In anticipation of our annual end-of-year feature article by MPO Managing Editor, Michael Barbella, two questions were posed to the brand’s Editorial Advisory Board members. As always, a great response was provided to the following questions.

• What news headline, event, or technology was the most significant in 2019 and why?
• What’s one expectation you have for 2020 that will make an impact on the medtech industry (i.e., what will you be keeping an eye on?)

Following are the responses provided by a number of board members. Take a moment to peruse the responses to see if you agree with the board members or if you have your own perspective on the questions. Further, if you’d like to share your thoughts with me, they may be used in a future feature on the MPO website. Provide those thoughts to me at sfenske@rodmanmedia.com.

Note: These responses were provided throughout October 2019, so that should be taken into account given events that have occurred since that time period, which may alter how a given response is viewed.

Elyse Blazevich, Co-Founder, COO & CFO, Securisyn Medical
A Look Back—In 2019, the medtech industry faced a looming sterilization crisis amid stricter regulations on and abrupt closures of ethylene oxide (EO) sterilization facilities due to concerns about carcinogenic risks. More than 50 percent of medical devices rely on EO to avoid product damage during the sterilization process and there are few viable alternatives to EO. Resulting device shortages have raised concerns about the ability to adequately meet patient needs, and with increasing pressures to reduce hospital acquired infections and preventable deaths, effective sterilization methods are critical. The FDA responded to the crisis by issuing challenges to encourage the development of new approaches to medical device sterilization. As new medical devices and single-use products enter the market, and the costs and risks associated with EO sterilization increase, the medtech industry is likely to see significant changes in the utilization of existing and new sterilization methods.

Gazing at 2020—Leading nationwide and state industry organizations such as AdvaMed, MDMA, and CBSA have joined together with 600 stakeholders from across the healthcare and medical device industry ecosystem to turn up the heat on lobbying efforts for repeal of the medical device excise tax, set to take effect after the current suspension expires on December 31, 2019. If reinstated, this onerous tax will put innovative medtech companies and an estimated 20,000+ jobs at risk. It will force redirection of spending away from manufacturing, R&D, and other important investments. It will also significantly burden small businesses—the heart of our nation—which are not yet profitable, as the tax is based on sales, not on profit. Unless Congress acts quickly, this tax could have devastating consequences for our industry and, more important, for the patients we serve.

Michael Drues, Ph.D., President, Vascular Sciences
A Look Back and Gazing at 2020—There has been a near record number of regulatory changes and updates coming from FDA and the EU in the last twelve months, most of which are in direct response to problems with devices in the past. While preventing problems from reoccurring is certainly a noble goal, is creating more regulation the best solution? Can we assume more regulation means safer and more effective medical devices? If our devices were better, would that mean we would have less regulation? Unfortunately, many of the recent changes are purely administrative (i.e., paperwork). Very few involve actual substance (i.e., don’t directly impact the safety and efficacy of a medical device in an engineering or biological sense). So, if we don’t see a reduction in medical device adverse events in the coming year and beyond, aren’t all of these changes a colossal waste of time and money? Maybe just job security for regulatory consultants and FDA employees? Time will tell…stay tuned!

J. Mark King, President and CEO, Tegra Medical
A Look Back—It was big news when, early in 2019, the FDA announced a plan to update the regulatory approval process. For years there has been an expedited approval process for devices that are substantially equivalent to older, approved devices. They are now proposing a 10-year cut-off (i.e., no circumventing the rigorous approval process by comparing to devices that are more than 10 years old). This will require far more devices to be put through the entire validation process before they can go to market. The FDA’s finalized guidance is expected to be available in 2020.

Gazing at 2020—It will be interesting to see what effect the stricter FDA validations have on the device manufacturing industry. We know from first-hand experience how involved and time-consuming the process is. It can take three dozen manufacturing processes to make something as simple as a needle—and every single one of those processes (even cleaning) needs to be validated. Not all manufacturers have the resources to get involved in that level of validation. Those who can handle it will see an increase in business, but that can cause lead time and delivery challenges.

Patrick Lynch, Supply Chain & Quality Systems Consultant, chainLEANk
A Look Back—The most significant events in 2019 impacting medtech were the advancements and mass scale-up of digital patient monitoring. AI and predictive algorithms take this technology to a new level and digital monitoring will soon be commonplace.

Gazing at 2020—Heading into an election year, with the economy continuing to tighten, and the threat of the suspension of the device tax repeal, 2020 will be a historic year in terms of the numbers and magnitude of mergers and acquisitions. The economic growth in the last several years brought significant funding, leading to breakthroughs in development, and brisk action is likely in the repositioning of these technologies and devices, ahead of the events.

Steve Maylish, Co-Founder and CCO, Fusion Biotec
A Look Back—I think one of the biggest headlines this year in life science is CRISPR Prime Editing. This new technology for gene editing is more precise, less likely to cause unwanted edits, and can target and insert a new DNA sequence without cutting both strands of DNA. It’s predicted this editing technique may one day correct close to 90 percent of pathogenic human genetic variants. It’s hard to believe CRISPR technology has evolved so quickly over the last 10 years. We are certainly in a brave new world.

Gazing at 2020—I think the biggest impact on the medtech industry will come from the elections in 2020. If the Democrats win the presidential elections, this will help evolve the Affordable Care Act. If the Republicans stay in, I’m hoping to see a repeal of the medical device tax. Either way, healthcare will be an important political issue in 2020.

Brent Noblitt, Co-Founder and Senior Partner, Noblitt & Rueland
A Look Back and Gazing at 2020—Concern regarding the EU Medical Device Regulation (MDR) implementation by May 22, 2020; many are worried a lack of notified body resources will not allow companies to properly prepare for the deadline. (This is probably one of the most important issues for the medical device industry due to the size of the EU market and one to keep an eye on to see if transition requirements and dates change.)

Other items I’ll be keeping an eye on and could be significant for the industry include software as a medical device (SaMD), along with AI and machine learning. Also, the implications of the FDA 21st Century Cures Act. The growth of MDSAP and its impact on FDA inspections and warning letters is yet another item; this will be interesting to watch. Cybersecurity, with regard to its impact and vulnerabilities—again for both this year and 2020—continues to be a concern.

Finally, the possibility of FDA transitioning from current Quality System Regulation (21 CFR Part 820) to ISO 13485:2016 is worth keeping an eye on. This was previously mentioned by Scott Gottlieb when he was FDA Commissioner, but I have not heard anything since, so it may not have any traction. Issues may include ISO 13485:2016 copyright issues, training, buy-in, remaining differences between the regulation and the standard, etc.

Matthew Robida, VP Corporate Development, Spectrum Plastics Group
A Look Back and Gazing at 2020—My comments for both questions relate to MDR and the regulation deadline (with it officially going into effect in May 2020), along with all the preparation, panic, dismay, and other emotions going into it. Further, it is interesting how the new regulations set up a comparison or juxtaposition with the FDA, as some are saying companies that once went after a CE mark first are now inverting their priorities to the 510(k). So it isn’t a single event, but the slow, creeping escalation of risk this year as the date approaches and the final reality settling in that this is around the corner and firms need to get it together.

As ever, the thing we focus on for 2020 (and keep our eye on in general) relates to evidence or headlines for ongoing consolidation and how it—and the effects (notably price pressure)—ripple through the supply chain.

Bryce G. Rutter, Ph.D., Founder and CEO, Metaphase Design Group Inc.
A Look Back—The field of robotics is on fire. All the major players now have a stake in this game with a wide variety of technical strategies. Over the next two years, we will see how this active market space evolves and how players like Medtronic, Stryker, Intuitive Surgical, Verb, Transenterix, and others carve-out unique areas of specialization.

Also, biologics and drug delivery devices are in a transformational period. Devices in market today are mechanical design platforms in search of delivering Pharma's next wonder drug, with little to no consideration of the end user. User centered design will transform this market sector by spinning out designs that are driven by usability and intuitiveness while preserving the dignity of the user.

Gazing at 2020—In 2020, Metaphase will be deeply involved in the research and design of advanced robotic surgical systems, smart instruments, and next generation drug delivery devices and wearables.

Dave Sheppard, Co-Founder and Managing Director, MedWorld Advisors
A Look Back—The most significant development in 2019 was the increasing innovation, investment, and development of robotics in the medtech industry. Backed by literally hundreds of millions of dollars in investment, there are numerous new entries with focused and specialized technologies that will have impacts in various specific applications in the next few years. And headlining the robotic battle are the industry giants—J&J, Medtronic, and Intuitive Surgical. It will be an interesting “innovation” and “footprint” war to observe for years to come.

Gazing at 2020—While there are many issues and opportunities to watch in 2020, there is no issue greater in the coming year than the implementation of the EU MDR. If the deadline stays in place, there will be literally hundreds of products removed from the EU marketplace forever and some companies will simply go out of business. It is our hope that there will be some rare common sense in Brussels and this deadline will be extended into 2021 (or beyond). Our fingers are crossed for our medtech friends who market in Europe.

Thad Wroblewski, Sterilization Strategy Consultant
A Look Back—The headlines pertaining to ethylene oxide and other sterilization technologies were most significant. Issues pertaining to sterilization will change the landscape of medical device sterilization. For ethylene oxide—the technology used for approximately 50 percent of all medical devices—there is concern as several facilities may need to cease or already have stopped processing based upon an unstable legislative and regulatory landscape. Facilities may cease operations in municipalities that are enacting laws to prevent the use of EO. If facilities are prevented from processing, devices will be shifted to other sites, however processing capacity is an issue. EO installations involve large capital expenditures and perhaps are a risky investment at a time when EO emissions, device EO residuals, and potential worker level exposure regulation changes will complicate device supply.

For gamma radiation technology, Cobalt-60 availability and pricing is a concern. With many nuclear reactors involved in the production of the isotope, retiring at various times, and even though some new capacity is being added at sites, the overall availably of Cobalt is of concern. Electron Beam technology is definitively taking market share and X-Ray technology is advancing to the point of becoming a reality for large volume processing. Look for growth in electron beam/X-ray processing into the future.

Gazing at 2020—My one expectation is that outsourcing entities will develop closer ties to sterilization suppliers to ensure the device supply chain to market. Outsourcing manufacturers will follow these critical paths:

• Evaluation the current EO position and ensure cycle optimization to limit the EO gas concentrations needed for assurance of sterility. Establish back up chambers and facilities. Understand processing capacity within the network of chamber/facilities validated.
   
• Consider non-isotope radiation (i.e., electron beam and X-ray technologies). X-ray is particularly interesting in that its penetration characteristics are like gamma, and likely will product better DURs [dose uniformity ratios].
   
• Consider sterilization options in the upstream of R&D as a longer-term solution in the design of medical devices to ensure flexibility in the use and management of sterilization technologies to navigate the changing landscape of regulations and capacity availability to ensure stringent supply chain expectations for device delivery to market.