A nonprofit seeking to increase medtech's diversity, MedTech Color, has shared its accomplishments during the prior year and its future goals to increase diverse stakeholders. The organization, which was formed in 2018, has set its sights on increasing the number of African Americans and minorities in executive and decision-making roles in medtech. Greater diversity is expected to influence device design, clinical trial design, and engagement to equitably serve all medical communities.
Currently, the medtech industry is not particularly diverse with less than a quarter (21%) of executive roles held by women and only 3.2% of leadership positions occupied by African Americans, according to a survey of member companies by AdvaMed.
FDA’s Jeff Shuren, MD, director of the Center for Devices and Radiological Health, noted the importance of diversity in device creation.
“These collaborations with diverse stakeholders are not only a strategic priority for the FDA’s Center for Devices and Radiological Health, they also provide much needed forums for deep discussion and solution-driven initiatives to tackle important issues within the medical device ecosystem," Shuren said. "The insights and outcomes developed by these groups will have long-standing impacts on public health.”
Missed opportunities with narrow patient view
The lack of diversity in medtech has serious implications, according to Nada Hanafi, chief strategy officer, Veranex, collaborative community executive planning committee of MedTech Color, who highlights personal experience as a driver in device development. Not having diversity in medtech “leads to major missed opportunities and continues the cycle of health inequities. Lived experiences are critical to informing the development of meaningful medical technologies that address unmet needs.”
“Thought Leadership that champions the development of medical products and innovations that target the unmet needs of racial and ethnic groups, can go a long way to moving us toward equitable health,” Hanafi said. “These [minority] groups are disproportionately impacted by diseases such as cardiovascular disease, diabetes, devastating maternal health outcomes, obesity, just to name a few. Political constructs drive the social determinants of health, so we need to change the landscape to be more representative of our society.”
Medical devices can improve inequalities in healthcare through its approach to research and development. This is because focusing on a certain demographic rather than the whole potential patient population can lead to failures in patient use of a device. This can be due to not including all populations in research and data analytics, Hanafi said.
“With the advancement of digital technologies and the use of AI and machine learning, many of the algorithms are developed, trained, and validated using a non-representative patient data set, and as such are not applicable for use in the general population," Hanafi said. "So, the technology/therapy/diagnostic could be a powerful innovation but will result in poor and unreliable outcomes when used in the broader patient population. When devices are not developed with the end-user in mind and further not tested on the intended patient population, there is a propensity for them to not work safely and effectively.”
Diversity as driver in development
Similarly, having diverse voices involved in strategy, research, and development broadens the approach to device platforms, device design, and clinical trial design. An exclusive group of executives and researchers runs the risk of missing out on reaching some patient groups, and related return on investment, Hanafi said.
“Representation among clinicians from underrepresented groups is important to provide informed perspectives on disease progression,” said Hanafi. “Insights from clinicians who have a clear line of sight regarding the nuances of disease progression within underrepresented populations are important to understanding and characterizing the potential clinical benefits of products under development. That perspective is critical to appropriate trial design. A key step in having more diverse clinical trial populations is having more diverse researchers. An important step for both objectives is to build relationships with the clinicians who work in those communities.”
MedTech Color's 2021 accomplishments and 2022 goals
MedTech Color is working toward efforts to diversify stakeholders throughout the device process and lifecycle. Some of these efforts were noted in the group’s Collaborative Community annual report which marked its accomplishments to date and its forward-looking plans for years to come. In 2021, the group created subcommittee workstreams focused on areas related to unmet medical needs among minority patient populations, including understanding disease states in populations, clinical research recruitment and maintenance, research and development of products, and minority health needs currently underserved.
In 2021, MedTech Color took part in a Collaborative Community FDA town hall meeting and hosted community events to discuss increasing access and inclusion in clinical trials. Into this year, outreach efforts have continued, including highly-targeted and deep-dive focus groups with underrepresented patients, panel discussion with the American Medical Association on reaching out to patients for greater diversity in clinical trials, and a 2,000-respondent survey on clinical trial impressions to create an action plan.
“MedTech Color aims to help build a community of leaders of color in the medical device industry and drive thought leadership,” said Hanafi. “We want to reach this goal by being the destination and catalyst for professional development, thought leadership, and increasing the number of underrepresented executives who enter, stay, and contribute to the medtech industry.”
Click below to listen to MD+DI Editor-in-Chief Omar Ford's conversation with Kwame Ulmer of MedTech Color on Let's Talk Medtech.