It’s incredible what a few thousand people can accomplish together in less than six hours.

During a recent, two-day public workshop held by the Food and Drug Administration (FDA) and the Digital Medicine Society (DiMe), nearly 45 speakers and 2,000 attendees explored the implementation of patient-generated health data (PGHD) throughout the total product life cycle (TPLC). The “Using patient-generated health data in medical device development” workshop featured 10 discussions highlighting real-world examples of how PGHD can promote medical device innovation and forming a shared vision 2030 of how we want to move forward as one ecosystem.

“DiMe and CDRH are aligned on our missions to advance patient access to safe and effective medical products by centering the patient using patient-generated health data throughout the total product life cycle,” said Suzanne Schwartz, Director of the Office of Strategic Partnerships and Technology Innovation, FDA’s Center for Devices and Radiological Health (CDRH).

“True progress in digital health demands ecosystem-wide collaboration,” added Smit Patel, Program Director, DiMe. “By uniting our efforts, we elevate patient-generated data from mere information to a catalyst for profound impact. When we join forces, we build trust and amplify the patient voice, paving the way for better trials, better health products, and better regulatory science.” 

The unique blend of diverse perspectives over the two days led to some clear themes and considerations that are critical to account for when using PGHD to support improved trials, medical device development products, and regulatory science.

Take a patient-first approach

Using PGHD, we can listen to patients across the total product life cycle to develop products that people want and are meaningful to them. This includes usability, the frequency of data collection, trust, and keeping patients’ data safe. 

Several workshop participants shared their personal experiences with PGHD for clinical conditions including epilepsy, Parkinson’s, sleep disorders, and physical activity. One presenter, Elena Izmailova, CSO, Koneksa Health, shared a powerful story of her cancer journey and how, as a clinical scientist, she was able to use devices to collect PGHD, understand the data, and use them for clinical decision-making. 

“I felt empowered by my own PGHD. I felt I was contributing, not just a passive recipient of medical services. I felt like I was part of the team,” Izmailova shared.

Through the rich discussion, it became clear that:

• By using PGHD, we have the potential to not just design for patients, but also with patients.
• We must give patients who participated access to and feedback on the data.
• Technology products have to have a high value to patients – including actionable PGHD that patients feel connected to. 

Expanding access to power exceptional outcomes 

In addition to keeping the patient front of mind, it’s equally important to account for all patients – not just some.

As Smit Patel of DiMe stated, “Each piece of data collected from patients is making clinical research more informed and infinitely more impactful. So it’s on leaders like us to ensure all patients can contribute—and benefit—from this transformative power, driving better health, and outcomes for everyone.”

PGHD can be a vehicle for us to fulfill our collective responsibility to ensure that medical devices work for everyone. When used inclusively, PGHD captures and reflects the unique health challenges of underrepresented communities, promoting the development of medical technologies that are more reliable, equitable, and accessible. 

And, as Catherine Young, Assistant Director of Cancer Moonshot Policy and International Engagement at The White House, pointed out, there have been recent, significant regulatory advancements to support the use of PDGD.

“I did want to take just a moment to recognize the FDA when they released this new guidance yesterday about enhancing diversity in clinical trials because I think it has components in there that really provide that guidance that encompasses everything that we’re talking about here. And I really want to give acknowledgment to everybody at the FDA who has worked on this because it is an example of how federal agencies are moving in this direction right now and are making critical decisions and becoming very intentional about how we think about these things,” said Young.

Participants agreed: with intentionality, we can use PGHD to avoid exacerbating inequities from the digital divide and, instead, decrease the burden of participating in trials. This would allow us to advance the development of medical products with an understanding of the cultural competency of all the communities we intend to serve. 

Collaboration is a catalyst to accelerate research innovation

Alongside being patient-first and mindful of health equity, breaking out of silos and working together also emerged as a key theme of the event. Collaboration is particularly important in producing and working with high-quality data. 

“Let’s keep the end in mind and focus on what we need to do together in a collaborative fashion, to move the needle in a way that we all know,” said Jeremy Wyatt, CEO, ActiGraph.

Several case examples showed how regulators, industry, clinicians, and patients came together proactively and in a pre-competitive space to move forward on meaningful aspects of health that can be measured and matter to patients, using PGHD. For example, Tidepool used extensive patient-generated health data to develop the Tidepool Loop, the first fully interoperable automated insulin dosing app. By engaging directly with the #WeAreNotWaiting patient community, they gathered more than 175,000 person-days of data from 1,127 participants, providing critical insights into the safety, efficacy, and usability of the product. This data-driven, patient-led approach helped Tidepool secure FDA clearance in 2023, ensuring that the device reflected the unique needs and challenges of insulin-dependent individuals with diabetes. 

“You need patients. You need communities. You need tech developers. You need the measurement scientists. You need healthcare integration….The partnership aspect is key and the idea of pre-competitive collaborations is really important so that we’re not all doing our own things and wasting resources,” said Annie Saha, Associate Director for Strategic Initiatives, Digital Health Center of Excellence, FDA.

The group of experts and leaders emphasized how collaboration and high-quality PGHD are key to paving the way to a new and improved healthcare system in 2023; one where: 

• Research is no longer limited by geographic boundaries; participants’ race, ethnicity, language; or socioeconomic barriers. 
• Clinical trials aren’t just for the privileged few or the White male population but are available to everyone. 
• Patient voices are not just a checkbox on a checklist, but we prioritize capturing real-world outcomes that matter to patients, leading to the development of devices fundamentally aligned with patient needs and preferences.

Next steps

“The workshop successfully illustrated how patient-generated health data can bring together industry sponsors, regulators, academics, and most importantly, patients, to foster innovative device development,” said Schwartz.

Insights from the workshop will now be used to develop a roadmap for using PGHD in TPLC and provide a vision for the future with better trials, health products, and regulatory science.