Our dozen-plus experts from across the medtech sector agreed that 2024 was the year when AI went mainstream. They expect it to continue shaping the sector into 2025 and also hope for increased international harmonization, a more business-friendly US government, and increased investment.
What was 2024 the year of? What will 2025 be the year of?
Matt Burton, strategic development director, IMed Consultancy
In my line of sight, 2024 was the year that Artificial Intelligence as a Medical Device (AIaMD) crashed broadly into the public purview, touting a promise of early-stage diagnostics, critical decision-making support, and groundbreaking healthcare efficiencies.
I saw controversy erupt and I felt annoyed when Elon Musk encouraged industry to submit medical data to xAI’s chatbot (Grok) whist it covertly harvested patient data. This constitutes illegal practice in marketing nonregulated AI models; at the same time, it also yielded unsafe results.
Concurrently, President Donald Trump, after winning the 2024 election, set forward his plan to cut red tape, reduce departmental spending and indicated deregulation and restructure of the US Food and Drug Administration (FDA).
Clinicians and patients publicly endorsed AI’s potential as a disruptive new chapter in health care. Responsible regulators and industry experts began warning early adopters that unproven and unregulated technologies could result in significant patient harm. I strongly feel that AIaMD must be shown to meet a minimum standard of safety, performance, and efficacy.
I believe 2025 promises rapid innovation, requiring collaboration between regulators and industry to establish safeguards like regulatory sandboxes and guardrails. Jurisdictions that achieve a balance of regulation and fast track pathways will be the ones who will attract global investment, setting the stage for transformative healthcare advancements and large economic growth in those territories.
Ahmed Elmouelhi, president & CEO, TRiCares
2024 was a year marked by a number of cardiovascular technology breakthroughs, including in pulsed field ablation, transcatheter mitral valve replacement, renal denervation and transcatheter tricuspid valve replacement.
Some highs in the year included the first major approvals by the FDA for a number of cardiovascular therapies. 2025 will be an important year for demonstrating the proven value of these new therapies as they progress through advanced clinical studies.
Emily Elswick, president, Medtronic Pelvic Health
2024 saw more people getting comfortable discussing historically uncomfortable health topics. I’m excited to see how this continues to impact the future of urology and urogynecology, where there is significant need and a lot of room to reach more patients. I don’t know what 2025 will bring, but I do know that this is the place to be, and I’m energized by the potential for increased innovation and investment aimed at meeting the unmet need of millions of patients.
Kyle Faget, partner, Foley & Lardner
2024 was the year of AI in health care. Where AI was once used predominantly in the radiology space to sift through large swaths of imaging data, innovators and investors are now razor-focused on how AI can be used to streamline clinical care and support if not wholly undertake clinical decision-making.
Marissa Fayer, CEO, DeepLook Medical
2024 was the year of AI promises.
2025 will be the year of private sector investment in health care.
Adam Fine, founder and general partner, Windham Capital Partners
2024 was the year of the “recap,” 2025 will be the year of “recovery”.
Since the Fed started raising rates, the fundraising market has been challenging. There has been less capital to deploy, and it’s been a challenge to pull syndicates together, especially for companies without “AI” in their name and those that have yet to achieve key milestones and are burning significant cash. 2025 will see an improvement as the Fed has started to cut rates and the new Administration seems to be focused on growth.
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)
In 2024, medical devices advanced across areas such as glucose monitoring, surgical robotics, and wearables, with significant progress in technologies like pulsed-field ablation, renal denervation, and neurostimulation. Enabling technologies including artificial intelligence, remote monitoring, and medical extended reality are driving a transformation in which devices are increasingly connected in a revolutionary, data-rich ecosystem.
For 2025, we anticipate continued technology convergence that will increasingly focus on person-centric approaches. These innovations will deliver enhanced personalized care, incorporate patient perspectives, and support more equitable access. For the MDIC, this reinforces the importance of our work to advance the scientific and technical disciplines that enable technology innovation, improve evidence assessments, and drive the adoption of medical devices.
Christoph Massner, principal, Earlybird Health
2024 was the year of the possibility of generative AI; 2025 will be the year of proving the value of generative AI across multiple medical fields.
Marla Phillips, CEO and president, Pathway for Patient Health
2024 was the year of finding meaningful ways to use artificial intelligence. In other words, companies are realizing that you can’t just hire a data scientist, who will create an algorithm that can tell you something you didn’t know.
Companies are collaborating with each other and innovative service providers to see how best to implement artificial intelligence to speed the discovery of new therapies. Many new therapies are coming in the form of personalized treatments. This makes it difficult to recoup costs without having extremely high-priced treatments. So the use of AI to reduce these costs gives companies an opportunity to recoup research investments (especially if the AI can predict success rates at very early stages of clinical trials), and gives patients hope that they can afford the life-saving therapies that are being developed.
Additionally, I am seeing quality organizations find ways to use artificial intelligence to help find true root causes of failures, which will then prevent recurrence, and use AI to scan external intelligence as part of post-market surveillance. These advances decrease risk to patients by detecting and eliminating failures before they occur and before they cause harm.
2025 will be the year of increased harmonization across global regulators. With the Center for Devices and Radiological Health (CDRH) aligning its regulatory requirements with ISO standards, this opens the door for further harmonization. Industry will still be challenged with fledgling regulatory agencies that are cropping up around the world. Countries are creating their own regulatory bodies, and establishing regulations without much experience, and sometimes, intentionally creating discord with other regulators, like FDA. Why? To exert power, and to bring revenue into their country. This will be an ongoing challenge that industry must navigate. If industry does not figure out how to manage these one-off regulations, then it threatens the ability of these companies to implement changes that might be needed based on new intelligence, to increase the safety of their products, and/or to advance with the speed of innovation.
Deepak Sahu, managing director, Trinity Life Sciences
2024 was the year of a return to larger transactions, including Johnson & Johnson’s $13.1bn acquisition of Shockwave Medical and Boston Scientific’s $3.7bn purchase of Axonics.
2025 will be the year of more cross-border deals with increased focus on expanding into APAC and MEA regions. Hospital systems will further adopt payment-per-procedure business models for innovative yet capital-intensive technologies. While these models may increase procurement prices over the device’s lifetime, they will provide hospitals with better cost control, addressing ongoing cash flow constraints.
Steve Silverman, president, The Silverman Group
2024 was the year of
2025 will be the year of
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Scott Trevino, senior VP of cybersecurity, TRIMEDX
2024 was the year of first steps forward: Accepting the need for more effective regulation and/or legislation to address cyber-risks.
2025 will be the year of accelerating actions: Implementation of cyber-risk reduction efforts and increased investments in healthcare cybersecurity.
US Food and Drug Administration
In 2024, CDRH remained steadfast in our commitment to further advancing innovative, safe, and effective medical devices and safe radiation-remitting products. As CDRH heads into 2025, we will continue to keep the people we serve at the core of our mission as we carry out our statutory responsibilities to protect and promote the public health with a focus on continuing to advance medical device safety and innovation.
Susan Van Meter, president, American Clinical Laboratory Association (ACLA)
For 2024 I think it was the recognition of the importance of innovation and how critical that diagnostics are to personalized medicine, to ensuring patients that we are doing the best that can possibly be done for them, like delivering the latest technology.
There has been an increasing bipartisan awareness that if we want to have a clinical laboratory infrastructure that is strong, that is delivering to patients the testing they deserve, that is allowing for investment and innovation, then long term reform has to happen. So that increasing recognition of the general importance of laboratory diagnostics and how innovation is essential to advanced patient care, to improving and saving lives, that’s been a thematic high point for us.
And for 2025, I think there will be increased awareness among policymakers of the importance of diagnostics and that regulation must be appropriate to ensure patient access and innovation. I think we’ll see policy advance to support that. We are looking forward to working with the new administration to roll back the LDT rule and looking forward to working with Congress on diagnostics legislation.
