MedTech

The combination of rapid development in healthcare technology and increased consumer demand for tech-enabled care is continuing to fuel innovation in the MedTech industry. Whether it’s digital health, wearables, and AI-driven offerings in healthcare, or diagnostics, telemedicine, and health IT solutions, there is no shortage of innovation at the intersection of technology and life sciences. We are seeing increasing deal volume in MedTech M&A around the world, as COVID-19 related revenue enables MedTech acquirors to add assets and consolidation trends continue in the digital behavioral health and health IT markets. Innovators adopting a global approach to the development and commercialization of their MedTech offerings continue to face a patchwork of laws, regulatory guidance and ethical quandaries across the world, as evidenced by some of the key trends in Q2 and associated legal considerations.

Focus on Increasing Diversity in Clinical Research

Despite being disproportionately affected by certain diseases, racial and ethnic minority groups are frequently underrepresented in clinical research. The MedTech Industry is working to provide technologies and tests that result in accurate diagnosis of disease and improved patient outcomes across all populations. Recently, Pfizer and Headlands Research announced a partnership to open research sites in diversely populated areas, and Abbott and Women as One launched a new program to train underrepresented physicians to pursue clinical trial research and to help recruit clinical trial participants from historically underrepresented groups. In parallel, we are seeing increased interest from regulators to boost participation of diverse populations in clinical trials, as evidenced by the US FDA’s draft guidance for product manufacturers on how to develop diverse recruitment plans for clinical trials early in the drug development process. Because different people may have different reactions to the same treatment based on their age, gender, race, ethnicity and other factors, clinical trials must include a diverse pool of participants so that everyone can benefit from the latest scientific advances. Without diverse data inputs, resulting analyses may be biased, leading to potentially inaccurate conclusions and other consequences. As regulators and innovators increasingly acknowledge the problem of underrepresentation in clinical research, MedTech companies may consider leveraging technology-enabled tools and practices, such as decentralized clinical trials and digital endpoints, to help boost clinical trial diversity.

FemTech  

The U.S. Supreme Court’s decision to overturn Roe v. Wade may serve as a catalyst for consumer health tech adoption for reproductive care. FemTech companies such as Maven Clinic and Hey Jane are expanding their virtual fertility and pregnancy, telemedicine and other services to patients. At the same time, FemTech companies need to consider how their data collection and tracking practices may trigger privacy and security concerns among their patients and the wider public.  The Female Talent for Tech team at Freshfields recently hosted a global MedTech-focused event featuring Shannon Klinger, CLO of Moderna and President of the Moderna Foundation. The event brought together women from the healthcare and technology sectors to discuss, among other topics, the key issues facing FemTech and other healthcare technology companies in today’s rapidly evolving digital health landscape.

Launch of European Health Data Space

The European Commission recently launched the European Health Data Space (EHDS), which will allow individuals to access, and make certain decisions with respect to, their health data in any EU member state. The EHDS will also provide a legal framework for the use of health data research, innovation, policymaking and regulatory activities. Data holders, such as healthcare providers, must make certain electronic health data available for secondary use by data users, who must meet obligations with respect to data anonymization and pseudonymization, security, and publication. MedTech companies operating in Europe will need to assess the impact of the EHDS on their data use and sharing practices while navigating the emerging patchwork of rules governing health data, including the interplay between this latest proposal and other data legislation, including the GDPR, Medical Device Regulation, Data Act and AI Act. We expect MedTech companies to invest in data-related infrastructure, work collaboratively to address existing barriers to data sharing, and advocate for the adoption of international interoperability standards. Learn more about the European Commission’s EHDS proposal.