Medical Design & Outsourcing - MARCH 2017

MARCH 2017

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FAILURE TO THRIVE:

from medical device innovations that missed the mark

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MARCH 2017

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FAILURE TO THRIVE:

from medical device innovations that missed the mark

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Medical Design & OUTSOURCING

medicaldesignandoutsourcing.com ∞ March 2017 ∞ Vol3 No2

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 Associate Editor Sarah Faulkner sfaulkner@wtwhmedia.com Assistant Editor Danielle Kirsh dkirsh@wtwhmedia.com

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Medical Design & Outsourcing

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HERE’S WHAT WE SEE

Want a word to sum up 2017? Try ‘uncertainty’

It’s March 1 as I write, and Wall Street investors remain on a sugar high from the new Trump administration and Republican Congress. The Dow Jones Industrial Average is up hundreds of points, the day after President Donald Trump’s promise to a joint session of Congress that he wanted to massively reduce corporate taxes and “job-crushing regulations.”

For the most part, the medical device industry’s top executives have sounded positive about the situation during earnings calls with analysts. And when Medical Design & Outsourcing and MassDevice. com readers responded to an online survey on Trump and the Republicans, 42% said they would be good for medtech, versus 33% who thought they would be bad.

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

Medtech insiders are especially optimistic that the much-hated medical device excise tax will soon be dead for good. “Fully repealing the medical device tax, establishing a more transparent and predictable regulatory process, lowering corporate taxes and properly reimbursing medical technologies would create an environment that allows this proud American industry to thrive,” Mark Leahey, president & CEO of the Medical Device Manufacturers Assn., said in a statement after Trump’s address to Congress.

Here is one word, though, that should give the device industry pause: Uncertainty.

Over my 16 years as a journalist – 10 as a business journalist – I’ve learned that “uncertainty” is a toxic word. It’s the one executives

and business owners use when they’re explaining why they aren’t hiring, building a new plant, investing in R&D or taking other risks.

There is a lot of uncertainty in the present political environment. Don’t take my word for it: Respected hedge fund manager Seth Klarman – ”The Oracle of Boston” – recently made waves with a private letter to investors, relayed by media outlets including CNBC and the New York Times. Klarman warned that Trump’s unpredictable style and protectionist trade stance create even more risk and uncertainty.

As the ancient Romans liked to say: “Fortune favors the bold.” But it is also smart to identify the unknowns out there, the hazards of the current environment.

Here are 5 major uncertainties to keep an eye out for as the year progresses: 1. What’s going to happen with the Affordable Care Act? “Tonight, I am also calling on this Congress to repeal and replace Obamacare – with reforms that expand choice, increase access, lower costs, and, at the same time, provide better healthcare,” Trump said during his Feb. 28 address to Congress.

Mandating that Americans buy health insurance was the wrong solution, Trump said. He laid out 5 principles to guide Congress as it seeks to replace the ACA:

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Keeping coverage for Americans with preexisting conditions (a popular feature of Obamacare); Encouraging Americans to buy coverage through tax credits and expanded Health Savings Accounts; Giving states more flexibility in managing the Medicaid health

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• •

insurance program for the poor and disabled; Lowering costs through legal reforms and combating high drug prices; Allowing Americans to buy health insurance across state lines.

It remains unclear, though, whether Trump and his allies will be able to get a “repeal and replace” plan through Congress. A leaked draft of the legislation actually drew criticism from some of the most conservative House members, who complained about using refundable tax credits to help people pay for insurance, according to The Hill. Plus, Trump and Republicans face some major political risks: A previous GOP plan from 2015 to repeal parts of the ACA would have caused 18 million people to lose their health insurance, according to the Congressional Budget Office. That kind of thing won’t play well at the mid-term polls next year.

2. What’s going to happen to Medicare?

The situation could get even more dicey if Trump gravitates toward the previous positions of Dr. Tom Price, the former congressman from Georgia who is now Trump’s Health & Human Services secretary. Price for years has called for changes to the popular Medicare health insurance program for seniors. For now, Trump is adamant that Medicare will not be changed, and Price said during Senate confirmation hearings that there were no immediate plans to change Medicare.

It might be worth asking, though, whether Medicare is going to walk back its shift toward value-based payment models under the ACA. The new payment models have caused medical device companies to make significant strategy shifts. Industry insiders have generally insisted that valuebased care is here to stay.

3. What’s going to happen with trade?

“I believe strongly in free trade, but it also has to be fair trade,” Trump said Feb. 28. Pressures to bring manufacturing back to the United States could especially be a material burden on medical device companies, nearly all of which rely on low-cost manufacturing outside the country (including in Mexico), S&P Global Ratings said in a post-election report.

4. Is deregulation going to be confusion-free?

Here’s a recent example: Trump in January signed an executive order requiring all government agencies including the FDA to eliminate 2 regulations for every new regulation they institute – including guidance documents. Eliminating FDA guidance documents could cause confusion for medical device companies, which rely on the guidance to understand the thinking behind FDA standards and interpretation of the law. And what about product liability lawsuits, in which the legal profession defers to the FDA as a science-based organization? If that changes, it could upend years’ worth of legal cases.

5. What else is going to happen?

So far, every day has been an adventure with the new administration, especially when the president takes to Twitter. The biggest shocker could be something we never anticipated. M 3 • 2017

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CONTRIBUTORS

NEWMARKER

BODOR

ANASTASI

FAULKNER

SZORIK

THOMPSON

MIDDLETON

FLEMING

HUTTER

DVORAK DENSFORD

VICKI ANASTASI is global head of medical device and diagnostic research at ICON plc. Anastasi has more than 18 years of experience in the medical device industry.

ROB BODOR is currently VP and GM of the Americas at Proto Labs, an online- and technology-enabled digital manufacturer of rapid prototypes and ondemand production parts.

FINK DENSFORD is associate editor of Medical Design & Outsourcing. He has a passion for covering science, engineering and tech development.

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.

ALISTAIR FLEMING is vice president of Sagentia’s medical business. He has more than 20 years experience in innovation and technology development in the medical device industry.

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JACKIE HUTTER has been recognized by her peers as a top global IP strategist for the last 8 years. She has more than 20 year of IP and business experience.

TOM MIDDLETON is a solutions architect at Sparta Systems. He has spent 20 years conducting registration, surveillance, internal and supplier audits.

CHRIS NEWMARKER is managing editor of Medical Design & Outsourcing.

He's a professional journalist of 16 years, with a focus on technology and business.

MARK SZORIK is the senior sales territory manager for MKS Instruments, Ophir-Spiricon Products. He's worked in industrial manufacturing for more than 30 years.

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 ∞ March 2017 ∞ Vol3 No2

DEPARTMENTS 4

HERE’S WHAT WE SEE: Want a word to sum up 2017? Try ‘uncertainty’

6 CONTRIBUTORS

10

40

14 REGULATORY: Medtech needs clinical registries for pre- and post-market data

Disruptors who weren’t: Lessons learned from medical device innovations that missed the mark

ON THE COVER:

18

PATENT PROTECTION: Medtech entrepreneurs are making a big mistake when they patent their work

22

MANUFACTURING & MACHINING: Gaining a competitive edge with digital manufacturing

26

THE CATH LAB: Clever catheter lets surgeons see inside arteries to trim plaque

30

ENGINEERING 911: Reducing production waste with laser profiling and characterization

34

TUBING TALKS: Five things you need to know about micromanufacturing

67

DEVICE TALKS: The secrets of a product liability Jedi

FEATURES 40

46

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Failure to thrive: Lessons learned from medtech’s megaflops

Some of the industry’s most anticipated disruptors wind up being its biggest failures.

Here’s what we can learn from their mistakes.

Disrupting fee-for-service: Acelity aims to prove its value in wound care

Value-based care is disrupting the old fee-for-service models in the U.S. healthcare industry, and medical device makers must adapt or perish. Here’s how wound care company Acelity is responding.

7 disruptive innovations from medical device suppliers

Medical device innovation doesn’t just come from small, single-product startups – contract manufacturers are increasingly a part of developing truly disruptive medtech.

54

The stem cell therapy that isn’t a stem cell therapy that could reverse hearing loss

Frequency Therapeutics is betting that its technology can change the lives of millions of Americans living with hearing loss by triggering the body’s natural ability to heal itself.

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8

Aerospace may have something to teach medtech about materials: Here’s how

QuesTek has used advanced computer modeling to produce innovative materials in the aerospace sector. Now it’s looking to recreate the same magic in the medical device space.

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LEGAL COMPLIANCE: Your burning questions answered by FDA

70 PRODUCTS

How surgical robots are creating super surgeons

Faster than a scalpel-wielding hand, able to snake to hard-to-reach surgical sites in a single bound – future surgeons could be super surgeons thanks to robotics.

Medical Design & Outsourcing

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LEGAL COMPLIANCE

Medical device reporting: Your burning questions answered by FDA A final guidance on medical device reporting aims to clarify, but some questions remain.

To m M i d d l e t o n | Solutions Architect | Sparta Systems |

In November 2016, the FDA released its final guidance on medical device reporting (MDR). MDR has been an intrinsic part of the medical device regulatory process for many years. There’s no specific change or new information in this document, but it does answer some fundamental questions about when and how to do things. It is organized as an FAQ-style reference, to be used in conjunction with online MDR requirements and guidelines.

This 46-page document is welcome outreach from the FDA to help industry through the reporting process. There have been some gray areas with MDR submissions for a number of years.

Manufacturers had multiple questions and challenges in terms of gathering data and understanding the requirements for various scenarios. The FDA clearly hopes that this document will help standardize a manufacturer’s approach and provide support and clarity for unusual scenarios.

Used appropriately, the guidance should make the process clearer for manufacturers.

The FDA has been building the guidance document for a number of years using questions they’ve heard from the industry, such as: • • • •

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How is “when you become aware of an adverse event” actually defined?

What’s considered a serious event or a serious injury that would necessitate an event being reportable?

When does a complaint concerning a device manufactured by my company not have to be reported?

What are the stipulations that would make a complaint not reportable?

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What are the types of reports that could be out there?

What are the criteria for 30-day reports or 5-day reports and the supplemental/ follow-up reports? What defines these?

Think of the guidance as a supplemental document to the MDR requirements.

Guidance documents explain what needs to be done and (perhaps most importantly) review the intent of the required steps. This can help alleviate confusion. The following sections answer some of the questions I’ve had from clients on subjects such as electronic submissions, the link between device labeling and adverse events and, of course, when to report.

Electronic submissions In 2016, FDA made electronic submission of adverse events mandatory, as opposed to a choice between electronic and paper submissions. A valuable aspect of the guidance document is that it provides a resource companion for electronic submissions, even answering some of the simple but frustrating questions related to the FDA website, for example.

Making the switch from paper to electronic is a cumbersome undertaking.

Many manufacturers have had to adapt their processes to meet the new requirement and some are still adjusting.

Troubleshooting for electronic submission is built into the guidance.

Device labeling There are lingering questions around whether device manufacturers are required to report

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an adverse event if a label lists the event as a possible risk. In devices, such labeled risks could result in an injury. The FDA said quite clearly in the new document that such events are indeed reportable. If an adverse event occurs, it does not matter whether the event came with a warning.

When and how to report The first determination that manufacturers should make is whether the event is considered a reportable event. The second question is when, or how soon, the event must be reported. But the answers to these questions don’t necessarily come in that order. The first thing you need to determine is the date that anyone in an organization – an employee, a contractor, a sales rep or a customer service rep – became aware of information that reasonably links the event with the company’s medical device. That moment starts the clock for a 30-day submission.

The 5-day window However, for serious events there are stipulations that could require the report to be made within 5 days instead of 30. The 5-day window is based on working days as opposed to calendar days; it kicks off when someone within the company’s organization who is knowledgeable about adverse events makes a judgement call. It might be management or a supervisor that can make the appropriate assessment that this adverse event is a serious event and could potentially require a recall or some type of remediation.

The FDA’s new MDR document delves deeply into making these determinations. It answers the question of how to define a serious injury that triggers the 5-day window. It clarifies that if something is considered lifethreatening, causes permanent impairment or requires medical

or surgical intervention, it is to be determined a serious event. An event is also considered serious if there is reason to take immediate action on the product or repair or rework the product to prevent recurrence.

To report or not report To aid in determining whether an event is reportable or not reportable, the FDA provided a questionnaire to help you arrive at an answer quickly. But, most importantly, every complaint must be investigated and a determination made and documented as to whether an event needs to be reported or not reported.

You must show your work.

Some circumstances that might not require a report include those in which it can be reasonably concluded that your device did not cause or contribute to death or injury. Sometimes adverse events are reported to device makers,

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LEGAL COMPLIANCE

but the reporter may not know whether it was your device that contributed to the event. Determining the root cause of an adverse event requires investigation. If the medical device was not part of the root cause, this can be shown through the investigation record(s). Having said that, I would advise most companies to be very conservative in making such determinations. Of course, you don’t need to report if, after an investigation, you discover the reported event was erroneous, didn’t actually occur or your company is not the manufacturer.

Additionally, there can often be multiple reporters of the same event. For example, if a doctor calls, as well as the patient, the device manufacturer only needs to report the event one time. However, you should always bear in mind that additional information, gained from separate reporters of the same event, might necessitate a follow-up report.

GUIDANCE DOCUMENTS EXPLAIN WHAT NEEDS TO BE DONE AND (PERHAPS MOST IMPORTANTLY) REVIEW THE INTENT OF THE REQUIRED STEPS.

Clarification on follow-ups There is one confusing portion of the guidance document that we hope is an oversight the FDA will correct in a new edition (we’ve reached out to the agency for clarification). When companies find it necessary to submit a supplemental report, they might have to complete 50-75 different fields to complete the report via XML. Follow-up reports should only contain the fields that are different from the original report. If you’ve just learned 2 pieces of new information, you’re supposed to submit only those 2 pieces of information on top of the report ID. But this is actually rather cumbersome from a technical standpoint with the electronic file. In reality, it is actually easier to resubmit the entire document.

In 2015, when the FDA went live with the latest system for making electronic reports mandatory, the agency said it had fixed an issue with its old adverse event database whereby manufacturers could resubmit the entire package. The system is able to determine and update only the aspects of the submission that need to be updated.

The new version of the adverse event database still contains instructions specifying the original process of submitting only the new or changed data, so manufacturers are still somewhat confused. It could be that policymakers kept the old language, not realizing that the technical side of the issue had already been resolved.

The take home This guidance answers a number of questions and facilitates decision-making so manufacturers don’t have to continually question the FDA. In today’s regulatory environment, companies just don’t have time to wait on a response from the bureau. It’s always better to do this adverse event stuff right the first time.

Nobody wants to have to constantly resubmit data to get it right.

Managing an adverse event can be a very stressful time for an organization. The FDA has published a very useful tool in this guidance for manufacturers to have on hand, and is always willing to hear more questions from industry and can always make more revisions to this document should more questions come up. M www.medicaldesignandoutsourcing.com

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REGULATORY

Medtech needs clinical registries for pre- and postmarket data The value of clinical registries is growing, but using them effectively depends on your KOLs

Vicki Anastasi global head of medical device and diagnostic research ICON plc

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Clinical registries are becoming valuable resources for medical device manufacturers.

These clinical registries can be used in a few ways: Building preapproval documentation and in postapproval monitoring. Using registries effectively will save both time and money for medtech companies, but companies need to better understand how to find them, how to use them and how to get the most out of them.

How to tap into clinical registries Key opinion leaders (KOLs) and medical advisory staff are critical to collecting existing clinical data and generating post-market data. They should be knowledgeable and up to date on what registries exist and how medtech manufacturers might harness them. These clinical registries are used primarily by surgeons and doctors. Companies need to ensure that KOLs are savvy to determine what registries are available, the information required from the registry, what’s being collected and whether those data would advance the product. These are driven by the medical community, and device makers don’t necessarily know what is out there. Clinical registries are a big category. There are a lot of them out there, and there is a lot of data available, but it may not always be the data companies need.

It could be that there’s an existing clinical registry with data available. It could be that there isn’t one, and you need to own one about your product. Or it could be that there is a therapeutic area registry that’s available, but the data being collected doesn’t work with your product.

3 • 2017

Post-market clinical registries When people talk about traditional registries, they’re usually talking about a registry that’s created based on a product that’s undergoing a regulatory submission and moving, aligning or shifting the burden of data collection from pre-market into post-market.

These are usually products that have limited claims, based on a discreet population attainable in a clinical study. These data are followed into post-market. Once the product is on the market, that patient population can be expanded via a registry.

Device makers that build evidence for broader populations using this type of registry are generally able to save money compared with those who chose to do additional prospective studies.

In addition, they can be useful for making a case for subpopulations, such as those at higher risk or “orphans” (populations that are very small). Companies that have used a registry to build evidence over time have a successful track record.

Therapeutic registries Therapeutic clinical registries are not generated by a single company; rather, they are a registry for a therapeutic area, such as orthopedics. These data, what I would call “real-world data,” can be enormously valuable because they often contain thousands of patients who have been followed for many years. If a company is developing a product for a sector, this is one of the first places they would find to draw insight. Armed with such data, a prospective clinical study might require fewer enrollees, thereby saving money and time, as well as possibly broadening the clinical population.

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Using therapeutic registries is one of the most valuable ways to for companies to obtain critical market and outcomes data for new products. And these can continue to be used post-market to measure outcomes.

Working with existing registries Existing clinical registries can be an immense tool for new products on the market. These can be therapeutic registries or registries that have been started for equivalent products. The important issue to keep in mind, however, is that there is a certain data set being collected and that set may or may not align with a medtech company’s product needs.

Due diligence is key. This is where KOLs can really come into play. Chief medical officers should be involved, as well as a medical advisory board. There is no reason for a company to set up its own registry if an identical one already exists.

Building your own registry However, if there is no registry already that meets the needs of the product and the company’s clinical goals, creating your own registry may need to be part of your strategy to enter the market.

Companies need to understand what that means and how they are going to support and maintain that registry. It can be expensive and time-consuming, so getting it right early is critical. Some companies may want to find a partner who can build the registry and support it.

Talk to regulatory and reimbursement agencies.

Keep in mind that the FDA and other agencies want companies to take advantage of these existing clinical registries. These agencies will often ask submitters whether they explored data options because they provide such a rich source of information.

No one designs a perfect clinical study. There is no such thing. The FDA and CMS have said that companies need to get smart about their industry and their therapeutic space and provide evidence of their product. You have to incorporate many different factors.

Companies need to talk to the FDA or other regulatory bodies. They also need to talk to payers to ensure they are looking 16

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at the right data sets. CMS might request that companies collect additional data.

However, in talking with these agencies or stakeholders, it is critical to be informed about your product. You don’t want to go into a meeting with a regulator and have them say, “Why aren’t you considering using registry A, B and C?” and you don’t know about registry A, B and C. This is not to say regulators won’t help, but you don’t want to be behind them.

Get help If firms don’t have the necessary KOLs, they will need to find a partner to help.

This is something companies cannot do alone – they need to invest in making sure they have a good plan. It is critical that companies are knowledgeable about their space. They need to know where patients are coming from, what sites are involved in the registry, who is contributing and what data is being collected.

This information is part of due diligence. You should be clear on where and how a product is going to be used in the marketplace, how it affects the continuum of patient care and the

be smart about how money is spent.

Clinical registries are very powerful tools. Registries using data already in a registry are powerful tools. Active data collection enables companies to move

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PATENT PROTECTION

Medtech patenting: You might be leaving money on the table

Medtech entrpreneurs might be making a big mistake when they patent their work.

Jackie Hutter | owner | The Hutter Group |

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Entrepreneurs bringing innovative new medical devices to market often make a significant mistake when they go to patent their work. I frequently find that these entrepreneurs focus their patenting efforts on the particular medical device product, without also recognizing that a wider scope of coverage for their innovations may be available. Although these innovators may obtain broad coverage for their go-to-market product, they nevertheless are leaving money on the table, because savvy players can leverage the innovator’s medical device product insights to create products in adjacent markets without having to pay a license fee. Often, the medical device entrepreneur’s singular focus on getting a regulated product to market results in gaps when they generate patent coverage.

Consider the hypothetical example of a podiatrist who for many years has been working on a “better mousetrap” for creating an orthotic for people with chronic plantar fasciitis. Recently, “Dr. Footwall” experienced the proverbial “lightbulb moment” in which her many 3 • 2017

years of thinking about the problem culminated in a simple solution – a lowcost orthotic product.

Dr. Footwall is by nature an entrepreneur: She founded a company, obtained outside investment, sought regulatory approval and is in the process of bringing her product to market. Of course, she also realizes that patent protection will operate as an integral part of capturing the value of her innovative insights, so Dr. Footwall hires a highly recommended medical device patent attorney. When meeting with this attorney, Dr. Footwall downloads the characteristics and value of her insights, and together they draft an application that covers the orthotic product in a myriad of ways. A patent application that broadly covers the medical device application is filed, publishes and issues. Notably, the patent claims to address the fact that the orthotic device is an insert for a piece of footwear.

Our doctor toils for a couple of more years, but finds that, notwithstanding the significant benefits her orthotic device provides to sufferers of plantar fasciitis, far too many barriers exist for her small

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PATENT PROTECTION

orthotic company to be successful in the marketplace. Dr. Footwall reluctantly shutters her startup and goes back to practicing podiatry full-time.

Shortly after that, however, she sees a new advertising campaign from a large athletic shoe company – let’s call them SportShoe – that hypes a new “No Foot Pain” product offering, which SportsShoe markets as being the first athletic shoe that almost entirely eliminates the possibility of a runner generating plantar fasciitis. Intrigued, Dr. Footwall obtains a pair of these shoes, and finds that the interior shape of the shoe mirrors the shape of the orthotic insert that she attempted to bring to market in her startup. She is steaming mad and seeks the assistance of her patent lawyer.

Unfortunately for Dr. Footwall, however, she has no recourse against SportShoe – even though the company’s new product provides the same benefit to consumers, even while it is clear that SportsShoe copied the doctor’s insight in the interior of the “No Foot Pain” shoe. The doctor’s patent, while broadly covering an orthotic insert, does not address the functional benefit provided by the orthotic itself. SportShoe is, therefore, able to mirror that functionality in the interior of an athletic shoe without infringing Dr. Footwall’s patent. As a result, Dr. Footwall reaps none of the financial rewards obtained from SportShoe’s successful new product.

This example is hypothetical, as noted, but I have seen this issue arise multiple times over my career. Medical device entrepreneurs who are working in their specific silos of product function and design should not be expected to more broadly recognize the value that their insights might bring outside of their workspace. But they should be counseled to conceptualize alternative or adjacent value propositions when they are working on generating patent protection. By viewing their innovations as not just “the trees” (the particular product they seek to bring to market) but also “the forest” (how their innovation presents in a group of related products), medical device entrepreneurs can improve the probability that they will get paid for their insights. M 20

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MANUFACTURING & MACHINING

Gaining a competitive edge with digital manufacturing Medtech companies are increasingly turning to digital manufacturing providers with the capacity, automation and ability to provide custom parts on-demand.

As suppliers to medtech manufacturers, we’ve had the opportunity to work with a variety of companies in this space – from large medical device OEMs to earlystage medtech firms – to help deliver transformative technologies and products to market.

This market is sizeable and a fiercely competitive one. The U.S. remains the largest medical device market in the world, with revenues expected to reach $155 billion this year, according to the U.S. Commerce Dept.

A number of industry trends are playing a role in this growth. Here are some of the key ones: •

Rob Bodor | VP and GM of the Americas | Proto Labs |

•

The aging Baby Boomer population that’s living longer, setting new life expectancy records and driving up demands and costs on the healthcare system; The trend toward increased proof of product effectiveness by many healthcare systems;

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•

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The constraints of existing regulatory requirements and anticipated future regulation and compliance issues; The impact of greater patient engagement and the correlating move to human-factor engineering or user-centered design; and The growing customization of medical devices, such as prostheses and implants.

Given the above trends and the opportunities they present, it’s not surprising that the medtech space has become an increasingly competitive one. So what can medtech companies do to stay ahead of the competition?

One key enabler of competitiveness is an optimized product development and manufacturing supply chain.

Manufacturing gone digital Depending on the product, medical device companies often use contract manufacturers for parts and components. Identifying suppliers that not only can provide a variety of manufacturing services but also understand the industry trends and the deamand for accelerated product development cycles is an important success factor.

(ABOVE) Proto Labs is providing custom-machined aluminum-joint housings for this powered exoskeleton, which will be part of a futuristic brain-machine robotics system to help people with paraplegia walk again.

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MANUFACTURING & MACHINING

This is why an increasing number of medtech companies are turning to digital manufacturing providers who have the capacity, automation and ability to provide custom parts on demand.

It’s this kind of supply chain flexibility that enables iterative product design, validation and, ultimately,

When production runs reach the tens of thousands, medical device companies generally turn to injection-molded components, due to cost considerations.

Image courtesy of Proto Labs.

market launch. In some cases it could even make or break a product, giving it a first-mover advantage, or conversely, its absence could hinder or even cripple design and development.

Before this digitization of the manufacturing supply chain, a more traditional manufacturing approach meant, in many cases, a design-and-wait approach, with initial prototyping and oneat-a-time design iterations taking months to reach the engineering-build phase.

Conversely, digital manufacturing – which can be applied across all manufacturing processes, including traditional manufacturing processes and additive manufacturing (3D printing) – can have a transformative impact on product development. Here’s how: •

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Drastic reduction in R&D spend by shortening development cycles from months to days;

•

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Improved product quality and adoption rate through multiple design iterations, reducing design risk and minimizing failure rate; An optimized supply chain with reduced lead times, lower inventory and better management of demand volatility.

Selecting the right digital manufacturing process Although the digital manufacturing model, like the one at Proto Labs for example, offers a variety of manufacturing processes to choose from, not all processes are suitable for every medtech application.

Additive manufacturing processes, also known as 3D printing, can accommodate complex designs, work well to reduce multipart assemblies and support customization of prostheses, dental implants and body parts. (Think tracheal implants and ribs, legs, joints and hands.) Companies can also use 3D printing to make microfluidics products, such as fluidically sealed devices like chips, sensor cartridges, connectors and valves created on a sub-millimeter scale.

3D printed parts are ideal for physical testing and validation, including tests that digital simulation may miss, making them invaluable for early evaluation of new medical devices and components.

There are multiple 3D printing processes out there, but the most commonly used ones are stereolithography, selective laser sintering, direct metal laser sintering, fused deposition modeling and polyjet technologies. Most are capable of producing parts in as fast as a day.

In addition to 3D printing, CNC machining also works well for prototyping, as well as short-runs of end-use parts. Material properties with machined parts are representative of injection-molded parts. Plus, hightemperature-resistant plastics such as PEEK and PEI (Ultem) work well for sterilization, so manufacturers regularly use parts made of these plastics for medical applications. Parts can be manufactured through high-speed milling and turning techniques from a variety of plastic and metal materials.

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YOU DESIGN

Surgical instruments, implantable devices, bone screws, ventilator parts and pump components are just a small sampling of components often prototyped with CNC machining. And with the digital manufacturing model, parts can be delivered in as little as 1 day as well.

THIS MARKET IS SIZEABLE, AND A FIERCELY COMPETITIVE ONE. THE UNITED STATES REMAINS THE LARGEST MEDICAL DEVICE MARKET IN THE WORLD.

Shifting to higher volumes While 3D printing and machining provide repeatability and precision in lower quantities, neither is conducive for production runs into the tens of thousands or beyond. Medical device companies designing a product or device to take to market on that scale regularly move to injection-molded components, due to cost considerations.

Injection molding is a common production method used for medical components made from plastic and liquid silicone rubber (LSR), which is especially well-suited for medical products because of its thermal, chemical and electrical resistance. LSR parts are also biocompatible, so they work well for products that have skin contact.

Examples abound of molded medical device or medtech parts made rapidly: Monitor shells, electronic housing, diabetes-testing equipment, eyeglass frames, actuators, bio-absorbable fasteners, operating room equipment, hand-held devices and so forth. The digital manufacturing model, when applied to injection molding, produces a tool in 15 days or less, so rapid manufacturing is possible – even with some of the traditional manufacturing processes like injection molding.

Ultimately, staying competitive in a growing and increasingly fragmented market space is made easier when medtech providers adopt and start leveraging some of the digital manufacturing strategies mentioned above. M Opus KSD designed this handheld medical stapler for minimally invasive surgery that dispenses proprietary bio-absorbable fasteners beneath a patient’s skin. The SubQ It! stapler is composed of 9 plastic parts. Proto Labs manufactures all of them through injection molding.

WE BUILD Rapid Prototyping Custom OEM Manufacturing Cleanroom Manufacturing Automation and Assembly Supply Chain Management

Image courtesy of Proto Labs.

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THE CATH LAB

Clever catheter lets surgeons see inside arteries to trim plaque The Pantheris catheter developed by Avinger takes the physician out of the radiation field.

Paul Dvorak | Founding Editor | Medical Design & Outsourcing |

A clever catheter design lets cardiologists see inside arteries and precisely remove plaque from diseased tissue. The Pantheris catheter is safer than conventional radiation-guided procedures because it takes the surgeon out of the radiation field, and along with on-board optics, it allows greater precision than previous methods.

“The device is the culmination of recent size reduction – it’s 2 mm in diameter − and resolution in fiberoptics, combined with signal processing capability and catheter technology, which is getting better at transmitting torque,” said Bart Beasley, the vice president of marketing with developer Avinger. “The progression of all three technologies and the entrepreneurial

THIS NEW DEVICE IS A SIGNIFICANT STEP FORWARD FOR THE TREATMENT OF PAD WITH A MORE EFFICIENT APPROACH FOR PLAQUE REMOVAL AND LESS RADIATION EXPOSURE TO THE DOCTOR AND PATIENT. catheter, and back into the computer and processor, which creates the highresolution image. Pantheris, which won FDA approval last year, has been used successfully in 1,500 patients with no vessel wall perforations, Beasley said.

Other catheter procedures used a contrast-inducing die in the vessels and high-radiation-emitting X-rays to give surgeons an idea of where they were operating.

Avinger has devised the Pantheris, an imageguided catheter for atherectomies.

spirit of the inventor Dr. John Simpson made the Pantheris possible.”

Beasley said that Pantheris for the first time lets surgeons see inside arteries they are working on. An OCT fiber in the catheter transmits laser light to the vessel wall, then back into the 26

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“Shortcomings of previous devices also include a difficulty in assessing the 3D nature of the obstructive plaque in the vessels with only contrast angiography and 2D fluoroscopy,” Beasley said.

See more and radiate less, said the developer.

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The image-guided Pantheris device lets surgeons see the plaque during an atherectomy, a minimally invasive procedure that involves cutting plaque away from the artery and capturing and removing it to restore blood flow.

The catheter is intended for patients suffering from peripheral

artery disease (PAD), a common circulatory problem in which plaque builds inside arteries and obstructs blood flow to the lower limbs and feet.

The catheter, with a fiberoptic lens less than 0.5 mm in diameter, is fed through a small incision in the groin that does not require full anesthesia.

Now without radiation, the cardiologist

This sequence shows how the device is used to remove plaque. An image from onboard optical coherence tomography (black and white images next page) lets surgeons identify diseased tissue in cross sections. The working portion of the catheter (left) is inserted to the plaque area. A torque shaft and cutter window (center) along with an apposition balloon provide the direction and precision to avoid disrupting plaque layers. The cutter and nose-cone (right) remove and capture only diseased tissue.

All images: Avinger

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can see what must be removed without damaging the artery wall.

Patients with PAD frequently develop life-threatening complications including heart attack and stroke.

In severe cases, amputation can be necessary. The condition affects nearly 20 million adults in the U.S. and more than 200 million globally.

“Peripheral artery disease greatly impacts quality of life, with patients experiencing cramping, numbness, and discoloration of their extremities,” according to Dr. Mitul Patel, a cardiologist at UC San Diego Health.

“This new device is a significant step forward for the treatment of PAD with a more efficient approach for plaque removal and less radiation exposure to the doctor and patient.” M

In the top image from optical coherence tomography (OCT), Avinger’s Pantheris shows layers and disease in the bright arc from about the 11 o’clock to 4 o’clock positions. The radial lines are indicators opposite the cutting area.

After a procedure (bottom) the image shows that the disease tissue has been removed.

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ENGINEERING 911

Reducing production waste with laser profiling and characterization

NanoScan 2s is an scanning slitbeam profiler that captures and analyzes wavelengths from 190 to 950 nm. The user interface reports the measured beam characteristics.

Mark Szorik S a l e s Te r r i t o r y M a n a g e r MKS Instruments, Inc. O p h i r- S p i r i c o n P ro d u c t s

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As a general rule, most industries preparing a production line run a few sacrificial products, and then, if all checks out, begin running production.

This is all well and good until the unexpected hits product quality or volume – or both. When something malfunctions on a modern, precision, high-speed process, it can quickly affect hundreds or even thousands of valuable parts, creating a mountain of scrap, often at great cost.

Within a laser manufacturing process, it’s critical to know which process parameters or key control characteristics to measure and how they relate to product quality and waste. A laser profiling system can be of great benefit in this matter. It is not uncommon to discuss a user’s laser process and come to realize that they have never evaluated the quality of their beam beyond the initial delivery and assessment of their laser’s commissioning or certification document.

Many companies merely run a few test parts after the initial system set-up and, if all goes well, continue to run until bad parts inevitably crop up.

When this happens, operators, process engineers, maintenance personnel and supervisors actively engage in adjusting various knobs and controls in the hopes of getting the process back to “normal.” This can go on for days

before someone loses patience with the mounting scrap and its expense.

This is when a frantic call goes out to a service organization to get data on what potentially went wrong, incurring further expense and extending the downtime. This approach, unfortunately, is merely a stopgap that rarely leads to the identification and permanent elimination of the problem.

A better way Six Sigma teaches that you can ultimately control waste and lower overall cost if you map a process and understand the key variables associated with each step, along with the sources of variability associated with these variables. To reduce waste, it is paramount to understand the variables within the process and correlate these to end product specifications and suitability (fit for use). Regarding laser applications, key variables can be the beam diameter, beam tomography or modal structure, spatial power, energy density and distribution, collimation or alignment.

• Beam diameter or symmetry, also known as beam width, refers to a laser’s circular cross-section with respect to its major and minor axes.

Related names include: D4 sigma, 1/ e2, and 10/90 or 20/80 knife edge.

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ENGINEERING 911

• Beam tomography or modal structure refers to the 1D, 2D, and 3D profiles or aspects of a given beam.

• Spatial power is the amount of total energy or power measured with a device within a known or defined area – circle, square, ellipse, etc. Typically, power and energy measurements are taken using a power meter and an appropriate power or energy sensor head.

• Energy density is the amount of energy measured within a defined area. Like spatial power, this is typically measured using a power meter and an appropriate pyroelectric energy sensor.

• Collimation is a broad term used in many different fields that relate to lasers. It is a measure of how well aligned the laser propagating source is to the end target. Many lasers have embedded collimators in order to adjust or optimize the focus of the beam.

Understanding, measuring and correlating these variables will have a positive impact on final product quality (fit and finish) and waste reduction. Accurate process data gathered before and after a production run provides critical process knowledge and the traceability required by many industries. Waiting for a failure or relying on the final product to act as the problem indicator should be a thing of the past.

WITHIN A LASER MANUFACTURING PROCESS, IT’S CRITICAL TO KNOW WHICH PROCESS PARAMETERS OR KEY CONTROL CHARACTERISTICS TO MEASURE AND HOW THEY RELATE TO PRODUCT QUALITY AND WASTE. Yet many people using lasers are unaware that there are a number of tools available beyond the basic power meter and sensor combination to help measure, characterize and understand their laser output in real-time. The following summary lists a few of many profiling instruments and their capabilities.

Scanning-slit profilers: Microwatts to 1,000 of watts NanoScan, a high accuracy instrument, measures continuous wave and kHz pulsed laser sources with beam sizes from 7µm to 6 mm, depending on power and wavelength. The device measures wavelengths from 190 nm to 100 µm. This is done by choosing 1 of 3 different single element detectors: Silicon 32

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The Pyrocam IV pyroelectric array camera is a camera-based beam profiling system.

(190 µm to 950 nm), germanium (700 nm to 1,800 nm), or pyroelectric (190 nm to 100 µm).

Once aligned with the laser source, results are instantaneous. Customizable results include beam width, centroid position, beam divergence, ellipticity, Gaussian fit, pointing stability and more.

NanoScan software logs the measured data and generates charts and reports.

Because this is a scanning slit device, additional attenuation is not required in most cases. This portable device uses direct USB connectivity and so requires no external controllers or power supplies.

Camera-based profiling: Microwatts to 1,000 W As a rule, camera-based systems include a camera, beam attenuator accessory, and software. This arrangement lets users evaluate continuous wave and pulsed sources with wavelengths from 190 nm to 3,000 µm. Cameras systems use an arrayed detector as opposed to a single element. Because these cameras have detector arrays, which are primarily a function of pixel size, they are somewhat limited as to the smallest beam they can accurately measure without additional optical enhancements. As a general rule we like to illuminate a minimum block of 10 x 10 pixels to ensure that the laser source is accurately represented.

Beam sizes from 40 µm to 4 mm can be analyzed depending on the camera and array. Most cameras have USB interfaces so they easily connect to a computer.

Non-contact: 500 W to 120 kW BeamWatch, a high-power, non-contact, focus-spot size and position monitor, measures lasers with wavelengths between 980 nm to 1080 nm. The beauty of this instrument is that it can effectively measure laser outputs as low as 500 W, and because it’s a non-contact instrument, there is no reported upper power limit.

BeamWatch measures the signal generated from Rayleigh scattering around the laser’s beam waist. This lets users instantaneously measure the focus-spot size, focus-spot location, beam wander or shift, centroid location, beam parameter product and other key spatial and beam quality parameters. BeamWatch can be coupled to automation with tools that support various automation clients. Communication is done through a PC using GigE Ethernet connectivity.

For an output interface, BeamGage profiling software helps analyze the laser source in real time. The software comes in two versions, standard and professional. BeamGage PRO, an upgraded version of BeamGage STD, has additional sections called Automation Interface (LabVIEW, .NET VB, and Excel), Custom Calculations (programmable and user determined) and Image Partitioning. After alignment and attenuation, data acquisition is instantaneous with a high degree of resolution and accuracy.

The beam-profiling devices mentioned here provide an excellent step in understanding and controlling a process. These world-class tools are recognized and well established within the laser industry. It doesn’t take long to become proficient, and by doing so a laser operator can quickly and efficiently gather accurate and highly reproducible information.

Many industries already use laser measurement tools to conduct root-cause analysis studies, verify alignment and set-up, understand laser sub-component effects, conduct screening experiments and correlation studies, establish preventative maintenance schedules and develop process application windows. Knowing that a process is stable, consistent, predictable and capable goes a long way toward generating sustainable profit, minimizing waste and improving customer satisfaction. M

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BeamWatch analyzes the laser source in real time.

(Left) Spatial and beam quality results include waist width, waist location, M2, and divergence, etc. (Center) Tomography of the beam in 3D. (Right) The caustic images show the beam waist location X-Axis and Y-Axis, which are important in determining if a beam is astigmatic.

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Micro-manufacturing: 5 things you need to know Minimally invasive surgery would not be possible without ultra-small tubing and tiny molded parts. Here are 5 things to be aware of regarding micro-manufacturing.

The co-extruded tubing with embedded wires improves the tube’s kink resistance. A wide variety of wire materials and polymer combinations can be adapted to an application.

Paul Dvorak | Founding Editor | Medical Design & Outsourcing |

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The health outcomes that minimally invasive surgical devices provide – shorter hospital stays and recovery periods – are as remarkable as the micro-manufacturing methods that produced the devices.

Micro-manufacturing involves more than making conventional tooling smaller.

Micro-extrusions and micro-molding also involve ultra-fine wires and electronic components.

Helmbrechts, Germany-based Raumedic, which has its U.S. headquarters in Mills River, N.C., has been touting its capabilities when it comes to ultra-small dimensioned tubing and molded parts.

The company even has a motto around its marketing efforts: “Think small.”

“Micro-extrusions can have inner diameters of 0.004 in. with wall thicknesses of 0.002 in., and coatings can have microlayers as thin as 0.0002 in.,” explained Rudi Gall, a vice president at Raumedic.

Micro-molding generally involves components with sizes or tolerances so small that suppliers can’t make them correctly or with a high degree of precision using traditional injection3 • 2017

molding equipment. “More specifically, micro-molded parts have a typical range from 1 g to less than 0.004 g.

Dimensional tolerances required are often much tighter than ±0.001 in.,” noted Gall.

“Although the molding equipment has improved in recent years, coating and over-molding features require a high skill level from the machine operator,” he said.

Here are 5 things, courtesy of Raumedic’s Gall, that medical device designers and engineers should consider when going the micro-manufacturing route: 1. Understand the material’s characteristics Before launching production of a micro part, Gall suggests getting input from the material supplier and a manufacturer’s engineering team. For example, he said, semi-crystalline or amorphous resins, fillers and fibers, and even colorants can all impact the product consistency required to meet critical dimensional requirements. Selecting the right material is a foundation for long-term manufacturability. Use consistent amorphous engineering-grade resins for tight tolerances,

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All images courtesy of Raumedic

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and apply fillers for added dimensional stability where necessary.

2. Go beyond general part design principals Gall further recommended that for a successful design, follow general part design principals. Micro-molding, he added, requires meeting or exceeding these guidelines. “For example, in a conventional part, slight areas of sink, in ribs, slight warpage in sharp corners, or flowing thin-to-thick may cause minor problems. But in a small part, such flaws are disastrous and result in deformation that can exceed the allowable tolerance.”

3. It’s all about the details Be prepared to disclose shot weights, material selections, part size and critical features, Gall said. Shot control may exceed what is possible for a check-ring screw. A plunger or ram may best fit an

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A Colpotransilluminator (the dual diameter item to the right) and vacuum hoses produced by Raumedic are used in a gynecological application. The tubing set consists of various tubes, fittings, clamp and bonds applied in multiple production steps.

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application. Consistency is key to longterm success.

The micro-molded and micro-extruded parts from Raumedic provide examples of the technology. For instance, the small ball shaped end on the white tube is an over-molded part with a shot size of 0.004 g. The pointed parts to the right include fenestrated tips, holes formed by mold features, not in a secondary operation.

4. Have you considered multilayer tubing?

Multilayer tubing is another design possibility that offers a practical solution for various medical applications, according to Gall. “The tubing provides an inert material on the inside for drugdelivery applications and a bondable outer layer. The trick is keeping the co-extruded layers within a specified tolerance range.”

Gall said Raumedic engineers have also developed processing capabilities to co-extrude a wide variety of metal wires and glass fibers within the tubing walls.

“When necessary, it is possible to coextrude and work with copper, stainless steel, nitinol, platinum alloys, nickel and silver plated wires in combination with a variety of polymers,” Gall said.

The materials include polypropylene,

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ALTHOUGH THE MOLDING EQUIPMENT HAS IMPROVED IN RECENT YEARS, COATING AND OVER-MOLDING FEATURES REQUIRE A HIGH SKILL LEVEL FROM THE MACHINE OPERATOR. polyethylene, nylon, polyurethane, and silicone, as well as high performance resins (FEP, PEEK, PPSU, PEI and PTFE Moldflon). The PTFE Moldflon is significant because it resists the flaking and cracking common to recent PTFE formulation when applied to wires.

5. Explore co-extrusion of wires.

Also consider that many medical products call for hand-stringing wires, cables and coils though multi-lumen tubing, which can be labor-intensive. Gall said that device companies can avoid extra labor by co-extruding wires within the tubing walls to significantly reduce fabrication costs.

The wires provide kink resistance, but also serve as a path for sensor signals and data transfer from the device and patient to an analytical or diagnostic system. The latter is used in neuro-monitoring devices, electromagnetic positioning systems and cochlear implant hearing devices.

It is important to also note that medical device manufacturing trends have component manufacturers delivering more than parts: OEMs want more complete product sets. Gall cited a colpotransilluminator as an example. All of its components are produced in-house, making it easier to control manual and customizedtool-supported processing techniques such as extrusion, molding, cutting and assembly (bonding). The tubing set ensures a hygienic and minimally invasive procedure, and residue-free suctioning of the wound secretion provides healing in a shorter period than previously possible. M 38

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FAILURE TO THRIVE:

from medical device innovations that missed the mark

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SOME OF INDUSTRY'S MOST HERALDED DISRUPTORS WOUND UP BEING ITS BIGGEST FAILURES. HERE’S WHAT WE CAN LEARN FROM THEIR MISTAKES. FI N K DEN SFORD ASSOCI AT E EDI TOR o one in medtech sets out to fail. No one invests in building a device believing that, despite years of research and development, it won’t make the cut.

There are few other fields in which disruptive, innovative technologies can make waves as big as they do in medtech – where outcomes can be life or death.

The discovery and exploration of antibiotics revolutionized infection treatment and saved billions of lives. X-rays gave us an actual window into ourselves and changed how we view and treat the human body.

Advances in robotics are making surgeries faster and more repeatable and are returning mobility to paralyzed patients. Next-generation 3D-printed biologics and advances in DNA modification, such as CRISPR, aim to change how we develop and design regenerative therapeutic products.

But not all technologies – even seemingly wellvetted, cutting-edge innovations – manage to make an impact on the field. Many companies fall short when it comes to products that initially promised disruptive innovation. Sometimes their quest for revolutionary change can veer to catastrophe.

Notable megaflops include Theranos, which promised to revolutionize blood testing with its needleless, micro-sized nanotainer and lab-in-a-box Edison tester. Then there are washouts like Johnson & Johnson’s Sedasys, which the company hoped would eventually automate the delicate anesthesia process. And who could forget the fiasco of metalon-metal hips, on which major medtech players placed bets that they would significantly improve mobility and health?

Exploring the failure of these devices offers valuable insights into what it takes to make a truly innovative device.

“This industry has gotten very good at talking about things that we're proud of and things that we do well. That’s terrific, but one of the things that we're not very good at is talking about things that we don't do well, in order to try to figure out how to be able to do them better,” said regulatory consultant Michael Drues, president of Vascular Sciences (Grafton, Mass.).

Theranos: The importance of R&R (research & regulatory) strategies

Most people in medtech know the Theranos story by now: The company promised to revolutionize blood testing, removing needles from the equation, and rose to a $4 billion valuation before flaming out in spectacular fashion.

Formed by needle-phobic Stanford-dropoutturned-entrepreneur Elizabeth Holmes, Theranos sought to disrupt the blood testing industry with its 1.29-cm “nanotainer” – a needleless system designed to draw a minuscule amount of blood, but supposedly enough to perform a wide array of tests using the proprietary Edison tester.

In 2014, Theranos was offering more than 100 tests using the novel draw and test systems at a fraction of the cost of conventional lab tests.

For a time Theranos was a media darling, the poster child for disruptive innovation. But the company didn’t have the research to back up its claims. (Theranos media relations did not respond to requests for comment for this article.)

“This is one of my favorite sentences, and it’s so apropos to this,” said Medgineering managing partner and principal consultant David Amor in a presentation at the 10x Medical Device Conference last year. “‘In God we trust: All others bring data.’

If Theranos would have followed this model, I think they would be in less trouble than they are today.”

(The “In God we trust…” quote, by the way, comes from William Edwards Deming, an

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engineer and statistician best known for helping reinvigorate post-World War II Japanese industry.)

Theranos’s much-lauded technology had little in the way of solid research supporting its claims, but the company was still able to drum up more than $8 billion in funding. Although its failure would seem to rest largely on the shoulders of its management and board, Amor said some responsibility lies with its backers.

“I think investors systematically failed in their Theranos plays, because they also didn’t do enough vetting or due diligence,” he told Medical Design & Outsourcing recently.

Technologies can often promise too much, according to Kablooe Design president & CEO Tom KraMer. Enthusiasm for a particular technology can blind developers and investors to potential flaws, KraMer explained.

“In an effort to prove out the feasibility of the technology, the development team will jump on the first product device idea that they have that will embody this technology. They just go with that. Their focus isn't proving out the technology.

But as they focus on that, often they will

Investing in early research and spending more time developing ideas, concepts and iterations of a device can create better scenarios for a device’s survival on the market, KraMer said.

Beyond a lack of appropriate research, Theranos faced a storm of regulatory issues related to its blooddrawing technology – issues that led the U.S. Centers for Medicare & Medicaid Services to ban Holmes from operating a medical lab for at least 2 years. (Theranos said in August 2016 that it would appeal.)

Federal prosecutors and the U.S. Securities & Exchange Commission are also reportedly investigating the company.

Had investors dug a little deeper early on, they would have discovered significant errors in the company’s regulatory strategies, Amor said.

“Having a vetted regulatory strategy is always a necessity when it comes to medtech,” Amor said. “You can’t just take the Silicon Valley innovation approach that lots of high-tech companies do, with mobile labs and other tech plays, and think that you’re still going to have that same agile development pathway when you’re facing those sorts of regulations.”

Observations noted on Form 483s the company received from the FDA showed some deficiencies in design controls, CAPA, and production and process controls, illustrating that the firm is a long way off from achieving a successful regulatory strategy.

“The key takeaway for companies is to have multiple representatives in regulatory fields vet your strategy. I’m not sure why Theranos built their boat the way they did, with several big names – but not in health or related fields. I think it’s important to

‘IN GOD WE TRUST: ALL OTHERS BRING DATA.’ IF THERANOS WOULD HAVE FOLLOWED THIS MODEL, I THINK THEY WOULD BE IN LESS TROUBLE THAN THEY ARE TODAY. forsake the development of the product and the device that's encompassing the technology. That becomes a stumbling block to anyone adopting the use of technology, because it operates poorly,” he said.

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hire consultants who are strong in their regulatory fields,” Amor said.

More regulatory representatives and better communication with the FDA may have been a boon for the company, which seemed to struggle to nail down

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the regulatory pathway for its platform.

But Theranos, like many medtech companies, may have seen the FDA as more of a hindrance than an asset and tried to avoid cooperating on a robust regulatory pathway.

“One thing that frustrates me a lot about so many people in our industry, certainly not everybody, but many people, is they view the FDA as an obstacle, as a hurdle – in some cases even the enemy,” Drues said. “That's very unfortunate. The FDA has a very difficult job to do. As one of my friends who used to be a senior FDA reviewer was fond of saying, ‘Physicians can kill patients one at a time, but an FDA reviewer can kill patients thousands at a time.’ Quite frankly, this is something that more people in our industry really need to remember.”

Research and regulatory pathways

aren’t the only hurdles that keep innovative tech from taking off: Opposition can arise from the users the device looks to aid.

Johnson & Johnson’s Sedasys: Know your audience

J&J’s Sedasys device was a computerized sedation and anesthesia system that aimed to disrupt the field of anesthesia by removing the need for a highly trained anesthesiologist during routine colonoscopies.

The system won FDA approval in 2013 after an initial rejection in 2010 and some subsequent back-and-forth with the federal safety watchdog. Johnson & Johnson touted the device’s ability to reduce oversedation and improve recovery rates – and, importantly, substantially reduce the cost of patient sedation to around $200 per procedure,

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about a 10th of what it would take to pay a fully trained anesthesiologist.

But the device failed to gain traction and was discontinued in March last year, only 3 years after it was approved and only a year into its launch. Sales were modest at best, with only a handful of providers adopting the system. (Johnson & Johnson media relations did not respond to a request for comment about Sedasys.)

The device ended up facing a major hurdle outside of regulatory issues – opposition from the anesthesiologists J&J had targeted as customers.

The Washington Post published an article in May 2015 touting Sedasys as a “new machine that could one day replace anesthesiologists,” quoting an anesthesiologist as saying, “That’s going to replace me.”

That threat did not go unheard. The

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American College of Anesthesiologists and the American Society of Anesthesiologists lobbied against Sedasys during its early development, claiming anesthesia was too delicate and sensitive to trust to a system.

Both groups would eventually back the device, but only after Johnson & Johnson modified its ambitions.

Indications would require an anesthesiology doctor or other

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operator to be on call and limit the device to simple procedures such as colonoscopies and endoscopies, significantly narrowing its usefulness.

“The most common area that we see these things fail is not fully understanding and addressing the needs of the user or not even understanding who the actual user of the device is,” KraMer said. “There are other people involved who could be considered ‘users,’ all the way down to the purchasing person who buys the equipment.”

Although the device appealed to hospital managers and beancounters, it didn’t sit well with anesthesiologists, who require an additional 4 years of training after medical school.

Many companies end up developing new, novel and sometimes groundbreaking technology without spending enough time considering the users’ specific needs, KraMer said.

And without that consideration, people are hesitant to adopt a new technology – especially if they see it as a threat to their practice.

“If It doesn’t fit into their practice, it’s not reasonable for them to use,” KraMer added. “Those

THE MOST COMMON FAILURE IS NOT FULLY UNDERSTANDING THE NEEDS OF THE USER – OR NOT EVEN UNDERSTANDING WHO THE ACTUAL USER IS. things are often ignored for the sake of a flashy technology.”

Early opposition, a narrow scope and a lack of knowledge of the user base may have contributed to Sedasys being pulled from the market. Other devices end up in the bin for different reasons – and with much more severe results.

Next-gen metal-on-metal hip implants: Test from every angle or face the consequences

Metal-on-metal hip implant problems are not a recent issue. In the 1970s, studies of early versions of the devices showed serious adverse reactions from cobalt and chromium ions released over time as part of standard wear-and-tear.

Studies indicated that cobaltchromium implants would release metal ions that could infiltrate local tissue with long-term adverse effects, including, in some cases, permanent disabilities.

But their potential promise – a lifetime of reliability, resistance to wear-and-tear, a lower risk of dislocation and a more active lifestyle – were hard to resist.

So, despite early indications of metal-on-metal’s health risks, hip resurfacing with metal components saw a resurgence in the late ‘90s and 2000s.

The hope was that innovation would reduce the risks seen in earlier versions.

Over time, however, similar problems emerged for all makers of MoM hips.

Johnson & Johnson’s woes are but one example: In 2010, its DePuy subsidiary

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recalled the ASR hip prosthesis; in 2012, J&J pulled the Pinnacle implant; and last year the company agreed to settle a raft of product liability claims for $1 billion.

(MoM hip makers still face thousands of similar lawsuits.)

Metal-on-metal implants are a good case study of a major hurdle device makers face: How to appropriately test implanted medical devices meant to last a lifetime.

“It’s a tough one, because it’s an implant. It’s hard to say, ‘Let’s do a bunch of studies and watch a bunch of users with this implant.’ I mean, you do say that, but you can’t,” KraMer said.

“You'd have to backpedal and say, ‘Where along the way could they have done something different that could have alleviated this decision to go metal-onmetal?’ That's a hypothetical guessing game at this point, but they certainly couldn't have found out that repetitive, usage-bearing weight is going to do this unless they set up some sort of long-term tests,” he explained.

With external devices, user testing can provide input on material use.

But with an implant, patient feedback doesn’t cover the material; as KraMer observed, only long-term studies would have detected the long-term effects of micro-sized particles.

But he theorized that attempting to think outside the paradigm of medical device development could have caught the problem.

“It’s a tough scenario. Maybe you could look at the automotive industry and say, ‘Well, you know, pistons and

go bad, and what causes it to go bad.

What causes it to go wrong? And then try to use those ideas to create your own tests for your specific implant.”

For now, metal-on-metal hip implants are mostly disused again due to the array of problems that cropped up with them, and testing may never get done to explore how to improve the devices to avoid shedding dangerous metal particulate.

Learning from mistakes

Thomas Edison supposedly said, “I have not failed.

I’ve just found 10,000 ways that won’t work.”

Medical device designers should take Edison’s words to heart. The industry has a passion for innovation, and for a good reason – to save and improve the lives of all humanity.

While exploring why a promising, innovative or even possibly disruptive device failed may be a difficult topic to explore, it can yield valuable information to avoid those same pitfalls.

“I think one of the big takeaways is, when we see other companies struggling, we shouldn’t applaud that,” Amor said “We should really say, ‘How can we

IT’S HARD TO SAY, ‘LET’S DO A BUNCH OF STUDIES AND WATCH A BUNCH OF USERS WITH THIS IMPLANT.’ I MEAN, YOU DO SAY THAT, BUT YOU CAN’T. cylinders in a car's engine undergo a lot of revolutions. What do they do to not have particulate?’” KraMer said. “Maybe you could learn some lessons there. You could talk to mechanics and automotive engineers and find out when does this

prevent ourselves from going through those same issues?’”

If the industry wants to succeed at improving and saving lives, we all need to look at our failures and understand how to keep history from repeating itself. M

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Disrupting fee-for-service: ACELITY AIMS TO PROVE ITS VALUE IN WOUND CARE

Value-based care is disrupting the fee-forservice model in the U.S. healthcare industry, and medical device makers must adapt or perish. Here’s how wound care company Acelity is responding.

Acelity CEO Joe Woody believes value-based care tackles the concerns of the medical system that will never go away: quality, outcomes, and cost.

The rise of value-based care in the U.S. is causing a major shift in the medical device industry. Healthcare providers want to know how medical devices are going to improve overall efficiency and quality of care, so device makers are investing in service-related products that are not traditionally “money makers.”

Medtech companies also acknowledge that within an event of care, there are countless details with the potential to achieve better health outcomes.

Over the 25 years of Joe Woody’s career, he’s seen how those details can add to the overall cost of care. Five years ago, Woody accepted the CEO position for what used to be KCI and has since transformed into Acelity. (Before that, he was global president of vascular therapies for Covidien, and before that, global 46

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president of the wound care business for Smith & Nephew.)

Acelity is involved in wound care and regenerative medicine, but Woody said the company is refocusing and has decided to create products that fit the “wound care continuum.” To that end, its regenerative medicine business, LifeCell, was recently sold to Allergan, and 3 years ago, Acelity bought J&J’s Systagenix wound care business.

“We want to cover VAC therapy, dressings, biologics – really anything and everything that has to do with a wound.”

Within that goal of covering the continuum of care is a larger calling: Tying everything Acelity does to disrupting fee-for-service and furthering value-based care.

“A few years ago, we really took a look at the way we innovate in terms of

H EATH ER TH O MPS O N S EN I O R ED I TO R

lowering the cost of care,” Woody said.

That means “proving, not just saying, to customers that our products really get the best clinical outcomes.”

Proving value To that end, Acelity invested in data.

The company tapped Optum, an arm of United Healthcare, for a study of Acelity’s flagship product versus the competition.

The research focused on economics and performance metrics of concern to providers, such as hospital readmission rates. The study prompted Acelity to expand its Prevena closed-incision management technology, designed to reduce the rate of complications like hematoma, dehiscence or infection.

These typically lead to longer-thanaverage hospital stays and possibly the need for further surgical intervention.

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focused on episodes of care. Solving issues that create additional costs, like infection or quality problems, helps – but that’s only one level.”

The second level involves the ability to monitor data and respond to issues as soon as they arise. Achieving that level of disruption, Woody said, is what drove Acelity to get involved in patient monitoring.

Acelity commissioned research to show that its Prevena Plus product reduced hospital stays.

Woody said the impact of surgical site infections is about $3.3 billion per year in the U.S. alone. In developing Prevena, Acelity examined strategies to potentially mitigate the risks of infection and looked for ways to take “double-digit infection rates and reduce those down to low single-digits, and in some specific cases, zero.”

That kind of thinking, so necessary to disrupt fee-for-servic, also solves a problem by making the case to an ACO, he said: “They’re trying to reduce infections and get patients healed and home quickly.”

Improving value for the business Companies also need to innovate in their business processes, Woody noted. For Acelity, that meant aligning its products to the continuum of wound care and developing some beyond the category of “wound care.” One example is the iOn Progress remote monitoring system, which enables data sharing between the Activ.A.C. home-based negativepressure wound therapy and Acelity’s Care Network, a group of highly-trained nursing professionals who can interact with patients to drive proper utilization.

The goal is to monitor patient use and connect that metric to the rate of healing.

“You have to think about innovating from a mindset of solving problems,” Woody said. “If you have a provider dealing with Medicare or a commercial payer, they are going to be www.medicaldesignandoutsourcing.com

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The here and now of disrupting feefor-service In the future, Medicare or a private payer might reward providers for total population and savings across a population.

“We’re in a fee-for-service world today, and although we’ve started to think about care more holistically, that is still in its infancy,” Woody noted.

To make the transition, companies are going to have to change product development processes, accounting processes and provider strategies. Providers need OEMs that will be able to be partners.

“We do a lot of meeting with our customers to assess their wound cases, so that we can gather a broad view of the outcomes of the patients,” Woody said.

Acelity had a bit of a head start thinking about value-based care, he admitted. The company doesn’t just work with ACOs and providers; it also works with payers, directly billing some 600 (including Medicare) for services in the post-acute segment of its business.

This means it’s had more than 20 years of dialogue with the medical officers from payment organizations.

“Those conversations often require a view on health economics, or a view of the outcomes of your product,” Woody explained.

Medical device companies need to catch up in having those conversations about disrupting fee-for-service. At the same time, providers and payers need to get better connected, he said.

“We’re all connected, and we need to be better connected directly with payers – and this isn’t just coming from me. Medtronic is talking about this; J&J is talking about this.”

Woody also advised companies not to get trapped into only talking about the lowest cost.

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“Value-based care is sometimes about spending a bit more on innovative technology that will take cost out of the overall equation. I think Medicare is trying to drive this concept to other payers, and the healthcare community must work together to support this.”

Value-based care is here to stay Even though the Accountable Care Act is on the chopping block with the new Trump administration and Republicancontrolled Congress, Woody is confident that value-based care isn’t going anywhere.

“If you think about when Medicare came into play, it has changed quite a bit over time, and quite dramatically over the decades,” he noted. "Value-based medicine is inevitable because it tackles the concerns of the medical system that won’t go away: Quality, outcome and cost. It provides an efficient way for clinicians, payers and administrators to tackle big episodes of disease.”

Acelity’s future Woody said his main goal is to broaden Acelity’s portfolio.

“We can’t just be in one segment of care,” he explained. “We’re going to get into a discussion about episodes of care,” he said – even if that means that some of Acelity’s products become obsolete to make sure patients heal more quickly.

For example, the company’s VAC Veraflo Therapy cleanses wounds and can help them heal more quickly than previous products. Ostensibly, that means fewer trips to the OR, and getting the patient home and healed – but it also means taking the older models out of the sales channel.

Woody said expanding the company’s reach is a two-pronged effort. The first is to develop technology across the continuum of wound care. That could include developing products for debridement, dressings, biologics and skin substitutes, for example. The second aspect is improving the service side.

Acelity has begun a pilot program, Acelity Plus, in partnership with a number of customers, to consult on care in a way that’s agnostic to product portfolio. Woody said 48

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this is “because in some cases the wound is not the primary concern, but customers want an expert that can help think through the best care for the condition.”

Other services, slated to launch this year, will work with caregivers to follow the patient and give treatment oversight.

“It allows us to kind of work with clinicians, in real time, and troubleshoot, to avoid costs and complications,” Woody said. M

VALUE-BASED MEDICINE IS INEVITABLE BECAUSE IT TACKLES THE CONCERNS OF THE MEDICAL SYSTEM THAT WON’T GO AWAY …

QUALITY, OUTCOME AND COST.

Remote therapy monitoring, provided by the Ion Progress line is not in Acelity’s traditional wheelhouse. It represents a commitment from the company to treat throughout the continuum of care.

www.medicaldesignandoutsourcing.com

3/10/17 9:23 AM

DISRUPTION

This microscopic image shows the carbon particle matrix behind the Heraeus sensor technology.

Image courtesy of Heraeus

disruptive innovations from MEDICAL DEVICE SUPPLIERS Medical device innovation doesn’t just come from small, singleproduct startups – contract manufacturers are increasingly a part of developing truly disruptive medtech.

C H R I S N E W M A R K ER M A N A G IN G E D ITO R

People sometimes make the mistake of viewing innovation as the product of a few geniuses and mavericks. But, in fact, it’s often the result of teamwork, as the writer Walter Isaacson brilliantly explained in The Innovators, his 2014 book about the digital revolution.

Whether it was teams of people at IBM or Microsoft or Apple, the digital revolution was the result of the efforts of

many people, Isaacson wrote.

The same thing can be said about medical device innovation, too.

Medtech advances are often the result of collaboration, and contract manufacturers are increasingly being brought into the fold to contribute.

Here are 7 recent innovations out of medtech contract manufacturers that have the potential to truly benefit the industry.

www.medicaldesignandoutsourcing.com

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1. Heraeus: A printable and flexible smart sensor Heraeus (St. Paul, Minn.) is touting new printable and flexible smart sensor technology that has two major benefits: It is cost effective, and medical device companies can easily add it to existing designs. In other words, there is no need to design around it.

“With this ground-breaking new sensing technology, we currently see great opportunities to add functionalities in a variety of applications such as catheters, health-monitoring wearables and robotics-assisted surgical procedures.

Imagine a device with this new sensing technology providing a tactile feeling to a catheter or surgical robot,” said Stefan Schibli, sensor development program manager at Heraeus.

Heraeus officials said the sensor technology is so hassle-free because it can be put into any form and shape – and it is printable. Even better, the sensor can actually be printed or overmolded into the device – replacing part of its polymeric body. A manufacturer can use the same substrate as before and mix it with Heraeus’s sensor matrix to seamlessly integrate the sensor.

The smart sensor technology includes two main elements: • An elastomer to provide the deforming function at mechanical impact, depending on the device’s application.

• Even more important is the microscopic carbon particle matrix that Heraeus developed, which provides the necessary electrical feedback for various smart-sensing functions, according to the company.

A smart material with a unique poresize distribution, the matrix’s purity, porosity, surface functionalization and microstructure can be adjusted by medical device designers and engineers to fine-tune its performance.

Plus, the materials used in the technology are biocompatible, so there is no need for encapsulation.

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Image courtesy of TTP Ventus

2. TTP Ventus: The ideal pump for breath biopsy TTP Ventus (Melbourn, U.K.) has an unusual micropump that’s enabling such innovations as Owlstone Medical‘s breath biopsy technology, which is designed to detect early lung or bowel cancers through volatile organic compounds (VOCs).

The Technology Partnership spun out TTP Ventus to help commercialize the second generation of its signature product, Disc Pump.

The pump is a portable, lightweight disc featuring ultra-low pulsatility for smooth flow with millisecond response times to set-point changes. Rather than changing the volume of a chamber, the micropump excites a high-frequency acoustic standing wave in a fixed-volume cavity.

It offers silent operation and flexibility to meet product needs for wearables.

The Disc Pump is a great example of the medical device industry taking advantage of technologies initially developed for other markets. The Disc Pump technology was initially developed to address a need in the micro fuel cell market, but it now has proven applications in sectors including medical devices, healthcare and scientific research. www.medicaldesignandoutsourcing.com

3. Zeus: An LCP fiber–enabling MRI during catheter procedures Procedures involving catheterization have used X-ray imaging rather than magnetic resonance imaging to guide the catheter, because the metal in the catheters makes them MR-incompatible. But X-ray is not ideal for patients and clinicians due to the ionizing radiation involved.

Enter Zeus (Orangeburg, S.C.) and its liquid crystal polymer (LCP) monofilament fiber, which the company touts as ideal for catheter braiding reinforcement. Because the fiber contains no metal, the catheters created with it can be used with MRI. Zeus officials said they perfected a process to produce LCP as a monofilament fiber that can be easily braided; the fiber boasts LCP properties including mechanical strength, heat tolerance for autoclaving, and chemical inertness.

Image courtesy of Zeus

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DISRUPTION

4. Bosch Rexroth: Giving Industry 4.0 a boost Bosch Rexroth (Charlotte) could be enabling a whole new host of Industry 4.0 capabilities in advanced manufacturing fields such as medtech, thanks to the IoT Gateway it debuted at CES in Las Vegas early this year.

The IoT Gateway makes it easy for manufacturers to connect to the Internet of Things (IoT) without intervening in automation logic. The system doesn’t need software for setup and is entirely configurable through web interfaces. The users don’t even have to learn a programming language.

Advanced manufacturing experts often point to the difficulties of getting manufacturing experts on the plant floor to work seamlessly with the information technology experts seeking to collect analytics.

The IoT Gateway appears to make an end run around the problem because it doesn’t need a great deal of IT expertise for operation.

Image courtesy of Bosch Rexroth

Custom Automation Equipment Our engineers utilize time tested platforms and new technologies to provide you the most cost-effective solution

www.arthurgrussell.com www.medicaldesignandoutsourcing.com

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DISRUPTION

Wicab’s BrainPort V100

Image courtesy of Wicab, via Proto Labs

5. Proto Labs: Helping the blind ‘see’ with their tongues Proto Labs (Maple Plain, Minn.) has become a medical device prototyping hub, thanks to its quickturn manufacturing capabilities. One of the most interesting prototyping stories to come out of Proto Labs recently involved Middleton, Wis.-based Wicab and its BrainPort “oral electronic vision device.”

Injection-molded polycarbonate parts from Proto Labs have played a significant role when it comes to Wicab ramping up production of the BrainPort.

The BrainPort V100 received FDA de novo marketing approval last year for use among the profoundly blind.

It uses a small headset-mounted video camera to capture visual information. The user feels the information as tingling or vibrations on a small mouthpiece embedded with electrodes and placed on the tongue. By taking three 3-hour training sessions mandated by FDA, users learn to substitute the sense of touch on their tongues for some of their lost sight.

BrainPort helps them recover abilities such as being able to walk to a store or dine at a restaurant.

6. Covestro: Polycarbonate enabling better ventilators Transparent Makrolon 2858 polycarbonate from Covestro (Leverkusen, Germany) played an important role supporting a slim, lowprofile design for Breathe Technologies’s Breathe Pillow Interface. The interface is used in both of Breathe Technologies’s portable wearable ventilation systems – the Non-Invasive Open Ventilation (NIOV) device and the Life2000h ventilator for life-support patients.

Breathe Technologies also used the Covestro polycarbonate in the Pillow Interface Sizing Gauge, a feature in the latest generation of the NIOV and Life2000h ventilation systems that helps patients determine the interface size with the most effective and comfortable fit.

Breathe Technologies carefully considers the materials it uses in its ventilation systems, according to Larry Mastrovich, president and CEO. “Our company is committed to bringing the highest-quality devices to market, so we chose durable, lightweight and long-lasting materials for all of our products,” said Larry Mastrovich, Breathe Technologies’s president and CEO.

Breathe Technologies molded its Breathe Pillow Interface, shown here, out of Makrolon 2858 polycarbonate from Covestro.

Image courtesy of Breathe Technologies, via Covestro

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DISRUPTION

Precision Positioners and Piezo Transducers

Covestro touts Makrolon 2858 polycarbonate as a medium-viscosity resin that features easy release from the mold. The material is acceptable for ETO and steam sterilization at 121 °C, and it is biocompatible according to many ISO 10993-1 test requirements.

6-axis robotics

Multi-axis highspeed positioners

Medical piezo transducers

Mini 6-axis positioners

Mini XYZ stages

Image courtesy of Micromo

7. Micromo: New 10 mm motor doubles output torque The new Faulhaber 1024 SR series DC motor from Micromo was a finalist this year in Design News’s Golden Mousetrap Awards in the category of automation and control in drives.

“Its strengths include low noise and vibration, smooth operation and strong output torque. In combination with a gearhead, the output torque can achieve 300 mNm – twice that of similar products on the market. Portable medical devices and optical systems are excellent application matches for the motor’s performance points,” said Micromo spokesperson Sheryl Yengera.

Micromo redesigned nearly all of the motor’s elements.

The Faulhaber 1024 SR series DC motor has a new coil, new commutation system and new magnet. The result, according to Micromo, is a wider speed range under load, with a continuous torque of 1.5 mNm at 7500 rpm and output power above 3W. M Senior editor Heather Thompson contributed to this story.

Controlled by ACS Motion Control

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PRECISION | SPEED | STABILITY MOTION CONTROL & POSITIONING SOLUTIONS 3/10/17 9:28 AM

FREQUENCY THERAPEUTICS

THAT COULD REVERSE HEARING LOSS Frequency Therapeutics is betting that it can change the lives of millions of Americans with hearing loss, by triggering the body’s natural ability to heal itself.

SA R A H FA U LK NER | ASSOCI AT E EDI TOR

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Image courtesy of istockphoto.com

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FREQUENCY THERAPEUTICS

Researchers have used cells in regenerative medicine for decades – in 1931, the father of cell therapy, Paul Niehans, treated a patient with material from calf embryos. Although today’s healthcare practitioners have left bovine embryonic cells behind, procedures such as bone marrow transplants are routinely used to replenish a patient’s cells after they’ve been destroyed.

When scientists first derived stem cells in 1981 – a decade after Niehans’s death – many heralded the innovation as a new chapter in regenerative medicine. Stem cells, with their ability to proliferate and differentiate into a variety of cell types, opened up entirely new avenues of research.

Today, many companies use scaffolds seeded with stem cells to trigger the body’s natural healing abilities. But MIT professor Robert Langer and Harvard professor Jeff Karp, the co-founders of Frequency Therapeutics (Woburn, Mass.), had a different idea: They see enormous potential in another type of differentiated cell called progenitor cells.

“We think we’re leading the revolution for ‘Regenerative Medicine 2.0,’” said Frequency Therapeutics co-founder and COO Chris Loose.

“As we look back, we think maybe this is the way that regenerative medicine should have been done in the first place.”

Another, special type of cell Every human being is born with tens of thousands of hair cells in the ear’s cochlea that move in response to sound. But noise exposure, age and other factors combine over time to cause the hairs to die off. And although animals including birds and reptiles can regrow the aural hair cells in their ears, mammals cannot - even though we have the “fundamental machinery” to regrow them, said Frequency co-founder and CEO David Lucchino.

For Frequency Therapeutics, the key discovery was that the mechanism, triggered via progenitor cells, is already present in the inner ear, Lucchino explained. Progenitor cells are similar to stem cells in that they can form into many different types of cells, although not as many types and not indefinitely. Think of progenitor cells as more mature versions of a typical stem cell, that only divide spontaneously during certain stages of human development.

Langer and Karp discovered that the epithelium in the human GI tract is filled with hyper-active progenitor cells that drive the epithelium in the GI tract to regenerate itself every five days. These particular progenitor cells, united by a similar activation pathway, are also found

The stem cell ‘skin gun’ that’s aiming to disrupt wound care Pennsylvania state police officer Matthew Uram suffered severe seconddegree burns to his face, right arm and leg after a friend's bonfire got out of control. Uram was facing months of painful skin grafts, the standard treatment in wound care for burns.

But instead, he was one of the first patients to be treated with RenovaCare's stem-cell-spraying SkinGun. The device uses a sample of stem cells collected from a patient's healthy skin, which are isolated and placed into a water-based solution in a syringe, which is then attached to the SkinGun. The SkinGun guides the cells through the syringe and into an airstream, creating a gentle mist that’s sprayed over the patient's wounds.

RenovaCare’s SkinGun uses a patient’s own Treatment takes just 90 stem cells to heal their wounds faster and more minutes. efficiently than a traditional skin graft.

RenovaCare president & CEO Thomas Bold said the technology represents a shift in how researchers think about wound care. When the body heals itself, it attempts to seal a wound from the edges. But the SkinGun's mist of cells creates "thousands and thousands of little regenerative islands all over the wound," Bold explained.

Patients can spend months healing when they're treated with skin grafts, Bold said, but Uram was treated on a Friday and walked out of the hospital just four days later.

Apart from the obvious physical benefits of the technology, rapid burn healing could hold promise for a patient's mental health too, Bold pointed out. Severe burns and the resulting scars can leave burn victims suffering from trauma and depression. Researchers at the University of Adelaide's Center for Traumatic Stress Studies found that 42% of childhood burn victims suffered from some form of mental illness. The 30-year follow-up study also showed that 30% were depressed at some point in their lives and that 11% had attempted suicide.

“That is a big problem, and it is very important to come up with something with new ideas, with new strategies,” Bold said. He believes that his technology “could really be an answer for the future.”

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Newly formed cochlear hair cells contain intricate hair bundles with many stereocilia, which are critical for sensing sound.

Photo courtesy of Will McLean, Frequency Therapeutics

in the inner ear, eye, skin and pancreas, but they are especially active in the GI tract.

Once they figured out how those cells were activated, the researchers had an idea: What if you could activate the progenitor cells that live in a human’s ear and trigger them to regrow the inner ear hairs to recover hearing?

8 “When people began ‘Progenitor Medicine 1.0,’ they would take cells out of the body, manipulate them and try to put them back in the right place and get them to integrate and do the right job. That’s really complicated, particularly from a cell delivery and integration perspective,” Loose explained.

Instead, Frequency Therapeutics developed a proprietary combination of small molecule drugs that’s injected into the ear to activate the progenitor cells. The company plans to use a clinically-established injection into the middle ear of a slow-release gel, in a 3-minute office procedure that’s been used for years to administer drugs to treat ear infections.

“If it was easy, everyone would do it, and then it wouldn’t be disruptive,” Lucchino said. “Partly what allows us to be a so-called ‘disruptor’ is that Langer and Karp did all the early intellectual property work.”

Betting on technology to fundamentally changes a field is risky; Loose pointed out that disruptive companies need to seek out leadership that’s willing to think big.

“I think you need founders and a board to think boldly and be comfortable trying to create very new types of therapies that may take some time, but can finally create a great deal of value,” he noted. “I think it’s easy, in a startup company when there’s so much risk, to try and focus on just building onto something that’s been done and making it a little bit better. There’s kind of a safety involved in that.”

But when MIT’s Langer – who has launched dozens of companies and is said to be the world’s most-cited engineer – is involved with a startup, he isn’t usually looking to make a small change in a scientific field.

“Disruptive is the opposite of incremental,” he told us.

“Incremental change certainly happens, but fundamental changes – they’re much rarer. I think that’s what Frequency could be.”

It’s all about the patient Nearly 40 million Americans suffer from some degree of hearing loss for which there is no therapy. Lucchino often receives emails from people looking to be a part of clinical trials, he said, crediting them as the driving force behind Frequency’s work.

NEARLY 40 MILLION AMERICANS SUFFER FROM SOME DEGREE OF HEARING LOSS FOR WHICH THERE IS NO THERAPY

Disruption demands bold leadership and powerful technology The team at Frequency Therapeutics, which has 12 full-time employees, believe that their progenitor cell activation technique will be disruptive in regenerative medicine. Lucchino, who led Semprus Biosciences to an $80 million acquisition by Teleflex in 2012, said that truly disruptive companies need to unite strong technology and intellectual property – which is easier said than done.

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“The goal is impact,” he said. “How can you help the most people? And by doing right by the patient, it’s going to lead you to a highly innovative place.”

Loose said working with Frequency Therapeutics and its progenitor cell activation technology reminds him of Langer’s advice when Loose was a graduate student at the Massachusetts Institute of Technology: “It takes the same amount of work to solve a really important problem as it does an unimportant problem, so work on something that’s really important.” M

www.medicaldesignandoutsourcing.com

3/10/17 4:37 PM

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

INTRODUCING A NEW & IMPROVED DEVICETALKS IN 2017 For the past decade, we’ve been creating media and educational content that supports our industry. That means we create content that is relevant to how our readers effectively do their jobs and we deliver it on the platform they desire.

This formula has worked seamlessly with our flagship publications like MassDevice, DesignWorld, and Medical Design and Outsourcing. Now we’re bringing this formula to our live industry events.

For five years, we’ve been running successful programming for medtech executives throughout the country. In 2017, we will continue that legacy of bringing the best minds in the industry to our DeviceTalks events.

However, many engineers and engineering managers in our community of more than 100,000 readers need relevant live content that helps them effectively do their jobs.

MINNESOTA

JUNE 26-27, 2017 INTERCONTINENTAL ST. PAUL St. Paul, MN

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That’s why this past summer and fall the DeviceTalks team went to work creating a new engineering focused staff development curriculum for engineers, developed with the assistance a core group of leading engineers. The DeviceTalks team has met with R&D teams from medtech companies to learn and understand the kind of panels and workshops engineers require.

Our new Engineering Track is focused exclusively on how to help engineers do their jobs better. This includes Engineering Workshops, Panels, and Hot Technology sessions designed around the topics critical for today’s engineers and engineering managers. This is not another conference where you’ll hear a CEO talk about the need to move faster.

This is about how to do your job better when everyone around you is telling you to move faster.

We’re bringing together the best of the best in the industry, so I hope you’ll join us this year, whether it’s your first time, or joining us once again.

We still have a limited number of sponsorships available for this year’s slate, so I invite to learn more by downloading a prospectus, or listening to our recent webinar. There’s much more to come, so keep tuned.

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OCTOBER 2, 2017 THE WESTIN BOSTON WATERFRONT Boston, MA

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3/10/17 9:17 AM

AEROSPACE

HERE’S HOW QuesTek has used advanced computer modeling to produce innovative materials in the aerospace sector. Now it’s looking to recreate the same magic in the medical device space.

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

C-5 Aircraft Roll Pin QuesTek’s ICME-designed, ultra-high-strength, corrosionresistant Ferrium S53 steel went into this roll pin for a Lockheed C-5 Galaxy, a large military transport aircraft.

Image courtesy of QuesTek

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AEROSPACE

WHAT IF IT WAS POSSIBLE TO SIMPLY DESIGN AND THEN CHOOSE AND VALIDATE MATERIALS THAT MEET THE DESIGN’S CRITERIA WHEN IT COMES TO STRENGTH, FATIGUE LIFE AND CORROSION RESISTANCE?

Medical device developers typically turn to off-the-shelf materials and then design based on the properties of the materials.

But does it have to be this way? What if it was possible to simply design and then choose and validate materials that meet the design’s criteria when it comes to strength, fatigue life and corrosion resistance?

That’s the tantalizing concept proposed by officials at QuesTek (Evanston, Ill.). The idea is nothing new, either. QuesTek has years of success in using computer modeling to create innovative alloys for the aerospace sector.

The 20-year-old company has managed the creation of Ferrium M54 steel for U.S. Navy aircraft hook shanks, Ferrium C64 steel for the transmission gear boxes in next-generation Bell and Sikorsky helicopters, Ferrium S53 steel for critical components on SpaceX’s Falcon rocket, and Ferrium C61 steel for a robotic rover destined for Venus.

Company officials say they doubled annual revenue over the past three years after a technology transfer deal with an undisclosed Silicon Valley company, which saw the potential for QuesTek’s materials modeling.

“What QuesTek has enabled is that people can come to us and say, ‘We want a material with this set of properties, and this material does not exist. Can you design it?’ It’s whatever is important to them,” explained Jeff Grabowski, manager of applications and product commercialization at QuesTek. Grabowski and others at QuesTek think the same could be done in the medical device space: “This is about getting the medical device community to stop using off-the-shelf materials and start to think what kind of materials properties they need to achieve a gamechanging device.”

What computer modeling can achieve There are two types of computer modeling QuesTek has worked to perfect over the years: Integrated Computational Materials Engineering (ICME) and Accelerated Insertion of Materials (AIM).

ICME provides a more efficient way to create an alloy with the properties needed for a design, while AIM greatly reduces the amount of testing needed to qualify the alloy’s properties.

ICME has been around since the 1980s; QuesTek co-founder and chief science officer Greg Olson played an important role creating the computational models that made it useful, according to the company.

Before ICME, creating an alloy was all about trial and error, explained senior materials design engineer Nick Hatcher. A steel company, for example, would melt 50 to 100 chemistries and heat treat them and test them all.

ICME draws on physics, density functional theory, thermodynamics and phase diagrams of materials, Hatcher said. It starts with databases of thermodynamic and kinetic properties of the elements, and crunches the information with predictive software and models to quickly go through thousands of iterations of chemistries and thousands of subsequent virtual heat treatments to optimally target a set of performance requirements. www.medicaldesignandoutsourcing.com

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Once Hatcher and his colleagues get the results, they then might come up with 2 or 3 or 5 chemistries – versus 50. They take each chemistry and do a quarter-sized melt in the laboratory, heat-treat it and examine the microstructures. What phases have formed? What is the hardness of the material? Can the material achieve what it was designed to do? In most cases, they said, QuesTek is then able to fine tune the design before going to an outside vendor for a much larger sample.

“ICME allows me to design the materials more quickly, at a lower cost, and we arrive at better properties than traditional trial-and-error methods,” Hatcher said.

Meanwhile, the company is also a leading contributor to the AIM program, spearheaded by the U.S. Defense Advanced Research Projects Agency and the Office of Naval Research. AIM is a probabilistic approach to forecasting property variability and material properties – including 1% minimum properties. A 1% minimum for, say, yield strength means that there is a 99% probability that yield strength will be above the 1% minimum, so determining the 1% minimum is crucial when it comes to qualifying a material’s performance, noted Dana Frankel, a materials design engineer with the firm.

Grabowski said AIM allows QuesTek to take a material it designed, with its chemistry and heat treatment, and then make perhaps three full-scale test melts of the material, which are then tested. “And then, based on the data from your three 3 • 2017

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AEROSPACE

QuesTek’s ICME-designed, ultra-high-strength, stresscorrosion-cracking-resistant Ferrium M54 steel went into this T-45 Goshawk training jet aircraft hook shank.

Image courtesy of QuesTek

heats, you can use AIM to predict, ‘If I make 10 heats of this material or 100 heats of this material, these are the minimum properties you should expect,’” Grabowski said.

“There’s this added benefit of AIM that it allows you to do fewer melts of a given material and then have a high degree of confidence you will have a certain minimum set of properties,” he added.

ICME and AIM have allowed QuesTek to design new aerospace alloys the company says have displaced other steels used for decades. And company officials think they already have alloys in their wheelhouse that could be attractive to medical device companies. They include the company’s QuesTalloy SMA, a nanodispersion-strengthened, high-performance shape memory alloy that the company is marketing as an improved material for use in stents and catheter lead wires.

Grabowski also expected QuesTek to have titanium alloys for medical additive manufacturing commercially available in the next 12 to 18 months; the company says its titanium alloys have 20% higher strength at equivalent ductility than the Ti-6-4 presently used in medical 3D printing. QuesTek has also designed superior cobalt chrome alloys that could have medical device uses.

Changing old habits Company officials, however, acknowledged that it has been slow going when it comes to marketing their alloys to medical device OEMs. The predicament is not a surprise: The medtech industry has a reputation for being highly conservative when it comes to novel materials, because they can greatly add to the time it takes to achieve regulatory approval.

Aerospace and medtech are alike in that failure of a material or a component could result in loss of life. But there’s still a difference, said Olson, the company’s co-founder and chief science officer.

“The difference is we designed airplanes, but we didn’t design humans,” he explained. “Working with aerospace engineers, they really know what they need, and if we meet their requirements, it’s going to fly. In medical, because we don’t know what humans are ...

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there’s going to be a lot of testing in an environment that we’re still trying to better understand.”

Olson is optimistic because the company has heard from FDA officials interested in incorporating more computer modeling when it comes to determining the safety of materials intended for medical device use, especially given the rise of 3D printing in the medical device industry.

The FDA, in fact, has already shown more openness to using computer modeling in medical device studies, even issuing a guidance document in September 2016 with suggestions on how to report on such studies.

FDA’s Center for Devices & Radiological Health has accepted computational models for a decade, but the new guidance formalizes the reporting recommendations.

The guidance document includes a suggested outline for reporting that includes such items as clear identification of the quantities being analyzed, scope and type of analysis, software quality assurance and much more.

“Computational modeling and other approaches that could spur innovation or improve and reduce premarket burden are assessed on a case by case basis,” said FDA spokeswoman Deborah Kotz, when asked about the agency’s interest in using AIM methods and other computer modeling techniques from aerospace.

FDA is also part of the federal government’s multiagency Materials Genome Initiative, which has the goal of deploying advanced materials twice as fast, at a fraction of the cost.

“We have high hopes that FDA in the near future will take a page out of the AIM playbook and

✓ ✓ ✓ ✓ ✓

in

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Introtek

AEROSPACE

will get to these statistically informed accelerated qualification methods that will allow for these highperformance designer materials to make it into the marketplace,” said QuesTek’s Frankel.

As Siemens PLM life sciences director Kristian Debus said in a recent blog post, interest is growing when it comes to the use of modeling and simulation in life sciences clinical and trial studies. Debus thinks FDA has been especially supportive of using modeling tools in cardiovascular device design.

When it comes to using computational tools to prove the safety of medical devices, it’s important to be careful of using off-the-shelf computational tools and to pay attention to validation – how close the model comes to reality, said medical device regulatory consultant Michael Drues, president of Vascular Sciences (Grafton, Mass.).

Said Drues: “Like any tool, in the hands of someone who knows what they are doing, it’s very useful. In the hands of someone who doesn’t, it can be disastrous.” M

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Changing the

FUTURE 3/1/17 11:32 AM 3/10/17 4:41 PM

SUPER SURGEONS

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Image courtesy of istockphoto.com

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SUPER SURGEONS

L A C I G R U S W O E H R A S ROBOATTING CRE

R E P U S s n o e g r su FLEMING A A L I S T A I RC A L A T S A G E N T I I D VP ME

FASTER THAN A SCALPEL-WIELDING HAND, ABLE TO SNAKE TO HARD-TO-REACH SURGICAL SITES IN A SINGLE BOUND— FUTURE SURGEONS WILL BE SUPER SURGEONS, ALL THANKS TO ROBOTICS.

In many industries, the advance of robotics has created worries about robots supplanting humans.

But in the world of surgery, the next generation of robotics is set to do the opposite – to supercharge the surgeon and put him in control as never before.

First-generation systems Intuitive Surgical’s da Vinci system defined the first generation of general surgical robotics. It promised a revolution in surgery and is today used for hundreds of thousands of procedures annually. The da Vinci System “is powered by robotic technology

that allows the surgeon’s hand movements to be translated into smaller, precise movements of tiny instruments inside the patient’s body,” according to the company. The surgeon is provided with a high-definition, 3D window on the operative world through a laparoscope also operated by one of the robot’s arms. Characteristics of first-generation robotic surgery systems include the large size and physical dominance of the operating room, the placing of the surgeon into a console outside the sterile field, and surgeons receiving feedback limited mostly to visual cues on-screen.

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SUPER SURGEONS

Image of da Vinci Xi with splayed arms Courtesy of Intuitive Surgical

The invisible man

The effect of this “fly-by-wire” surgery has in part been to abstract the surgeon from his traditional role at the heart of the operating room. Once in the middle of the team, he is now pushed to the margins of the room, almost invisible at his console, controlling the operation remotely. (Indeed, the system was originally designed with a completely physically remote battlefield use in mind.)

New breeds of robotic surgical systems aim to change this, and they will have fundamentally different characteristics from the first generation.

The invisible robot

Whereas systems such as da Vinci have visual-only feedback, the latest systems are being designed for haptic feedback, synthesizing the sense of touch. Ideally, the surgeon should feel that he or she is operating the surgical instruments at the end of the robotic arm directly; it is important to restore the sensory nature of open surgery to the surgeon. Haptics is a key area of development in surgical robotics: It aims to make the robot invisible to the surgeon and to help the surgeon directly react to what he or she feels.

Restoring sensory feedback

In this context, haptic feedback covers two main types of sensations: force and vibration sensation. Imagine an example of the end-effector as a pair of scissors which the surgeon is controlling remotely.

When you cut with a pair of scissors, you

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can instinctively tell if you are cutting through paper or cardboard. You can tell this by the resistance of the material you are cutting through and the resulting reaction force exerted through the instrument; this is force feedback. Haptic solutions are arriving on the market which can directly translate the effector forces to the hand. The new haptic features can help to control the forces applied to delicate structures while laying sutures or resecting friable tissues.

In the same example, imagine the difference between cutting through a sheet of paper or plastic. Again, you can tell without looking which is which: Paper is fibrous and almost gritty compared to plastic, which is smooth and silky.

There are subtle differences in vibration feedback as you cut. Picking up such differences requires an extra level of sensitivity, and technologies such as acoustic pickups or local piezoelectric sensors can capture the analog sensation of surface textures and material properties. These type of technologies may well be developed further to help provide this kind of feedback.

In surgery, processing such force and vibration subtleties in combination can help distinguish structures from each other such as arteries from veins or a cancerous growth from healthy tissue.

It is further imaginable that the robotic systems can help in this differentiation if they can be taught to know what to look

for during procedures.

Device designers, however, should not underestimate the technical challenges of achieving haptic feedback.

Being able to provide haptic feedback to the surgeon ideally requires sensors right at the tip of the end-effectors. The data harvested at the tip then needs to be communicated back to the surgeon.

At present, first-generation surgical robots can only capture this data distant from the tip of the device, losing fidelity through the cables and pulleys that connect it to the drive motors.

Conversely, a tip-mounted sensor has to be suited to the surgical environment.

It either has to be disposable and cheap (while also robust and safe) or it has to be able to withstand repeated sterilization.

The super surgeon: enhancing reality

Haptic feedback is about restoring the lost sensation of touch to the surgeon, but what about giving him or her entirely new powers? Enhanced visualization is a key area of development; it means allowing surgeons to see better or more than they can with the naked eye.

The da Vinci provides some enhanced visualization with its Firefly feature.

Augmented visualization developments could make the image on the surgeon’s

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SUPER SURGEONS

screen look more akin to textbook illustrations. They may use techniques such as fluorescent or hyperspectral imaging to help the surgeon distinguish between different structures in his visual field. For example, this might mean highlighting blood vessels in one color, a ureter in another, nerves in a third, etc.

One of Sagentia’s clients, Lightpoint, has launched an intra-operative molecular imaging system called LightPath to assist surgeons in identifying cancerous tissue. The system detects Cerenkov luminescence, a faint light produced by PET imaging agents widely used in cancer diagnosis. The LightPath system visually highlights the presence of the cancer cells, allowing the surgeon to be more certain that he has removed all cancerous matter while avoiding the unnecessary removal of healthy tissue.

There is also a wealth of pre-surgery data such as MRI, X-rays or CT scans which could be beneficial to a surgeon if merged into a surgical system's live view. Presently, there are examples of this in neurosurgery, where structures don’t move much, but for soft tissue surgery, the surgeon is looking between screens; bringing this data together into a single interface to guide the surgeon would be a powerful tool. To accommodate the dynamic morphological changes in tissue shape and relative position, fiducial markers and intensive image processing may be necessary.

Image of LightPath imaging scan Courtesy of Lightpoint Medical

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Image of the Flex Robotic System Courtesy of Medrobotics

Small world – physical changes

First-generation systems have been big pieces of equipment that have dominated operating rooms. There is a desire to reduce the size of these systems, make them less intrusive and more adaptable.

How system designers can achieve this is an open question. In practical terms, the clinical need drives architecture.

Clinically derived specifications for the range of motion and strength of the instruments defines their scale, the size of drive motors and consequent specs for mounting structures. However, the overall scale can also be affected by where arms are mounted and motors are located. The newer da Vinci systems occupy far less space than their predecessors, and across the industry this trend will continue, providing surgeons with readier access to their patients and enabling a wider range of surgical procedures to benefit from robotics. In parallel to this, the wider industrial robotics arena is transitioning from brutal, unyielding systems in cages to “softer,” “self-aware” systems that are safe to work around and even interact with humans. These developments are also vital for future generations of surgical systems, with clinicians recapturing a much more hands-on presence in the OR, in touch with their patients again.

Equally, entirely novel architectures that move away from conventional multiDoF (degree of freedom) robotic arms have potential to disrupt this model. The trend for minimally invasive surgery has for some years pointed toward fewer (or no) incision 66

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sites, but it is difficult to get there with conventional instruments. Still, the ability to enter one area of the body through a single entry site and then use the robot to snake along to the target of the surgery is proving an enticing objective for one cadre of newer system developers. Sagentia’s client Medrobotics won “Best in Show” at the 2016 Medical Design Excellence Awards for their Flex Robotic System, reflecting the trend toward more flexible systems.

The product represents the first of its kind as a flexible robot for advanced surgical procedures, enabling surgeons to navigate around or through tortuous anatomical structures. The Flex delivers high-definition visualization along with two-handed surgery to distant anatomies.

Distant horizons

Is there an appetite for an autonomous robot that takes the place of the surgeon completely? We can see the potential for robots to undertake some discrete tasks autonomously, and there are already examples of pre-planned execution (primarily in the orthopedics world).

However, we could be a long way from a future where robots are even technically capable and competent of reactive control; and that’s before considering the ethical and regulatory challenges this raises. That said, robots are good at doing defined, specific repetitive tasks well, and a lot of

surgery falls into this category. There has already been a recent pre-clinical example, at Children's National Health System in Washington, D.C., of a robot performing suturing in an animal operation. But there is certainly no regulatory enthusiasm for robots to take on more than very controlled tasks. We believe we are many years away from anything like this.

Restoring surgery to its roots

The word “surgeon” came into the English language after the Norman Conquest and derives from the Greek “kheirourgia," from “kheirourgos,” "working or done by hand." Robotics often seems the opposite of this, but new robotic surgery developments have actually returned to the old sentiment. Surgeons are returning to center stage and regaining some of the manual feel of open surgery within a minimally invasive surgical environment.

Even better, the surgeon can increasingly see the unseeable and integrate that in one view with pre-surgery scan data. The trend toward minimally invasive surgery continues as innovators look for ever more subtle ways to access anatomy via small openings and snake their way through to the location for surgery. The next generation of robots will enable all of this happen. They will be smaller, more mobile and more flexible – and they will be more collaborative, even part of the team. M

www.medicaldesignandoutsourcing.com

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DEVICE TALKS

The secrets of a product liability Jedi: Greenberg Traurig’s Lori Cohen Lori Cohen, a product liability litigator with Greenberg Traurig, enjoys a 57-for-58 lifetime win-loss record in the courtroom.

Here’s how she does it.

When it comes to defending product liability lawsuits, it’s tough to top Greenberg Traurig’s Lori Cohen and her 98.3% winning percentage – she’s 57-for-58 lifetime in the courtroom.

Cohen, a shareholder at the law firm, is chairwoman of GT’s pharmaceutical, medical device & healthcare litigation practice and its trial practice group. Based in Atlanta, she’s saved her medical device and pharmaceutical clients at least $174 million in potential damages over the years.

We asked Cohen recently about her best advice for medtech makers, the secret to winning over juries in cases with sympathetic plaintiffs and when it’s time to settle.

Below, edited for clarity, is a transcript of our conversation: MASSDEVICE: You’ve had a long and very successful background in product liability defense.

What’s the 1st thing you tell medical device companies who are looking to protect themselves against either existing or potential liability claims?

LORI COHEN: Obviously, the most important thing is to have a good product and all that goes with that, including, obviously, good testing, good compliance, regulatory compliance, good safety measures, that sort of thing.

If a company, a client starts with a good product then that’s obviously a great place to start and an important place to start and then everything builds from there.

That’s No. 1. If you have a company that makes a safe product that’s tested well for the company, is involved in good regulatory compliance that’s, obviously, a great place to start and a good jumping-off point.

I should add that no matter what a company does, they’re not going to be immune to potential lawsuits, litigation, the fees that often occur in this industry. But they can do things, obviously, to put themselves in a better position. That would include making sure that people within the company understand how to conduct themselves in terms of communications and not emailing crazy thoughts that aren’t supported, making sure that people comply with protocols and standard operating procedures. I think beyond having the right, safe products is making sure the people who work

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at the company understand how to conduct themselves in terms of communications; verbally and also, importantly, in writing.

MASSDEVICE: Can you tell us about your favorite case?

LORI COHEN: If I’m focusing on the trial itself and the courtroom experience, obviously, I’ve had a lot of amazing, really rewarding experiences in the courtroom. Sometimes it seems that the most recent trials are the most rewarding, because they’re so fresh in your mind, but I have had a lot of really significant courtroom successes and I attribute it to, obviously, having really supportive, great clients, but also having the really great team that I’m working with, a cohesive team in terms of presenting our cases.

Some of the ones that stick out in my mind are ones where we had very seriously injured plaintiffs with a lot of sympathy, but yet we were able to combat that and have the jury overcome that tremendous sympathy and recognize that my client didn’t do anything wrong.

I was defending Medtronic (NYSE:MDT) in a case that turned out to be … you’ll see a theme here that these cases tend to start with the idea that they’ll be 3 • 2017

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a pretty short trial and they end up being a really long trial. That was the case here, it ended up being an 8-week trial in Connecticut. It was the Hurley vs. Medtronic case that started in 2007 and the case went through 2008. We went from Halloween through Martin Luther King Day 2008.

In that case we had a really sympathetic, nice, young woman who had a Medtronic pacemaker implanted, and she ended up having a cardiac arrest, and ended up in a persistent vegetative state as a young woman. It happened when she was about 13 and by the time we went to trial she was in her early 20s in a vegetative state. It was a very challenging, very sympathetic situation. There wasn’t a dry eye in the courtroom, basically, when they wheeled her in and her mom testified.

In that case, again, through our efforts and presenting the facts and the evidence to the jury, it helped the jury see that Medtronic, even though it was a big company, didn’t do anything wrong.

That was, I think, a monumental trial, and one that I remember very vividly, and that was a very important win for a number of reasons.

Then there’s another Medtronic case, [with] a really sympathetic plaintiff, again. She was a very nice woman who was a singer, if you can believe it, and involved in her church singing group, and loved karaoke. She went in to have just a 10 minute outpatient procedure and ended up with this blowtorch injury and on a ventilator for the rest of her life until she actually died, after our trial.

That was a very challenging case, because we not only had the plaintiff coming after us and an excellent plaintiff’s attorney and firm but also a number of co-defendants who wanted us to, basically, bear the burden of the case being the big out-of-town company, and so they were coming after us as well. We were in the crossfire of the plaintiff and the co-defendants, and we were able to come out of that one with a win. That was another memorable success, again, a really well-fought victory and cohesive team on our part for Medtronic.

Another case was last year. We tried a case in state court in Missouri which was a vaginal mesh case for C.R. Bard (NYSE:BCR). As you probably know, most of the mesh litigation cases have been these really huge plaintiff verdicts. This was a case where we tried in Missouri state court and we ended up with a defense verdict after 9 weeks. That was one where the plaintiff’s attorney said, “We’ll have a 3 week trial.” It ended up

being 9 weeks. We had a woman who took the stand, and she was getting very sympathetic, and telling her story, and we ended up winning that case as well as the co-defendant Boston Scientific (NYSE:BSX). Those are 3 big trial victories that I think have very strong memories.

MASSDEVICE: The obvious theme is overcoming that natural sympathy the jury has with the plaintiff. What do you have in the toolkit that you deploy against that?

LORI COHEN: Always remembering the plaintiff, and always basically being very respectful and showing the appropriate degree of empathy, not being too critical, and not being too aggressive towards the plaintiff is very important.

Finding ways to let the truth come out about different issues

time, being very respectful to the jurors. Not talking down to them, not being patronizing to them in any way.

Some lawyers will get up in the opening statement and say, “Aw shucks, I can’t figure this out, and this is going to be all technical and complex medical issues that you’ll never figure out and I’ll never figure out.”

Whereas I take the opposite approach, which is, “This is really interesting. It’s going to involve medicine, and science, and engineering, and we’re all going to figure it out together. We’re going to go on this journey together and figure it out together.”

You’re not patronizing. You’re being respectful to jurors and letting them know that you respect them, and that you’re going to help lead the path for them but that you know that they can figure it out as well.

One more thing I would say

NO MATTER WHAT A COMPANY DOES, THEY’RE NOT GOING TO BE IMMUNE TO POTENTIAL LAWSUITS, LITIGATION, THE FEES THAT OFTEN OCCUR IN THIS INDUSTRY.

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and let the jury come to their own realization, because juries are very smart. Most lawyers don’t give them enough credit to figure things out on their own. Many attorneys want to, basically, repeat things, beat them over their heads with things, and feel that they have to really spell things out for juries.

A lot of times if you lead them in the right path and let them reach their own conclusions, that can be very effective. In other words, not be overtly critical but give them enough pieces of the puzzle to let the jurors then figure out on their own. The other component of that is being very respectful to the plaintiff, not being critical, not looking like you’re on the attack, and then also, at the same

is I think that my persona in court is the same thing that you get if you run into me in the airport, or if you’re having a drink with me after work. I think that my personality and persona in the courtroom is the same as who I am normally. I think that’s very important. I don’t try to be anyone that I’m not.

MASSDEVICE: Is there a point when you tell a client it’s time to settle? How do you approach that conversation? And how do you then turn and approach the other side?

LORI COHEN: I think that people view me as more of the “trial warrior” than the settlement counsel, but in any case I have to consider the

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SAVING AND

IMPROVING

settlement aspects as well and when that’s a good recommendation for the client. Most often I will try to look at the case right from the beginning and say, “This is a case that should settle early, or this should be discovery.” Then I think it’s something that you have to reassess as the case goes on. You make an initial assessment, you look at it, try to give your client your best judgment and recommendations: “Look this is a case where somebody had a very small injury. It’s going to cost a lot of money to proceed with the case. This is one that you may consider for early resolution.”

It’s something that you assess initially, and then you’d have an open dialogue with your client, and you reassess at different junctures in the case. I think that’s really important, that you keep an open mind and have an open dialogue with the client. The last thing your client ever wants to hear is, on the eve of trial, a complete about-face or shifting of position where for 2 years you’ve said, “This case should never settle,” and all of a sudden you’re about to go to trial and you say, “Oh guess what? This case should settle.” I think it should be an ongoing evolution of discussion where you’re checking in with the client and giving them your best judgment if things go wrong.

There’s a lot of strategy that goes into the timing of settlement or the potential for settlement. It may be a situation like [the Medtronic airway case], where we tried to mediate the case several times, we tried to settle the case, but the demand was so great and the co-defendants had so little in terms of insurance money available that it was virtually impossible to get it settled because of the severity of the injuries, the alleged damages. In that case we ultimately had to go to trial. There are a number of cases where you may recommend settlement, but you cannot get it resolved because of these competing factors of the amount sought and then the potential liability for your client.

In terms of talking to the plaintiff’s attorney, again, it’s “pick your time wisely.” There may be a lot of benefit for doing certain types of discovery. You may have witnesses who are from the company who you need to tell your story 1st, so that the other side can realize that you have a strong defense. You may have to put up other witnesses 1st, so that the other side realizes you have a strong defense. You may have to depose the plaintiff to show that they understood the risks of procedure or that they really will not make a good appearance at trial. There may be different factors that play a role in when you reach out to opposing counsel for settlement. There may be things that have to happen 1st but again, it’s an evolution in the case and something that you’d have to consider initially, and then reconsider over time. Then be very strategic and very collaborative with your client, in terms of determining when would be a good time to broach the topic of settlement with opposing counsel or if it’s a case where you never broach the subject. M

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PRODUCT WORLD

Customizable foot switches designed by Steute Meditech Steute Medical offers customizable, medical-grade foot switch designs for the medical device OEM market that have no tooling or engineering development costs. Designed through what the company calls a unique custom design program, the foot switches are designed to address the limitations and control functions needed by certain applications.

Steute engineers specifically pick components that best match the needs of foot switches by first picking a base plate. The base plate defines the shape and size of the

actuators that are chosen based on whether they will perform the required control functions or not. Engineers then determine the actuating force and which output connectors are needed for select device compatibility.

Consumers also have the choice to add carrying handles, foot rests, pressure points and IP ratings, and they can change the colors of actuators.

Steute Meditech steutemeditech.com

Tilt-yaw rotary system from IntelLiDrives has high-speed capabilities The two-axes rotary Tilt-Yaw rotary system from IntelLiDrives provides high-speed micromachining capabilities from 3D part geometries.

This precision-aligned system has accurate positioning for hemispherical surfaces and can be used for general testing, purpose pointing, scaling and tracking applications for small options, antennae and other sensors.

Universal input, multiple output ac-dc power supplies

It also features high performance rotary stages with stiffness and load capacity that can be used in a wide variety of applications. It is motorized with high-torque NEMA 17 stepper motors and can rotate 95° on the tilt (A axis) and 360° on the yaw (B axis).

With a load weight of 10 kg, it can also reach speeds of up to 60 rpm with a positioning accuracy of 30 arc-sec.

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The MUI65 dual and triple output and MUI40 single output devices are part of a series of universal input ac-dc power supplies for medical applications offered by Polytron Devices.

Both devices have a 0.15-watt low standby power consumption, 85 to 246 Vac, 47 to 63 Hz voltage range and low leakage current that is under 75 microamps. The MUI65 can be used in applications up to 65 watts and is 2 in. x 3.5 in. The MUI40 can be used in applications up to 40 watts and is 2 in. x 3 in.

Both power supplies have a built-in class B EMI filter, 2MOPP insulation and 5000M operating altitude. They also meet medical electrical safety standards and are RoHS-compliant.

Polytron Devices polytrondevices.com

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3/10/17 10:55 AM

We’re more than Valves...

Fast camera models and sharpening feature from Basler Basler, a manufacturer of industrial digital cameras, has added more Microscopy ace camera models that have the latest CMOS sensor technology to its PowerPacks for Microscopy line. The PowerPacks have highquality camera with components for simple setup and installation. The Microscopy ace 3.2 MP and Microscopy ace 5.1 MP feature Sony’s high-quality Pregius sensors for a speed of 55 images per second. This allows smooth screening of sample and analysis of movements in small samples. The Microscopy ace 1.3 MP 160 and Microscopy ace 1.3 MP 200 have high speeds as well. With ON Semiconductor’s sensors, the cameras have the potential to have a resolution of 1.3 MP

at 200 images per second. They can be used to analyze cell movement, in spermatology, or for fast moving patterns.

All of the cameras have a sharpening feature that can optimize the image for depth of focus. The white balance has also been improved in these new cameras and features the latest and cost-optimized vision technology. All of the microscopy cameras come with fully tested, high-quality USB 3.0 cables and an installation guide with professional microscopy software.

Basler baslerweb.com

Reflective optical sensor provides reliability and versatility TT Electronics is touting a reflective optical sensor called the Photologic V OPB9000. It is meant to provide dependable edge and presence detection of reflective media within a range of ambient lighting conditions in industrial and medical applications. It can be used for industrial printing, dispensing, manufacturing automation, safety and security devices and portable lab and medical equipment.

The OPB9000 has programmable sensitivity, output polarity and drain select. It has unique 25+ kilolux ambient light immunity and a wide operating temperature range. It also self-calibrates as the LED ages. The OPB9000 eliminates circuit complexity and reduces board space by 80% with a fully-integrated analog front end and digital interface. The infrared emitter and integrated logic sensor surface-mount is 4 mm x 2.2 mm x 1.5 mm.

TT Electronics ttelectronics.com www.medicaldesignandoutsourcing.com

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B. Braun Medical | OEM Division | USA

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