Reflections on 2022 and What’s Ahead for Medtech: MPO Sounding Board

Dec 2

To view this article on the Medical Product Outsourcing website, click here.

Flex Health Solutions President Randy Clark will be keeping a close eye on the progress made in the medical wearables space moving forward as they become smaller, yet more effective for a growing number of applications.

At the end of each year, I like to reach out to the MPO editorial advisory board to get their input on what’s been the top headlines in medtech for the year and what they anticipate the new year will bring. It’s a great opportunity to get the thoughts of those throughout the industry who are experiencing many of the ups and downs first hand.

Specifically, I asked the following two questions:

What news headline, event, or technology was the most significant in 2022 and why?
What’s one expectation you have for 2023 that will make an impact on the medtech industry? (i.e., What will you be keeping an eye on for positive or negative reasons?)

As is often the case, I had several fantastic responses from a number of board members and wanted to take an opportunity to share them with you. You may also like to compare their responses to our own analysis of most significant topics for the past year in Michael Barbella’s Year in Review feature from the November issue of MPO.

Dave Sheppard, CMAA, Co-Founder and Managing Director at MedWorld Advisors

2022 Reflections—To answer this question, there are many good options to choose from. These include inflation, COVID rollercoasters, China seclusion, reshoring, labor availability, decline in healthcare investment and M&A (from 2021), the 2022 CURES Act, and international regulatory challenges.

In picking one, I must emphasize the impact of the global regulatory environment, which cannot be understated. The transition from the EU MDD to the MDR is literally eliminating important medically necessary products from the marketplace and CRUSHING good quality, small companies from around the world. We are seeing SME (small- to medium-size enterprises) in our industry literally “tap out” and sell their companies/technology rather than deal with these increasing bureaucratic burdens. Even large companies are pruning their portfolio of medically helpful products due to these challenges.

2023 Expectations—As our business is M&A, it’s one of our key focuses within the industry. The record amount of investments in digital health tech and consumer health tech in recent years has resulted in an exciting plethora of digital health companies (segments like “telemedicine,” “hospital at home,” “remote monitoring,” “wearable technologies,” “patient engagement,” “doctor on call,” etc.). As a result, we expect “winners” and “losers” to emerge within the marketplace as the convergence of consumer health tech and traditional medtech accelerates. This convergence will create an exciting time of necessary consolidation onto fewer platforms that will ultimately be successful in the marketplace. In summary, watch for more M&A in these types of digital/consumer health tech segments as the key players make moves to ensure they survive and thrive into the future.

Randy Clark, President of Health Solutions at Flex

2022 Reflections—“Our Wearable Future: What Will New Tech Look Like?” by WebMD editor Jerilyn Covert is one of my favorite headlines from 2022, and a topic I anticipate will guide discussions from the board room to operational back rooms of many medical product outsourcing companies and the customers they serve. This article reminds us that healthcare wearables aren’t just for counting steps anymore! Thanks to advances in materials, along with smart and connected tech, next-gen wearables will alert people of oncoming illness, manage chronic conditions, and personalize treatments based on an individual’s needs. They’ll also be smaller, more reliable, and more sustainable to reduce environmental impacts across the entire product lifecycle. It’s an exciting time to be partnering with leading medtech and pharma companies to design breakthroughs in patient care and deliver innovations to market faster.

2023 Expectations—As medtech innovation accelerates, this is a market to watch for exciting opportunities and the evolutions taking shape. From diagnostics and dialysis to infusion markets, care is moving from a traditional hospital site to the clinic environment, and now further into our living rooms. We are experiencing a shift in patient monitoring, from large form factors to small, connected wearable devices, translating into positive patient outcomes. In minimally invasive surgery, innovation has shifted from open procedures to laparoscopy to lap robotics and even further segmented to endoluminal robotics. We have an opportunity as a healthcare ecosystem to accelerate innovation cycles, and enable customers to get to market faster and scale, reliably and with sustainable practices.

Steve Maylish, Chief Commercial Officer for Fusion Biotec

Being in the diagnostic industry, 2022 has been a very interesting year due to COVID. First, few people thought the pandemic would last this long. The FDA has had to extend the Emergency Use Authorization (EUA) numerous times and continues to invest in ways to fight COVID and infectious diseases. Their intent is to provide more readiness and a better response to the next epidemic or pandemic.

At the beginning of the pandemic, I don’t think anyone expected the EUA to extend late into 2022. Now, with the pandemic subsiding, the EUA is expected to expire early next year. For diagnostic companies with an EUA, their authorization will need to be converted to an FDA 510(k) clearance. This will represent a significant amount of effort and cost, especially for startup companies. As diagnostic companies weigh their options, some firms may exit the market.

The existence of the EUA and NIH funding over the last three years has helped many companies enter the market and, to some extent, stay in the market. Next year, as competition for these diagnostic dollars shift from COVID to infectious disease, NIH funding is re-prioritized, sales dwindle, and companies have to resubmit for 510(k) clearance, there may be another major shift in the diagnostic industry.

Paul Orlando, Global Operations Business Development Lead for OLYMPUS SURGICAL TECHNOLOGIES AMERICA

2022 Reflections—I expect the material and labor shortages the entire medtech device industry is dealing with will be a common significant headwind. The pent-up demand we all helped cause due to past inventory decisions made when the pandemic hit is making the “big catch up” that much more difficult. Wish we had a do over.

2023 Expectations—So many things to keep an eye on and manage like no other time I can recall in the last 30 years—China, labor/material shortages, trickle down shortages we have not yet seen, geopolitical unrest, and upcoming elections. All this while trying to do our day jobs!

Dennis Rubenacker, Senior Partner at Noblitt & Rueland (on behalf of EAB member Brent Noblitt)

Some items of note from 2022; most of these will continue to be headlines to watch in 2023:

Cybersecurity is a current FDA hot button addressed in the latest draft of FDA Cybersecurity guidance, along with recalls spawned by cybersecurity breaches in medical devices.
AI/ML (artificial intelligence/machine learning) and SaMD (software as medical device) implemented in a plethora of new medical devices will spawn future regulation to be addressed by FDA.
The U.S. government has promulgated an AI bill of rights, laying out voluntary guidelines to avoid AI misuse in all areas with potential application to medical devices powered by AI.
Risk management including usability/use error are key areas to address as part of Total Product Life Cycle (TPLC) for medical devices.
Real world evidence and postmarket surveillance are potential key areas emphasized by FDA for integration into the overall medical device TPLC.

In addition, the FDA published their proposed rule for comment for harmonizing the Medical Device Quality System Regulation (21 CFR Part 820) with the international quality system standard ISO 13485:2016.