Bringing a medical device to market requires more than a great idea. From navigating FDA pathways to building design controls that actually work, most startups and growth-stage companies hit regulatory and technical roadblocks that slow momentum or derail launches entirely. Founders are often brilliant innovators but lack the depth of R&D and regulatory strategy experience needed to clear FDA hurdles efficiently.
That's where I can help. I provide Fractional CTO and R&D consulting services through Fractional MedTech LLC, specializing in regulatory strategy, design controls, and FDA submission processes for medical device companies. My work focuses on translating innovation into FDA-cleared products through smart regulatory pathways, disciplined design controls, and risk management that holds up under scrutiny.
With 20+ years of medical device development experience, 18 US patents, and 16+ devices guided through FDA clearance, I've seen what works and what doesn't. My background spans neurovascular devices, catheter-based systems, and complex implantables. I recently left Stryker Neurovascular to focus full-time on helping startups and growth-stage companies navigate the technical and regulatory complexity of bringing devices to market.
What sets me apart: R&D leadership with deep regulatory strategy expertise across 510(k) and De Novo pathways, paired with hands-on development experience that bridges innovation and compliance. I also collaborate with Georgia Tech's Office of Technology Licensing to assess early-stage medical device technologies for commercialization potential.
What I deliver: regulatory strategy and pathway selection, design control frameworks aligned with FDA and ISO standards, risk management (ISO 14971) and design verification/validation planning, FDA submission preparation and deficiency response support, IP assessment and commercialization planning, technical feasibility evaluation and development roadmaps.
If you're building a medical device company and need senior-level R&D leadership without the full-time cost, let's connect.
https://linktr.ee/jasonglithero
https://linktr.ee/jasonglithero
