From regulations to technology to market dynamics, 2024 was a year of change for the device sector. We asked 14 experts from industry, regulation and other stakeholders to tell us which changes were welcome, and which they’d like to leave in the past.
What were the high and low points of 2024 for medtech?
Matt Burton, strategic development director, IMed Consultancy
In 2024, IMed Consultancy expanded UKRP Services, joined the UK Responsible Person Association (UKRPA), and opened a new EU Authorized Representative (EUAR) office in Ireland. Demand for Person Responsible for Regulatory Compliance (PRRC) services grew, and we helped many clients maintain legacy status.
Helping innovators bring their new technology to market is a part of IMed’s fabric, and I find it deeply rewarding. However, it was disheartening to see promising technologies miss out on the CPI medtech accelerator program. It closed after just nine days, 42 days early. We urged applicants not to delay but to act decisively.
2024 posed significant challenges for medtech, especially with double deadlines for legacy status. Unresponsive EU Notified Bodies (NBs) and excessive fees led to established, safe, and effective devices being withdrawn from the market. Some clients faced NB fees 2.2 times higher than those published under MDR and IVDR, along with admin charges exceeding €1000/hour (~$1,039) just to chase absentee scheme managers. This was unsavory behavior and contrary to the spirit and intention of the new EU regulations.
But 2024 was a wonderful year for me personally. I continued to expand my network, and I was surrounded by innovative thinkers and amazing clients, together we managed to overcome some very tough regulatory hurdles. I learned something new every day.
Emily Elswick, president, Medtronic Pelvic Health
One 2024 highlight was seeing the American Urologic Association (AUA) update its guidelines for overactive bladder (OAB), putting a greater emphasis on treatment based on each patient’s unique situation compared to the traditional stepwise treatment approach. The updates suggest Sacral Neuromodulation can be used earlier in the treatment continuum and recognize implantable tibial stimulation, an exciting new way to treat OAB that Medtronic is currently exploring through an IDE clinical trial!
Kyle Faget, partner, Foley & Lardner
I think the high point for medtech has been FDA actively engaging with AI/ML medical devices. In the first half of 2024 alone, FDA approved 107 AI-powered medical devices. Additionally, FDA just released its final guidance re: predetermined change control plans (PCCPs) for devices that utilize artificial intelligence-enabled software functions. Although consistent with its draft guidance from April 2023, the final guidance is broader in scope and now includes all AI-enabled devices instead of ML devices only.
A potential low point for industry (or high depending on your view) was FDA’s release of its final rule phasing out enforcement discretion of laboratory developed tests (LDTs). There is a lot of concern about the burden this new oversight will place on LDT developers and there exist concerns that much needed LDTs won’t get to market in a timely fashion – or ever, in some cases.
Marissa Fayer, CEO, DeepLook Medical
AI is both the high point and the low point of 2024. It has the ability to equalize, accelerate, and facilitate better medtech innovations but it has been overhyped and overpromised in 2024. There has been the pendulum swing from incredible to disappointing in roughly 6-8 months, which is simply because most people don’t understand the capabilities and the value of AI at this stage.
But one high point is certainly, and finally, the focus on women and women’s health. The White House Women’s Health Coalition task force was created (which I was honored to be part of); more open discussions about women in menopause on a public stage from both the media and conferences; investors starting to get more comfortable investing in women’s health as non-women’s health investors started to invest in women’s health; and the general discourse around women has certainly started to build in momentum.
Adam Fine, founder and general partner, Windham Capital Partners
While M&A was at a low point earlier in 2024, activity has improved throughout the year and total M&A is expected to surpass 2023. There were several large transactions, reflecting a continued need for strategics to acquire companies and new technologies to grow their top line. For instance, J&J bought Shockwave and V-wave, Boston Scientific acquired Silk Road Medical and Axonics, and BD bought Edward’s Critical Care business for more than $4bn.
Andy Fish, president, Medical Device Innovation Consortium (MDIC)
MDIC made significant strides in 2024 by continuing to foster collaboration among regulators, payers, patients, clinicians, researchers, and other key stakeholders. One standout initiative is the work of our National Evaluation System for Health Technology (NEST), which is advancing the development of real-world evidence to support regulatory submissions. In the area of quality manufacturing, we launched the Advanced Manufacturing Clearing House, creating case studies to drive transformation in manufacturing, alongside initiatives like our Accelerate Sustainable Capability Program Pilot Study.
At our annual Patient Summit, we showcased how Patient Preference Information (PPI) is reshaping medical device development, reinforcing the importance of patient engagement at all points in the medical device lifecycle. Additionally, we celebrated a decade of progress in our Early Feasibility Studies (EFS) program, which continues to streamline the path from early clinical insights to pivotal trials. Furthering our efforts to connect with payers, we introduced the Commercial Payer Council to deepen stakeholder understanding of how coverage decisions are made for medical devices.
Sheryl Jacobson, Consulting Medtech Practice Leader, Deloitte
It is clearly an industry in a significant state of flux – meaning, you’re coming out of COVID, your health care provider has significant margin issues, your clients have margin challenges. You got hit very, very hard by inflation and you had to absorb it, because you couldn’t pass it on to your clients, and then you’re doing this portfolio structuring. It was a year of the best of times and the worst of times without a clear high and a low, just a lot of turmoil and change. For 2025, that is absolutely going to continue.
Christoph Massner, principal, Earlybird Health
The Highs
On the upside, pharma, and medtech incumbents are heavily investing in generative AI, with early proof of new business models emerging and encouraging progress in reimbursement—signaling a pivotal shift toward innovation and scalability.
The Lows
The wave of bankruptcies among public digital health companies like Akili, Babylon, and Forward Health has been a significant setback, revealing the unsustainability of many current business models and shaking confidence in the sector and in private markets.
Marla Phillips, CEO and president, Pathway for Patient Health
The Highs
From a US perspective, I think the shift in 1st-in-trials occurring in the United States is a great win. We had been favoring the EU and other countries due to the long cycle time of gaining approvals in the US. This was moving the availability of innovative treatments to other countries and delaying access to Americans. I know this had been an issue for many years, so the changes that have occurred to create this shift is a “high”.
As stated previously, having CDRH shift to align with international standards is a high that will pave the way for further harmonization. This lowers the hurdle for companies to launch products in many countries that previously had their own specific requirements.
The Lows
In my opinion, the failures of clinical trials related to the development of Alzheimer’s therapies were a low. There is a tremendous need to combat this disease, along with Parkinson’s and others. I am hopeful that AI in R&D can help speed the development of successful therapies.
Another low is the lack of progress being made such that companies can use AI through digital twins in the development of specifications. Regulators are not comfortable with the industry’s ability to demonstrate the credibility of the outcomes. We have to make advances in this space, and it will require industry and regulators to work collaboratively, so they both learn at the same pace.
Deepak Sahu, managing director, Trinity Life Sciences
A key high point for 2024 was the successful mitigation of the perceived threat from GLP-1 drugs on medtech revenue. Through strategic clinical and business initiatives, industry leaders effectively offset concerns and maintained growth trajectories.
On the downside, Medicare payment reductions posed a significant challenge. The Medicare Physician Fee Schedule (PFS) conversion factor dropped by 3.4% from $33.89 in 2023 to $32.74 in 2024, leading to reduced physician reimbursement. Outpatient occupational therapy services saw a 3.1% decline, and home health agencies face proposed cuts of up to 7% in coming years. Despite partial relief through legislative actions like the Consolidated Appropriations Act, the cuts underscored financial pressures on providers, marking a major low point for the year.
Steve Silverman, president, The Silverman Group
The Highs
Michelle Tarver’s choice as the new CDRH Director
I previously predicted that it would take a year to pick a new CDRH director and for him or her to settle in. I was wrong and that’s a good thing. In late October – only months after past CDRH Director Jeff Shuren announced his departure – the FDA chose Michelle Tarver as the next CDRH director.
Dr. Tarver is a CDRH veteran who partnered with Dr. Shuren to develop and launch innovative CDRH programs. Now she runs the device center, helping to assure that these programs take hold. With the tumult around the election, CDRH needs a steady hand at the helm.
Finalization of the Quality Management System Regulation (QMSR)
The QMSR harmonizes FDA’s device-quality regulations with the leading international standard. That’s good for device makers; instead of two parallel regulatory frameworks, now they can follow a single model. Plus, the single model is a lot like FDA’s old framework, making the QMSR transition easier. Still, there are many moving parts, so the QMSR won’t go live until February 2026.
The Lows
FDA is sued for laboratory developed test (LDT) regulation
Fights over whether FDA can regulate LDTs are evergreen. Last summer, after FDA proposed a rule governing LDTs, a lab coalition sued the agency. That suit is ongoing, but the incoming Trump administration may make it moot. In his first term, Trump directed FDA not to regulate LDTs. When he takes office again, a similar directive is likely – meaning no FDA LDT oversight unless there’s intervention by Congress or a later administration.
The New York Times “exposes” Jeff Shuren’s conflicts of interests
In August, the NY Times reported that Allison Shuren, former CDRH Director Jeff Shuren’s wife, co-leads a law firm’s FDA practice. The Times also reported that, about a decade ago, Shuren may have participated in matters from which he should have recused himself. There’s no evidence that Shuren acted to benefit his wife or her firm.
It’s widely known that Allison Shuren is an FDA lawyer. It’s equally well known the lengths to which she, her firm, and her husband go to assure zero undue influence. Were there a few times when Shuren departed from ethics regulations? Possibly. Did he put his thumb on the scale to benefit his wife’s clients? No way.
The Times article is troubling. It conflates allegations that, even if true, show no improper influence. Whether you approve of Jeff Shuren or not (and there are plenty of both), he deserves better treatment.
Scott Trevino, senior VP of cybersecurity, TRIMEDX
High points include increasing awareness around the significant challenges the health care industry faces regarding medical device cybersecurity; as well as the introduction of legislation, standards, guidance, and executive orders related to healthcare cybersecurity (e.g., Cassidy-Baldwin bill, Warren-Markey bill, talk of rural health funding for cybersecurity).
Low points include a significant impact of ongoing cyberattacks (e.g., financial, access to care, contributing to closure of some hospitals); and even though the robust dialogue around health care cybersecurity continues, minimal action or change has occurred to improve matters plus unfunded mandates continue to be a challenge.
Susan Van Meter, president, American Clinical Laboratory Association (ACLA)
Both have been the challenge of the FDA final rule on LDTs — the inappropriateness of it, the illegality of it, and how it’s not the right thing for patients. What we see in engaging with policy makers is an increasing understanding of the importance of clinical laboratory diagnostics, that they are foundational to inform decision making. There is a bipartisan understanding, for example, that that the FDA final LDT rule is the wrong direction for the advancement of innovation. That’s very clear. And that’s been a bipartisan response.
