Patients are the experts about their own bodies and their disease. We now have an unprecedented recognition by regulators and industry that patient experience is valuable. I recently read an interesting white paper published by the Harvard Business School that focused on a theoretical model for how the structure of “user communities” provides a unique context within which ideas and knowledge flow to generate innovation in commercial "firms". It occurred to me that this model could be applied to the relationship between patient communities and medical product industry to ensure that patient experience is a necessary component to product development. Though not a perfect fit, I believe this model could provide some guidance for a framework within the medical product industry and patient communities have greater authentic, transparent, and effective exchange of ideas to drive medical innovation.
Read MoreWhat is patient preference? We have FDA's definition, which describes preference as patients' desire for outcomes or attributes given a choice. But, what does patient preference really mean? And, how can patient preference help medical product sponsors bring their product to market? Preference is much more than making a simple choice between treatments. Patient preference is complex assessment of patients' priorities and desired treatment outcomes. Sponsors can harness these data to support product development, regulatory decisions, commercialization, and more.
Read MorePatient x Design is a concept by which we include patient input throughout the medical product life-cycle. Like Quality by Design, Patient x Design compels medical device sponsors to seek patient input at all points during medical product design, development, clinical testing, regulatory submission, post-market surveillance and beyond.
Read More