Michelle Bonn

I’m a MedTech executive and seasoned entrepreneur with a track record of scaling life sciences companies through commercialization, capital strategy, regulatory leadership, and project execution. I lead organizations through inflection points. From FDA clearance and investor readiness to market launch, delivering measurable growth and stability.

I bring a strong blend of technical expertise and business acumen, with experience across capital raises, M&A management, corporate restructuring, and P&L responsibility. I’ve built global teams across the U.S., EU, and Asia to execute complex market entry plans.

Career Highlights:
💠 Led a company turnaround that doubled profit margins in one year and drove a $2M+ pipeline, resulting in a strategic sale to private investors.
💠 Secured capital funding to support a targeted acquisition, operational growth, and successful exit.
💠 Directed multiple FDA 510(k) submissions, international filings, ISO 13485 projects, and post-market compliance for medical device and pharmaceutical companies.
💠 Built strategic partnerships with large life science companies and high-growth MedTech innovators.
💠 Served as the face of the company at industry events, investor meetings, and media interviews to strengthen brand, attract capital, and expand market presence.

Core Expertise:
💠 MedTech Commercialization
💠 Capital Raise Support & Investor Readiness
💠 FDA Regulatory Pathways (510(k), De Novo, PMA)
💠 Global Market Entry & Regulatory Compliance (U.S., EU MDR, Asia-Pacific)
💠 Operational Turnaround & High-Functioning Team Leadership
💠 Board & Executive Stakeholder Engagement

I’m especially drawn to opportunities that combine growth capital strategy with market launch execution. This is where my regulatory, operational, and strategic strengths can directly accelerate revenue.