The lack of representative patient voices in medical device development impedes our ability to improve the safety and efficacy of new and existing medical devices.
To address this issue, DiMe is working with the FDA and other stakeholders to develop “Vision 2030: A strategic roadmap for implementing the patient voice into the total product life cycle (TPLC) for medical devices via patient-generated health data (PGHD)”.
Through this effort and with this roadmap, stakeholders from across the digital health ecosystem can work together to establish a future with better trials, health products, and regulatory science.
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Developing Vision 2030
We are building open-source resources to help you use PGHD while developing and deploying medical devices. These efforts are underway:
Conduct a literature review and interviews with patients, patient care partners, and PGHD users (including DHT developers, sponsors, clinicians, researchers, and regulatory experts)
Create a Value Matrix that maps benefits, data quality considerations, roles, and responsibilities across stakeholders for using PGHD throughout the medical device TPLC
Based on the value matrix, develop a Theory of Change model to ensure all stakeholders work towards a shared vision of the future state of medical device development
The resources from this effort will help you advance the use of PGHD to build safer and more effective medical devices, grounded in the appropriate regulations, to build a future with:
Tracy Gray
FDA
Tracy Gray
FDA
