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Wara Samar

24th September 2024

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. 

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. 
 

Yulia Yurevich, Head of Clients Relations and Partnerships at MedTech World, expressed her enthusiasm for Ulmer’s participation: “We are honored to have Kwame Ulmer return to Malta as a keynote speaker this year. His expertise in both US and EU regulatory frameworks, along with his deep industry knowledge, will provide critical insights for MedTech startups and established businesses alike. Beyond his professional excellence, Kwame is a truly outstanding person, which is just as important when selecting the right industry partner. We are proud to collaborate with MedTech Impact Partners as our trusted regulatory partner for this conference and beyond.” 

Why does FDA Clearance Matter?

FDA clearance is crucial because it provides a reasonable assurance of a medical product’s safety and effectiveness, confirming it meets stringent regulatory standards. It allows products to be legally marketed in the U.S., the largest healthcare markets, and boosts confidence among healthcare providers, patients, and investors. This clearance not only provides a competitive advantage but also reduces legal risks, as non-compliant products can face fines, recalls, or lawsuits. Additionally, FDA clearance often serves as a benchmark for international markets, helping companies expand globally while maintaining high standards of quality and safety. 

Why Choose MedTech Impact Partners? 


Choosing MedTech Impact Partners (MIP) is a strategic decision for MedTech companies seeking to navigate the complex regulatory landscape of the FDA. MIP offers deep expertise with over 50 years of combined experience in regulatory strategy, FDA communications, and compliance management. They guide companies through critical milestones, helping them address potential gaps in submissions, assess risks, and streamline the approval process. 

FDA Approval: No Cakewalk 

The FDA approval process is notoriously difficult, as it requires rigorous testing and detailed submissions to ensure that medical devices meet safety and efficacy standards. Companies face numerous challenges, including developing proper documentation, preparing for FDA meetings, and addressing feedback from regulatory officials. The time and resource investment is significant, and missteps can lead to delays or rejections, increasing costs and time to market. 

MIP helps alleviate these challenges by offering tailored regulatory solutions, reviewing FDA responses, and preparing companies for crucial interactions with the FDA. Their expertise ensures that submissions are thorough and compliant, reducing the risk of rejections and helping companies reach regulatory milestones faster. This support is invaluable, especially for early-stage MedTech firms, as it allows them to focus on innovation while MIP handles the intricacies of regulatory compliance 

Join Us in Valletta, Malta: November 6-8, 2024 

MedTech Malta 2024 promises to be a landmark event, bringing together pioneering startups, leading investors, and top-tier professionals from the medical technology sector. To be held in Valletta from November 6-8, this global summit is an opportunity to engage with the brightest minds in healthcare innovation. Don’t miss out on shaping the future of MedTech

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