I bring deep experience in medical device development, manufacturing, and post-market compliance, with particular expertise in product realization, design controls, human factors, and regulatory and quality requirements. I help founders understand how these considerations should inform product development early—before they become costly barriers to commercialization.

Having worked with and for startups throughout my career, I’m especially passionate about helping medical device founders bridge the gap between prototype or proof of concept and successful regulatory clearance. I enjoy helping teams identify what they need to demonstrate, anticipate regulatory and compliance challenges, and build a practical path toward a product that is ready for both regulatory review and the market.

QUESTIONS I CAN ANSWER

• How should I be thinking about regulatory requirements at my current stage of development?
• How can I prepare my product and processes for manufacturing?
• What regulatory and compliance considerations should I be planning for before going to market?