Transforming Patient Engagement in Medical Technologies' Evolving Regulatory Landscape

Description: The regulatory landscape is continually evolving to incorporate patient input in the medical technologies’ lifecycle. This panel session addresses the evolving landscape, while leveraging actionable insights from a recent “Patient Engagement in MedTech” survey. The survey responses, provided by over a dozen medical device companies, offer insights into the current barriers to patient engagement in the industry.
Patient engagement in the MedTech product development lifecycle offers a vital pathway for manufacturers to leverage insights from target patient populations to discover unmet needs, improve usability, and optimize patient experience. Several guidance documents on patient input from the US FDA and the newly passed US legislation requiring diversity plans in clinical trials exponentially catalyze the need for improvement in patient and community engagement by MedTech companies. However, there continue to be several barriers to improving effective patient engagement including incorporating patient insights into regulatory strategy. Patients’ perspectives on perceived benefits, risks, and usability of devices as well as on disease outcomes and management offer valuable information for product development, study design, quality surveillance, and performance monitoring. Furthermore, patient engagement provides an opportunity for device companies to tailor their products and clinical study communications to patient communities and target populations.
The panel will discuss not only the value of engaging with patients throughout the MedTech lifecycle, but also elucidate interdependencies with the regulatory framework and strategy. Industry examples of patient engagement will include those related to clinical trial design, digital health application development, post-market risk, and safety communications. In addition, the regulator’s perspective on patient input and its impact on decision making will be included.