Kwame Ulmer from MedTech Impact Partners to Deliver Keynote at MedTech Malta 2024
Each year, the world’s leading medtech and healthtech innovators, experts, and investors converge at MedTech Malta, setting new standards for the industry. MedTech Malta 2024 promises to be no exception, and among the distinguished keynote speakers is Kwame Ulmer, Managing Partner at MedTech Impact Partners, who will share his insights and expertise on the global stage. With a distinguished career spanning over two decades in digital health, cardiovascular care, and ophthalmology, Ulmer has played pivotal roles, including serving as Deputy Division Director at the FDA and Vice President of Regulatory Affairs/Quality Assurance at Fortune 150 company, Danaher. His extensive background in both the public and private sectors positions him as a leading voice in MedTech innovation.
Key Insights into Global MedTech Trends
Ulmer’s keynote builds on his 2023 address titled Future Proof Your Global Company, which explored crucial industry topics such as investment trends, regulatory shifts, and strategies for companies aiming to enter the U.S. market from Europe. His talk at MedTech Malta 2024 will dig deeper into these areas, offering attendees a comprehensive look at the evolving challenges and opportunities within the MedTech sector.
Kwame Ulmer, said, “As the MedTech industry continues to innovate, one of the greatest challenges remains balancing rapid technological advancements with regulatory and reimbursement frameworks. Understanding both the U.S. and European systems is critical for companies looking to scale effectively across borders.”
Parallels Between U.S. and EU Regulations
Ulmer’s 2023 keynote highlighted the growing alignment between U.S. and European regulatory frameworks. He noted that while Europe has developed a robust system ensuring device safety and efficacy, the main obstacle lies in harmonizing reimbursement processes with the fast pace of digital health advancements. Recent developments at the FDA, including new guidelines for the 510(k) pathway, reflect ongoing efforts to streamline regulatory pathways. However, Ulmer emphasized that reimbursement remains the top challenge for MedTech companies navigating global markets.