The new year promises to bring plenty of challenges and opportunities for the medtech industry, with experts eyeing developing markets, technological advances and better reimbursement as areas of significant potential. But counterfeit devices and political chaos remain significant challenges. Marissa Feyer of DeepLook Medical may have summed up the spirit of the industry: “We need to focus on moving forward, no matter what.”
What are your biggest concerns and where do you see the biggest opportunities for the new year?
George Breen, Chair of National Health Care and Life Sciences Practice, Epstein Becker Green
I am eager to see to what extent a second Trump administration presents the opportunity for a Department of Justice (DOJ) that is more “business friendly” or, perhaps better stated, “business realistic.”
The first Trump administration reflected a focus on regulatory reduction, review, and elimination. We also saw during that time the issuance of the Brand Memo by the Department of Justice directing that prosecutors not rely on sub-regulatory guidance in bringing matters against defendants in False Claims Act (FCA) cases—guidance that was subsequently rescinded by the Biden administration when Attorney General Garland took office.
I hope defendants in FCA cases will be better received when they approach DOJ and request that, when the agency is considering a case brought by a qui tam relator and declines to intervene in the case, DOJ also seeks to dismiss the case outright, thus saving subject defendants the cost and expense of a litigation that DOJ does not see the merit to litigate on its own.
I expect defendants in FCA cases to continue to challenge the constitutionality of the FCA’s qui tam provisions, following Justice Thomas’ dissent in US ex rel. Polansky v. Executive Health Resources. A recent decision from the Middle District of Florida, US ex rel. Zafirov v. Florida Medical Associates LLC, found the provisions to be unconstitutional. While this decision is an outlier among those cases where these provisions have been challenged, I do expect this will continue to be pressed by defendants in cases across the country.
Matt Burton, strategic development director, IMed Consultancy
I’m concerned about the influx of counterfeit and falsified devices in the UK market but remain hopeful that new UDI requirements, e-labelling and AI in MHRA processes will help.
I’m uneasy about the cost and impact EU Article 10a requirements as given in Regulation (EU) 2024/1860, upcoming in January 2025. It feels very much like trying to treat the symptoms but not the disease. Europe must find the right answers for the urgent revisions to the EU regulations, or the “US first” wave may continue unabated. That said, Trump’s return, along with his planned tariffs and US-centric supply chain, could also make the US market less attractive.
In the aftermath of the MDD transition, I’ve been supporting clients in seizing emerging EU opportunities. Disruption often brings fresh possibilities, and while US-first strategies are happening, I see strong potential instead for US-to-UK/EU trade. With the right guidance, UK/EU regulations are far more navigable than they first appeared, especially when partnering with the right experts and supporting bodies.
Looking ahead, I will be focusing on reciprocal opportunities in emerging economies like Brazil, India, and further east.
Emily Elswick, president, Medtronic Pelvic Health
My biggest concern is what led me to my role as President of Medtronic Pelvic Health, and that isn’t one concern, it’s millions. The millions of people who qualify for but don’t receive advanced therapy to treat their urinary or fecal incontinence, advanced therapy such as InterStim sacral neuromodulation. Medtronic developed the sacral neuromodulation industry 30 years ago and we continue to innovate today. It’s an exciting time, one with many opportunities as we think about delivering care that puts a greater emphasis on each patient’s unique situation. I predict the options of the future will look wildly different than what we see today.
Kyle Faget, partner, Foley & Lardner
I think we can anticipate a more hands-off approach from FDA under the Trump administration, which could lead to a lot of unregulated or underregulated AI in clinical care. I think we will see explosive innovation in this space, but I am concerned that lack of strict regulatory oversight could lead to safety and efficacy issues.
Marissa Fayer, CEO, DeepLook Medical
My biggest concern is related to women’s health and the questionable direction of our future. This is not simply reproductive rights (which is the start), it is the industry and women in general. We have finally started to gain momentum going into 2025 and are uncertain of the future and uncertain of investment and innovation in the sector. But I see continuing the momentum as our greatest opportunity. AI, technology, innovation, private-sector investment and support, and advocacy for the wins we can achieve are all within our power and we need to focus on moving forward, no matter what.
Adam Fine, founder and general partner, Windham Capital Partners
My biggest concern continues to be the challenging financing market, especially for clinical-stage medtech companies. Another concern generally has been a FTC that has been pretty aggressive in challenging deals. We expect this may improve as well in 2025, fostering a more active M&A market which will strengthen the financing market.
Andy Fish, president, Medical Device Innovation Consortium (MDIC)
Looking ahead to the coming year, it is critical to realize the benefits of advances in medical devices both quickly and equitably. MDIC continues to highlight gaps and solutions concerning equitable access, with our recent Annual Public Forum bringing a timely and provocative emphasis on inequities in women’s health. We also will work energetically to ensure implementation of our growing library of resources to create greater impact across the medical device ecosystem.
Sheryl Jacobson, Consulting Medtech Practice Leader, Deloitte
This is just an industry in a great deal of flux. It went from med device to medtech and now it’s figuring out the tech part of the business. Yes, it’s the product, but a lot of it is the data and the digital and the service models around it. It’s actually starting to resemble one of the tech companies that went from hardware to software. That is more what this industry is starting to look like and so that turmoil is going to continue through continued M&A as companies restructure. They are going to have to rethink global growth, because China has become a very different market than it was five or six years ago. It is not clear where Europe is going to go from a growth standpoint. I think the story of resiliency will be the story of 2025.
Christoph Massner, principal, Earlybird Health
Biggest Concern: The accelerating pace of innovation in medtech is exciting, but it brings heightened competitive pressures and the risk of fragmented adoption. Many promising solutions, particularly in digital imaging analysis, face hurdles in scaling due to regulatory complexity, data standardization challenges, and slow shifts in clinical workflows. Ensuring alignment between innovation and practical implementation will be critical.
Biggest Opportunity: Digital imaging analysis solutions are poised to redefine the medtech landscape. Companies like Elucid, HeartFlow, and Cleerly are challenging traditional imaging catheter markets, while platforms like Quibim and Perspectum are driving breakthroughs in therapy-informed diagnostics. With increasing reimbursement momentum, these technologies have the potential to fundamentally enhance diagnosis, treatment pathways, and patient outcomes, creating immense value for the entire ecosystem.
Marla Phillips, CEO and president, Pathway for Patient Health
With the new year occurring in such a short-term range, the advancement we make in any aspect will likely be small. Having said that, though, there is groundwork that can be laid to support more aggressive advances in the near future. For example, I believe our industry needs to increase its ability to pivot, its agility. Why? Covid shut us down, because we locked ourselves into boxes through very specific regulatory filings, through narrow windows of design space, through supply chains that were very fragile. My belief is that agility is increased when all employees can co-lead with every decision they make. The only way they can achieve this ability is if companies take the time to develop their employees. Development needs to take the form of teaching “why,” not just what and how. We currently prepare our employees to use their hands, but now we need to prepare them to use their brains. They can help identify ways to increase agility if they understand this as a goal, and understand the more holistic impact of the work they do and the area in which they can influence.
Deepak Sahu, managing director, Trinity Life Sciences
In 2025, the biggest challenge and opportunity will revolve around AI. AI offers transformative potential to enhance the efficacy, development lifecycle, and overall value of medtech products. However, the business models and ethical frameworks for AI’s use remain underdeveloped. This dual role of AI—serving as both an enabler of innovation and a source of uncertainty—will shape the industry’s direction. AI in medicine is a powerful tool, but its unregulated implementation could pose risks, requiring careful navigation of its opportunities and threats.
Steve Silverman, president, The Silverman Group
My first response featured an Airbnb in a missile silo, but that’s not helpful.
There are big changes coming to FDA, which definitely affect CDRH. So now more than ever, effective regulatory counsel is key. Part of effective counsel is knowing when to act and when not to – sometimes the best strategy is doing nothing. Plus, a lot of CDRH in 2025 will look the same as 2024. Even with a new FDA Commissioner, much CDRH blocking and tackling won’t change (think Q-sub meetings, device premarket review, and facility inspections).
A key caveat is health care access. This means device study and use that benefits underserved populations. Broad access is a hallmark of Dr. Tarver’s career, and this theme will show up in CDRH’s operations next year.
A brief note about Marty Makary, FDA’s likely next Commissioner. Makary doesn’t count as a “concern.” He’s a seasoned doctor and a well-published academic from a leading institution. Certainly, Makary holds strong views that traditionalists (like me) won’t fully support. But he operates from inside the tent. That means evidence and science-based decisions, not arguments about whether cow medicine cures Covid.
Scott Trevino, senior VP of cybersecurity, TRIMEDX
My biggest concern in the health care cybersecurity space is the increasing cyber-threats and the sophistication of bad actors behind them compared to the lagging health care industry as it pertains to cyber-resilience. That being said, I believe we turn this into our biggest opportunity by addressing health care cybersecurity with a combination of investment, improved legislation/regulation, and health systems’ adoption & investment in solutions that reduce risk and impact patient safety.
Susan Van Meter, president, American Clinical Laboratory Association (ACLA)
Reimbursement is a huge focus for us, and there’s a significant opportunity as well. There’s been a lot of momentum for making rational prior authorization requirements on so-called medical utilization management practices. So, we think there is a good opportunity for continued advancement of rational policy that doesn’t block patient access to services, and that allows providers to get paid for services delivered. We’re optimistic there. We’re moving in the right direction.
We know that it’s difficult to get Medicare payment legislation over the finish line. But we think the recognition of the importance of labs is going to help us move something forward, but we’ve got a lot of work ahead of us.
