With over two decades of operational, regulatory, and commercialization experience—spanning early-stage startups, global MedTech companies, and Fortune 500 organizations—Steve Duddy delivers hands-on, results-driven leadership where it matters most.
From pre-revenue strategy to commercialization scale-up, the services below are purpose-built for organizations needing experienced C-suite guidance, investor alignment, and disciplined execution.

Hands-on, high-accountability leadership for companies navigating critical growth phases, operational realignment, or leadership gaps. Steve provides C-suite direction grounded in strategic clarity, disciplined execution, and organizational alignment. With a history of leading early-stage MedTech ventures and managing large P&Ls at 3M and Johnson & Johnson, he delivers the experience needed to stabilize operations, drive momentum, and guide companies through transformation.

Comprehensive commercialization expertise to take MedTech and Biopharma products from concept to market success. This includes market assessment, launch planning, sales and distribution strategy, pricing, channel activation, and early revenue acceleration. Steve has taken multiple products from zero to scale, built global distributor networks, and executed high-impact commercialization programs for both startups and global organizations.

Comprehensive commercialization expertise to take MedTech and Biopharma products from concept to market success. This includes market assessment, launch planning, sales and distribution strategy, pricing, channel activation, and early revenue acceleration. Steve has taken multiple products from zero to scale, built global distributor networks, and executed high-impact commercialization programs for both startups and global organizations.

Expert guidance navigating FDA pathways including 510(k), De Novo, Breakthrough Device, IDE, and global regulatory readiness. Steve aligns regulatory strategy with product, clinical, and commercialization timelines to reduce risk and accelerate market access. He brings operational insight into preparing teams, documentation, strategy, and cross-functional communication that supports regulatory success in MedTech environments.

Strategic advisory support for founders, CEOs, executive teams, and boards facing high-stakes decisions. This includes organizational alignment, corporate development strategy, governance support, operational restructuring, and M&A evaluation. Steve provides clear, actionable guidance that strengthens leadership effectiveness and drives disciplined execution across the organization.

Identification, evaluation, and development of strategic partnerships, licensing agreements, distributor networks, and commercial alliances. Leveraging extensive global MedTech and healthcare connections, Steve helps companies expand market reach, activate distribution channels, and secure relationships that accelerate commercialization and growth — including support for international organizations entering the U.S. market.

Early-stage teams preparing for FDA submission, investor readiness, or first commercial launch.

Growth-stage companies needing seasoned leadership to build commercial infrastructure or stabilize operations.

Visionaries seeking experienced support in execution, board communication, and organizational alignment.

Investors requiring fractional leadership, turnaround insight, or commercialization expertise across healthcare portfolios.

International organizations needing regulatory guidance, go-to-market leadership, and U.S. commercialization execution.

Scientist-led teams needing strategic operating support to translate innovation into market value.
Let’s discuss how Steve Duddy can help your business scale with clarity and confidence.
We use cookies to analyze website traffic and optimize your website experience. By accepting our use of cookies, your data will be aggregated with all other user data.