Patient 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 MoreA recent commentary by Peter Pitts of the CIOMS patient engagement working group warrants further discussion. He makes excellent points about the need for meaningful patient data, but highlights the institutional roadblocks and questions that linger about the benefit of patient engagement in medical product development. In reality, the roadblocks are real, and it will take sophisticated change management to overcome existing barriers to make patient engagement a ubiquitous reality in the medical products industry.
Read MoreModern patient engagement regulatory policy has its origins in the HIV/AIDS advocacy movement. Legislation in 2012 provided FDA with the power to initiate several new patient-focused initiatives. There has never been a better time for the patient voice to be heard by regulatory decision-makers.
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