I'm at my best helping small teams execute on big ideas.. Over the last 18+ years, I've had the opportunity to commercialize multiple disruptive medical devices, assays and platform technologies that bring efficiency, quality and scale to healthcare. These were launched in regulated (IVD, 510(k), CLIA LDT), research-use (IUO, RUO) and. consumer (D2C, DTC, B2C) markets.. Domain Knowledge - I've successfully navigated multiple product lifecycles as a product owner and have lead business units through triple-digit growth (from scratch) organically and via M&A. - Acquired and successfully integrated two companies / facilitated the divestiture of a company - Designed and developed medical devices for collecting and stabilizing nucleic acids from a variety of biological sources. - Participated in establishing technical standards for the emerging field of metagenomics / microbiome analysis - Led a team through a de novo 510(k) for a novel microbiome-related medical device - Led multiple teams through microbiome-derived biomarker discovery and validation, through assay development toward launching molecular diagnostic assays (PCR and NGS) for research use, and platform-as-a-service. - Interested in the commercialization of companion and complementary diagnostic assays (CDx, CoDx). - Passionate about clearly communicating the big picture (mission, vision, strategy) in sufficient detail (business plans, technical diligence, market analysis, competitive analysis, product requirements, target patient profiles, user journeys) to drive buy-in and focused execution throughout an organization.. Accolades - World Economic Forum - Technology Pioneer Award - Red Herring - Top 100 private companies in North America - Frost & Sullivan - Technology Excellence Award
