Patient-Centric Regulatory Affairs & Policy
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Posts tagged Patient experience
Why Do Patient Communities Matter for Medical Product Strategy? - August Newsletter Feature

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.

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Regulatory WOQUE-ness: Some Commentary on Patient Engagement

A 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.

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