conductors must increase at high altitudes because it takes much less voltage to traverse an air gap at low atmospheric pressures.

Paschen curves, named for Friedrich Paschen, give the breakdown voltage of parallel plates in a gas as a function of pressure and gap distance. Paschen was the first to find the voltage necessary to arc across the gap decreased up to a point as the pressure was reduced.

It then rose, gradually exceeding its original value. He also found that reducing the gap with normal pressure caused the same behavior in the voltage needed to cause an arc. The relationship displayed here is the Paschen Curve for air determined with two flat parallel copper electrodes, separated by 0.1 inch, for pressures between 3x10-2 Torr and 760 Torr. The curves are slightly different for gasses other than air.

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SAFETY STANDARDS

In leakage-current measurements, the concept of an “applied part” is important. The term “applied part” refers to the portion of the medical device that may physically touch the patient during normal operation. The 60601-1 standard divides applied parts into three classifications going from least- to moststringent shock protection levels: B (body), BF (body floating), and CF (cardiac floating).

Type B applied parts may be connected to earth ground. Type BF and CF are separated from earth and are considered floating. Power supply isolation voltages vary depending on the type rating.

Type B classification goes on applied parts that are normally not conductive and can be immediately released from the patient.

Examples include MRI body scanners and hospital beds. Type BF applied parts have conductive contact with the patient or touch patients for a long duration. Examples include blood pressure monitors and ultrasound equipment. Type CF applied parts are those that may come into direct contact with the heart, such as dialysis machines.

B U ILDI N G I N CLEARAN CE AN D CREEPAGE Clearance is the shortest distance through air between two conductors. It is the path where short duration maximum peak voltage will cause damage. Creepage is the shortest distance between two conductive parts along the surface of any insulating material common to both.

The breakdown of the creepage distance is slow and depends on the dc or RMS voltage. The creepage and clearance distances required to meet medical and industrial specifications at sea level must increase to meet safety specifications and prevent breakdown at altitude.

The requirement for lower leakage currents and higher isolation levels can be met mainly by spacing circuit components farther apart.

But that doesn’t mean that medical power supplies are bigger than industrial supplies with the same power ratings.

“You might think the more severe creepage and clearance ratings would force the supply to be bigger. But you are talking an increase spacing of only few millimeters,” says TDK-Lambda Americas Inc. Director of Marketing Tom Tillman. “So medical supplies can be the same overall size as generalpurpose models. In fact, many power supply makers don’t design separate units for medical

and offer both ITE 60950 and IEC 60950-1 in a single model. Usually the only visible difference is the medical safety approval on the label and dual fuses for both the line and neutral connections, where general purpose units typically just have one.”

It ‘s also worth noting that the IEC60601-1 third edition requires a risk management process and record retention in compliance with a standard for the application of risk management to medical devices, ISO14971.

“The risk management requirement is coming from hospitals that must show a risk management process to get accreditation. These requirements trickle down to power supply makers,” says Excelsys Technologies’ Parmenter.

Meeting the IEC60601-1 risk management requirements can be a big undertaking for power supply makers because it involves aspects of the manufacturing process. It may entail meeting the requirements of another standard, ISO 13485, that spells out a quality management system for the design and manufacture of medical devices. “When medical equipment makers are evaluating a supplier of power supplies, they’ll first ask about ISO 9000, then about whether the manufacturing facility complies with ISO 13485.

Manufacturers want to know this because if you are compliant, they are,” says Parmenter. “And the ISO 9000 quality standard is a prerequisite of ISO 13485. All in all, it can take a couple years to get certified to 13485.”

Equipment makers might wonder whether they can get a qualified medical power supply from a supplier lacking ISO 13485 status.

Parmenter says that’s possible, but ISO 13485 compliance makes it easier for the equipment maker to get certification themselves.

“Eventually, it will be the law of the land that all medical power supplies will have to be made in 13485 facilities.” M For further reading: • TDK-Lambda Americas medical power supplies: https://us.tdk-lambda.com/lp • Excelsys Technologies medical power supplies: http://www.excelsys.com/overview/ • Paschen’s law: https://en.wikipedia.org/wiki/ Paschen%27s_law

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www.medicaldesignandoutsourcing.com

1/13/17 12:45 PM

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LEADERSHIP

?

What is

Leadership IN A WOR D, I T CO ME S DO WN T O CU LT U RE .

Finding examples of strong leadership is much easier than pinning down a good definition of the concept. Take for example Howard Root, profiled in this issue – leadership lessons abound in Root’s 20-year journey as co-founder & CEO of Vascular Solutions, particularly his winning battle against federal prosecutors.

Then there’s the cadre of female executives we spoke with about the state of women in medtech, and the trove of fine leadership examples from their collective decades of experience in the industry.

An actual definition of leadership is more elusive, so we asked for some insight from a pair of folks with unique perspectives on the field.

GREAT LEADERS HAVE PASSION THAT’S INFECTIOUS. “The leader sets the culture of the organization by his or her example. I've seen so many companies over the years, and without fail the culture directly reflects the values of its leader,” said Mike Travis, principal at executive recruiting firm Travis & Co. “If the CEO treats people with respect, you see that through the organization.

If he treats people poorly, that trickles down, too. The same goes for other values – if the CEO cuts corners to make a number or please investors, everyone cuts corners. If she always does the right thing, even if it means taking heat, employees model the same behavior.”

Laura Nobles, founder & CEO of PR shop Nobles Global Communication, agreed that establishing a healthy culture starts at the top.

“Great leaders have passion that’s infectious. They are transparent and committed to ongoing communication. They always do the right thing for the organization, even when it’s hard,” Nobles said. “Having worked with many CEOs over the years, I believe leadership is about assembling the right team and then building a culture that inspires and motivates that team to work together towards a shared goal.”

“Harry Truman had that sign on his desk that said, ‘The buck stops here,’” Travis added. "Good leaders live by that – they take responsibility for everything that happens in their organization, good and bad. It's worth pointing that out because these days it's increasingly rare.” www.medicaldesignandoutsourcing.com

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LEADERSHIP

Howard HOW

ROOT

GUIDED VASCULAR SOLUTIONS TO A $1 BILLION ACQUISITION,

and beat the U.S. Justice Dept. along the way

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LEADERSHIP

Fresh from a huge legal win over the U.S. Justice Dept., Howard Root guided Vascular Solutions to a $1 billion buyout.

Here's what he learned about leadership along the way.

It’s been a banner year in many ways for Vascular Solutions. Apart from top-line growth of

OT

some 17%, the company was named to the Forbes 100 Most Trustworthy Companies list and agreed to a $1 billion acquisition by Teleflex.

But the biggest win was over its most daunting challenge: Vascular Solutions went toe-to-toe with the U.S. Justice Dept. for five years and walked away with a win.

Co-founder and CEO Howard Root has been at Vascular Solutions’s helm for the entirety of its 20-year history. Not only did he guide the company through a gritty, $25 million defense against extended Justice Dept. litigation and criminal prosecution, he also helped grow Vascular Solutions from a single device and a small investment to a thriving business. The company has more than 550 employees and nearly $150 million in annual sales.

Root told Medical Design & Outsourcing that although his previous life as a lawyer helped prepare him for the storm of a DoJ investigation, it was the strength of his company and its leaders that kept the business on track.

"That's a testament to getting your work done ahead of time, so if something like this hits you from out of the blue, you can manage that while still having a business that not only sustains but grows," Root told us. "The benefit that we had was that our business was rock-solid.

We had a repeatable, sustainable business that I could unplug from for a matter of months while I was in trial, and when I came back the business was still operating. That was not only a good thing, that was a necessary thing."

Vascular Solutions faced federal charges in an alleged off-label promotion scheme for its now-discontinued VariLase varicose vein treatment, specifically a "Short Kit" version designed for treating perforator veins. Root said the charges stemmed from a disgruntled ex-sales rep who filed a whistleblower case that was picked up by federal prosecutors.

Even though the device only made up approximately 0.1% of sales, bringing in $500,000 for the company between 2007 and 2011, the ex-sales rep claimed the company was intentionally promoting the device off-label to bring in more money.

FINK DENSFORD A S S O C I AT E E DITO R

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Medical Design & Outsourcing 53

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LEADERSHIP

WE HAD A REPEATABLE, SUSTAINABLE BUSINESS THAT I COULD UNPLUG FROM FOR A MATTER OF MONTHS WHILE I WAS IN TRIAL, AND WHEN I CAME BACK THE BUSINESS WAS STILL OPERATING

The company and its employees faced intense questioning during the extended probe; Root himself faced a felony conspiracy charge.

And even though the company cooperated with the government, his employees were over-scrutinized by investigators and strong-armed in a way that made him question prosecutors’ motivations.

"The worst thing, said to my female employee, was, ‘If you do not deliver us with the answers we want to hear today, it should be made known that we have power to withhold rights and privileges provided to your natural-born son,'" Root explained at an AdvaMed panel late last year. "These are federal prosecutors.

Federal agents on a charge of off-label promotion of a product that made up

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0.1% of our sales and never harmed a single patient."

Even with a strong business and stalwart employees, Root said his experience as a lawyer and long history with the company were essential to managing the situation. A federal jury in San Antonio acquitted Root in February 2016.

"I don't think I could have managed it if I wasn't a lawyer by training. I was [also] extremely fortunate that I had started the company, so I knew everything about the company – that we had a solid business and that I was a lawyer,” Root said.

Though he had never been on the

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criminal side of the legal field, Root said his knowledge of the system and how to handle the case was vital to the successful defense effort.

"I've said many times that I've seen more companies that are destroyed by their own lawyer than by the other side's lawyer. That wasn't going to happen in our case," he explained. "You can either do too much or too little. The lawyers can get off track or on track. Someone has to be there with the legal knowledge and the details to figure out what to do next step and to make sure the lawyers don't run the process. You have to make

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LEADERSHIP

sure the business runs the lawyers who run the process."

Root credits his intricate management style, which he says shifted from "micromanagement" to "nano-management,” and the company's comprehensive record-keeping, for enabling the federal court win. Root’s defense lawyers did not have to call a single witness, he added.

Making the right hires is key Root also credits the strengths of the team he and his co-founder assembled for the win. He founded the company in 1996 with Dr. Gary Gershony, inventor of the company’s first product, the Duett arterial puncture sealing device. Since then Root has focused on creating a vertically integrated, individual empowerment organization – which takes a special focus on selecting the right personnel.

"To me, leadership starts with picking the right people to work for you, with the

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1 • 2016

right approach to the work and the right ability, and then getting them in the right position. Then continue to grow them so they can do more, in order to grow the company," he explained. "You can't just go out and buy people and put them into roles.

You have to partner with people in roles that they can grow into, because as the company grows from a single-product company to a 100-product company, your employees have to grow right along with the business."

That’s even more essential in medtech, Root said. Not only can mistakes bring on intense federal government scrutiny, but they’re also a matter of life or death for the patients you're trying to help.

"I love the medical device business because the products that we manufacture can save someone's life – and they have.

But at the same time, if the products aren't made the right way or aren't designed the right way or aren't trained the right way, they can harm patients. We have

TO ME, LEADERSHIP STARTS WITH PICKING THE RIGHT PEOPLE TO WORK FOR YOU, WITH THE RIGHT APPROACH TO THE WORK AND THE RIGHT ABILITY, AND THEN GETTING THEM IN THE RIGHT POSITION.

www.medicaldesignandoutsourcing.com

1/13/17 2:00 PM

LEADERSHIP

With screenwriter and former white-collar defense lawyer Stephen Saltarelli, Root authored the book “Cardiac Arrest: Five Heart-Stopping Years as a CEO On the Feds' Hit-List.”

to take that responsibility," Root said.

"While I'd love to give people free rein to make mistakes, when that mistake could translate into a [bad] clinical outcome for a patient, we just can't let that happen."

The employees you select have to reflect that same focus on clinically correct decisions, he added, which means delivering products that not only work, but exceed current technologies on the market.

"If we do that, the financial part of the business is easy. If you don't have that clinical focus, the financial part is impossible," Root said. "If you make a mistake, not only could you hurt someone with your product, but if they make a mistake with just one of these government rules, the corporation could get charged with a crime and someone could go to prison.”

Pondering the future With the case behind him and the Teleflex acquisition ahead, Root said his future as a leader in medtech is uncertain. The strain of seeing his employees scrutinized and threatened and the anxiety and stress associated with being investigated were a heavy load to bear, he said. Still, he doesn't want to leave his experiences behind; the investigation changed his life and will be a central part of his future.

"I don't know if I'm going to stay in medical devices. If I do, I don't want and don't think I'll be a CEO of a public company, with the responsibility that that entails," Root said. "One thing that I know is that I'm still going to be talking about this criminalization of American business and the gross misconduct that seems to be prevalent in the Dept. of Justice and prosecutorial departments across America. A lot of people who are less fortunate than me couldn't fight what I fought and won. That's going to be a passion of mine for the rest of my life." M 1 • 2017

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LEADERSHIP

MEDICAL DEVICE ENFORCEMENT DEVELOPMENTS IN THE NORTHEAST

By Maureen Ruane and Scott McBride, Lowenstein Sandler

There are more questions than answers on what a new and unconventional administration in the White House will do in 2017 in many areas, no less so in medical device enforcement. One thing is certain: whatever the course, it will need to contend with aggressive momentum on the side of federal anti-corruption enforcers, in particular in the Northeast.

Federal investigations and prosecutions for violations of the federal AntiKickback Statute (AKS), the Foreign Corrupt Practices Act (FCPA), and other anti-bribery statutes have been energetic as the U.S. Justice Dept. added resources to these efforts in recent years and enjoyed a measure of success. In international markets, device makers are compelled to contend with third-party intermediaries; supervising and controlling those entities will perpetually be a challenge.

Also, as the health care industry evolves from a fee-for-service model into a more outcomes-based model, creative arrangements among providers will increase anti-bribery scrutiny. Corruption enforcement is likely to remain robust.

On the other hand, it remains to be seen whether a series of setbacks for the government in its off-label enforcement efforts – with both the courts and juries – could spell a lessaggressive posture on this front in the future. At the least, companies in the government’s crosshairs have demonstrated that they are more emboldened than ever by these developments to fight allegations of illicit off-label marketing.

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Anti-corruption enforcement The Justice Dept. added resources to combat commercial corruption, which has and may inevitably continue to have an impact on the medical device industry. In November 2015, the agency announced it was increasing the size of its Fraud Section’s FCPA Unit by 50%. The FBI in turn established three new squads devoted to FCPA enforcement. Shortly thereafter, on April 5, 2016, the Justice Dept. announced a new FCPA Pilot Program, “designed to motivate companies to voluntarily self-disclose FCPA-related misconduct, fully cooperate with the Fraud Section, and, where appropriate, remediate flaws in their controls and compliance programs.” The Pilot Program allows self-disclosing companies to avoid prosecution altogether. In cases which the department determines warrant criminal prosecution of a selfdisclosing company, it will grant a fine reduction of up to 50% of the bottom of the applicable range under U.S. sentencing guidelines, and will further decline imposition of a monitor. Taken as a whole, these initiatives are plainly intended to dramatically increase the volume of FCPA matters.

Enforcement of the federal AKS will also likely remain a priority. The federal government has viewed its efforts to combat healthcare fraud as a tremendous return on investment – indeed, the Justice Dept. and the U.S. Health & Human Services Dept. have boasted publicly that for every dollar they spend on healthcare fraud

investigations, they recover nearly $8 for taxpayers – and its AKS and other anti-bribery investigations should continue unabated as a result.

The investigators pursuing these cases have also benefited from the Affordable Care Act, which relaxed the criminal intent standard to make AKS cases easier to prosecute. It also created the Sunshine Act, which requires healthcare companies to disclose most of their payments to physicians. The Sunshine Act has resulted in negative publicity for the industry and enabled the federal government to use the payment data to investigate corruption more effectively.

A recent example of the Justice Dept.’s success in anti-corruption is the prosecution of Olympus Corp.’s U.S. and Latin American units, announced March 1, 2016. Olympus, the largest U.S. distributor of endoscopes and related equipment, agreed to pay a staggering $646 million to resolve criminal and civil probes into illegal kickbacks and bribes to hospitals and doctors. The Justice Dept. hailed the settlement as the largest ever for violations of the AKS. Meanwhile, a portion of the company’s payout, $22.8 million, resolved similar bribery allegations in Latin America. The massive settlement was the result of an investigation that revealed Olympus made payments in various forms – research grants, consulting arrangements, luxury trips, and free equipment – to induce influential doctors to order more Olympus

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LEADERSHIP

MEDICAL DEVICE ENFORCEMENT DEVELOPMENTS IN THE NORTHEAST devices at prominent hospitals and to keep competitors’ equipment out of those hospitals.

Were it not for the ultimate outcome in the matter, Olympus’ marketing strategy appeared to have been successful. After one key doctor took a trip to Japan and received a grant from Olympus, an Olympus executive sent an email that joyfully declared, “We have received all of the orders expected and have kept [a competitor] completely out of the [hospital] system. Hooray!”

As U.S. Attorney for New Jersey Paul Fishman stated, “Kickbacks are illegal because they taint buying decisions.”

“Doctors and hospitals should decide to purchase medical devices based solely on legitimate considerations, like quality and price,” not based on “free trips, free equipment, consulting agreements or research grant money,” 7 Fishman wrote.

Another recent investigation brought by the Justice Dept. was a parallel criminal and civil qui tam case alleging that Hollister Inc. and other manufacturers of continence and ostomy care products paid unlawful kickbacks to medical device distributors such as Byram Healthcare Centers, aiming to have the distributors conduct promotional campaigns designed to refer patients to the manufacturers’ own products. Hollister settled with the Justice Dept., agreeing to pay $11.4 million to resolve the matter, and Byram Healthcare Centers agreed to pay $9.3 million. U.S.

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Attorney for Massachusetts Carmen Ortiz echoed the Justice Dept.’s dedication to these cases, stating, “We are committed to rooting out commercial bribery, especially in the healthcare industry, where the payment of kickbacks erodes patients’ trust in the quality of their medical care.

Ortiz said the “unlawful cash incentives also threaten the integrity of the healthcare system and siphon taxpayer dollars from our nation’s healthcare programs.”

But not all of the manufacturers and distributors targeted in Massachusetts agreed to resolve the matter by settling with the government. CCS Medical, one of the distributors alleged to have received kickbacks, filed a motion to dismiss the qui tam complaint.

CCS argued that the discounts were permissible under a recognized safe harbor within the AKS. The district court initially ruled in CCS’s favor and dismissed the complaint. However, the qui tam relators filed a motion for reconsideration, and the Justice Dept., highlighting its anti-corruption commitment, filed a statement of interest urging the judge to revisit the decision. The relators and the Justice Dept. had both argued that the AKS safe harbor for discounts does not shield an arrangement in which the continence and ostomy manufacturer gave price reductions to CCS. Instead, they argued that because the price reductions were contingent on CCS’s “conversion” of patients to the given manufacturer’s products, they were kickbacks and

not mere discounts. The district court granted relators’ motion for reconsideration August 24, 2016, prompting CCS to file its own motion for reconsideration and also ask the court to certify the ruling for interlocutory appeal to the First Circuit if the court does not reconsider its most recent determination. Additionally, on September 23, 2016, the Pharmaceutical Research & Manufacturers of America trade association filed an amicus brief supporting CCS’s motion, arguing that the government was unconstitutionally regulating “through a statement of interest in litigation.” The motions are pending.

Off-label enforcement The Justice Dept. also devoted considerable resources to offlabel enforcement. For example, the bureau’s FCA efforts – which frequently target illegal off-label marketing in the medical device industry – were reinforced in recent years. In September 2014, the Justice Dept. announced it was “redoubl[ing its] efforts to work alongside” qui tam relators, creating a new protocol where new complaints are immediately shared by the Civil Division and Criminal Division to determine whether a parallel criminal investigation is in order. According to the Justice Dept., it recovered more than $18.3 billion in FCA cases involving fraud against federal health care programs. Much of this comes from U.S. attorneys in the Northeast,

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LEADERSHIP

MEDICAL DEVICE ENFORCEMENT DEVELOPMENTS IN THE NORTHEAST including New Jersey, which has reportedly collected more than $1.3 billion since 2010.

The Justice Dept. also obtained a number of notable settlements in the off-label space, but a series of recent letdowns has signaled the courts’ increasing willingness to protect drug and device makers’ First Amendment right to truthful and non-misleading statements about potential off-label uses of their products. These setbacks may also signal a decreased willingness of juries to convict individuals for engaging in such behavior.

The Acclarent case is illustrative of the government’s challenges in off-label enforcement. Acclarent, a California-based medical device manufacturer, was purchased by Johnson & Johnson in 2010. In 2011, an Acclarent saleswoman filed a qui tam complaint alleging that the company marketed its Relieva Stratus microflow spacer off-label as a steroid delivery product, notwithstanding the FDA’s refusal to approve that use. The resulting federal investigation led, in April 2013, to federal indictments for two former Acclarent executives, ex-CEO William Facteau and ex-sales vice president Patrick Fabian. Facteau and Fabian were alleged to have carried on the off-label scheme.

While Johnson & Johnson ultimately settled its case with the Justice Dept., agreeing to pay $18 million to resolve the matter, Facteau and Fabian went to trial. After six weeks, a federal jury convicted the pair only of misdemeanor misbranding counts,

acquitting them of all felony charges involving willful and fraudulent conduct. The jury appeared to reject the government’s allegation that the defendants conspired to conceal from the FDA their true intent to market the spacer as a steroid delivery device. Worse yet for the government, the jury also may have convicted on the misdemeanor counts solely as a result of the trial judge’s instruction allowing use of the controversial Park Doctrine, which provides for strict liability for corporate executives with authority to prevent violations, even if they had no knowledge of the violations. The defendants appealed their convictions, arguing that, by virtue of their acquittals on the fraud counts, their misdemeanor convictions were based solely on truthful, non-misleading speech about the Stratus’ off-label use. It remains to be seen whether or to what extent the First Circuit will join the Second Circuit’s Caronia holding that such speech cannot form the basis of a prosecution.

Another setback for the government was the case against Vascular Solutions and its CEO Howard Root (see page 52). The Justice Dept. indicted Root and his company in the Western District of Texas in 2014 for conspiring to market Vascular Solutions’ Vari-Lase Short Kit, a laser energy to treat varicose veins, for unapproved uses.

The government argued that Root’s sales force had been coached to market the kit as a treatment for deep veins, even though the FDA had approved its use only for veins

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near the skin’s surface. After being instructed by the trial judge that it is not a crime to provide truthful, nonmisleading information to doctors about unapproved product uses, the jury acquitted Root and Vascular Solutions of all charges.

Summary The federal government’s aggressive anti-corruption efforts in the medical device industry have a great deal of momentum behind them.

Enforcement agencies have publicly committed to these efforts through their words and backed up those words with increased resources and impressive resolutions. Meantime, off-label enforcement in the medical device area will probably fade significantly as healthcare companies continue to challenge such allegations in court, and the federal government reassesses its posture given the recent success of some of those courtroom challenges under a new administration.

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LEADERSHIP

WOMEN IN MEDTECH: Making gains, but not there yet

More women are taking leadership positions in medtech, but there’s still a lot of ground to gain. And it’s not just about correcting the gender imbalance, female executives say.

SARAH FAULKN ER ASSOCI AT E EDI TOR When IBM Watson Health general manager Deborah DiSanzo, a 30-year medtech veteran, began as a project manager at Apollo Computer, there were plenty of women working beside her.

Three decades later, DiSanzo said, “I can now point to one woman who’s still in medtech from that.”

The anecdote illustrates the continuing gender imbalance among medtech executives. Data published in a survey conducted by LeanIn.org and McKinsey & Co. show that women hold 45% of entry level positions but only 19% of C-suite roles. For every 100 women promoted to a managerial position, 130 men climb up the ladder, according to the study.

Problems start as early as engineering school: Negative group dynamics during team-building activities make the engineering profession less appealing to women, according to an MIT study published last year. For women who continue into the medical device industry, it appears that team activities remain a challenge well into their professional careers.

Illustration courtesy of MIT

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LEADERSHIP Deborah DiSanzo Appearing on a panel at MassDevice’s DeviceTalks Boston event last year alongside DiSanzo and InfoBionic CEO Nancy Briefs, Rotation Medical CEO Martha Shadan remembered a company event featuring activities geared toward her male colleagues: paintballing or mountain biking. Briefs said that she and colleagues were once offered a choice between golf, cigars or running a half-marathon as a part of a corporate event.

The disparity between men and women in medtech is narrowing as more women take leadership positions, DiSanzo and Shadan noted. IBM Watson Health’s executive team is 40% women, according to DiSanzo, and Shadan reported that 40% of Rotation Medical’s employees are women and three of them are in the C-suite. All three executives said they enjoy great relationships with men in their field and that, most of the time, they feel respected. But there’s still room for

improvement – and it’s not just about correcting the gender imbalance, they said.

“If you just look at the statistics, they say the more inclusive, the better their performance,” Briefs noted. “I think performance at the end of the day in the business is what we’re all driving for.”

“It is important to have more women, but I think fundamentally it’s important to have divergence of thought,” Shadan added.

Make a plan for diversity—and stick to it Halt Medical president & CEO Kim Bridges – the only female CEO of a women’s health company – said that if firms want to encourage women and make their staff more diverse and inclusive, they have to have a plan.

Otherwise, it’s all just talk.

“Saying, ‘We value diversity,’ and saying, ‘We value women,’ and saying that, ‘We have succession planning,’ a lot of times just end up being words on slides,”

“I CAN NOW POINT TO ONE WOMAN WHO’S STILL IN MEDTECH FROM [WHEN I BEGAN].”

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Nancy Briefs

Bridges said. “My suggestion for companies is to put a plan together. And if I'm Medtronic, or if I'm Boston Scientific, or if I'm one of the big companies, it's a metric, just like all the other metrics you look at.”

Executives we spoke with also highlighted the importance of mentorship in molding the next generation of women leaders. Briefs said she tries to mentor at least two women annually who are in the early stages of their careers. Bridges thinks that creating mentorship programs for women and minorities – and sticking with it – is one of the best things a company can do, noting that many mentorship programs come and go with leadership changes, or they aren’t funded or supported.

Mentorship programs and open-door policies between executives and employees go a long way toward creating an atmosphere in which employees feel comfortable enough to share their ideas freely.

“I think that it starts at the top, in terms of creating a culture where it's valued for women and diversity to thrive in the company,” Bridges said.

“I THINK PERFORMANCE AT THE END OF THE DAY IN THE BUSINESS IS WHAT WE’RE ALL DRIVING FOR.”

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Kim Bridges

Jennifer Palinchik

Global Leader

“WE HAVE AN INCREDIBLE OPPORTUNITY WITH A LOT OF REALLY SMART WOMEN TO BRING THEM ALONG, AND WE HAVE OTHER WOMEN WHO ARE BLAZING THE TRAIL RIGHT NOW.”

“THERE’S A LOT MORE TALENT THAT YOU CAN TAP INTO THAT COULD REALLY BRING A DIFFERENT PERSPECTIVE THAN A CERTAIN AGE-LEVEL MALE IN THESE LEADERSHIP ROLES”

“We have an incredible opportunity with a lot of really smart women to bring them along, and we have other women who are blazing the trail right now. My hope is we can capitalize on that trend and be mentors.”

Don’t be afraid to ask if you want to advance At 36, Jennifer Palinchik is an accomplished biomedical engineer and the president of a medical device consulting firm, Jalex Medical, in Westlake, Ohio. Part of the reason she has advanced so quickly, Palinchik said, is that she wasn’t afraid to argue her case.

“I think a lot of women can be intimated by asking for something that they rightfully deserve,” she said.

“You have to have that confidence. I have been in many, many rooms and presentations where I am the only female or there's maybe three or four of us in a room of 100. I think that I know just as much as the majority of the people in there, whether they're male or female.

“I actually have a very good camaraderie with some pretty significant leaders here locally, as well as across the nation,” Palinchik said. “On the flip side, sometimes 1 • 2017

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I’ll be speaking with somebody and they’re extremely surprised at my role and my title because of my age.

It’s like, ‘Well, I do have 15-plus years of experience in this field.’”

Palinchik echoed the other executives in arguing that companies that want to be disruptive should seek out candidates who don’t fit the status quo.

“There's a lot more talent that you can tap into that could really bring a different perspective than a certain age-level male in these leadership roles,” she said.

And although Palinchik agreed that things are improving for women in medtech, she added that there’s more to be done. “I think that over some time it's definitely going to be more a level playing field across both genders,” she said. “It's going to take some time for women to get the experience to really take their expertise to the next level.”

“We have to talk about it until it goes away,” Bridges added. “It's just like sales numbers. If you stop talking about the sales numbers, they're going to stop coming in.” M Heather Thompson and Brad Perriello contributed to this article.

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LEADERSHIP

Inside the

medical device acquisition in history H E AT H E R T H O MP SO N S E N IO R E D I TO R

Medtronic and Covidien shook the industry with a merger of unprecedented scale. Here’s an inside view of the biggest medtech deal ever. rust between Medtronic and Covidien officials helped them overcome the political blowback from the two companies’ $50 billion merger of equals, which moved Medtronic’s official headquarters from Minnesota to Ireland.

That was a major takeaway when Brett Wall, former president of Covidien and current president of the neurovascular business at Medtronic, interviewed Geoff Martha, who led Medtronic’s team for the deal, at OCTANe’s Medical Investor Forum, held in Irvine, Calif., Oct. 27-28.

Back in 2014, Medtronic was three years into the leadership of Omar Ishrak and looking at what was coming Image courtesy of istockphoto.com

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down the pipeline, Martha explained. There were enough problems in the healthcare space – particularly when it came to costs and meeting the needs of providers, payers and government – that Medtronic leaders felt they couldn’t solve them with the company as it was.

That model was still very transactional, Martha said, “and we wanted to get at something much deeper in terms of meeting patient needs.” In addition, the company knew it needed more expertise, breadth and depth for globalization. “If you are thinking to build infrastructure in China, for example, scale matters,” he said.

Medtronic needed a partner that would help it further engage with providers, payers, and, most importantly, patients. “We were known for organic growth and strategic deals, but we needed to do something big,” Martha said.

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LEADERSHIP

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Martha approached Medtronic’s board and began laying out the possibilities of making an acquisition of a large medical company that would provide the needed breadth. “The board had started to warm to the idea, but we hadn’t settled on anything.” Covidien, he noted, was on the top of the list.

Then one day, Covidien CEO Joe Almeida called Ishrak and said he was going to be in the area and wanted to go to dinner.

Covidien had done its own analysis, Martha said, after making a commitment to its stakeholders to double its enterprise value before the year was out. To do that with unique tech or organic growth would be extremely difficult and take too long, so Almeida presented Ishrak with an option to purchase Covidien.

“We were a little surprised at how fast it went,” said Martha. “Getting the deal through our internal process took only a few months, from April 2014 to June 2014. There were only six people involved until the signing.”

After that, Martha said, it got more complicated. Another surprise was the different stakeholders who needed information. “It was really important to have a clear, consistent, and constant message. We had to hire a special PR team to help handle the press, retail investors and even employees.”

The big mistake “The tax inversion issue was my one regret,” Martha recalled. “It was one thing we didn’t anticipate.” The team had the technology strategy and the business strategies laid out and those, Martha said, went fairly smoothly. Tax inversion, however, became a far larger issue.

Inversion was a second-tier strategy in which the headquarters move would give Medtronic access to cash earned outside the U.S. Martha said company leaders knew the government wouldn’t like it, but they underestimated the level of objection. “When the Treasury Dept. told us it was illegal, we had to make our case. We should have checked in with key senators and the Obama administration, and explained our position earlier. Once we did explain, it dramatically changed the tone and tenor of the conversation.”

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LEADERSHIP Work with a testing laboratory you can trust Geoff Martha, LEFT, and Brett Wall, RIGHT, at OCTANe’s Medical Investor Forum.

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Martha said the mistake shook the core of leadership and made them question everything. “The only way were able to keep going was because of our trust in each other and the teams.”

The heart of the deal It was important for Martha and everyone else involved that the deal be treated as a merger of equals going into the January 2015 closing.

“It was almost like Noah’s Ark,” he said. “We had two talented, functional teams and a lot of overlap.” The exceptions to the rule were R&D and sales.

“We were able to keep both of those teams completely.”

Martha said he thinks they took Medtronic and Covidien employees by surprise, however, by announcing that every job was up for discussion. “We were looking for ambassador behavior, and we had a lot of respect for both teams.” For the transition, leadership said it would be making staffing decisions on a case-by-case basis. “To be frank, we didn’t want people who took their positions for granted. That kind of attitude can be a poison.”

“The biggest day we had was the first day,” Wall said.

Instead of making big announcements, Medtronic’s leadership presented “Mission Day,” where it broke into groups and talked about the Medtronic mission statement. “That first day was a day of reflection and contemplative thought,” Wall said.

“We knew we wanted to retain the Medtronic name and the mission,” Martha said. “What we really cared about was sharing that sense of purpose.” M

IT WAS ALMOST LIKE NOAH’S ARK. WE HAD TWO TALENTED, FUNCTIONAL TEAMS AND A LOT OF OVERLAP.

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DEVICE TALKS

DeviceTalks: A conversation with Verb Surgical CEO Scott Huennekens

Few CEOs have been given the mandate Scott Huennekens was charged with as employee No. 1 at Verb Surgical, the robotics spinout backed

by Google and Johnson & Johnson: Change everything.

“Don’t worry about capital, don’t worry about funding,” Huennekens told MassDevice.com publisher Brian Johnson recently. “Just go out and change the world.”

Many CEOs might find that daunting. Then again, most CEOs don’t have a $400 million war chest and the backing of two of the world’s most innovative companies. And, as you’ll see, Huennekens may not be your average CEO, having been involved in medical device startups for some 20 years. His previous company, Volcano, was acquired by Philips in 2015 for more than $1.2 billion.

Huennekens also discusses the mission at Verb Surgical to change the way surgery is performed and how their solution is less a product than a platform.

Below are some highlights, edited for clarity, of our chat with Huennekens at the DeviceTalks West event Dec. 12, 2016, in Newport Beach, Calif.:

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BRIAN JOHNSON: Let’s talk about Verb Surgical. I think it touches on so many things that fascinate us. First, it’s the collaboration between Google and Johnson & Johnson, and it deals with robotic surgery. It’s hitting all these awesome buzzwords. In [an earlier] discussion we talked about one of the premises that Verb Surgical is built on, that there are something like 133 million surgeries a year globally that don’t happen because of lack of access.

Talk me through that premise a little, because robotic surgery makes up what, 5% of all surgeries? The leader in robotic surgery is Intuitive Surgical right now. I would not call that a low-cost provider by any stretch. What do you see in these 133 million surgeries a year that don’t happen?

SCOTT HUENNEKENS: We’re on the fringe of this next “Medtech 3.0” era, where 1.0 was industrial devices, then 2.0, you made some devices with micro-electronics and some digital, but mainly analog. Now we’re at 3.0, where you have smart devices with machine learning capabilities, connectivity. All this stuff is free with computing power. Arguably J&J’s the biggest and the best at medtech 2.0. Google’s the best at information technology. You put them together, that’s super-exciting and intriguing.

And hey, here’s $400 million to go do it, not having to worry about financing. But again, it’s a $10 billion to $20 billion opportunity, with all of Google’s technology, J&J’s putting them together to go make this happen.

BRIAN JOHNSON: Seriously, how do you even begin to start carving this out? As much as you can share, what will the products you create look like? Or is it even a product?

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SCOTT HUENNEKENS: We think in terms of a platform. In the world of surgery, there was open surgery – that was Surgery 1.0. Then there was laparoscopic surgery – 2.0. Robotic surgery – 3.0. We think in terms of this new era of digital surgery, what we call Surgery 4.0, that a number of key opinion leaders have talked about, and we’ve adopted that language, which is to say that robotics is a tool. It will be used on open surgeries, laparoscopic surgeries. Data analytics and machine learning, again, working on open and laparoscopic procedures as a tool.

We’re not a robotics company.

We’re a platform company. There will be robotics – which are a key element – but also advanced instrumentation, advanced visualization, data analytics and machine learning. You’ve heard of things like Google Brain, TensorFlow, Deep Mind. And connectivity. All of these robots, just like

every Google driverless car, is connected, and all the data goes up and you have learning that comes back to the device. All of our devices will be connected.

But Generation 1 can have a level of information different from two years out, four years out, relative to its capability. There’s a generational, iterative process that’s going to go into this. Just like a Tesla car. I was a meeting a couple months ago – this is kind of a knock on Google. The Google guy got up and said, “Hey, over the last two or three years, we’ve got a million miles on these cars, on self-driving.” The next speaker was Tesla, and the guy got up and said, “We’ve got

a million miles in the last week.”

The last week, by putting the technology on all of their cars, every car. They’re collecting all that data, so they can have better algorithms.

They’ve got more data. It’s all about the data, which is incredible relative to a connected platform and learning.

I think that’s going to happen across medtech over the next 10 to 15 years, whether it’s with Google or IBM Watson that Medtronic is working with on their platform.

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MEDICAL CONNECTOR AND CABLE SOLUTIONS

DEVICE TALKS

THE PRODUCT IS NO LONGER ROBOTICS. THE PRODUCT IS ROBOTICS, ADVANCED INSTRUMENTS, THE VISUALIZATION, MACHINE LEARNING, THE CONNECTIVITY. THAT’S THE PRODUCT. BRIAN JOHNSON: Tesla’s a car, and that’s very tangible. But what you’re talking about as the value prop of Tesla is it’s this hivethinking automobile that works on the power of the collective. Is that similar to what you’re envisioning as a product with Verb?

SCOTT HUENNEKENS: What we’re envisioning as a product is, today I would compare it to a

LEMO offers a variety of connector solutions for medical device manufacturers:

mainframe computer. Intuitive, great company, incredible what they’ve created. We’d all be proud, super-proud. Three billion dollars in revenue, $27 billion market cap. But like mainframe computers, they had a hard time transitioning to minis to PCs to cell phones. Really only 1 company transitioned even from PCs to phones. That was Apple. Everybody else, it’s taken a

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• Metal Connectors • Plastic Connectors (PEEK or PSU) • Single-Patient Use Connectors

DeviceTalks, the live interview series from MassDevice, returns in 2017 for another season of insight from the brightest leaders in medtech.

• Hybrid and Custom Configurations • Custom Wire & Cable Assembly Solutions

Learn more about our events and stay tuned for more announcements on the rest of our 2017 season.

• ISO 13485 Certified LEMO will showcase the new HALO LED at MD&M! Visit booth #1955 February 7-9, 2017 Anaheim, CA

MINNESOTA JUNE 2017

LEMO USA, Inc. 800-444-5366 info-us@lemo.com www.lemo.com

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different company to disrupt and create that new platform.

I look at what we’re doing, what Medtronic’s doing, as moving from mainframes to PCs, where robotics and those platforms will be always there, or always on, like a PC on every desktop.

Every OR will have them.

Back to my Volcano days, we said we need to put our system in every single interventional cardiology cath lab. Five years later, we had 8,000 installed systems.

Between us and Boston Scientific, we were in every single cath lab. We had 80% of the installed base, because we said, “Hey, we’re going to have an open platform with all of these apps.”

Similarly, it’s our intention [at Verb] to be open-platform, to have multiple apps.

We put in this platform that allows it to be always there, always on, available to help you, as the surgeon, do surgery. If that’s one portion of the procedure, if it’s the entire procedure, we’re indifferent. If

that’s just using an advanced instrument with J&J on it. If it’s the advanced visualization, because now we have machine learning on visualization to help you identify a ureter or a nerve, et cetera; or if it’s the segmentation, because we can track through your procedure the steps relative to simulation and training.

All of those are going to be part of a total solution.

The product is no longer robotics.

The product is robotics, advanced instruments, the visualization, machine learning, the connectivity. That’s the product. Who cared if Lotus 123 was a little better than Excel? It doesn’t matter! The product was Microsoft Office. You had to have PowerPoint, Word, Internet Explorer. The whole thing was the product. At the same

time, you can’t be the copier, printer, fax.

It’s a shitty copier, a shitty fax. We’ve all been there. It’s got to be best-in-class in each of those segments.

It’s a platform. The vision is that it’s in every OR. Every single one of them is connected to the cloud. We have a whole suite of products at Google, Google Cloud, YouTube for organizing all the videos, 3 different machine learning algorithms with TensorFlow, Google Brain and Deep Mind, AR, VR, all their gaming stuff. Both Android and Chrome from an operating system. All the cybersecurity. M

Read the full interview online! devicetalks.com

Behind the scenes.

Ahead of the curve.

Inside the corner office.

Our clean room molding, assembly, & packaging facilities are among the finest in the industry.

Visit our website to take a virtual tour & see for yourself.

Medical & Biotechnology Manufacturing

www.medbioinc.com www.medicaldesignandoutsourcing.com

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PRODUCT WORLD

Excelitas Technologies customizable, multiwave illumination system Excelitas Technologies introduced its fluorescence illuminator X-Cite Vitae vIR to its popular X-Cite line of illuminators. Excelitas designed the customizable and multi-wavelength illumination system for high precision medical illumination and diagnostic applications. Six highpower wavelengths (400-410 nm, 450-460 nm, 500-600 nm, 625-640 nm and 780-790 nm) allow for maximum flexibility for fluorescence excitation. The high brightness and solid-state white light has adjustable color temperature and repeatable output for a ready-to-use system.

X-Cite Vitae vIR also has numerous control options that allow customers to customize the wavelengths based on the application. Customers can also customize footprint, controls and spectrum to befit different application requirements.

Excelitas Technologies excelitas.com

Ultra-low noise and power AMR sensor provides stability Providing the industry with the highest accuracy with the lowest noise and power consumption, MEMSIC added its MMC5883MA 3-axis magnetic sensor to its Anisotropic Magneto Resistive magnetic sensor line. Operating with a supply voltage of 2.16 to 3.6V and a low noise level of 0.4 mGauss total RMS noise, the magnetic sensor integrates innovative design architecture to create a dependable, high-performance solution for industrial and drone system designers who need stability for their designs.

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The new 3-axis ± 8 Gauss full-scale range (FSR) magnetic sensor has a 16-bit operation with a linearity of ± 0.2% FSR and repeatability of 0.2% FSR on each axis, allowing faster algorithms for hard and soft iron interference correction. It also incorporates on-chip signal processing with its low-profile package, measuring at 3.0 x 3.0 x 1.0 mm, and emits a low current consumption of 20uA.

MEMSIC memsic.com

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1/13/17 3:44 PM

Phihong 24V 8A lead acid battery charger designed for mobile medical applications Phihong has released its 24V, 8A lead acid battery charger, the DA200U-250A. The battery charger is designed for AGM or GEL batteries in power wheelchairs and scooters and has a USB output connector, consumer electronics control wiring and LED indicators that show the charge level of the batteries. The battery charger has built-in protection for over voltage, shortcircuit and over-temperature.

The DA200U-250A provides better than 87% average efficiency based on Level V Energy Star ratings and complies with the critical safety standards of the Rehabilitation Engineering and Assistive Technology Society of North America, Canadian Standards Association and European Committee for Electromechanical Standardization and also meets CE safety specifications.

Phihong phihong.com

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PRODUCT WORLD

Medical instrument traceability improves with Roland part marking device Roland DGA recently announced what it says is a unique device identification (UDI) barcode impact printer and direct part marking (DPM) kit. The METAZA MPX-95 UDI and optional DPM kit are used in medical settings to permanently imprint unique identifiers to scalpels, forceps and other medical instruments. The diamond stylus can mark different materials, including stainless steel, iron, titanium, platinum, gold, silver, copper, nickel and aluminum. With pinpoint accuracy, the MPX-95 can imprint GS1 standard 2D DataMatrix barcodes that can be as small as 1 square mm.

The MPX-95 also has a laser pointer that helps new users with no training to apply markings with accuracy. The optional DPM kit comes with software that allows the user to easily create unique identifiers for each instrument and a vise for marking irregular items.

Roland DGA rolanddga.com

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PRODUCT WORLD

Qosina adds Y connector hemostasis valves to product line Qosina has added four new Y connector hemostasis valves to its product line. Each latex-free valve has a rotating male luer lock or luer slip and a female luer lock sideport. The connector features an ergonomic design while the housing is made from tinted polycarbonate material that minimizes discoloration during sterilization. The silicone gasket creates a seal for secure positioning and can fit devices from 0 to 4.5 FR or 0 to 7 FR. The Class IV compliant valves are also suitable for EtO and Gamma sterilization.

The new Y connector hemostasis valves add to an already extensive line of hemostasis valves offered by Qosina that are available in other styles and sizes.

Qosina qosina.com

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Oven Industies released its 5R9-355 Temperature Contoller (Peltier Effect). It contains a mechanical enclosure with mounting holes and a user-friendly keypad menu selections with an LCD screen. The 5R9-355 is operationally similar to the 5R9-350 model that was released earlier in 2016, but offers a temperature resolution of 0.01°C and control stability of ± 0.1°C.

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The 5R9-355 Temperature Controller was designed for applications that needed a temperature control range of -40 to 250°C. Oven Industries ovenind.com

www.medicaldesignandoutsourcing.com

1/13/17 3:44 PM

Guill releases new layer extrusion tooling Guill has released a new generation of 2-to-6 layer extrusion tooling that is designed to produce the highest quality, highest material-efficient 1/8 in. to 6 in. OD tubing for automotive, medical, appliance and industrial applications. It produces smooth extrusion and layer definition of Fluropolymer and other materials for all multi-layer, multi-lumen medical tubing. It also allows thin layer combinations of polymers and adhesives to .02 mm or less.

The new tooling features precision Feather Touch Concentricity adjustments and the Seal Right System, and is designed to process all compounds.

Guill guill.com

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2017 I N T R O D U C T I O N L E A D E R S H I P

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

The medical device industry just wrapped up another record year, with blockbuster mergers grabbing headlines around the world and new, innovative technologies emerging seemingly every day.

This level of success wouldn’t be possible without the innovation, ingenuity and determination of the people who drive it: leaders. These individuals and companies are working for the growth of the entire medical device industry.

The future of medtech will build on the foundation of today’s efforts.

Medical Design & Outsourcing would like to acknowledge such achievements on the following pages.

We think they deserve recognition from you, too. Vote online for one or more of the companies listed through October.

VOTE

ONLINE

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

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

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Micro-Mold®

These minute parts are often measured in microns and are no bigger than 0.5 cubic inches; they typically weigh less than a gram. In addition to their size, these parts have very tight tolerances and must be molded efficiently and precisely — time and time again.

Accumold builds specialized molding machines for this unique capability. The machines are engineered to handle volumes from prototypes to millions per year while maintaining consistent, precise tolerances that are unique in the industry. The specialized tooling and molding for micro-sized components are only available at Accumold.

Today the company now focuses on industries that require fast turn around and complex parts for high tech industries such as Micro Electronics, Micro Optics, and Medical, as well as new emerging markets and technologies.

Our founders established high standards of quality when the company began. These standards still exist today! We still have many of the original customers that entrusted their most valuable parts production to us. We believe this is due to our professional management staff, expert tool makers, and our top notch production team.

Small Parts

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

Lead Frame / Insert Molding

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

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

Facilities

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

ONLINE

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

www.medicaldesignandoutsourcing.com

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UNRIVALED EXPERIENCE UNRIVALED RESULTS Medical manufacturing is constantly evolving. In order to compete in today’s market you need to rely on a company that has the experience to bring your design to life without compromise. This experience is why AIM Plastics is considered a premier medical plastics manufacturer.

AIM collaborates with some of the medical industry’s largest companies looking to fulfill their mid to high volume medical manufacturing needs.

Tool Manufacturing

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

Advanced Molding

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

AIM Plastics, Inc.

Scientific Processes / Quality Validation

22264 Starks Drive Clinton Township, MI 48036

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

586.954.2553 Rfq@aimplastics aimplastics.com

Pad Printing

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ONLINE

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

Assembly

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

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

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Automatic Assembly Equipment Innovator

and electronics industries. Headquartered in Bristol, Connecticut, AGR is an ISO 9001:2008 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 heavyduty construction methods and components, cam and servo-driven mechanisms, and state-of-the-art control and inspection systems, are our trademarks.

Through dedication, focus, and experience, AG Russell is able to meet your most demanding automation applications. Providing more than just assembly equipment; we provide you with “the edge” you need to stay competitive in your market.

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

VOTE

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 9001:2008 registered private company.

ONLINE

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

www.medicaldesignandoutsourcing.com

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

Our dedicated project management teams have the expertise to turn your ideas into reality.

B. Braun OEM Division B. Braun Medical Inc.

For more than 175 years, B. Braun has worked to improve the health of people.

With thousands of pioneering achievements in the medical field, the privately owned company remains at the forefront of medical innovation. The OEM Division operation has been part of B. Braun for over 30 years.

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

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

Every day, 56,000 B. Braun employees worldwide share their expertise with colleagues and customers to enhance safety for patients, doctors and nurses, and to improve working processes in hospitals and medical practices.

B. Braun Medical Inc. (B.Braun) has global headquarters in Melsungen, Germany and operations in 64 countries. In the U.S., B.Braun’s corporate headquarters is located in Bethlehem, Pennsylvania with primary manufacturing facilities in Allentown, Pennsylvania and Irvine, California.

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

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Bansbach - Easylift Motion Controls Bansbach Easylift® is a world leading manufacturer of motion control products since 1919. Our uniquely engineered products focus on product performance to provide the highest lifecycles, in the most challenging environments. We provide a wide array of motion controls which allows you to streamline your engineering and procurement. Our products include gas springs, linear dampers, large industrial shock absorbers, mini shock absorbers, rotary dampers, disk dampers, vane dampers, wire rope isolators, microhydraulics and linear actuators. Industries served Aerospace, Medical and Industrial.

Bansbach Easylift® is known for quality.

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

Advantages of Bansbach Gas springs: •

• • • • • •

Highest corrosion resistance achieved through powder coated cylinders and CeramPro® treated piston rod surfaces.

Minimal friction for the production of lowest extension forces.

Best life cycles.

Protection against vibration and light side forces.

Integrated grease chamber.

Low break away forces.

Installation and storage in any position.

Powdercoated cylinders provide and extremely durable finish and is much better than our competitors painted finish.

Customer Service - Our dedicated

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

We have locations around the globe in the US, Europe, Singapore and Japan.

Our CeramPro® Piston rod surface treatment is a new innovative

Bansbach-Easylift 50 West Dr. Melbourne, FL 32904

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

www.bansbach.com

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About binder USA binder USA is part of the global binder Group, a family-owned enterprise and one of the market leaders in the area of circular connectors. A combined total of 1,400

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

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

Reliability, quality, responsibility

3903 Calle Tecate Camarillo, California 93012 805.437.9925

Binder is a traditional company characterized by values that stand for absolute reliability towards customers, employees and service providers. Our daily operations are thereby governed by quality backed by UL listed products and various ISO certifications, including ISO 13485 for medical applications. We take responsibility for our employees.

binder-connector.us

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As technology continues to demand precision and smaller tolerances, engineers are turning to Bird Precision microdrilled inserts, fittings and filter components. We offer a high value solution in nozzle, restrictor and orifice applications, all designed with Bird Precision accuracy.

If you’re involved in product design and production, you’re always on the lookout for ways to improve manufacture, performance and quality in your products. Now is the time to investigate the wide range of accuracy and workmanship Bird Precision continues to supply for micro miniature components and assemblies.

Bird’s early experience in aircraft instrument bearings & micro assembly techniques for timing mechanisms has prepared us well for the critically demanding needs of modern instrumentation.

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

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

Ruby and sapphire materials are used exclusively because of their durable material characteristics. This economical man made crystal has amazing credentials 1. Extreme hardness, 9 mohs scale, next to diamond 2. Practically chemically inert, highly resistant to most alkalis and acids

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.

One Spruce Street Waltham, MA 02454 800.454.7369 Fax: 800.370.6308 sales@birdprecision.com birdprecision.com

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Bird’s unique manufacturing process

those most demanding applications.

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

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

This unique wire lapping method insures that our orifices are round and highly polished. .

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

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

Our orifices and micron level filters are conveniently packaged in a huge variety of stainless, plastic and brass fittings, inserts and connectors.

Bird Precision continues to focus on putting orifices and filters where you need them.

We also offer a host of standard Swagelok, Smc, Parker and Value Plastics, retrofits

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

ONLINE

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

www.medicaldesignandoutsourcing.com

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Winner of 2016 Leadership in Medical Technology

Emerson leads the medical global

Unmatched Technology, Service and Support for Medical Assembly

assembly-technology market with the advanced portfolio of Branson Ultrasonic plastic joining, metal welding, and precision-cleaning equipment. Our in-depth medical-industry experience provides a competitive advantage to device manufacturers for everything from product development and regulatory compliance

Emerson is uniquely qualified to offer a “process neutral” approach, due to the extensive Branson Ultrasonics 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.

to robust manufacturing solutions. Part of Emerson since 1984, the Branson brand is now aligned with Automation Solutions, committed to providing our customers with the solutions they need in today’s challenging marketplace.

www.bransonultrasonics.com Americas: 203.796.0400 Europe: 49.6074.497.0 | Asia: 86.21.3781.0588

Branson Ultrasonics Corp.

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

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ONLINE

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

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

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

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

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

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Market Leadership Through Design Innovation Founded in 1928, C&K is one of the world’s most trusted brands of high-

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C&K’s switch portfolio is comprised of high performance and high reliability switches for the mission critical applications found in the medical industry. Key attributes for medical products include high reliability, miniature size, long cycle life, sealing to IP67/IP68, and corrosion resistance against body fluids. C&K is uniquely positioned to address the needs of the medical device industry, whether the application is a surgical device in a hospital operating room or a vital signs monitor in the rapidly growing home health care market.

quality electromechanical switches. The company’s unmatched custom design

Diagnostic Equipment

capabilities are recognized globally by

C&K is a market leader when it comes to high performance tact and pushbutton switches used for the man machine interface (MMI) on diagnostic equipment. C&K has a wide portfolio of high performance pushbutton switches, miniature and ultra-miniature tact switches, and illuminated and non-illuminated rocker switches for power buttons and menu selection keys on a variety of medical diagnostic equipment.

design engineers who demand reliable switch performance. C&K offers more than 55,000 standard products and 8.5 million switch combinations to companies that design, manufacture and distribute electronics products. Used in medical, automotive, industrial, IoT, wearables,

• • • • •

telecom, consumer products, aerospace, and POS terminals, C&K products include tactile, pushbutton, snap-acting, toggle, rocker, detect, DIP, keyswitch, navigation,

Patient Monitor Clinical Lab Equipment X-Ray Equipment ECG Machines Ultrasound Equipment

rotary, slide, switchlock, thumbwheel, smart card readers, high-rel connectors

Electro-surgery & Critical Care

and custom assemblies.

C&K’s tact and pushbutton switches are well suited to the mission critical requirements of surgical and critical care equipment and are optimal choices for a variety of hand held instruments used in electro-surgery, defibrillators and endoscopy equipment. C&K miniature power switches are trusted to power ventilators and electro-surgery generators.

• • • • •

C&K

Electro-surgery instruments Anesthesia & Ventilator Machines Defibrillators Endoscopy Equipment OR Equipment

617.969.3700 www.ckswitches.com

Home Health Care & Hearing Aids

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C&K is one of the market leaders for miniature and ultra-miniature tact and slide switches used on traditional Behind the Ear (BTE), Mini-BTE, and newer In the Ear (ITE) hearing aids as well as other home health care products.

ONLINE

• • • • • • •

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Blood Glucose Testers Pulse Oximeters Digital Thermometers Blood Pressure Monitors Hearing Aids Hearing Test Equipment Wearable Medical Devices

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Cadence, Inc. is a single source contract manufacturing partner for medical device and diagnostics companies worldwide.

Cadence provides end-to-end product realization solutions focused on best-inclass total value. Cadence employs 450 people with headquarters in Staunton, VA and other locations in Pennsylvania, Rhode Island, and Wisconsin.

Major Markets Served: •

Analytical Science

•

Cardiology

•

Drug Delivery

•

Point of Care

•

IVD

•

Fluid Delivery

•

Interventional Therapy

•

Neurology

•

Biopsy

•

Dianostics

•

Endoscopy

•

Pharmaceutical

•

Orthopedics

•

General Surgery

•

Minimally Invasive Surgery

•

Opthalmology

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

• Design Services • Rapid Prototyping

Cadence, Inc.

• Certified Cleanroom Manufacturing

9 Technology Drive

• Finished Device Assembly

Staunton, VA 24401

• Complete Supply Chain Management • Final Packaging and Labeling

sales@cadenceinc.com

• Sterilization Management

Tel: 540.248.2200 Fax: 540.248.4400 cadenceinc.com

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ONLINE

We also provide a very broad set of core capabilities that are competitive and differentiated in the marketplace. Unlike most contract manufacturers, we also have significant manufacturing expertise; making new products a reality.

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

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

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

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Chieftek Precision Co., Ltd. (cpc) manufactures complete linear motion mechatronic solutions including profile linear guide, linear motor, compact linear stages, servo driver, xyz table, and gantry system for automation, machine tools and robot industries. With distribution center in California, cpc provides excellent customer service to America customers. cpc offers Germany quality, Taiwanese flexibility, prompt delivery service and very competitive cost

Chieftek Precision Co., Ltd. (cpc) includes professional managers, engineers and technicians who devote their efforts to the R&D and manufacture of high-quality linear motion components.

Beginning with its first product—MR series linear guides for precision measurement and inspection—cpc soon expanded to offer general-purpose ARC guides for automated machine tools, HRC and ERC guides for heavily loaded axes, and RR guides with roller bearings.

After intensive R&D, cpc then began offering P series ironless linear motors (with the highest thrust density and efficiency of their kind). Next came compact C series iron-core linear motors that deliver high thrust with low cogging. For users familiar with tradition belt or ballscrewdriven systems, cpc also packages its linear motors into CLS/CLMS Compact Linear Stages and subsystems. These integrate a linear motor, guide, and positioning in a turnkey package.

As linear motors cannot operate without a control system, today cpc also offers the TC1 series servo drive.

The TC1 series features high power density, easy-to-use autotuning and advanced features to let machine builders create breakthrough products.

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

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2016 A D ribbon V Ecables, R T variations I S Eof these M E Named A Dwas V founded E R in T 1956 I SwithE anM E Cicoil flat cables are used today most innovative newstill product for theinearly computers, printers, and many mainframe computers - the flat electronic ribbon devices. cable. The ribbon cable allowed compa-

2017

N N

TCicoil high-flex flat cables are the Future of Cabling. Our patented T extrusion technology produces the most high performance flat cables available with the superior attributes you’re looking for:

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Todayensuring – Innovating www.designworldonline.com/leadership

CICOIL

L E A D E R S H I P

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2016 2016

Leadership in Engineer

CICOIL

Leadership

CICOIL

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VOTE

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DESIGN WORLD DESIGN WORLD

ONLINE

January 2016 January 2016

for the Future 4 toflexible 44 gauge, also including fiber optics, tubing, or coax, so you Complete Cable Assemblies cables with sleek, ribbon cables. million potential Cicoil continues its proud history of of Cabling get theconnectors exact of cable you need Cicoil high-flex flat cables are the Future Named ribbon can cables, variations these Cicoil can provide complete cable assemblies, with any rations. Drag an innovation, with the company’s autoextrusion technology the most high perform • still Extreme Environments: Our cables perform from -65°Cproduces to flat cables are used today in most simplicity. required the customer. cable assembly is 100% tested by mated, by state-of-the-art facilityEvery in Valencia, cables available with the superior computers, printers, andand many electronic +260°C, under exposure to water, steam, chemicals, and oils attributes you’re loo By implementing the latest leanaward-winning quality system is ourCalifornia. automated test equipment.

Our devices.

• Ultra f!exible: Tens of millions of flex cycles in con the manufacturing production techniques, Submit your certified to ISO 9001 standards, including the strictFlexibility AS9100 aerospace Built-In Cicoil continues to design and manufacradius applications to receive a no-o www.designworldonline.com specification.

Cicoil Today – Innovating www.designworldonline.com In addition to the strong,flexible cable •jacketing, every Cicoil cable ture the highest quality products, with fast, Unlimited variation: Micro size toquote 400mm wide and finalcad

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responsive lead times for our custom- for the Future incorporates finely stranded, ultra-flexible 4wire conductors.

Conductors to 44 gauge, also including fibering. optics, tubing, Order and ro its proud of ers. Our efforts have earned numerousCicoil continues and shields arehistory also specially heat-treatedcan andget plated to maximize their the exact cable you need your cable in les innovation, flexibility, with the company’s autocustomer and industry awards for quality, while providing extremely long life in the most demanding • flex Extreme Environments: Our cables perform from weeks. facility Valencia, delivery, and continuous improvement,mated, state-of-the-art applications.

Cicoilinflat cables are rated for over tenand million cycles, and to water, steam, che +260°C, under exposure implementing the latest lean and our continued R&D has resulted inCalifornia. By our cables have performed for hundreds of millions of flexing cycles multiple US and worldwide patents. manufacturing production techniques, in some of the most demanding robotic, continually flexing equipment Built-In Flexibility Cicoil continues to design and manufacapplications.

In addition to the strong,flexible cable jacketing, every ture the highest quality products, with fast, Cicoil Corporation responsive lead times for our customincorporates finely stranded, ultra-flexible wire conduc 24960 Avenue Tibbitts Standard or Custom Cables ers. Our efforts have earned numerous and shields are also specially heat-treated and plated Valencia, CA 91355, USA customer and industry awards for quality, Cicoil’s patented extrusion process makes custom cables easy,extremely so you long flex life in the flexibility, while providing Phone: 661-295-1295 www.medicaldesignandoutsourcing.com delivery, and continuous improvement, can quickly get the exact cable you want.

Try our Online Fax: 661-295-0813 NEW EZ-Flexx™ applications.

CicoilConfigurator, flat cables are rated for over ten m and our continued R&Dcan hasdesign resulted in own cableour where you your in minutes and get an immediate www.cicoil.com Cable Designof cables have performed for hundreds of millions multiple USdrawing and worldwide patents. and quote!

• continually Easy to Sepa in some of the most demanding robotic, fle Visit Cicoil.com to learn more, and Strip Co applications.

Check out our many standard cables and assemblies, all available1/12/17 from 9:25 PM Cicoil Corporation or call (661) 295-1295 to speak directly • Lighter and M stock for immediate delivery.

2017

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COMSOL is a global provider of simulation software for product design and research to technical enterprises, research labs, and universities.

Its COMSOL Multiphysics® product is an integrated software environment for creating physics-based models and simulation apps. A particular strength is its ability to account for coupled or multiphysics phenomena. Add-on products expand the simulation platform for electrical, mechanical, acoustic, 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 the COMSOL Server™ product to deploy apps to their design teams, manufacturing departments, test laboratories, and customers throughout the world.

COMSOL, Inc. Burlington, MA 01803 +781.273.3322 info@comsol.com www.comsol.com

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Using a local installation of the COMSOL Server™ product, simulation specialists give colleagues and customers worldwide access to the apps they developed. Shown is an app simulating dielectrophoretic separation of red blood cells. App users can input patient blood characteristics and testing parameters to evaluate the effectiveness of the filtration process.

We at COMSOL realize that designing great products is a company-wide challenge.

Therefore, we are leading the democratization of simulation efforts by providing engineers from various fields with the software tools to collaborate and simultaneously optimize a design based on geometrical dimensions, material properties, and external conditions while including all relevant physics in the mix.

Developed specifically for solving multiphysics problems, our software is already uniquely positioned to address these complex design challenges. That is why we expanded our suite of products to include the Application Builder in COMSOL Multiphysics® and COMSOL Server™. The Application Builder provides design teams with tools to turn detailed virtual multiphysics models into easy-to-use apps.

COMSOL Server™ further allows worldwide deployment of these apps by hosting them locally and making them readily accessible through the latest web technology.

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The adoption of simulation apps makes the workflow streamlined and inclusive. Design teams can reach the optimal solution faster by providing other departments with apps to let them experiment with parameters affecting manufacturability and esthetics, for example.

With simulation apps, you do not have to be an expert in numerical simulation to suggest a design iteration based on high-fidelity multiphysics simulation results.

We are committed to continue to deliver the most efficient and robust multiphysics environment with a wide range of products for electrical, mechanical, acoustics, fluid, thermal, and chemical simulations. With the Application Builder and COMSOL Server™, we provide design teams with the software technology to bring multiphysics to everyone, from departments in their organization to customers worldwide.

To learn more, visit https://www.comsol.com/ showcase/application-builder.

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

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Colder Products Company (CPC) is the world’s leading supplier of plastic quick disconnect couplings, connectors, and fittings. We exist to help companies and entire industries change the way they think about fluid handling at the critical point of connection. By collaboratively creating rightengineered solutions, we help our customers achieve their mission and make the world a better place. CPC invented the category and to date has produced over 10,500 custom and standard products to meet the fluid handling challenges of countless industries worldwide. We never settle and continue to invent better connections and deliver worldclass fluid thinking, day in and day out.

Founded in St. Paul, Minnesota in 1978, CPC has more than 300 employees, operations in St. Paul, Germany and China, sales offices in ten countries, and more than 200 distributor partners around the globe. CPC is a Dover company.

CPC – Colder Products Company 1001 Westgate Drive,

Cleaner. Faster. Safer.

St. Paul, MN 55114 U.S.A. 800.444.2474 F: 651.645.0091

CPC quick disconnect couplings make medical device connections that are cleaner, faster and, most important, safer. Whether your application calls for non-valved or non-spill, low flow or high flow, reusable or disposable, our broad range of standard and custom-engineered components can meet your every specification. Our team is passionate about inventing the best fluid connectors in the market and continuously inventing better solutions through rigorous thinking, testing, and design. We never rest until the right solution is found for your application.

info@cpcworldwide.com cpcworldwide.com

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CPC’s products are used across a broad range of medical devices and equipment, including surgical, dialysis, blood pressure monitoring, patient therapy devices, and in vitro diagnostics.

A de facto standard in several applications, CPC connectors improve patient safety, prevent misconnections and increase the overall usability and effectiveness of medical devices. Medical device OEMs around the world choose CPC connectors because of our proven performance in operating rooms, life science labs, and home healthcare settings.

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

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DDL is a full-service testing lab that provides package, product and materials testing to the medical device industry. 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 expertise, a robust quality system and scalable capacity.

All of our testing services are delivered with integrity, professionalism and a commitment to meeting our customer’s timing needs.

Package, Product and Material Testing Experts.

DDL is an ISO/IEC 17025 accredited and ISO 9001 certified, third party test laboratory that maintains a high level of data integrity. We promote accurate data, quick turnaround times, the highest level of customer service, and superior quality systems. Our staff is involved with a number of industry organizations such as ASTM, ISO, and IoPP in order to do our job of staying on top of industry trends. We offer the highest level of technical expertise to our customers.

DDL’s single source, totally integrated approach enables globally recognized corporations to maximize product performance, reliability and safety while seamlessly achieving regulatory compliance. We work hard to build strong relationships with our clients in an effort to partner with them and assist them in getting their product to market on time. We work one on one with clients to ensure all of their testing needs are being met and to direct them to the right test the first time. Our experienced engineers can consult on package, product or material failures and initial design processes when needed.

DDL, Inc. 10200 Valley View Road Suite 101 Eden Prairie, MN 55344 800.229.4235 www.testedandproven.com

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Delivering stainless steel, high nickel alloy & titanium components to customers in medical, aerospace and high tech manufacturing.

Since its inception in1982, Eagle Stainless has a sterling record of on-time delivery, fair pricing, product quality and highly skilled employees dedicated to continuous improvement and training. Eagle has earned its reputation as a supplier of choice for off-the-shelf stainless steel products and fabricated stainless steel products.

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.

With “Eagle Eye Quality” you are assured: 100% parts made to your specifications.

100% on time delivery. 100% traceable certified material.

ISO 9001 • AS 9100 • ISO 13485

Eagle Stainless Tube & Fabrication, Inc. Call us. We are ready to help with any

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

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

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

of your metal needs!

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.

Phone: 800.528.8650 Fax: 800.520.1954 www.eagletube.com

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

• Round

• Oval

• Square

• Triangular • Rectangular • Hexagonal • and more!

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

State-of-the-art tube bending

www.medicaldesignandoutsourcing.com

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manufactures custom precision wire forms, metal stampings, coiled springs (or compression that are utilized throughout the medical, aerospace and industrial markets.

ISO 9001:2008 Certified ISO13485 Compliant Company FDA Registered Facility

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

Engineering Success Stories

Economy Spring, a division of MW Industries,

springs) torsion springs and product assemblies

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• Designed and developed two stainless steel RNS (Rigid Needle Shield) removal stampings that are now used in three different drug dispensing systems • Developed unique packaging methods to improve part introduction / throughput on cellular assembly lines by visiting manufacturing sites and working with R&D teams • Led customer NPD teams in creating new surgical device / assembly techniques that led to new FDA product listings • Created numerous implantable biopsy markers that are utilized in breast therapy for determining changes in cellular growth with minimal migration characteristics • Developed stamping techniques for piercing holes in tubing to reduce laser cutting / machining costs • Designed metal-stamped assembly techniques that eliminated costly machined components and led to overall improved product quality

Rapid Prototyping Service Highlights: • • • • • • • • •

Economy Spring, a division of MW Industries 29 DePaolo Drive Southington, CT 06489 www.mw-ind.com/brands/economy-spring 860.621.7358 Info@mw-ind.com

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Design and engineering assistance as well as manufacturing feedback In-house 3-D printing capabilities to print parts and soft tooling In-house EDM services In-house tool room Extensive range of product materials CAD/Solidworks supported models accepted No minimum quantity order No minimum fee Prototype products include: springs, wire forms, metal stampings, tubular components/needles, & related product assemblies

Laser Capabilities:

Applications:

• CNC Swiss machining • Laser machining (holes, slots, recesses, pockets, and spiral features) • Laser welding • Laser ablation • Laser marking • Machined features (threading, knurling, milling, high speed grinding, tapping, and various machined geometries) • Laser interlock features • Up to 20mm/.787” rods and tubes • Machined features with accuracies down to .0001” rods and tubes

• • • • • •

Cardiovascular products Orthopedic components Implantable products Drug delivery Cosmetic procedures Laparoscopic and endoscopic procedures • Diagnostic equipment components • And more, including those within aerospace, electronics, and fuel delivery systems

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

www.medicaldesignandoutsourcing.com

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ElectroCraft, Inc. is a global provider of dependable, application-engineered fractional-horsepower motor and motion products. The ElectroCraft Powering Innovation custom manufacturing services cover the following products: AC motors, DC motors, brushless motors, gearboxes, servo motors, AC gear motors, DC gear motors, brushless gear motors, stepping

Dependable Fractional-HP Motion, Globally

motors, linear actuators, integrated motor drives, motor speed controls, servo and stepper drives.

Our products are found in thousands of different applications from air conditioners to aircraft. While ElectroCraft provides a wide array of standard product with many configurable options, we have built our brand on custom OEM solutions that meet the precise performance, cost and quality our customers require. Utilizing our lean business process and worldwide resources, we delivery these solutions with responsive yet reliable flexibility.

The integration of our design engineering and manufacture engineering teams ensures that ElectroCraft custom LPRX solutions are innovative both on paper and efficient and exact in production. With more than 100 years of motion control engineering and manufacturing experience, ElectroCraft brings that cumulative knowledge to our life science customers’ most difficult design challenges, and our manufacturing team is unparalleled in cost effective and qualitative implementation.

ElectroCraft, Inc. 844.338.8114 www.electrocraft.com

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ElectroCraft custom motion control services are driven by our engineering innovation coupled with our long history in serving medical equipment needs. The company’s product are found in a variety of life science applications ranging from medical equipment, lab equipment, lab automation, diagnostic and surgical equipment, to ultra-quiet power wheelchair transmissions. The LRPX-Series , low-noise brushless motor and planetary gearbox family was specifically designed to address the miniaturization trend in the life science market. The new ElectroCraft LRPX-Series brushless motor is optimized to run at typical gearbox input speeds and delivers premium performance in a smaller overall package. The ElectroCraft LPRX gear motor solution can achieve the equivalent output torque and speed performance of current industry leaders with 25% more efficiency and nearly 40% smaller package size.

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

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Fischer Connectors has been designing, manufacturing and distributing high performance connectors and cable assembly solutions for 60 years. Our connectors are known for their reliability, precision and resistance to demanding and harsh environments.

Fischer Connectors’ products are commonly used in fields requiring faultless quality, such as: medical equipment, industrial instrumentation, measuring and testing devices, broadcast, telecommunication and military forces.

Primary design and manufacturing facilities are located in Saint-Prex, Switzerland, with additional ISO certified cable assembly operations in the US and Germany. Fischer

Leadership at Fischer Connectors

Connectors has eight subsidiaries and many distributors located worldwide.

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

|

800.551.0121

mail@fisherconnectors.com www.fischerconnectors.com

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Leadership at Fischer Connectors is more than just a commitment to producing some of the most reliable and innovative connector solutions on the planet. Our leadership involves a strong, long-lasting commitment to our customers, and finding new ways to help them achieve design and product goals while breaking new ground in their respective industries.

Our tradition of innovation – Fischer Connectors has been designing and manufacturing rugged, circular connectors and cable assembly solutions for more than 60 years – has served our customers well. We help designers make devices smaller, faster & smarter by imagining and manufacturing innovative connectors, data storage devices, and cable assembly solutions to fulfill industry’s ever-changing needs.

• Miniaturization & wearable connectivity solutions to reduce space, weight, and costs • Ultra-fast & reliable data transmission to transfer large amounts of data quickly (USB 3.0, HDMI, Ethernet, etc.) & safely • Sealing & ultra-ruggedness to protect equipment against environmental stresses (corrosion, radiation, temperature, chemicals, etc.)

• Complete cable assembly solutions designed and manufactured in ISOcertified and ITAR registered facilities. www.medicaldesignandoutsourcing.com

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

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Fluid Metering, Inc. (FMI) manufactures unique, patented, valveless piston metering pumps and dispensers.

FMI Pumps utilize only one moving part, a rotating and reciprocating ceramic piston to accomplish all fluid control functions within the pumps, thereby eliminating valves and their associated maintenance.

Flow rates range from 2.5 µl/dispense to flows of 4,600 ml/min with pressures to 100 psig.

FMI pumps will dispense and meter fluids for millions of cycles with a drift free accuracy precision of 1% or better.

These pumps are ideal for Medical Applications including precise dispensing, aspirating, rinsing, & mixing systems and for syringe pump replacement in diagnostic, clinical chemistry, dialysis and medical equipment manufacturing.

Also for dispensing adhesives and lubricants used in assembly of disposable medical components.

Ideal in other industries with typical applications including fluid metering, dispensing and sampling for chemical process, laboratory, pilot plant, food processing, water treatment, and environmental analyzers.

Ultra-Precise Fluid Control. . . from Microliters to Liters FMI is a metering pumps and dispensers manufacturer, who pioneered the first valveless rotating and reciprocating piston metering pump concept over 56 years ago. Enhanced and improved over the years FMI metering pumps continue to provide innovative fluid control solutions. Our dispensers and metering pumps are the industry standard for high degree of accuracy, precision and reliability.

Utilized in a broad range of Medical, Laboratory, Analytical, Industrial Process, Environmental and OEM applications requiring precision fluid control, FMI pumps have provided users with the ultimate performance Our Unique Valveless Pump Design Features: • Patented “No-Valve” Pump Design Eliminates problems and errors caused by valves which clog, leak, hang up, and require service.

One Moving Part!

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

Fluid Metering, Inc. 5 Aerial Way, Suite 500 Syosset, NY 11791 USA 516-922-6050

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

800-223-3388 Fax: 516-624-8261 Pumps@fmipump.com www.fmipump.com

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Metering Pumps and Dispensers

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• Proven Performance!

Over 56 years of experience and more than 1 million metering pumps and dispensers in service.

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Precision metal fabrication for med-tech companies.

Celebrating 50 years, Fotofab is committed to suppling high quality, custom etched-metal components to a wide range of leaders in the aerospace, defense, medical, industrial, and electronics industries. We are ISO 9001:2008 certified and we are working toward AS9100 certification, which is projected for 2017 implementation. 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

Delivering the Highest Quality Custom EtchedMetal Components, since 1967

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.

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

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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 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.

www.medicaldesignandoutsourcing.com

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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 Titanium to Tungsten to Molybdenum, 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.

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In 1958 Helical invented the beam style HELI-CAL Machined Spring®:

flexible shaft coupling by taking a novel concept and developing the method to generate the versatile HELI-CAL® Flexure into a piece of stainless steel. Over time, the adaptability of the HELI-CAL Flexure in flexible couplings, u-joints and machined springs has helped to solve thousands of mechanical misalignment problems.

Helical Products Company manufactures parts that provide a competitive edge combining simplicity of manufacture/ assembly with durability and quality in a

The HELI-CAL Flexure used as a machined spring is a single piece of material machined into a spring configured as either a compression, extension, torsion, lateral translation or lateral bending spring, to specific design requirements that provide more precise performance, feature and functions than other more traditional types of springs. Manufactured in a wide range of materials from Titanium, Stainless Steel, MP35N, Inconel, etc. The possibility of integrated attachments and multiple-start coil configurations (for squareness-under-load) give an endless array of solutions, offering engineers new levels of possibilities in their designs.

compact design at a reasonable cost for virtually any industry from military and aerospace to medical and energy. AS9100

U-Joints:

certified, RoHS Compliant and ITAR

The HELI-CAL Flexure is an advanced and unique u-joint solution that generally exceeds the capabilities of common u-joint designs. A Helical u-joint is really a Flexure capable of over 5° angular misalignment.

It may accommodate up to 90° of angular misalignment in certain circumstances. This type of u-joint will also compensate for axial and parallel misalignment. Replacement with a maintenance free Helical Flexure u-joint can save money, both on initial purchase price and on maintenance costs.

registered. Helical Products Company is part of the MW Industries (MW-Ind.com) family of premier manufacturers which includes Century Spring, Hyperco, Servometer and Bellows Tech.

Helical Products Company MW Industries, Inc.

Couplings:

901 West McCoy Lane Santa Maria, California 93455 877.435.4225 engineering@heli-cal.com. www.heli-cal.com www.MachinedSprings.com

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The HELI-CAL Flexure used as a coupling will transmit torque while compensating for lateral, axial, and angular misalignment movements.

This technology enables customer specified end attachments such as tangs, clamps, flanges or threaded ends, to be integrated into a single multifunctional component. Helical offers an extensive line of standard flexible couplings and has designed and manufactured over 20,000 custom couplings to maximize value and performance for 1000’s of customers.

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Technical support.

Consulting and services from the ultrasonic specialists.

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

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

The expert teams at Herrmann Ultrasonics will support you during every phase of your project. This includes understanding of your requirements, joint design discussion, component optimization, pre-production prototype welding in application laboratories, weld parameter definition for verification of the required component properties, training / instruction services and after-sales services.

Other typical applications include: medical packaging for disposable syringes, heat patches and inhalers. Laminating and embossing of nonwoven materials such as embossing of surgical facial masks, production of baby diapers, wound dressings and adhesive bandages.

Optimized solutions.

For your specific requirements.

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

Surgical tools

Strength, functionality and high-quality visual appearance are important requirements for surgical tools and devices. Typical applications: Grip plates of instruments, endoscopes, disposable clippers and devices for sclerotherapy.

Herrmann Ultrasonics, Inc. 1261 Hardt Circle Bartlett, IL 60103 Tel: 630-626-1626 Fax: 630-736-7514 info@herrmannultrasonics.com www.herrmannultrasonics.com

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Luehr adaptors and connectors

Unrestricted functionality, weld tightness, and particle purity, along with high outputs, are needed for these medical components.

Typical applications: luehr adaptor, lock, connector, coupler, checkvalve and cuvette with luehr lock fittings. In addition, plug valve housing, piercing membrane and needle embedding.

Fluid containers and hermetic housings

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The major requirements for these components are assured weld tightness and dimensional accuracy, as well as their unrestricted and reliable functionality.

Typical applications: Bottles, secretion containers and bags, transfer systems and tissue culture bottles.

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

www.medicaldesignandoutsourcing.com

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Who is Humphrey Products?

We have been in the manufacturing industry for more than 110 years in Kalamazoo, Michigan as a leading producer of pneumatic and fluid control products, serving organizations worldwide. These products are proudly built by a group of loyal and dedicated Humphrey employees, of whom the average service is 15 years. Our products are made in Michigan with 96% of our suppliers from the USA. Industries utilizing our products and engineered solutions include medical devices, healthcare rehabilitation, transportation, general industry and factory automation, and analytical instrumentation. Our subsidiary, South Haven Coil, in South Haven, Mich. manufactures coils and other electrical components and for over 50 years, we have maintained an alliance with Japan-based Koganei Corp, one of the largest and highest quality fluid control companies in the world.

Our quality management system has been assessed and registered by Intertek Testing Services NA, Inc. as conforming to the requirements of: ISO 13485:2003 and ISO 9001:2008.

• Download Literature, Catalogs and Engineered Solutions Case Histories • Find Product Specs • View and download 3D CAD Drawings for Valves and Cylinders • Request a Quote • Find one of more than 50 Humphrey Distributors Worldwide Or contact customer service at 1-800-477-8707

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

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

• Visit www.humphrey-products.com

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

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Our Standard Products • Solenoid Valves • Electronic Pressure Regulators and Flow Control Valves • Air Piloted Valves • Manual and Mechanical Operated Valves • Cartridge Valves • Quick Exhaust Valves • Pneumatic Auxiliary Components • Air Cylinders The Humphrey tradition of innovation continues as our familyowned company introduces three new valve technologies: The ProControl Proportional Control Series; Balanced Solenoid Valve Series; and Latching Valve.

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

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igusÂŽ develops industry leading plastic plain, spherical, and ball bearings, linear

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Plastics for longer life

bearings and guides, cable carrier systems, and guaranteed continuous-flex cables.

These seemingly unrelated products are all linked in a belief of making technically advanced, yet affordable components and assemblies for almost any moving application. With more than 50 years of research and development, igus is able to provide the right solution for your application based on a massive range of tested, reliable components from stock with the ability to ship as early as same-day.

igus has been manufacturing engineered plastics for more than 50 years, and develops each of the engineered plastic materials and all technology behind its products. A family developed and owned company, igus is committed to using its innovative materials to develop products to provide creative solutions, and exceed customer expectations while delivering fast, accurate service across all industries.

With over 28,000 products available from stock in our Rhode Island warehouse facility, we are able to provide customers with the components they need extremely quickly and efficiently.

Our lean processes and components inventory enables up to 97 percent of orders to be shipped within 24 hours.

Our team of sales engineers is available from 8 AM to 5 PM, coast to coast, with a dedicated team of technical sales experts located across North America for quick on-site assistance or installation and engineering services. Complimentary online CAD files, extensive free product samples, and a range of online tools also separate igus from its competitors.

igus Inc. PO Box 14349 East Providence RI 20914 1.800.521.2747 sales@igus.com www.igus.com

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

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

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INTROTEK, the Global leader for over 35 years, has produced non-invasive, ultrasonic air bubble detectors, continuous liquid and point level sensors, and optical blood component detectors for companies in industries such as medical device manufacturing, chemical processing, pharmaceutical development, clinical laboratories and food & beverage manufacturers. Since it’s early conception, Introtek has maintained its commitment in providing safe, reliable products to ensure customer satisfaction. Our products lead the way in meeting O.E.M. customers’ needs for sensors and electronics that are compact, accurate, highly reliable and reasonably priced.

Introtek’s standard sensors attach at the desired point of detection to the outside of stainless steel, or rigid and flexible plastic Introtek’s Engineering Design Team specializes in taking custom requirements from concept to completion using highly innovative ideas, while working closely with the customer in order to obtain maximum results.

Introtek’s AD8 / AD9 / ADU Integral Ultrasonic Air-In-Line, Air Bubble Sensors incorporate Introtek’s latest generation “MEC” pulse-type ultrasonic circuitry. The microcontroller based circuitry is located integrally in the sensor assembly.

Custom algorithms to control functionality, such as AD9 ADU response times, time delays and more can be designed at Introtek based on customer requirements.

ADU Series Sensor for non-standard soft tube sizes between 1/8” - 3/18” where standard AD9 housings are not available and can eliminate tooling costs for low volume requirements for some odd sized tubes.

INTROTEK® Drip Chamber and Drip Level Detect Sensors are custom designed for use with a variety of drip chambers or larger OD tubing to overcome conditions such as relaxation, slippage or vibration, which would normally cause false air alarms. These sensors are designed to meet OEM Point Level Sensor Drip Detect Sensor form, fit and functional specifications. Sensors are available with integral or remote circuitry and panel mount or self-standing designs.

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

PLD

CLD

Introtek’s PLD – Point Liquid Level Detector is extremely user-friendly with a sleek compact, non-invasive design, incorporating integral electronics that never require calibration.

The PLD is the most advanced pulse wave, ultrasonic sensor available for liquid level detection, emphasizing reliability, accuracy and repeatability.

Introtek’s CLD – Continuous Liquid Level Detector is a pulsed ultrasonic, continuous level sensor, scalable for small to large vials, containers and tanks for industrial, laboratory, pharmaceutical medical & beverage applications. Our unique, non-invasive design enables the liquid level from the bottom of vessel to be monitored quickly, accurately and dependably.

Introtek’s CLM – Continuous Liquid Detector for Metal Tanks delivers the answer for challenging non-invasive liquid level CLM monitoring for a variety of fixed tanks and vessels comprised of, Stainless Steel, Copper, Aluminum, Teflon and Plastic. The CLM is designed to operate under a wide range of supply voltages. Additional features include a bi-color LED visual indicator assuring optimum transducer placement, standard dip switch capability providing field adjustment for 8 various discreet tank levels.

INTROTEK INT’L designs, manufactures and markets non-invasive ultrasonic air bubble and liquid level detection systems Beginning operations in 1981, we became a wholly-owned subsidiary of Magnetrol International—a worldwide leader in industrial level and flow instrumentation in 1986. Since then the companies have engaged in collaborative R&D efforts for the enrichment of both firm’s product lines. Introtek’s production operations represent the leading-edge in manufacturing. Our manufacturing practices conform to the identical standards as those of medical device manufacturers.

An ISO certified company, our quality system is also TUV certified to meet the established requirements for the development, production and distribution of our complete product line. Introtek stands behind the quality of every product with a three-year product warranty. Whether you require standard or custom designed sensors and electronics, our comprehensive design and manufacturing capabilities—along with our solid record of O.E.M. service proficiency—will provide you with the most reliable ultrasonic-based detection products available today.

www.medicaldesignandoutsourcing.com

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s inception in 1983, IXYS tion (Nasdaq: IXYS), a Valley power semiconducSince its inception in 1983, IXYS pany, has been developing Corporation (Nasdaq: IXYS), a Silicon ogy-driven products to im-

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THE WORLD OF IXYS

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

• MOSFETs • BiMOSFETs company, ower conversion efficiency, Valley power semiconductor • XPT IGBTs e clean energy, improve • Standard Rectifiers has been developing technology-driven • Schottky Diodes ion and provide advanced Rectifiers products to improve•• Fast power conversion All in Discrete and Module Packages s in the transportation, mediVisit our website: www.ixys.com

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

generate clean energy, improve telecom industries.efficiency, IXYS eer in the development of automation and provide advanced emiconductors, integrated products in the transportation, medical and RF systems that efand telecom industries. IXYS is a monitor electrical voltage to • Microcontrollers pioneer of power maximum effect with least in the development

IXYS Power is providing efficient solutions for virtually any power conversion application. Rectifier products such as Schottky diodes, line frequency and fast diodes • IGBT Press Packs • Rectifier Diodesas (Studs and Capsules) as well thyristors are available in discrete packages as • Fast Recovery Diodes (Studs and Capsules) well as modules.

For your switching needs IXYS offers • Phase Control Thyristors • Fastsome Switching Thyristors edge and the highest power available leading www.ixys.com or www.ixyslongbeach.com in MOSFET, IGBT, BI-MOSFET and GTO technology which are offered in discrete solutions and both industry standard and custom multichip module package outlines.

In addition, we have the ability to offer these power products • IGBT Press Packs as customer specific sub systems which may be • Rectifier Diodes (Studs and Capsules) assembled world wide.

• Fast Recovery Diodes (Studs and Capsules)

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ture of energy.

• Creative Reference Designs semiconductors, integrated circuits and RF www.ixys.com or www.zilog.com

systems that effectively monitor electrical voltage to produce maximum effect with

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

least expenditure of energy.

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

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

isolation, control and feedback, IXYS IC division (CLARE) designs and produces SOI base HVIC´s flexible display drivers, driver IC´s, optically isolated drivers, solid state relays (SSR), isolated AC switches, optocouplers, photovoltaic chips and ASIC´s.

With the IXYS San Sebastian Division (ISS), we provide advanced RFID IC´s, solutions and Custom IC design.

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

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DESIGN WORLD

manufactures RF

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

Bringing all of these technologies together under one company allows THE WORLD OF IXYS to offer the power conversion designer a one stop solution.

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

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• Portable Solar Chargers • Solar Cells Through MWT and IXYS Colorado, Ixys • Solar Bits/Modules and • Solar Dies microwave products.

Visit our website: http://www.ixyskorea.com or www.ixys.com

ONLINE January 2017

For further information visit: www.ixys.com www.designworldonline.com

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

www.medicaldesignandoutsourcing.com

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HELPING ENGINEERS SUCCEED J.W. Winco, Inc. is a leading supplier and manufacturer of standard industrial machine components, and specializes in offering value-added services to engineers.

Along with an extensive selection of high quality parts, J.W. Winco strives to make engineers’ jobs easier. The company website at www.jwwinco.com is user-friendly and easy to search. Free CAD models are available for almost the entire product line, downloadable in all formats. Customers can check availability and pricing online, and purchase easily 24/7 with credit card, or set up an account.

Meanwhile, J.W. 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, J.W. Winco also offers manufacturing of custom engineered products, secondary machining of our standard products, special kit packaging, and barcoding.

Stainless steel leveling mounts have tear-drop design

GN 440.6 Stainless Steel Leveling Mounts with Tear-Drop Design from J.W. Winco, Inc. are offered in inch and metric sizes. They are available with tapped socket or threaded stud, and may be ordered plain, with plastic base cap, or with rubber pad.

These RoHS-compliant leveling mounts are a simple and economical product. The base is stainless steel with a shot-blast finish and is equipped with one lag bolt hole. The tapped socket or threaded stud is also stainless steel (American Standard Series 304), with a stainless steel (American Standard Series 303) assembly screw loctited into place. Versions with optional plastic base cap of black Elastomer (TPE) plastic are also available, as are optional vulcanized non-skid pads of black Nitrile Butadiene rubber.

These leveling mounts are offered in a range of base diameters and threaded stud lengths, and available in a zinc plated steel version as well.

They are able to bear static loads from 8 to 16 kN (1,800-3,600 lbf).

sales@jwwinco.com jwwinco.com

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These economically priced, RoHS-compliant mini-latches have smaller dimensions than our standard GN 115 series, making them perfectly suited for small doors and flap closing applications. They offer a straightforward latching action rather than a locking and clamping action. The latch distance of mini-latches is made to accommodate 8, 14 and 20 mm.

Latch housing and hardware are stainless steel. Offered types include with triangular spindle, with square spindle, and with slot.

Keys for the latches are ordered separately; key can be removed from latch in both open and locked positions. In the standard key latch versions, all latches have the same barrel and can be operated with the identical key. Latches requiring different barrels and keys are available upon request.

J.W. Winco’s GN 237 Hinges with Extended Hinge Wing have a compact and sturdy design.

They are used when wider spacing is required on the mounting surface.

fax 800-472-0670

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J.W. Winco has also introduced GN 115.6 Stainless Steel Mini Latches, available in metric sizes.

Hinges have extended wing design

800-877-8351

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Mini latches are ideal for small doors and flaps

1 • 2017

These RoHS-compliant hinges are offered with countersunk holes or threaded studs for mounting. Versions are available with one or both hinge wings extended. Additional styles of square hinges under the same GN 237 series are available, which also offer a wide variety of sizes and mounting options.

Hinge body is zinc die-cast, with black powder coated, textured finish or silver powder coated, textured finish; stainless steel hinges are also available in all versions. Hinge pins and threaded studs for all types are stainless steel. www.medicaldesignandoutsourcing.com

1/13/17 9:03 AM

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Quality Interconnect Components and Electronic Hardware Leading edge technology and precision manufacturing have defined Keystone’s performance since 1950. Their latest catalog M65 reflects this tradition.

Keystone personnel take pride in meeting all requirements, efficiently and promptly. Our skilled and dedicated technicians, experienced production personnel and customer service teams have made us an industry leader.

All Keystone facilities are fully integrated with 3D/ CAD product modeling and CAD/CAM precision tool and die operations. Applications and Engineering specialist utilize progressive dies, four-slide, wire forming, in-die tapping and high-speed blanking along with automated machining to produce tight tolerance standard and custom products. Secondary operations include Tapping, Drilling, Assembly and Finishing.

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

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

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

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

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

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

Application engineering services are available for product modifications or special design requirements.

Keystone is an ISO-9001:2008 certified company and complies with RoHS and REACH directives.

View inside the walls of Keystone Electronics and learn about our design and manufacturing capabilities, our customer service team and our complete line of interconnect components and electronic hardware. https://www.youtube.com/ watch?v=YhVH3DCngH0 There’s a Keystone in every great invention… Follow our latest blog. http://www.keyelco.com/blog.cfm

31-07 20th Road, Astoria, NY 11105-2017 800.221.5510 or 718.956.8900 www.keyelco.com

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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 the high quality and reliability. These connectors can be found in wearable electronics, catheters, scopes, surgical robotic navigation, x-ray equipment and dental equipment. LEMO purchased Northwire, Inc., a wire and cable manufacturer, in the Summer of 2014, for the ability to offer a complete solution.

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

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The Original Push-Pull Connector

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LEMO is the acknowledged leader in the design and manufacture of precision custom connection and cable solutions. LEMO’s high quality push-pull connectors are found in a variety of challenging application environments including medical, industrial control, test and measurement, audio-video, and telecommunications.

LEMO has been designing precision connectors for seven decades. Offering more than 75,000 combinations of product that continues to grow through custom specific designs LEMO, and it’s affiliated sister companies REDEL, NORTHWIRE and COELVER, currently serve more than 100,000 customers in over 80 countries around the world.

LEMO USA most recently acquired ISO13485:2003 Certification for the medical cable assembly market. www.medicaldesignandoutsourcing.com

1/13/17 9:17 AM

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Magnet Applications, Inc., is part of the Bunting® Magnetics Co. family of

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Why Magnet Applications is the leader in MedTech?

companies, a global provider of magnets and magnetic assemblies as well as a complete line of magnetic separation, metal detection and material handling equipment.

Magnet Applications is the only North American manufacturer of compression bonded magnets, injection molded magnets, hybrid magnets and magnetic assemblies for the worldwide Automotive

Magnet Applications, Inc. has been providing total magnetic solutions to the medical industry for 25 years. Whether a compression bonded magnet, injection molded magnet, hybrid magnet or a complete magnetic assembly, your magnetic needs are met quickly and will be competitively priced. Today, our products are found in MRI machines, CPAP machines, pacemakers, heart pumps, insulin pumps and other high-demanding, cannot-fail applications. And there’s good reason:

& Transportation, Industrial & Commercial, Medical Equipment, Military & Aerospace, Security and other industries. Its products are primarily used in PM motors and magnetic sensors. Magnet Applications, Inc.

DESIGN & ENGINEERING We provide complete engineering, design and consulting services. Our expert engineering team, with advanced 3-D modeling, rapid prototyping capabilities and design software, complement your design and manufacturing team to develop a permanent magnet or complete magnetic assembly specific to your need and application.

facilities are located in Dubois, Pennsylvania with sales support worldwide. The company MAGNET MANUFACTURING Magnet Applications, Inc., is the only North American manufacturer of compression bonded, injection molded and hybrid magnets. Our plant is ISO:2008 certified. In addition, our super clean world-class facility includes an option for glove box clean air assembly and an end-of-line pass/ fail test to promise a spotless brand and healthy reputation. Our capabilities span from a small volume single order to multiple large volume orders.

is ISO 9001:2008 registered.

Magnet Applications 12 Industrial Dr. Dubois, PA 15801 1.800.437.8890

FAST DISTRIBUTION Our facility’s location in Pennsylvania means our North American customers receive their products at lower freight costs with quick turn-around times. We will work with your lean replenishment programs, employing JIT, Kanban, Dock-to-Stock, and other distribution methods to ensure your magnetic assemblies arrive on time.

1.814.375.9145 www.magnetapplications.com

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For more information, contact Magnet Applications at magnetapplications.com * 800-437-8890 * 814-375-9145

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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

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

Hackensack, NJ 07601 Tel: 201-343-8983 Fax: 201-343-2132 www.masterbond.com technical@masterbond.com

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1/13/17 9:21 AM

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maxon drives set the world in motion.

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System Solutions

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

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

The drive components are assembled and designed according to your individual needs.

Our modular system includes planetary, spur and special gearheads as well as encoders and control electronics.

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

Individual, customized drive solutions are our greatest strength.

A perfect drive solution in a few easy steps DC brushed and brushless motors configurable online and ships in 11 days. maxon precision motors, inc.

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

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Now even stronger, more efficient and with yet more combination options: There are new additions to the maxon family of X drive products. Several long versions of brushed DC motors (DCX), with higher torques and more power, have been added to the product range along with matching planetary gearheads.

In addition, maxon’s brushless DC motor (ECX) line is also available with a larger variety of diameters ranging from 8 – 22 mm, achieving speeds of up to 120,000 rpm. They run very smoothly and are highly efficient in standard or sterilizable versions (up to 2,000 autoclave cycles). Ideal for use in hand-held surgical tools and industrial spindles.

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

Visit dcx.maxonmotor.com for more information. www.medicaldesignandoutsourcing.com

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Full Service Contract Manufacturer • ISO 13485:2003 Certified • FDA registered • Clean Room Molding

Medbio

• Clean Room Assembly

Located in West Michigan, Medbio is an ISO 13485:2003 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.

• Clean Room Packaging • Precision Injection Molding • Insert & Over Molding • Micro Molding

Our facility contains a certified ISO Class 8 clean room for molding, along with several certified ISO Class 7 clean rooms for assembly. We have flexible capacity to handle major projects or small custom orders. We mold most medical grade thermoplastics, including implant grade “PEEK”. We currently mold products for OEMs in Orthopedics, Cardiovascular, Ophthalmology, Neurological Surgery, General Surgery, Wound Care, Biotech (diagnostics & cell growth), and Dental.

Members of our leadership team average over 25 years of medical device industry experience, so we know what it takes to get a new product to market.

Supported by a staff of 19 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 southern NH’s best kept secret.

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

Services Offered

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

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

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Medo USA MEDO 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.

Medo’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 Medo pumps to be smaller and lighter than conventional aerators, allowing designers greater flexibility in system design.

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

Medo 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.

Medo USA, Inc.

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

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

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MICROMO (FAULHABER Group) is the quality leader for custom micro motion solutions and full service capabilities. MICROMO offers excellence in micro motor and encoder technology as well as design customization.

MICROMO brings together value-added services and cutting-edge technologies from around the world through high efficiency, high performance offerings, such as brushed, brushless, stepper, thin-profile DC, piezoelectric and linear motors for diverse applications (www.micromo.com). Founded in 1961 and based in Florida, MICROMO provides a variety of linear and rotary motion solutions for the North American market. MICROMO is part of the global FAULHABER Group, which has over 1,600 team members worldwide.

MICROMO is your full service, value added outsourcing partner: • • • • • •

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

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

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

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MICROMO WHY IS MICROMO THE LEADER WITH MICRO MOTION SOLUTIONS?

EXCELLENCE IN MICRO MOTION SOLUTIONS

For over 50 years, MICROMO has partnered with a range of markets to provide the highest precision and highest performance motion systems and components based on dc motor technology. MICROMO combines the widest range of linear and rotary motion solutions with value-added services and the global resources of the FAULHABER Group to provide a variety of benchmark custom motion solutions for medical applications such as drug delivery systems, medical robotics, surgical tools, diagnostics systems and prosthetic devices.

QUALITY LEADERSHIP

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

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

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

IT’S ALL HERE IN NORTH AMERICA

From concept to delivery, MICROMO (Clearwater, FL) provides it all. With on-site machining and assembly facilities, a versatile standard product line, an Advanced Engineering Group, and over 5,000 special executions, customization is MICROMO’s strength. MICROMO’s operations include a state-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. MICROMO’s engineering team partners with over 3,000 customers for the design, specification and after sales support of industry leading motion control products. With extensive local inventory and online product analysis and purchase via the MICROMO Motion System Selector™, many products can be delivered in three days or less to meet immediate design and testing requirements.

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

www.medicaldesignandoutsourcing.com

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Product Design.

Company History Since 1945, Minnesota Rubber and

Plastics has built a worldwide reputation

in the molding of elastomer and thermoplastic components and assemblies.

“We are known in the medical industry for our design expertise and providing the best optimal solution to our customers.

And, for our science-based approach that has made us the preferred manufacturing partner for industry leaders in North

Our product design engineers conceptualize and evaluate ideas by combining science and technology to create value. Utilizing the latest CAD programs and FEA models, our designers mathematically model and fabricate components and their function in your applications. Our rapid prototyping decreases development time, errors and changes while improving deliveries.

Manufacturing/Process Development.

Manufacturing/Process Development. Minnesota Rubber and Plastics provides the most comprehensive facilities. Our scientific approach ensures product compliance with products produced on time and on budget utilizing finest: • Tool design and construction • Four types of molding processes including compression, transfer, injection and liquid injection silicone (LSR) • Scientific molding with cycle time optimization and productivity • Latest vision inspection technology • FMEA • Analysis and (PPAP) documentation • Component assembly in class 10,000 and 100,000 certified clean rooms • Comprehensive testing • Customized packaging and labeling.

Sourcing/Quality Systems

America, Europe and Asia.

Meeting the expectations of our worldwide customer base requires diverse and strategically located manufacturing capabilities. Within these facilities, we combine: • Benefits of worldwide sourcing capabilities and pricing with technical resources and project management capabilities • Corporate wide quality systems including ISO 13485, ISO-TS 16949, ISO 9000 and ISO-14001 in all facilities.

Our 5 manufacturing facilities, located in North America and Asia, are complemented by 4 warehousing operations in the U.S., Europe and Asia.

Material Sciences Knowing materials, their properties and structures, how processing changes them and how materials perform in an application are all vital to the success of your molding project. We provide: • Onsite technical support at each facility • R&D center staffed with 23 technicians • Custom formulation materials laboratory • Over 1,600 different rubber compounds • Plastic materials expertise.

Micro-Molded Parts for the Medical and Pharmaceutical Industry Providing micro-sealing solutions to the medical and pharmaceutical industry with expertise in the precision molding of elastomer and thermoplastic parts including; PEEK and other high perfor-mance materials. All final part processing and inspection is completed in class 10,000 and 100,000 clean room environment • Implantables and non-implantables • Surgical components and minimally invasive surgical tools • Catheter tips and components • Valves and seals • Over-molding

Quniton® in the Medical & Pharmaceutical Industry Minnesota Rubber and Plastics is more than a molder of high performance elastomers to the medical industry. We provide complete services, in design and materials development, required to deliver performance enhancing products. Our clean rooms and assembly services complement our high volume parts capabilities, and provide customers with the critical quality and delivery requirements. Also, we are happy to announce that our Quniton® portfolio now includes globally compliant materials.

Global Headquarters 1100 Xenium Lane North Minneapolis, MN 55441-7000

Quniton® Medical Applications:

1.800.927.1422

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Phone: 952.927.1400 Fax: 952.927.1470

Features & Benefits:

Email: webmaster@mnrubber.com

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Plunger Seals •Valves •Pumps •Catheters •Diaphragms

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Not a coating, inherent low CoF properties

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Reduced friction and abrasion

•

Can eliminate lubricants

•

Maintains material characteristics: - No change to dimensions or surface - No micro-cracking - No flaking or wear - Chemical resistant, unlike coatings

•

ISO 10993-5

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Model Solution Does More: Precision Prototyping,

Tooling & Manufacturing Services

Medical equipment manufacturers rely on Model Solution for quality products delivered quickly. More than design

Air for Independent Living Seniors

validation, tooling, model making, injection molding, or 3D printing, Model Solution offers more design and manufacturing services, expertise, and support to accelerate medical product development -- getting you to market faster.

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

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

Precision Prototyping & Modeling Model Solution does more – especially when it comes to innovative medical product design & development. With a world-class team of engineers that work closely with customers and employs the latest design, prototyping and modeling techniques, Model Solution develops high quality medical products…fast and within budget. Model Solution condenses your design cycle and delivers prototypes and models to validate the design functionality and evaluate the color, material and finish.

Portable Medical Nebulizer

Model Solution supports a wide range of medical device manufacturers including makers of diagnostic, lab, monitoring, portable, surgical, therapeutic and treatment medical devices.

Model Solution delivers products with vivid colors, innovative materials and state-of-the-art finishes that meet your look, feel, function and build requirements. Model Solution’s precision, speed, expertise and innovation make it the default choice for your next medical device project.

Tooling Prototype to production – from rapid and hard tooling to injection molding, Model Solution precision prototype, pre-production and production tooling means more quality parts delivered quickly. State-of-the -art equipment and processes combined with Model Solution’s tooling experts results in your medical products reaching customers’ hands faster.

Model Solution 1.408.856.1257 Email: rfq@model-solutions.com www.model-solutions.com Surgical Endoscopic Carpal Tunnel Release Tool

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

www.medicaldesignandoutsourcing.com

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Incorporated in 2001, New England Catheter occupies a 14,000 square foot

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Custom Designed Medical Extrusions

state-of-the-art controlled environment manufacturing facility in the beautiful White Mountains of New Hampshire.

Working directly clients in the medical electronics and device industries, we design custom braid or spiral reinforced tubing, lined catheter shafts, and hybrid tubing built to exacting specifications.

Calling on the decades of extrusion and wireprocessing experience of our parent company, New England Catheter excels in thin-wall, close tolerance tubing, bonding layers of thermoplastic to fluoropolymer, and braiding all types of round and flat wire, specializing in tight tolerances, custom designs and short lead times.

This unique combination of advanced extrusion expertise & extensive wire processing capabilities allow us to produce custom braid or spiral reinforced tubing, lubricious lined catheter shafts, single/multi-lumen tubing and hybrid configurations. New England Catheter’s team of design engineers work closely with each individual customer to develop innovative, one-of-a-kind tubing solutions and custom OEM components from their specifications or to meet unique performance characteristic requirements.

We also offer a wide range of value-added and post-processing services—tipping, hubbing, flaring, Parylene coating, centerless grinding or cut to length to your specification. Through true vertical integration of manufacturing processes, New England Catheter is able to offer customers everything from rapid prototyping services and small quantity orders to full production and value-added services.

New England Catheter 132 North Main Street Lisbon, NH 03585 603.838.2261 www.necatheter.com

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

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Custom Designed & Manufactured Wire & Cable

stock ownership program. For over 115 years, we have manufactured the most Founded in 1898 in response to the birth of the communication age, today New England Wire serves a full range of industries including medical device and electronics, aerospace, defense, robotics/automation, power generation and alternative energy to name just a few. Our products include miniature, micro-miniature, single and multiconductor cables, low-noise, high temperature, coaxial and hybrid cables, cables with reinforced jackets, and medical braids. Additionally, we have provided cabling and insulating services to the superconductor industry since the 1960’s and are currently the only US cable manufacturer supplying services to the ITER program.

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.

Whether working with customer supplied specifications or designing to a unique requirement, 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, braid, cabling and extrusion services. And, since all of our proprietary equipment and tooling is designed and built in-house, we have complete control while also offering quick modifications when needed.

Through true vertical integration of the manufacturing processes our customers’ design-to-market curve is the shortest in the industry!

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

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New England Wire Technologies is committed to being the premier custom manufacturer of choice for customers in existing and emerging worldwide specialty cable markets.

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Norman Noble, Inc. is the most technologically advanced medical device contract manufacturer

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Microprecision Nitinol Impant Manufacturing

of nitinol implants and devices in the medtech industry supplying 18 of the top medtech OEM‘s in the world. Some of the products we manufacture for our customers include:

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

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

Norman Noble Inc.

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

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

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NSK is a world class manufacturer of motion and control products. Founded in 1916, NSK was the first company in Japan to develop and produce bearings.

For the last century, NSK has proven to be an industry leader backed by superior quality, engineering research and technical innovation. NSK manufactures and distributes a wide range of rolling element bearings, linear motion, mechatronics and automotive component products. Striving to set the future in motion, NSK will constantly find ways to innovate and bring value to society by creating new products and technologies for the next 100 years.

Operating in the Americas, NSK Corporations is a member of the NSK Ltd. Group and is headquartered in Ann Arbor, Michigan. NSK Corporation has a network of sales and engineering teams working in partnership with customers to deliver high performance products, applicationspecific solutions, superior technical support and exception service to the Americas market. The company’s strategically located manufacturing and distribution centers supply both original equipment manufacturers and the industrial aftermarket through a broad distribution network.

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Advancements in medical technology are enhanced with NSK linear motion innovation.

In the field of motion control, innovative engineering is paramount to optimal design and performance. Celebrating its 100th anniversary, NSK has proven to be an industry leader dedicated to applying innovative, technical solutions for the future advancements required in medical, biotech and pharmaceutical industries.

NSK linear motion and bearing solutions have been used for imaging, diagnostic, surgical robotic and medical equipment applications. As NSK continues to expand its capabilities, new product solutions are engineered. Our dedicated team of engineering staff collaborates with the customer to develop an integrated system. We understand the importance of delivering solutions to an environment that is constantly evolving and looking to new technology in order to improve outcomes within the field of medicine.

Medical Imaging

NSK’s NH/NS Series Linear Guides™ achieve the world’s highest load rating, while maintaining superior precision and accuracy required for medical imaging such as CT, PET and MRI scanning devices. Optional K1™ Lubrication Units reduce maintenance cost and extend operating life.

Diagnostics

Diagnostic devices, such as blood analyzers, need to process multiple samples while delivering consistent, accurate results in an efficient manner. NSK’s Monocarrier™ linear actuators are a low-maintenance solution. The MCM Series is ideal for light to medium loads and is available in miniature sizes for a compact, space-saving design. Smooth motion, low vibration, high rigidity and long operating life are all achieved when utilizing the MCM Series. Optional K1™ Lubrication Units reduce maintenance cost and extend operating life.

Robotic Surgery

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

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To ensure reliable and repeatable results that deliver smooth, accurate and precise movement, NSK recommends BSS Series ball screws for surgical robotic applications. The BSS Series is available in miniature sizes and can be used within the arm of a surgical robot. Each ball screw is designed for high precision, accuracy resulting in unparalleled smooth motion.

With the use of K1™ Lubrication Units maintenance costs are significantly reduced.

K1™ Lubrication Unit The K1™ Lubrication Unit combines oil and resin into a single unit designed for environments where grease replenishment is undesirable or where grease may be easily washed away.

These units can be installed on NSK ball screws, linear guides, Monocarrier™ and Robot Module™ products. Effective in any mounting orientation, the K1™ Lubrication Unit can be installed in various medical applications including NH/NS Series linear guides for medical imaging devices, MCM Series Monocarrier™ for diagnostics and BSS Series ball screws for robotic surgical equipment. These units are maintenance-free for up to 5 years or 10,000 km of operational distance; however, longer operating conditions can be achieved. An FDA-compliant option is also available.

For more information about NSK and our innovative product solutions for medical applications, visit www.nskamericas.com www.medicaldesignandoutsourcing.com

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Pexco is an ISO 13485 registered medical plastics manufacturer of tight tolerance

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Pexco has innovated bioresorbable manufacturing.

injection-molded, extruded, machinefinished and sub-assembly medical device solutions. Both U.S. and Mexico plant operations supply precision medical plastic parts for leading medical companies and affiliates addressing orthopedic, cardiology, vascular, blood management, and other life science product applications.

Pexco LLC / Pexco Medical 2500 Northwinds Parkway

Pexco Minneapolis has become a leading manufacturing partner for medical device companies requiring biocomposite and bioresorbable plastics processing expertise.

Pexco Medicalâ&#x20AC;&#x2122;s injection-molding and micromolding solutions across the full range of bioresorbable, Polyetheretherketone (PEEK), Polyphenylsulfone (PSSU) and other implantable materials has helped further metal replacement in surgical components and systems. Pexco Medical has helped companies develop products in the orthopedic, sports medicine, wound closure, micro vascular, and reconstructive surgery markets over the last 15 years, honing delicate skill in material handling, processing, and design for manufacturability of these complex plastic components parts and assemblies. Materials such as PLLA, PDLG, PLC PLG and other like derivatives including those composites supportive of bone growth pose unique preparation, processing and handling challenges due to their chemical makeup.

Pexco Minneapolis spent years developing this expertise into serving as a trusted partner for medical companies requiring such components in their devices and product solutions.

Suite 472 Alpharetta, GA 30009 1.404.564.8560 www.pexcoMD.com

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Proto Labs is the world’s fastest digital manufacturing source for custom prototypes and low-volume production parts. It’s a technology-enabled company that uses advanced 3D printing, CNC machining and injection molding technologies to produce parts within days. The result is an unprecedented speed-to-market value for designers and engineers and an on-demand manufacturing resource throughout a product’s life cycle.

Company History Proto Labs began in 1999 specializing in the quick-turn manufacturing of custom plastic injection-molded parts.

In 2007, the company introduced its CNC machining service and in 2014, expanded into 3D printing with the addition of additive manufacturing.

Proto Labs is a global company with full-service manufacturing operations in the United States, Europe and Japan.

Why Proto Labs?

Proto Labs has radically changed the economics and lead times traditionally associated with manufactured parts. The rapid manufacturer provides a fast, easy and cost-effective way to obtain 1 to 10,000 parts within days, routinely shipping parts before conventional suppliers can even quote them. These quick delivery times are possible because it has automated the manual process of mold design and toolpath generation through the use of proprietary software.

Interactive Quoting Product developers can upload a 3D CAD model online at any time and receive an interactive quote with real-time pricing information and free design analysis within hours. The manufacturability analysis helps eliminate problems, like sink or warp, so modifications can be made before any actual production begins.

3D Printing Proto Labs uses the latest additive manufacturing (aka 3D printing) technologies to provide precision accuracy to plastic and metal part production — from small pieces with complex geometries to large, highly detailed patterns. 3D printing is ideal for 1 to 50 parts and works well for form and fit testing, reducing multipart assemblies and as fully functional components in some cases.

CNC Machining Global Headquarters 5540 Pioneer Creek Dr. Maple Plain, MN 55359 USA 877.479.3680 customerservice@protolabs.com protolabs.com

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The company’s CNC machining service uses three-axis milling and turning with live tooling to machine up to 200 parts from more than 30 stocked plastic and metal materials. The result is functional parts made from engineering-grade materials for prototype testing, jigs and fixtures, and end-use applications.

Injection Molding For those who need low-volume production, bridge tooling or on-demand parts throughout a product’s life cycle, rapid injection molding can manufacture up to 10,000 parts from hundreds of different engineering-grade plastic and liquid silicone rubber materials. Proto Labs also now offers rapid overmolding. Engineers can use overmolding to improve grip and durability, dampen vibration and to add two-color aesthetics to parts.

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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. From low to high volume, simple to complex, prototype to production, PTI has delivered quality end products for over 30-years.

Certifications PTI is FDA, UL, and ITAR registered and ISO 13485:2003, ISO 9001:2008, ISO 16949:2009

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

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

There’s a science to being a highly productive plastics company.

PTI's Production floor currently host (44) injection molding machines ranging from 12-750 tons of clamping force, with .33-98 oz. shot capacity. Manufacturing capabilities include low and high volume production, insert/overmolding, high-temperature molding, contract manufacturing, assembly and packaging.

Meeting the demands for controlled environment manufacturing.

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

Saving you time and money.

PTI Engineered Plastics

PTI offers an array of secondary services including plastic joining and part decorating services.

50900 Corporate Drive Macomb, MI 48044 586.263.5100 teampti.com

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

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

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Qosina is a leading global supplier of thousands of stock components to the medical OEM and pharmaceutical industries, offering free samples, low minimums and

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

just-in-time (JIT) delivery.

Companies purchase from Qosina to eliminate tooling costs and receive immediate delivery from our inventory. We provide in-stock solutions based on the specific needs of your projects. Qosina is based in Ronkonkoma, NY, operating in a 95,000 square-foot facility with an ISO Class 8 Clean Room and is ISO 9001, ISO 13485 and ISO 14001 registered.

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

Our Extensive Inventory

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

Our Services

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• • • • • • • • •

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

www.medicaldesignandoutsourcing.com

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Resonetics is the leader in laser micro manufacturing for life sciences. Core competencies are laser ablating, cutting, drilling and welding. Resonetics’ expertise started in polymer processing and has expanded to metals and glass. Our passion for laser technology complements our customers’ passion for improving and saving lives.

In addition, Resonetics has many industry firsts and is serious about innovation; we invest in internal R&D initiatives each year, resulting in many process patents and novel applications for next generation life science applications.

Challenging the Limit of Laser Micro Manufacturing At Resonetics, we lead through our Advanced Technology Group (ATG) that thinks outside the current parameters of laser processing to solve customers’ most challenging technical problems. The ATG has produced many technical advances in 2016 encompassed by a wide range of next generation capabilities including 3D micro ablation, precision nitinol cutting, fine wire welding, 0 kerf glass cutting, small hole (single micron) hole drilling, and micro-scale additive manufacturing.

44 Simon Street Nashua, NH 03060 603.886.6772

A key innovation is 3D micro machining of metals. This is completed through a 3D micro ablation process, which is a miniaturization of swiss CNC machining.

The coupling of a precision ablation laser with a multi-axis workstation has enabled the micro scale manufacturing of parts in a variety of metals (Stainless Steel, Cobalt Chrome, Platinum, Platinum/Iridium, and

603.886.3655 Fax sales@resonetics.com resonetics.com

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Nitinol to name a few). 3D micro ablation was developed based on the unmet customer needs in the Neurovascular market, which required metal parts an order of magnitude smaller than CNC machining.

To innovate nitinol laser cutting, Resonetics combined a precision motion control workstation with a next generation laser and fundamental process knowledge to create a stent cutting system that is second to none.

This technology is capable of holding single micron standard deviations on 25 micron struts across 50 mm long stents.

The enhanced precision in cutting greatly improves the post processing consistency and manufacturing yield.

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The REVOX® Sterilization Solutions process uses a room-temperature vaporized peracetic

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REVOX VPA makes it possible

acid (VPA) method to achieve exceptionally low chemical residuals and unsurpassed materials compatibility. The REVOX technology eliminates inefficiencies associated with pre-conditioning and lengthy poststerilization wait times. This allows REVOX Sterilization to offer manufacturers a quick-turn, off-site sterilization service or cost-efficient on-site, in-line processing. In 2014, the FDA granted clearance to a Class II implantable device utilizing the REVOX sterilization process.

SUPERIOR MATERIALS COMPATIBILITY Until now, manufacturers have been limited by traditional sterilization methods that constrain their choices of materials and overall product design. Many materials that may otherwise be ideal for optimal product design simply are not suitable with common sterilization methods. REVOX changes that.

With true room temperature processing and demonstrated superior compatibility across a wider range of materials, manufacturers have more options to innovate more efficiently.

Chemical and heat-sensitive materials that were once off-limits to innovative product development are now available. The REVOX sterilization process is compatible with over 100 materials, including biologics, implantables, electronics, pharmaceuticals such as combination devices, and more.

You can now create the products that will demonstrate your true potential.

LEANER MANUFACTURING The complete manufacturing stream should be exactly that: complete. Pulling components from the line for sterilization defeats the very purpose of having a production line. REVOX enables scalable in-line sterilization, which finally allows manufacturers to integrate sterilization into a lean manufacturing process. It speeds up production and gives manufacturers a substantial competitive edge.

While some sterilization methods can take up to 44 cycles to sterilize two pallets of product, the REVOX 3000L machine takes just one.

Think of it as JUST-IN-TIME® sterilization.

REVOX Sterilization Solutions 14605 28th Avenue N Minneapolis, MN 55447 855.473.8690 www.revoxsterilization.com

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Simplifying machine building with compact integrated motors Automation component manufacturer Schneider Electric Motion USA (formerly IMS) is a proven leader in innovative motion control solutions for stepper motors and electronic controls, including the premier integrated motor brand MDrive®. SEM offers integrated motion solutions across multiple market segments, for a wide range of applications from factory floor to laboratory bench.

Lexium MDrive® is the newest addition to this premium product line. LMD products are well suited for industrial automation, incorporating robust design features and performance enhancements including closed loop to eliminate loss of synchronization/stalling, reduce heat, save energy, and lower operating costs.

NEW Lexium Motion Module / LMM is an ultra-compact, programmable motion controller delivering chipset flexibility with leading MDrive integrated motor features including MCode programming language. To facilitate rapid prototyping and design verification, development boards are available with features including isolated I/O, locking pluggable connectors and serial RS-422/485 programmable motion or CANopen. A range of motors, encoders, USB communication cable and starter kit are also offered.

Schneider Electric Motion USA 370 North Main Street, Marlborough, CT 06447 Ph: 860-295-6102 Fax: 860-295-6107 Email: info@imshome.com

MDrive® Linear Actuators integrate linear actuator stepper motors, electronics and mechanicals all in one compact linear motion system delivering high accuracy and long life.

Non-captive and external shaft styles are available, with nominal load limit of up to 200 lbs. Built-to-order, you specify the screw lead/pitch, length, end finish, coating, and nut style for your application.

MDrive® Plus integrated rotary motors are available in a wide range of low cost, extremely compact configurations. These all-in-one motion control solutions can reduce system cost, design and assembly time for a large range of motion control applications.

www.motion.schneider-electric.com

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Stock Drive Products/Sterling Instrument a Designatronics company Stock Drive Products/Sterling Instrument is an ISO 9001:2008 + AS9100C certified manufacturer of precision gears, high-quality machined parts, molded components and mechanical assemblies. We provide total motion control and power transmission solutions to a

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Established in 1950, Stock Drive Products/Sterling Instrument (SDP/SI) is the company engineers and OEMs depend on for high-quality components, subassemblies, and engineering expertise. As a company founded and managed by engineers we understand and respond to the developing needs of our customers better than anyone. Over 100,000 components are available off-the-shelf for fast turnaround. When a standard part won’t meet your requirements we can provide alternative solutions through custom design and manufacturing. Our engineering and manufacturing teams will partner with you throughout the entire process. By providing design, development, manufacturing, assembly, and testing in one location we can ensure the end product will meet your expectations. For prototype and small to large production runs you can rely on SDP/SI.

wide variety of product applications.

High Volume Precision Gear Production Precision Gears, Custom Gearboxes, Differentials, and Planetary Gearheads

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Surgical Robots

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Medical & Dental Instrumentation

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Medical Pumps & Drives

State-of-the-art gear production facility has increased capacity and offers new capabilities.

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Surgical Devices

• High-precision gear production 24/7

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Patient Positioning

•

3-D Printers

• Faster turnaround – including gear cutting on CNC lathes for one piece flow (depending on quality (UP TO AGMA 11) and process requirements).

In February, 2017 we will begin operations in a new state-of-the-art facility designed to improve lead times and efficiency.

Stock Drive Products/ Sterling Instrument 250 Duffy Avenue Hicksville, NY 11801 USA Tel: 516.328.3300 Email: sdp-sisupport@sdp-si.com sdp-si.com

Services and Products We Offer SDP/SI designs, manufactures and produces custom and standard gears and other power transmission components. Our precision gears, gear assemblies, high-quality machined parts and molded components are used in a wide variety of product applications worldwide including medical, robotics, aerospace, defense, military and commercial aircraft.

• Timing Belts and Pulleys • Precision Gears • Precision Gearboxes

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• Precision Machined Components • Molded Components

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• Mechanical Assemblies • Customized Components and Assemblies • Contract Manufacturing www.medicaldesignandoutsourcing.com

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Leader in linear transformers and SMD inductors Signal has over 50 years of experience manufacturing transformers, chokes, inductors and custom or modified standard products. Our commitment to quality is noted by its in-house ISO 17025 certified lab that enables us to participate in the CSA’s Supervised Manufacturing Testing & Certification (SMTC) program.

This program makes possible to certify and use the CSA/cCSAus mark on new designs within days. Signal leads the industry with custom tailored design solutions through direct engineering support. Signal offers the most comprehensive line of certified standard power conversion products.

Signal Transformer is known as the world’s leader of wire wound magnetic solutions since 1959. With over 50 years of experience manufacturing transformers, chokes, inductors and custom or modified standard products. Signal offers not only the most comprehensive line of certified standard power conversion products, with our vast engineering, manufacturing and regulatory resources; Signal Transformer excels in the design and manufacturer of cost effective, specialized platforms.

Signal embraces the entire wire-wound components spectrum. We maintain an extensive stock of standard ‘off the shelf’ products but some applications will require either product modification or a totally new design. Signal takes pride in demonstrating its capabilities in such instances by creating designs that are not bounded by convention, but defined by customers’ needs. Our personalized pro-active approach of working closely with customers’ engineers has always been the keystone that defines our customer support.

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

Signal Transformer 500 Bayview Avenue Inwood, NY 11096 www.signaltransformer.com

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SMAC Moving Coil Actuators manufactures a wide range of precision programmable electric

Benefits of Moving Coil Technology

actuators based on its patented moving coil technology. These proprietary and patented moving coil linear motor based designs are technically far ahead of old generation pneumatic and electric actuators, including moving magnet linear motors. SMAC’s technological edge,

• Safe and energy efficient: operates at low current, typically at 1.5 amps at 24 volt DC.

combined with continuous costdown/ qualityup process and its worldwide sales basis makes SMAC the most dynamic electric actuator manufacturer in automation today.

SMAC electric actuators are unique in that force, position, and speed are totally programmable.

They are designed to perform at exceptionally high rates >2000 cpm, repeatable within 1 positioning and have the patented capability to “Soft-Land” on surfaces and then perform work.

They also provide feedback on the work being done. This makes them ideal for a wide range of positioning, measuring, inspection, thread check where 100% verification is required.

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

• Long Cycle Life: >100 Million Cycles.

10x that of air cylinders or ball screw actuators.

millisecond. They are capable of submicron

and pick and place applications, particularly

Lower moving mass with the voice coil actuator means extremely high acceleration and velocity, as opposed to the heavier “moving magnet” technology used in most linear motors.

• Linear Rotary: SMAC invented linear rotary technology in 1998 and since have become the preferred solution for small parts assembly in the electronics industry, thread check in the automotive industry and capping in the packaging industry.

• High Accuracy: Designed for precision movement applications. A very light moving mass results in high accelerations with no backlash.

Soft-Land Phone (760) 929-7575 Email: info@smac-mca.com or visit www.smac-mca.com

SMAC’s “Soft-Land” is a patented unique routine which allows the actuator rod or gripper jaw to sense the surface of a component then applies a specific force.

It gives extremely accurate sensing of product location or dimensions. This is particularly useful for handling delicate or high value components. Soft-Land also elongates the life of the actuator. Used in:

Programmable Features

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

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

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

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

• Pick and place of delicate objects

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• Gauging of fragile or pliant materials • Bottle ejecting/diverting/sorting • Switch / material testing

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• Many, many other applications

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

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About Smalley: Innovation, quality and engineering excellence has driven Smalley to be the leading manufacturer of Spirolox® Retaining Rings, Constant Section Rings and Wave Springs. We believe that engineers should work with engineers. So our customers work directly with our experienced team. This access to technical expertise and problem solving, prototyping and collaboration is rare in the industry. But it allows you to take your designs further than you thought possible.

Every Smalley ring and spring is backed by our legendary customer support. Our commitment to service combined with our reputation for on-time delivery has earned us an approved supplier status with leading OEM manufacturers around the world. Our commitment is to quality, customer service, and finding the most cost-effective solution.

For over 50 years, Smalley has manufactured retaining rings and wave springs using our unique coiling technology. Smalley has become established as the top manufacturer of spiral retaining rings and flat wire wave springs.

Smalley is ISO 9001, ISO/TS 16949, AS9100 and ISO 14001 certified.

Products: Wave (Compression) Springs: Smalley Wave Springs offer the unique advantage of space savings when used to replace coil springs. By reducing spring operating height, wave springs also produce a decrease in the spring cavity. With a smaller assembly size and less material used in the manufacturing process, a cost savings is realized.

Wave springs operate as load bearing devices. They take up play and compensate for dimensional variations within assemblies.

A virtually unlimited range of forces can be produced whereby loads build either gradually or abruptly to reach a predetermined working height. This establishes a precise spring rate in which load is proportional to deflection.

Spirolox® Retaining Rings: Spirolox Retaining Rings, available exclusively from Smalley, have No Ears To Interfere® with the mating components in the assembly.

Spiral rings offer a 360° retaining surface, require no special tooling for removal and are interchangeable with ordinary snap ring grooves.

Smalley Steel Ring Company 555 Oakwood Road Lake Zurich, IL 60047 Phone: +1 847 719 5900 Fax: +1 847 719 5999 Email: info@smalley.com www.smalley.com

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Constant Section Rings:

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Constant Section Rings are often specified for heavy duty or impact loading applications.

Smalley offers eight series of rings from stock in over 1,000 sizes.

Hoopster Rings: Hoopster Rings fit into much shallower grooves than regular snap rings or retaining rings.

Hoopster Retaining Rings are suitable for light to heavy loads and are ideal for thin wall tubes.

Manufacturing Process: Smalley offers an exclusive Circular-Grain® Process. This process is not a stamping, but rather a continuous coil that is made from edge-wound, pre-hardened, spring-tempered flat wire. The flat wire has a grain structure that is linear, providing exceptional strength and dimensional stability.

Smalley’s unique manufacturing process reduces scrap allowing for the economical production of special alloy products including a large selection of stainless steel retaining rings and wave springs.

No-Tooling-Cost™ Process: Smalley’s Circular-Grain® Process offers unusual flexibility in production. There is no special tooling needed, even for prototype or custom configurations. This results in low prototype cost and quick deliveries.

Free Samples: Smalley will send samples of catalog items for your evaluation, free of charge.

Simply go to www.smalley.com/samples to request free samples, catalogs, download CAD models, design assistance or design your own application specific ring or spring.

Laminar Sealing Rings: A Smalley Laminar Sealing Ring is a metallic labyrinth seal consisting of multiple rings in a groove. This arrangement of the rings and the specific orientation of the rings are dictated by the application and the severity of the environment.

www.medicaldesignandoutsourcing.com

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Smart Products designs and manufactures check and pressure relief valves, JACO Smart Fittings, liquid and air pumps, and related components. Our products provide accurate, reliable flow control in advanced, low pressure, low flow systems.

An ISO 9001:2008 Certified Company.

People often ask, what makes your valves smart? The answer is the ability to take customizable components - plastic body material and o-ring and pair them with a precise opening pressure. This custom configuration coupled with a wide range of styles allows for over 3 million possible combinations to create an exclusive low pressure, low flow valve to meet a specific design criteria.

Smart Products, Inc. 644 Fanning Fields Road Mills River, NC 28759 www.smartproducts.com

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Ideal for liquid or gas applications, our valves are in a wide variety of medical devices. They are also economical, FDA & NSF compliant, corrosion resistant, and able to withstand operating temperatures ranging from sub-zero to 400°F, depending on materials specified.

The thermoplastic materials used in these check valves provide improved corrosion resistance and make them a superior alternative to comparable metal valves.

of our check valves can also be used as pressure relief valves as long as the o-ring side vents to atmosphere. We provide a unique and quality product for every customer based on liquids/gasses used, application environment, and intended shelf life.

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

The majority of our check valves incorporate a low inertia poppet design with double-tapered o-ring seats to achieve a fast, positive seal in ultra low pressure applications. Additionally, most

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Innovating Shock & Vibration Solutions Sorbothane, Inc. serves widely varied market segments with Standard and Custom Engineered components.

MARKETS SERVED TRANSPORTATION SHIPPING & LOGISTICS • Sorbothane® Safeguards Precious Cargo PRECISION LABORATORY EQUIPMENT • Sorbothane® Isolates Disruptive Vibration MOBILE ELECTRONIC DEVICES • Sorbothane® Attenuates Impact Shock & Isolates Vibration CONSUMER & COMMERCIAL PRODUCTS • Sorbothane® Damps Unwanted Vibration & Noise INDUSTRIAL & MANUFACTURING EQUIPMENT • Sorbothane® Extends Equipment Life AEROSPACE & AERONAUTICAL • Sorbothane® Protects Critical Components MEDICAL EQUIPMENT • Sorbothane® Protects Performance SPORTING GOODS & FITNESS • Sorbothane® Protects, Cushions & Comforts Sorbothane, Inc. is located in Kent, Ohio and operates 10 specialized pouring machines.

With 64,000 square feet of manufacturing space and supply support systems in place, the Sorbothane team stands ready to meet any production need. Sorbothane, Inc. has an engineering design staff that specializes in shock and vibration solutions plus an in-house testing and quality assurance lab.

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

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

Unique applications call for innovative solutions.

Standard Sorbothane® parts and custom engineered solutions are available to meet individual product objectives.

Sorbothane, Inc. - Innovating Shock & Vibration Solutions

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

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

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

These standard products have been developed over 30 years and are selected for their specific shock absorbing and vibration isolating applications.

The Sorbothane® Standard Products Guide is available at www.sorbothane.com or by contacting Sorbothane, Inc. directly.

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

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SCS is a global supplier of Parylene

SCS PARYLENE CONFORMAL COATINGS

conformal coating services and technologies.

Parylene is the name for members of a unique family of polymer conformal coatings. Due to their vapor-phase deposition, Parylenes can be formed as continuous films from as thin as several hundred angstroms to 75 microns, making the coatings an ideal ultra-thin solution to protect medical devices and components, including stents, pacemakers, catheters, neurostimulation devices, needles, ocular and cochlear implants, etc. Among their beneficial properties, Parylenes provide excellent moisture, chemical and dielectric barrier properties as well as low coefficients of friction. Additionally, SCS Parylenes are biocompatible, biostable and sterilizable.

Ultra-thin and biocompatible, Parylene coatings increase the reliability of devices and components throughout the medical device, electronics, military/avionics and automotive industries. SCS, a direct descendent of the companies that originally developed Parylene, employs over 4 decades of experience as it services customers through regional coating facilities around the world. In addition to Parylene coatings, SCS also designs and manufactures conformal coating and dispense, curing and contamination test systems.

SCS GLOBAL RESOURCES SCS thrives on providing innovative solutions for customers. From highly experienced sales engineers and some of the world’s foremost Parylene specialists to expert manufacturing personnel, every aspect of every project is in extremely capable hands.

The SCS team is backed by state-of-the-art resources. World-class Parylene facilities offer a full range of capabilities — from FTIR spectroscopy and surface treatment plasma processing to all aspects of substrate preparation and coatings testing. Once a coating solution is developed to meet customer specifications, the process moves into production at one (or more) regional coating facilities around the world.

SCS: DELIVERING THE BEST FOR CUSTOMERS EVERY DAY No one understands or engineers Parylenes better than SCS. We have over 45 years of experience providing Parylene conformal coatings and technologies to customers around the world. What’s more, SCS and/or SCS Parylene coatings comply with numerous standards and certifications; several are highlighted below.

• AS9100 and ISO 9001 certified coating centers • ISO 10993 and USP Class VI certifications • U.S. FDA Device and Drug Master Files • IPC-CC-830 requirements • QPL listing for MIL-I-46058C • UL (QMJU2) recognized

Specialty Coating Systems 7645 Woodland Drive Indianapolis, IN 46278 317.244.1200 www.scscoatings.com

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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 in-house graphics capabilities, has enabled us to address an infinite number of medical device OEM foot switch needs with our unique “off-the-shelf-custom” program.

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

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

With offices in 30 countries, our worldwide team is ready to share our ideas for realizing a human interface that optimizes your device’s performance and market appeal.

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

• • • •

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

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

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

Fast wake-up time Worldwide acceptance.

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

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

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

www.steutemeditech.com

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L E A D E R S H I P

Sunrise Labs is a full service product development firm specializing in complete

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

Making Bright Ideas Work

product development, Project Rescue, and engineering services, leveraging ISO-13485

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and ISO-9001 certified processes.

P R O D U C T D E V E LO P M E N T PRESENTED BY

20

Medical Design & OUTSOURCING

16

LEA

N DERSHIP WI

NE

RS

Sunrise Labs 5 Dartmouth Dr Auburn, NH 03032 Tel: 603.644.4500 sunriselabs.com

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For over 25 years, clients have come to Sunrise Labs for complete product development, Project Rescue, and engineering services, leveraging our ISO-13485 and ISO-9001 certified processes.

Client success stories reflect our strengths in system engineering, project management, and a full range of technical disciplines to turn novel ideas into commercially viable products. We are known for solving tough engineering problems nimbly and with integrity.

Our team has deep experience in developing medical devices, combination products, and life science instrumentation. Our extensive project portfolio includes patient monitoring solutions, imaging, cardiac, neuro, and IVD applications.

Our team boasts expertise in software and electronics spanning portable, wireless, and battery powered devices connected to mobile phones, tablets, and back-end systems, to complex instruments with high-performance analog conditioning, closed loop controls, real-time multi-tasking software, and intuitive user interfaces.

Sunrise Labs’ main facility is one hour north of Boston in Auburn, New Hampshire, with a satellite office in the Bay area of California. We proudly employ over 50 dedicated employees in a high performance culture based on engineering excellence, mutual respect, ethics, and integrity. We look forward to working with you to meet your product development needs!

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

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Precision Parts for the Medical Industry

Tech-Etch has been a leader in the manufacture of precision engineered parts, EMI/RFI shielding products, and flexible circuits for the medical industry for over 40 years. Our technology has enabled the development of cataract lens replacement surgery, artificial heart valves, and medical diagnostic ultrasound imaging. The Tech-Etch Quality Management System is registered to both ISO 9001:2008 and AS9100. Corporate headquarters is in Plymouth, Massachusetts, and additional facilities are located in Fall River, MA and Litchfield, Minnesota.

Precision Parts, Flexible Circuits & EMI Shielding Products Tech-Etch photo etches precision parts for medical imaging, implants and surgical devices.

Light gauge parts are manufactured from a wide range of medical materials, including elgiloy, titanium, tungsten, nitinol, stainless steels, niobium, molybdenum, and copper alloys. Applications include maxillofacial screens and cranial closure implants, HTC grids, X-ray ID tags, stents, vascular stiffeners and closures, haptics, needles, surgical blade blanks, springs, and interconnects.

Standard and custom EMI/RFI shielding products include finger stock gaskets, board level shielding, knitted wire mesh gaskets, conductive elastomers, metalized fabric, conductive foam, and shielded honeycomb vents and filters. Shielding solutions are offered to address interference at the component level, board level, or the assembly/enclosure level.

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

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

www.medicaldesignandoutsourcing.com

1/13/17 10:47 AM

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Known as the company that brings medical devices to life, Tegra Medical is focused exclusively on the medical device industry, providing end-toend solutions from prototyping to full production, and from complex components to finished medical devices.

Offering a wide range of manufacturing technologies, the company creates devices used in cutting-edge procedures for leading surgical, interventional and orthopaedic companies. Tegra Medical has 220,000 sq. ft. of modern manufacturing space in four locations in the U.S. and Costa Rica and is ISO 13485:2003 and FDA registered and QSR compliant. The company combines a broad spectrum of capabilities with a cando culture to deliver exceptional quality,

Tegra Medical is a complete solution provider, which is why we like to say that Tegra Medical is “where medical devices come to life.” Our customers look to us to manufacture everything from small simple subcomponents to finished products – from the “business end” to the handle – including assembly, sterilization and packaging.

solutions, speed and service. Tegra

There are several things Tegra Medical does to support and service our customers that separate us firmly from the competition: The independent and robust quality systems that each location is built upon; our broad and comprehensive capabilities; and the technical and engineering resources at all of our locations led by the prototyping and development expertise in our GENESIS Tech Center® operations. Unlike many other contract manufacturers, our employees also really set us apart. We invest in our people through training and growth opportunities, and we provide ongoing philanthropic and social significance in the communities we work and live in.

Medical is a brand of SFS Group.

Where medical devices come to life.SM

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

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Tegra Medical’s goal is not just to be a trusted partner, but the customer’s preferred supplier. We have a group of engineers and project managers who work closely with the customer with DFM and cost-effective manufacturing solutions.

Our GENESIS Tech Center provides these services as well as quick-turn prototyping and short-run production. In fact, the success of the GTC in our headquarters drove us to expand that concept to all of our locations. We are always very open and candid about our desire to establish strong, collaborative, and trusting relationships, developing a “win-win” situation for all parties.

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

GENESIS Tech Center is a registered trademark of Tegra Medical.

www.medicaldesignandoutsourcing.com

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L E A D E R S H I P

For over 65 years, The Lee Company has pioneered the development of miniature fluid control components for aerospace hydraulic and fuel systems, automated liquid handling in medical and scientific instrumentation, medical disposable applications, down-hole oil tools,machine tools, inkjet printing, and other industries worldwide. Products include miniature solenoid valves, high-speed micro-dispense valves, nozzles, dispense pumps, custom manifold systems, inert tubing, Lee Plugs, check valves, shuttle valves, pressure relief valves, directional flow controls, safety screens, flow restrictors and associated fluid handling components.

Lee’s unique capabilities in miniaturization and engineering expertise (one of every eight employees is a graduate engineer) keep the company at the forefront of fluid flow technology, and enable it to work effectively with customers to solve difficult fluid control problems. The Lee Company employs over 1,000 people at its Technical Centers in Westbrook and Essex, Connecticut where all engineering and manufacturing is performed. Lee Company sales offices, staffed by degreed sales engineers, are located throughout the United States and Europe, and the Company’s distribution network spans the entire globe.

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

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

Miniature Stepper Dispense Pump Designed for Flexibility and Cost Savings After 20 years of experience designing and manufacturing dispense pumps for in vitro diagnostics and scientific instrument applications, The Lee Company is pleased to offer its most cost effective design yet. The new LPD Series variable displacement pump meets the demands of modern day applications: consistent performance and significant cost savings in a compact lightweight package. Designed to be completely maintenance free, this miniature, chemically inert pump is readily available in 50, 250, 1,000 and 3,000 microliter full dispense volumes.

Standard performance models meet the demands of most applications, while high performance models are available for the most demanding applications.

The LPD Series Pump can be customized for a variety of performance characteristics, feedback options and port head materials. Contact your local Lee Sales Engineer today for additional information.

LPM Inert Solenoid Pump

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

The Lee Company’s new LPM Series Inert Solenoid Pump was designed to offer greater design flexibility and significant cost savings to the medical and scientific industries.

The LPM pump features a revolutionary port head design that allows tubing connections and manifold mounting. This enables the designer to test the fluidic system using connections to soft 1/16” tubing, and then once the system design has been finalized, the same pump can be manifold mounted using standard O-rings.

Fax: 860.399.2270 E-mail: inquiry@theleeco.com www.TheLeeCo.com

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Available in standard 10 µL and 25 µL models, the pump features low power consumption and a contoured end cap which provides secondary connector retention and is compatible with standard AMP connectors.

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L E A D E R S H I P

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

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

to show it the desired movement, or use the touch screen. The robots are sold in

With more than 10,000 cobots installed worldwide, Universal Robots is the unrivaled market leader of the collaborative robotics industry and continue to push the envelope for new human-robot interaction.

over 50 countries worldwide, typical ROI is 3 – 8 months.

Universal Robots USA, Inc. 5430 Data Court, Suite 300 Ann Arbor, MI 48108

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

Since the UR cobots can be set up quickly and operate with no safety fencing alongside employees, the overall cost of deployment is significantly reduced.

According to the old rule of thumb, the cost of a robot would be equivalent to one worker’s two-year salary. But collaborative robots are closer to one fourth of that price:

1.844.462.6268 Email: ur.na@universal-robots.com www.universal-robots.com

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

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

to teach students about molding and

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

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

Wabash manufactures other hydraulic and pneumatic presses in sizes from .5 to 1200 tons, and bed sizes from 6” x 6” to 6’ x 12’.

Custom presses can be designed to meet specific applications with various options and accessories available. Applications for Wabash presses include ASTM polymer testing, proppant crush testing, rubber, plastics and composites molding, R&D, laboratory and other specialized processes.

and are available in hydraulic and pneumatic versions.

Today, Wabash is a leading worldwide supplier of standard and custom engineered presses to the aerospace, medical, recreation, automotive, education and energy

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

markets.

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

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

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Web Industries is a leading medical Contract Manufacturing Organization (CMO) providing automated manufacturing of LFI devices, IVD test cartridges, diagnostic testing strips, and medical consumables. Specializing in medical device commercialization, we provide a full range of services necessary to bring new and existing medical devices to market at commercial-scale volumes.

LFI & IVD Device Contract Manufacturing For over 30 years, the world’s leading medical device companies have turned to Web

Industries when they need a proven silent-partner CMO to provide automated manufacturing of their medical diagnostic tests and consumables. Web offers a full range of contract services for successful commercialization of new and existing medical devices. We create highlycustomized manufacturing and supply chain solutions that help our partners overcome limited or non-existent internal capacity while reducing their risk and capital costs. Our medical facilities hold all required ISO and industry certifications, and we have been audited and validated by some of the largest organizations in the industry. Our rigorous quality assurance systems and commitment to quality has allowed us to successfully produce over 100 billion medical tests over the past two decades.

Web Industries Offers: Web Industries, Inc. 700 Nickerson Road, Suite 250 Marlborough, MA 01752 - 4715 T: +1 508.898.2988 F: +1 508.898.3329 webindustries.com

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• 30+ years of flexible goods & device manufacturing experience • 20+ years LFI manufacturing & product transfer knowledge • Flexible automated manufacturing systems • High commercial-scale capacity (>10MM units) • Prototype-to-Product Launch one-stop solutions • Comprehensive supply chain management • Non-competing CMO-only services • Robust ISO compliant quality systems • Manufactured with pride in the USA Web Industries applies expertise, innovative thinking, and creative problem solving to help speed time to market, drive down costs, and continuously improve processes to maximize product success. www.medicaldesignandoutsourcing.com

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2017 MEDTECH LEADERSHIP

AD INDEX

Accumold........................................................ 39 AIM Plastics..................................................... 15 Arthur G. Russell Co., Inc............................... 46 B.Braun...........................................................BC Bansbach Easylift............................................ 38 binder USA...................................................... 49 Bird Precision.................................................. 73 Branson Ultrasonics........................................ 17 Cadence, Inc................................................... 25 Chieftek Precision USA...................... 77, 79, 81 Cicoil................................................................ 54 COMSOL......................................................... 78 CPC-Colder Products Company................... 64 DDL, Inc........................................................... 71 Del-tron Precision, Inc.................................... 50 Eagle Stainless Tube....................................... 28 Economy Spring, a division of MW Industries..................... 3 Electrocraft...................................................... 57 Fischer Connectors......................................... 65 Fluid Metering.................................................. 5 Fotofab............................................................ 70 Helical Products Company............................ 59 Herrmann Ultrasonics..................................... 21 IGUS................................................................. 31 IXYS.................................................................. 66 J.W. Winco, Inc............................................... 73 Keystone Electronics Corp............................... 9 LEMO USA, Inc............................................... 74 Magnet Applications...................................... 45 Master Bond.................................................... 75 maxon precision motors.........cover/corner, 19 MedBio............................................................ 75 MEDEFAB.......................................................... 1 Medo USA, Inc.................................................. 5 MICROMO...................................................... 42 Minnesota Rubber & Plastics........................... 4 New England Catheter................................... 35 New England Wire......................................... 33 NSK Americas................................................... 2 PexcoLLC / Pexco Medical............................ 11 Proto Labs....................................................... 29 PTI Engineered Plastics.................................. 27 Qosina............................................................. 55 Resonetics..................................................... IFC REVOX Sterilization Solutions....................... 34 Schneider Electric IMS................................... 68 SCS Coatings.................................................. 56 SDP/SI-Stock Drive Product........................... 80 Signal Transformer.......................................... 67 SMAC MCA..................................................... 13 Smalley Steel Rings........................................ 41 Smart Products................................................ 23 Sorbothane..................................................... 20 STEUTE Meditech, Inc...................................... 7 Sunrise Labs.................................................... 71 Tech-Etch, Inc.................................................. 37 Tegra Medical...............................................IBC The Lee Company.......................................... 47 Universal Robots USA, Inc.............................. 32 Wabash MPI.................................................... 24 Web Industries................................................ 16 148

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Accumold........................................................ 83 AIM Plastics..................................................... 84 Arthur G. Russell Co., Inc............................... 85 B.Braun............................................................ 86 Bansbach Easylift............................................ 87 binder USA...................................................... 88 Bird Precision.................................................. 89 Branson Ultrasonics........................................ 90 C&K.................................................................. 91 Cadence Inc. .................................................. 92 Chieftek Precision USA.................................. 93 Cicoil................................................................ 94 COMSOL......................................................... 95 CPC-Colder Products Company................... 96 DDL, Inc........................................................... 97 Eagle Stainless Tube....................................... 98 Economy Spring, a division of MW Industries................... 99 Electrocraft.................................................... 100 Fischer Connectors....................................... 101 Fluid Metering.............................................. 102 Fotofab.......................................................... 103 Helical Products Company.......................... 104 Hermann Ultrasonics.................................... 105 Humphrey...................................................... 106 IGUS............................................................... 107 Introtek Int'l................................................... 108 IXYS................................................................ 109 JW Winco, Inc............................................... 110 Keystone Electronics Corp........................... 111 LEMO USA, Inc............................................. 112 Magnet Applications.................................... 113 Master Bond.................................................. 114 maxon precision motors.............................. 115 Medbio.......................................................... 116 MEDEFAB...................................................... 117 Medo USA, Inc.............................................. 118 MICROMO.................................................... 119 Minnesota Rubber & Plastics....................... 120 Model Solution............................................. 121 New England Catheter................................. 122 New England Wire ...................................... 123 Norman Noble.............................................. 124 NSK Precision................................................ 125 Pexco LLC / Pexco Medical......................... 126 Proto Labs..................................................... 127 PTI Engineered Plastics................................ 128 Qosina........................................................... 129 Resonetics..................................................... 130 REVOX Sterilization Solutions..................... 131 Schneider Electric IMS................................. 132 SDP/SI-Stock Drive Product......................... 133 Signal Transformer (Bel Fuse)...................... 134 SMAC MCA................................................... 135 Smalley Steel Rings...................................... 136 Smart Products.............................................. 137 Sorbothane................................................... 138 Specialty Coating Systems........................... 139 STEUTE Meditech Inc................................... 140 Sunrise Labs.................................................. 141 Tech-Etch, Inc................................................ 142 Tegra Medical............................................... 143 The Lee Company........................................ 144 Universal Robots USA, Inc............................ 145 Wabash MPI.................................................. 146 Web Industries.............................................. 147

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

Neel Gleason ngleason@wtwhmedia.com 312.882.9867 @wtwh_ngleason Jessica East jeast@wtwhmedia.com 330.319.1253 @wtwh_MsMedia Mary Ann Cooke mcooke@wtwhmedia.com 781.710.4659 Mike Francesconi mfrancesconi@wtwhmedia.com 630.488.9029 Michelle Flando mflando@wtwhmedia.com 440.670.4772 @mflando Garrett Cona gcona@wtwhmedia.com 213.219.5663 @wtwh_gcona

LEADERSHIP TEAM Publisher Brian Johnson bjohnson@wtwhmedia.com 617.905.6116

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

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

EVP Marshall Matheson mmatheson@wtwhmedia.com 805.895.3609 @mmatheson

CONNECT WITH US!

Follow the whole team on twitter @WTWH_Medical

www.medicaldesignandoutsourcing.com

1/14/17 11:34 AM

Breast cancer victor and all-around super hero.

Solutions Tegra Medical makes it possible.

At Tegra Medical we use our “super powers” to

The growth path of your device might start with

create medical devices — including products for

our GENESIS Tech Center , where we help nurture

women’s health. We’re innovative problem-solvers

your designs with prototyping and pilot production,

who work with you to get your product to market,

then progress to full-scale production, and end with

whether you need needles for breast biopsies or

final assembly, packaging and sterilization. We infuse

devices for gynecological surgery.

robust quality procedures into every step.

Our range of expertise includes tools and complex

Providing ingenious solutions for women’s health

assembled devices for arthroscopy, spine,

and many other medical-device challenges is just

neurosurgery, cardiac, orthopaedics, drug delivery,

one of the hallmarks of Tegra Medical, along

oncology, neurosurgery, gastrointestinal, laparoscopy,

with quality, speed and service.

®

ophthalmology, endoscopy, urology and much more.

Boston — Memphis — Costa Rica www.tegramedical.com or 508.541.4200 Where medical devices come to life.

O R T H O PA E D I C S

M I N I M A L LY- I N V A S I V E

INTERVENTIONAL

AND MORE

Tegra Medical and GENESIS Tech Center are trademarks of Tegra Medical. Copyright © Tegra Medical. All rights reserved.

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If you’re looking for a single-source supplier, how about one that has a full range of parenteral

pharmaceutical solutions? Or one with a catalog of valves as thick as a phone book? Or one that

carries all the admixture accessories you could ever pack into a custom kit for your drug or device?

& there’s more. Besides a line containing hundreds of products, we offer a full range of capabilities.

Project management puts your product on a fast track to market without compromising quality.

Our engineering and quality systems maintain exacting standards of excellence. Other services under our roof include full sterilization capabilities and regulatory expertise to ensure compliance in this country and around the world. It all adds up to a single-source supplier that goes far beyond being a vendor to being a true partner. Visit BBraunOEM.com.

B. Braun Medical | OEM Division | USA ©2016 B. Braun Medical Inc. Bethlehem, PA. All rights reserved. OEM 15-4993 1/16 LMN

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