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  4. Co-sponsored Public Workshop - Using Patient-Generated Health Data in Medical Device Development: Case Examples of Implementation Throughout the Total Product Life Cycle - 06/26/2024
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Workshop | Virtual

Event Title
Co-sponsored Public Workshop - Using Patient-Generated Health Data in Medical Device Development: Case Examples of Implementation Throughout the Total Product Life Cycle
June 26 - 27, 2024

Date:
June 26 - 27, 2024
Day1:
- ET
Day2:
- ET

Summary

The Food and Drug Administration (FDA) is announcing a co-sponsored public workshop with the Digital Medicine Society (DiMe) titled "Using Patient-Generated Health Data in Medical Device Development: Case Examples of Implementation Throughout the Total Product Life Cycle." The purpose of this co-sponsored public workshop is to illustrate how patient-generated health data (PGHD) can promote medical device innovation throughout the total product life cycle (TPLC). Patients, industry sponsors, regulators, and researchers will share their perspectives on how using PGHD can help advance remote clinical trial data collection and support clinical outcome assessments. The co-sponsored public workshop participants are slated to discuss how using PGHD in medical device development can promote improvements in patient science, patient engagement, and health equity.

Background

The FDA's Center for Devices and Radiological Health (CDRH) is committed to amplifying the patient voice in the service of equitable access to safe, effective, and high-quality medical devices. PGHD has the potential to help the CDRH meet this commitment in line with our strategic priority of advancing health equity. CDRH has been formally exploring and advancing the collection of PGHD since 2016.1 This co-sponsored public workshop builds upon the past work – including the Patient Engagement Advisory Committee meeting in 20182 and a public meeting in 20213 – by discussing case examples of how PGHD has been incorporated at the different phases of the TPLC.

The aims of this co-sponsored public workshop are to explore how patient-generated health data can achieve the following:

  • Advance remote clinical trial data collection and support clinical outcome assessments.
  • Capture patient perspectives and reduce patient burden to inform clinical study design and conduct, with a goal of reducing barriers to patient participation and facilitating recruitment and retention.
  • Improve patient science tools for medical devices and advance health equity through targeted incorporation of diverse patient perspectives and integration of data from diverse patients.

Date and Time

This meeting will be held on June 26-27, 2024, from 11:00 am - 3:00 pm (ET) by webcast only.

Webcast

The co-sponsored public workshop will be webcast. Register to receive the link to the webcast in a confirmation email. After the live webcast, a link for the recorded co-sponsored public workshop will be posted to the FDA webpage.

Preliminary Agenda

The following co-sponsored public workshop agenda is preliminary and subject to change. More information will be made available as presenters are confirmed.

June 26, 2024

Time Subject
11:00 am Welcome & Workshop Objectives
  • Jacqueline Burgette | Associate Director of Emerging Initiatives, Center for Devices and Radiological Health (CDRH), FDA
  • Smit Patel | Associate Program Director, Digital Medicine Society (DiMe) 
11:07 am Fundamentals of Patient-Generated Health Data (PGHD)
  • Robert Wright | Social Scientist, Division of Patient-Centered Development, CDRH, FDA
11:15 am Keynote Address: Receiving a Cancer Treatment, Decoding My Own Data, & Advancing Clinical Research: My Dual Life – as a Patient & Clinical Scientist
  • Elena Izmailova | Chief Scientific Officer, Koneksa Health
11:30 am Keynote Panel Discussion:Vision 2030: Advancing Clinical Research with Patient-Generated Health Data
  • Jeremy Wyatt | Chief Executive Officer, ActiGraph
  • Kristin Schneeman | Senior Director, FasterCures, Milken Institute
  • Anindita (Annie) Saha | Associate Director for Strategic Initiatives, Digital Health Center of Excellence, CDRH, FDA
  • Elena Izmailova | Chief Scientific Officer, Koneksa Health (Moderator)
12:00 pm

Session I: From Traditional to Digital: A Full Spectrum of PGHD Driving Clinical Trial Advancements 

Landscape of Person-Generated Health Data in Everyday Life (10 mins)

  • Joyce Nortey | Senior Director, Clinical Research & Digital Health Initiatives, Evidation

Jotting it Down To Building Library: The Classic PGHD Chronicles 
(10 mins)

  • Pamela Tenaerts | Chief Scientific Officer, Medable

Half a Decade of Evolution of Clinical Trials - An Analysis from the Library of Digital Endpoints (10 mins) 

  • Rachel Chasse | Associate Director, Digital Science Strategy, AbbVie

Panel Discussion (30 mins)

  • Vinay Pai | Digital Health Specialist, Digital Health Center of Excellence, CDRH, FDA
  • Mike Mittelman | Board Secretary, The Light Collective
  • Joyce Nortey | Senior Director, Clinical Research & Digital Health Initiatives, Evidation
  • Pamela Tenaerts | Chief Scientific Officer, Medable
  • Rachel Chasse | Associate Director, Digital Science Strategy, AbbVie (Moderator)
1:00 pm   

Session II: Measuring Health: One that Actually Matters to (Real) Patients 

Measuring Sparks of Brilliance: Newer Modalities of Epilepsy Monitoring (10 mins)

  • Marisa Cruz | Chief Medical Officer, Empatica

The Steady Touch: Fast-Tracking Progress in Parkinson’s with Digital Biomarkers (10 mins)

  • Erin Rainaldi | Head of Sensors Data Science, Verily

Everyday Tech, Extraordinary Health: Insights from Consumer World for the Medical Device Worlds (10 mins)

  • Nikki Batista | Vice President, Digital Health, WHOOP, Inc.

Panel Discussion (30 mins)

  • David White | Kidney Warrior, The Light Collective
  • Marisa Cruz | Chief Medical Officer, Empatica 
  • Erin Rainaldi | Head of Sensors Data Science, Verily 
  • Nikki Batista | Vice President, Digital Health, WHOOP, Inc.
  • Patrick Antkowiak | Team Lead, Neurodiagnostic Devices Team, Office of Product Evaluation and Quality, CDRH, FDA, (Moderator)
2:00 pm    

Session III: Turning Up the Volume of Health Monitors: New Modalities of Measuring Health

The Way Forward for Quantitative Assessment of Gait Impairments in Parkinson’s Disease Clinical Trials (10 mins)

  • Katharina Klapper | Director of Clinical Research, The Michael J. Fox Foundation for Parkinson's Research

Developing Novel Patient-Centric Digital Sleep Assessment Tools for People with Short and Disrupted Sleep (10 mins)

  • Jen Blankenship | Senior Research Scientist, VivoSense, Inc.

Panel Discussion (30 mins)

  • Kimberly Kontson | Biomedical Engineer, Office of Science and Engineering Laboratories, CDRH, FDA 
  • Katharina Klapper | Director of Clinical Research, The Michael J. Fox Foundation for Parkinson's Research
  • Jen Blankenship | Senior Research Scientist, VivoSense, Inc.
  • Alan Hamilton | Senior Director of Research, COPD Foundation
  • Benjamin Vandendriessche | Vice President of Science, DiMe (Moderator)
2:50 pm Closing Remarks
  • Grail Sipes | Senior Policy Advisor to the Chief Scientist, Office of the Commissioner, FDA
3:00 pm Adjourn 

June 27, 2024

Time Subject
11:00 am Welcome 
  • Jacqueline Burgette | Associate Director of Emerging Initiatives, CDRH, FDA
  • Smit Patel | Associate Program Director, DiMe 
  • Robert Wright | Social Scientist, Division of Patient-Centered Development, CDRH, FDA
11:05 am Opening Remarks 
  • Owen Faris | Acting Director, Office of Product Evaluation and Quality, CDRH, FDA
11:15 am Welcome Chat: Bring the Megaphone, Give it to the Patients First 
  • Grace Vinton | Healthcare PR Pro, Patient Advocate, Podcast Host of HITea With Grace (Moderator)
  • Grace Cordovano | Patient-In-Residence, Board Certified Patient Advocate, DiMe 
11:30 am Fireside Chat: A View from the Washington: Building the Clinical Trials Infrastructure in the U.S. for Healthier Future
  • Shari Targum I Deputy Director, Office of Clinical Policy, Office of the Commissioner, FDA
  • Jennifer Roberts | Director, Resilient Systems, ARPA-H 
  • Catharine Young | Assistant Director for Cancer Moonshot Engagement and Policy, White House Office of Science and Technology Policy
  • Grail Sipes | Senior Policy Advisor to the Chief Scientist, Office of the Commissioner, FDA (Moderator)

12:00 pm

Session I: What's Your Type? Digital Health Technologies has Got Diabetes Covered

Tidepool Loop: Bridging Patient Led Innovation with Regulatory Reality (10 mins)

  • Howard Look | President, CEO, Tidepool

Panel Discussion (50 mins)

  • Katie Gagel | Type 2 Diabetes Patient Expert
  • Willem van den Brink | Scientist, Netherlands Organisation of Applied Scientific Research (TNO)
  • Howard Look | President, CEO, Tidepool
  • Bray Patrick-Lake | Digital Health Specialist, Division of Digital Health Outreach, Digital Health Center of Excellence, CDRH, FDA (Moderator)
1:00 pm    

Session II: From Rarity to Clarity: PGHD’s Role in Rare Diseases 

Leveraging the Power of PGHD across the Spectrum of Rare Diseases  (10 mins)

  • Pamela Gavin | Chief Executive Officer, National Organization for Rare Disorders (NORD)

Journey to Innovative Digital Endpoints with Lessons Learned: A Case Study of Fibrotic Interstitial Lung Disease (10 mins)

  • Christine Guo | Chief Scientific Officer, ActiGraph

Developing a Multi-Sensor Digital Movement Analysis System for Ataxia (10 mins)

  • Kristen Sowalsky | Vice President, Product & Science, Clario

Panel Discussion (30 mins)

  • Tracy Gray | Patient Engagement Lead, Division of Patient-Centered Development, CDRH, FDA
  • Pamela Gavin | Chief Executive Officer, National Organization for Rare Disorders (NORD)
  • Christine Guo | Chief Scientific Officer, ActiGraph 
  • Kristen Sowalsky | Vice President, Product & Science, Clario
  • Jessie Bakker | Vice President, Clinical Development, Koneksa Health (Moderator)
2:00 pm     Panel Discussion (50 mins)
  • James Carroll | Head of RWE, Clinical Trials, Walgreens Boots Alliance
  • Shaye Mandle | Executive Director, AdvaMed 
  • Daniel Caños | Director, Office of Clinical Evidence and Analysis, CDRH, FDA 
  • Christine Von Raesfeld | Board Member/Patient Advocate, The Light Collective
  • Elena Emmanuel I Group Product Manager, Google
  • Charles Viviano | Chief Physician/Associate Director, Office of Product Evaluation and Quality, CDRH, FDA (Moderator)
2:55 p.m. Closing remarks
  • Suzanne Schwartz | Director, Office of Strategic Partnerships & Technology Innovation, CDRH, FDA
  • Jennifer Goldsack | CEO, DiMe
3:00 pm Adjourn 

Registration

If you wish to attend this co-sponsored public workshop and receive the link to the live webcast, please register by 4:00 p.m on June 25, 2024. For registration, please visit: https://us02web.zoom.us/webinar/register/WN_piEgChG3RIWfXZ3vG1VOFA#/registration

There is no fee to register for the Workshop.

Registrants will receive confirmation when requests for registration have been processed. If you require special accommodations due to a disability, or need additional information regarding registration, please contact Susan Monahan, Office of Communication and Education, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Avenue, Bldg. 32, Silver Spring, MD 20993, 301-796-5661, Susan.Monahan@fda.hhs.gov.

Comments

Please submit your comments regarding the workshop to https://www.regulations.gov/, Docket No. FDA-2024-N-2441 by July 29, 2024.

Please refer to the Instructions for submitting comments to the docket to ensure that your feedback is received.

Please be advised that as soon as a transcript is available, it will be posted in the Dockets and accessible http://www.regulations.gov/.

Contact Us

For questions regarding the co-sponsored public workshop content, please contact:

Robert Wright
Office of Strategic Partnership and Technology Innovation
Center for Devices and Radiological Health
U.S. Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993
robert.wright@fda.hhs.gov

References

  1. Webber, C. M., Riberdy Hammer, A., Saha, A., Marinac-Dabic, D., Caños, D. A., & Tarver, M. E. (2023). Integrating Patient-Generated Health Data Throughout the Total Product Life Cycle of Medical Devices. Therapeutic Innovation & Regulatory Science, 1-5. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10400470/
  2. Advisory Committee Meeting November 15, 2018: Patient Engagement Advisory Committee Meeting Announcement [Internet]. Silver Spring: U.S. Food & Drug Administration; 2018 [updated 2018 Dec 11; cited 2022 Aug 8]. Available from https://www.fda.gov/advisory-committees/advisory-committee-calendar/november-15-2018-patient-engagement-advisory-committee-meeting-announcement-11152018
  3. U.S. Food & Drug Administration. Patient-generated health data throughout the total product life cycle of medical devices, virtual. 4 May 2021. https://public4.pagefreezer.com/browse/FDA/28-12-2023T13:10/https:/www.fda.gov/medical-devices/workshops-conferences-medical-devices/virtual-public-meeting-patient-generated-health-data-throughout-total-product-life-cycle-medical
 
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