Bridging the gap between FDA guidance, published evidence, and clinical business implementation in regenerative medicine
The regenerative medicine industry navigates a complex landscape where FDA 510(k) device clearances, off-label clinical use, and patient response variability create significant compliance risks and clinical uncertainty.
My work focuses on: Translating regulatory frameworks into clinical business processes and helping regen doctors avoid risks of "false claims" and "misbranding".
Evidence-based insights on regulatory compliance and the gap between marketing claims and biological reality.
Mapping the evolving research landscape where PRP has captured the 'Share of Mind' in new clinical inquiry, compared to the established footprint of HA.
View Evidence Analysis →A systematic classification of FDA-approved HA products by physical state—Solutions, Fluids, and Gels—extracted from official SSED documentation.
Explore the Spectrum →Analysis of 178 studies reveals how strict PRP exclusion criteria create a "Goldilocks" cohort systemically biasing comparative HA/CS data.
Read Full Analysis →FDA-cleared PRP systems deliver remarkably similar platelet yields when normalized by blood volume, while clinical research still lacks responder profiles.
Read Full Analysis →Examining why combining PRP with HA may be synergistic while CS can be actively counteractive.
Read Full Analysis →Knee OA Treatment Trends: A PubMed analysis of research publication volume among the "Big 3" intra-articular treatments.
Read Full Analysis →I bring deep scientific training and decades of biopharmaceutical "scientific safe harbors" experience to the orthobiologics space. My PhD research in biochemistry shapes evaluate growth factor therapies like PRP.
I help practices navigate the gap between evidence, FDA guidance, and actual enforcement risks.
Engagement Structure: Project-based consulting with fixed-scope deliverables, ranging from focused evidence reviews to comprehensive process design.