Maximizing Patient Input in the Design and Development of Medical Device Clinical Trials

There are key distinctions between device trials and drug trials that present unique opportunities, challenges, and resource needs for engaging patient insights in the device field. In developing this report, the Science of Patient Input (SPI) Participation in Clinical Trials Working Group of the Medical Device Innovation Consortium evaluated a series of device trial characteristics (level of invasiveness, outcomes assessment, trial enrollment, and trial design) and prioritized them based upon their relevance for patient engagement.

It is hoped that this report provides a concise set of considerations for medical device developers to evaluate as they pursue patient engagement in their clinical trials and product development activities. Recognizing that this work is complex and made increasingly so by the heterogeneity of the device development landscape and understanding that no single compilation of information can provide everything a sponsor would need, the resources presented within this report are offered as a foundation from which sponsors can advance their efforts to generate and incorporate patient input into trial design and conduct.