Using patient-generated health data in medical device development: Case examples of implementation throughout the total product life cycle
DiMe and FDA are working to identify successful practices for using patient-generated health data (PGHD) and driving adoption of its use throughout the total product life cycle (TPLC). Join this upcoming free 2-day public meeting to help contribute to this work! You’ll have the opportunity to share insights that will help guide the development of new resources – and walk away with a better understanding of PGHD implementation during medical device development and clinical studies.
Register today for this unique opportunity to learn alongside industry leaders and contribute to future work on resources to advance the use of PGHD in clinical research and regulatory science.
Session information:
During this public meeting led by FDA and the Digital Medicine Society (DiMe), we will explore how PGHD can advance remote clinical trial data collection and facilitate high-quality clinical outcome assessment. Attendees will have the opportunity to learn about and discuss:
- How to implement PGHD throughout the total product life cycle development of medical devices
- Tangible case examples of how PGHD has informed medical device development
- How PGHD can help improve health equity by promoting inclusivity in research studies
- Case-based learning on the use of PGHD for medical device developers, scientists, and patients
Speaker
Kristen Sowalsky, Ph.D., D.C.
VP, Medical & Scientific Affairs, Precision Motion at Clario
Dr. Kristen Sowalsky is the Vice President of Medical & Scientific Affairs for Precision Motion at Clario. She oversees the scientific advisory, data science and biostatistical services for digital measures of human movement in clinical trials and academic research. Dr. Sowalsky has 18 combined years of experience in industry, academic/clinical research and clinical practice. Her academic achievements include a BS in Kinesiology and Exercise Science from Appalachian State University, a Doctor of Chiropractic from Logan University and a Ph.D. in Applied Neuromechanics from the University of Florida.
Dr. Sowalsky is also a member of the University of Florida Industry Board. Passionate about improving the lives of patients and their families, Dr. Sowalsky aims to advance meaningful digital mobility outcome utilization to inform therapeutic innovation and development.