By Vernessa Pollard, FDA Practice Leader and Co-Chair, Global Life Sciences Industry Practice, McDermott Will & Emery LLP
I joined MedTech Color as a founding member to support its mission of advancing representation in the medtech industry through community-building and thought-leadership, and to promote equitable clinical trial enrollment for patients from underrepresented groups.
Many stakeholders in medtech believe that inclusivity should start long before the first visit to the doctor’s office. Social determinants of health impact everything from access to clean drinking water, healthy food, access to routine health screenings, to access to appropriate medical care. Most of the medical technologies we rely upon to diagnose and treat an increasingly diverse population of patients are not developed with clinical trial data that include representative numbers of BIPOC and other historically marginalized patients groups. To achieve health equity and improve health outcomes, we need more diverse and inclusive product development and clinical research strategies, including the elevation and acceptance of real world evidence and policy making to enable broad participation of these patients in clinical research.
Last year we launched the Collaborative Community: a forum where medtech professionals and other stakeholders can work together to address these pervasive issues. We believe that together, we can shine a light on inadequate diversity in the industry and begin to heal the divisions that contribute to it.
Our organization aims to build a cohesive community of leaders of color in medtech. We are furthering the scope of our mission to encompass minority health issues in medical device product development and clinical research. In June of 2021, we kicked off the first Collaborative Community meeting and developed four subcommittee workstreams:
In July, we convened the first subcommittee meetings with the FDA and NIH participating in various workstreams, including 50 members from more than 25 organizations across the medtech ecosystem. In October 2021, the Collaborative Community participated in the FDA Town Hall, an event attended by over 900 FDA employees as well as members of 11 additional Collaborative Communities. Just a short month later we held our first webinar event on Nov. 11, 2021: Demystifying Clinical Trials: Engaging Patients and Communities of Color in Clinical Research. This event, produced by the Recruitment and Retention SubCommittee, focused on the challenges and importance of diverse representation within clinical trials. The webinar had over 120 attendees including patients, industry researchers, and regulators.
Over the next year, the Collaborative Community has some exciting initiatives planned by each subcommittee. The Disease State Awareness Subcommittee recently hosted a focus group about healthcare access for Black females, specifically those with cardiovascular disease. Also, the Evidence Development SubCommittee led a Virtual Panel Discussion in conjunction with the American Medical Association on the AMA Physician Innovation Network. This panel titled ‘Improving and Diversifying Evidence: Engaging Patients and Communities of Color in Clinical Research and focused on exploring how women have historically been underrepresented in clinical research.
In Q2 the Product Development and Clinical Research Subcommittee will be continuing a webinar series with leading experts who are transforming healthcare across medtech. The first of the series took place on February 22, 2022: Product Development and Clinical Research – Learning to Design with Diversity and Inclusion in Mind; A Fireside Chat with Leading Experts Transforming Healthcare Across MedTech. The discussion focused on best practices to ground product design considerations around the unique needs of end users. Following their first event for the Collaborative Community, the Recruitment and Retention Subcommittee will develop a repository of resources,guidelines, and other sources of best practices on the recruitment and retention of BIPOC subjects and investigators in medical device clinical investigations.
This community has become a catalyst for thought-leadership and engagement on critical issues of diversity, equity, and inclusion in medtech. We are grateful for the tremendous commitment, input, and dedication of the members of the Collaborative and we are excited to see what comes next! The future is bright for the Collaborative Community to broaden the impact on patients and begin to close the gap in health care disparities through innovative and informative messaging, action, and engagement. Our members are critical to accomplishing the long- and short-term goals of the community.
To date, the MedTech Color Collaborative Community has 55 members across 25 organizations within the medtech ecosystem and we are always looking for more collaborators. The community is open to all who work in the medtech industry or other healthcare fields and wish to join. This includes representatives from the FDA, NIH, and CMS, industry and academic organizations, investors and VC firms, patient groups, payers, and healthcare organizations, professional organizations, and our sponsors. We encourage participants to attend virtual meetings and provide input on how we can overcome health equity obstacles within medtech together.
Vernessa Pollard is FDA Practice Leader, Co-Chair Global Life Sciences Practice, McDermott Will & Emery LLP. She provides strategic business and regulatory advice to FDA-regulated companies on complex issues related to the development, manufacture, marketing, post-market safety and compliance for FDA-regulated products, including medical devices and digital health technology. Vernessa counsels companies on product development and pre-market strategy, corporate compliance programs and regulatory due diligence in mergers and acquisitions. She is a former Associate Chief Counsel for Enforcement in FDA’s Office of Chief Counsel and has been recognized in numerous Law and Life Sciences publications, including Chambers USA 2014 to 2021, Healthcare: Pharmaceutical/Medical Products Regulatory (DC) and LMG Life Sciences, Regulatory Attorney of the Year: FDA Medical Devices, 2018 and 2020. Vernessa received her B.A. in Communications from Howard University and her JD from Temple University School of Law.