Patient-Centric Regulatory Affairs & Policy


Recent Posts

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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Oh, but my darling...what if you fly?

After being fired, sharing my situation so publicly made me vulnerable to failure.  But it also opened me up to opportunity. When we acknowledge the possibility that there might be more for us out there, we invite opportunity to come knocking.  We will always be able to name the ways that we might fail.  But we really find our freedom when we discover all the ways we might fly.

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Characteristics of Attributes in Patient Preference Studies

Attributes are a critical component of patient preference studies. Identifying and defining attributes can be complicated and contentious. But, it doesn’t have to be this way. Those of use who have conducted patient preference studies can show you how to make attribute identification efficient and patient-centered.

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Patient Preference in Medical Product Development - July Newsletter Feature

What 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.

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Patient x Design - A Life-cycle Concept for Medical Products

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.

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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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