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Health Equity Forum Podcast: Episode 11 - Transcript

RDML Richardae Araojo: Hello! And Welcome to the Health Equity Forum Podcast. I’m Rear Admiral Chardae Araojo, the Associate Commissioner for Minority Health and Director of the Office of Minority Health and Health Equity (OMHHE) in the Office of the Commissioner at the U.S. Food and Drug Administration (FDA). I’m joined today by Dr. Jeff Shuren, who has been Director of the FDA Center for Devices and Radiological Health, or CDRH, since 2010. I am especially glad that Dr. Shuren is joining us for this episode, which is part of our observance of National Minority Health Month this April.

This year’s theme for National Minority Health Month is Better Health Through Better Understanding, and I want to thank you, Jeff, for taking the time to join us today to help the communities we serve learn more about the important work CDRH is doing, and your work to advance health equity.

So, Jeff, as we recognize National Minority Health Month, of course, health equity is a foundational topic. I’d like to get your overall thoughts on the promise of new technology to improve health and our long-standing challenges in working to achieve health equity.

Dr. Jeff Shuren: You know, Chardae, putting patients first is an empty promise if it only applies to some and not all. No person should be left behind in health care. Technologies, including digital health technologies, can help bridge that divide while advancing better health care, quality of life, and wellness for all; and should be designed and targeted to meet the needs of diverse populations. Global and domestic populations that continue to suffer overall from the digital divide, such as those living in rural communities or in poverty, have often experienced better outcomes when the digital health technologies are made available to them. 

Digital health technologies can also help bridge the gap by bringing health care directly to patients wherever they are – at home, at work, at school, whether they be in cities or in rural communities – and can facilitate the participation of all populations in clinical studies. It can also accelerate the collection of critical public health data, without a compensatory increase in the burden on patients or the health care system.

RDML Araojo: Thank you, and I know how important this is for you and the team at CDRH. Can you tell us about what CDRH hopes to accomplish related to health equity and the development of new technologies? 

Dr. Shuren: Well, we’re fortunate at CDRH because we’re uniquely positioned to advance the development of high-quality, safe, and effective technologies to meet the needs of all patients and consumers and the information necessary for different populations to make well-informed decisions about whether and how to use them. As part of our 2022 to 2025 Strategic Priority to Advance Health Equity, CDRH has set the following four objectives, to:

• Empower people to make informed decisions regarding their health care;
• Facilitate availability of and access to medical technologies for all populations;
• Reduce barriers and increase opportunities for participation by diverse populations in evidence generation; and
• Support innovation of emerging and existing technologies that address health equity by changing health care delivery to move care and wellness into the home setting.

And we know that to achieve these objectives, it’s important for us to partner with patients, health care providers, industry, and payers to advance solutions that promote equity along the total product life cycle of medical devices, including access to care. 

RDML Araojo: I think it’s so critical to emphasize the importance of those stakeholders, especially when it comes to CDRH’s work around medical devices. Digital technology has played a great role in addressing those disparities too, right Jeff? How are these technologies helping?

Dr. Shuren: Well, right. Fundamental to accomplishing this goal is ensuring medical devices are designed and targeted to meet the needs of diverse populations. CDRH is working to support innovation of technologies that address health inequities, as illustrated in the draft guidance update on the Breakthrough Devices Program. This select update, while still draft, explicitly states how the program may be applicable to certain medical devices that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions in patients impacted by health and/or health care disparities. 

Digital health technologies can help bridge the health care gap, by bringing care directly to patients, wherever they are as well as to facilitate the participation of all in clinical investigations, particularly people historically under-represented in clinical studies. In addition, CDRH is collaborating with the other medical product centers in FDA on the omnibus provisions related to diversity action plans. These plans hold the promise of fostering the generalizability of medical device clinical trial data to the very populations for whom they are intended. 

Wearables and sensors can also increase the ability to collect data that can be used as evidence to support medical device evaluation outside of the traditional clinical setting.

RDML Araojo: And of course, artificial intelligence or AI is just the latest technology that appears to be changing the conversation.

Dr. Shuren: Well, you’re right, it is. Increasingly, software enabled by artificial intelligence/machine learning is being integrated into clinical care. It’s important the data on which the software is being developed is reflective of the U.S. population that will be using that technology. In fact, CDRH posted an action plan that specifically acknowledges the importance of transparency to help promote health equity. 

Additionally, it’s critical that patients and health care providers trust the information used to develop and evaluate medical devices, as well as their output. CDRH will work to provide clear, accessible information in plain language that better informs people’s decisions about their health care, quality of life, and wellness.

Our efforts include addressing how we disseminate information through the technologies people already use, as well as building awareness to empower consumers to be well-informed when they make health care choices.

RDML Araojo: Those are excellent points. So how does CDRH work to reach diverse communities and build that trust?

Dr. Shuren: Well, these efforts cannot be done in isolation but require collaborative approaches. CDRH participates in a number of Collaborative Communities that are working to address health inequities. For example, the MedTech Color Collaborative Community on Diversity and Inclusion in Medical Device Product Development and Clinical Research is focused on working together to advance the representation of persons of color in medical device product development and clinical research. This community, like others in which CDRH participates, brings together patient organizations, health care providers, industry, researchers, payers, and others to solve shared challenges in a holistic manner. 

RDML Richardae Araojo: Thank you, Jeff. My office is also glad to be able to participate in the MedTech Color Collaborative Community and engage in its work on diversity and inclusion. I also want to thank you for your leadership and CDRH’s commitment to advancing health equity and for joining us today. Is there anything else you’d like our listeners to know? 

Dr. Shuren: Chardae, I’m glad to have the opportunity to join you on the Health Equity Forum, especially to stress how important digital health technologies can be to bridging the divide and advancing health equity. I also invite your listeners to visit the CDRH website to learn more about our ongoing work to assure that when it comes to health care, quality of life, and wellness, no person is left behind.

RDML Richardae Araojo: Thank you again, Jeff for sharing such critical information on the important work of CDRH. That does it for this episode of the Health Equity Forum Podcast. I also invite everyone to visit the Office of Minority Health and Health Equity website for more information about National Minority Health Month and other initiatives.

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