Commenters on FDA’s recently opened docket for proposed changes to the PPI Guidance made their recommendations clear: we need more specificity in FDA’s expectations for use of PPI data in regulatory decision-making. Specifically, there is a strong desire for FDA use existing best practice recommendations; the need to increase the expectation and accountability of those conducting PPI studies to engage patients in the study design process; more transparency around how FDA will use PPI data in its decision-making; a desire to see the guidance expanded to therapeutics beyond medical devices; consistency in attribute definition and utilization; and greater clarity around FDA’s expectations for study methodology. The hope is that FDA takes these thoughtful and substantive comments into account when updating the PPI guidance.
Read MoreFDA recently requested public comment on updates to the PPI Guidance. The most common theme in the comments submitted suggested that all of us want to know what FDA really thinks about PPI studies and how they can support medical device regulatory decisions. If FDA can update the guidance with more transparency, the medical device industry will benefit and so will patients.
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 MorePlanet formation provides an unlikely metaphor for rigorously assessing the patient experience. When individual patient stories are objectively assembled using scientific methods, they gain weight and the ability to influence decision-makers.
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