Medical Device & Regulated Product Executive | R&D, FDA Strategy & Risk Management Leader | Driving Approvals, Innovation & High-Growth Commercialization

Overview

An experienced executive with a multidisciplinary background spanning medical devices, cosmetics, OTC products, and regulated product development. Work includes leading companies through market expansion, overseeing regulatory approvals, and guiding innovation strategies from concept through commercialization. Brings a distinctive blend of hands-on engineering experience, strategic leadership, and entrepreneurial execution. Known for advising global businesses on technical risk, regulatory readiness, and product-market fit, while building systems and teams that accelerate growth.

Short Bio

Executive leader in medical devices and regulated product development, with extensive experience in FDA strategy, engineering management, and product commercialization. Former CEO, founder, and R&D director with a strong record of regulatory approvals, innovative product launches, and technical leadership across multiple sectors.

What I Bring

Proven leadership delivering 510(k), PMA, and NDA approvals across diverse medical sectors
Deep experience building R&D, engineering, and regulatory systems that enable rapid, compliant innovation
Strong capability navigating complex technical risk and guiding high-stakes product development
Record of growing brands, expanding distribution, and driving successful exits
Entrepreneurial execution including company founding, funding acquisition, and market strategy
Ability to build high-performance teams and operational systems in regulated environments
Expertise supporting global businesses entering the US market and adapting to FDA expectations

Key Technologies & Product Expertise

Class II/III medical devices
Cosmetics and OTC formulations
Surgical devices and catheter technologies
Risk management systems (including advanced methodologies)
FDA regulatory frameworks (510(k), PMA, NDA)
Manufacturing validation and transfer
Product development pipelines
GMP/ISO systems, quality tracking, and engineering databases
CAD/CAM, robotics, and advanced manufacturing

Titles Held

Chief Executive Officer, Tropic Isle Living (2019 – 2023)
Chief Strategist, President & Founder, Can Do Medical (2002 – 2019; rebooted 2023)
Director of Surgical R&D, CIBA Vision (2001 – 2002)
Director R&D and Engineering, Ophthalmic Innovations International (1991 – 2001)
Aerospace and technical roles (earlier experience listed under “Relevant Prior Experience”)

Career Highlights

Achieved over twenty FDA approvals (510(k), PMA, NDA) across ophthalmology, dental, obstetrics, and critical care
Founded two technology companies and secured $7.4M in funding plus additional grants and assistance
Increased specialty hair and skin care retail distribution 5× during the pandemic, enabling a successful brand exit
Increased patent filings tenfold at CIBA Vision, driving innovations that contributed to M&A product portfolios
Built R&D and engineering infrastructures that improved GMP/ISO compliance and development efficiency
Led teams through manufacturing transfer, process validation, and global regulatory navigation
Coached executives and boards on risk, opportunity forecasting, and technical growth strategy
Supported international companies entering the US market with robust regulatory and operational frameworks

Education & Professional Certifications

MS, Advanced Manufacturing, University of California, San Diego (1996)
BS, Engineering, Harvey Mudd College (1994)

Impact

Drove major value creation across medical devices, cosmetics, OTC, and regulated healthcare through regulatory excellence, delivering 20+ FDA approvals that unlocked new revenue streams and accelerated commercialization.
Transformed innovation pipelines by implementing advanced risk-management, validation, and engineering systems that reduced development uncertainty, strengthened compliance, and enabled faster market readiness.
Delivered high-impact operational turnarounds, including rebuilding organizations, redesigning supply networks, and executing expansions that multiplied retail distribution and positioned brands for successful exits.
Enabled global market entry for international companies by architecting FDA-ready regulatory frameworks and guiding high-stakes product strategies across the US, EU, and China.
Drove significant R&D productivity gains—such as increasing annual patent filings more than 10×—to support innovation, IP generation, and strategic acquisition opportunities.
Accelerated growth for startups and established companies through technical due diligence, funding acquisition, commercialization strategy, and cross-functional leadership, contributing to millions raised in venture and grant funding.
Strengthened enterprise-level technical capabilities by creating engineering databases, GMP/ISO-compliant systems, validation infrastructures, and other platforms that institutionalized quality and innovation at scale.

Expert Details