Here are 3 trends we expect to see in 2025:
It’s no surprise that AI will continue to be a popular topic, as we saw a number of articles and conference sessions in 2024 speaking to how AI can be a catalyst for innovation in healthcare. Regulatory use cases may expand to include using generative AI to summarize information in the AI Act, classify medical devices, or even draft a submission. With the right technology partner to develop, test, and support generative AI solutions, medtech companies can enhance human expertise while nurturing vital skills.
However, industry experts also caution against blindly trusting AI outputs that can be prone to “hallucinations” or are limited by data availability and quality. Instead regulatory teams should be careful to consider factors like potential fit, operational efficiencies, and associated risks.
This year, both regulators and manufacturers alike discussed ways in which they are ensuring everyone has fair and equal access to healthcare. The CDRH shared that they are committed to advancing health equity initiatives, striving to ensure all populations have equitable access to medical technologies that work for them, regardless of race, sex, geographic location, or other factors. Future focus areas may include leveraging the home as a health care hub and addressing accessibility of digital health technologies for patients in remote locations, with lower literacy levels and fewer resources.
Manufacturers like Medtronic also highlighted programs to challenge disparities, especially as they relate to women’s health. For example, Medtronic launched an initiative to better understand transfemoral transcatheter aortic valve replacement (TAVR) in women, who tend to have smaller heart valves than men. They hosted the largest ever TAVR randomized control trial to enroll primarily women (87% of participants) across 80+ global sites and saw excellent patient outcomes.
As the industry navigates complex regulations, there are opportunities for medtech leaders, clinicians, and regulators to collaborate on innovative solutions. Harmonization efforts can also play a key role in ensuring that critical treatments are available across multiple regions. By streamlining regulatory submissions with common formats, terminology, and templates organizations can conserve resources, which is a win-win for regulatory bodies and the industry.
To stay on top of the latest trends and learn from industry experts, register for the Veeva MedTech Summit in Austin from April 28-30, 2025.