Caroline Webster, PhD

Caroline Webster, PhD is the Founder and Principal Consultant of Webster MedTech Consulting, where she helps medical device innovators align engineering execution, structured product development, and regulatory strategy to bring safe, effective physical and software medical devices to market with clarity and confidence. Her work is grounded in the belief that strong engineering foundations and early regulatory alignment are not constraints, but enablers of efficient, scalable innovation.

With twelve years of experience spanning medical device development, orthopedic implants, patient-matched devices, advanced manufacturing, and Software as a Medical Device (SaMD), Caroline brings both strategic foresight and hands-on technical expertise to complex development programs. She holds a PhD in Industrial Engineering and a Bachelor's degree in Biomedical Engineering, and has held senior technical and leadership roles at organizations ranging from early and growth-stage startups to established top orthopedics companies. Her background spans Class II and Class III devices across regulatory pathways including 510(k), PMA, IDE, HDE, and 520(b) Custom Device Exemptions, as well as SaMD classification and software regulatory strategy.

Caroline is known for translating complex clinical, engineering, and regulatory requirements into clear, actionable development pathways. She has led cross-functional teams, partnered closely with surgeons and clinical stakeholders, and guided programs from early concept through commercialization across patient-matched implant programs, custom device exemption workflows, and FDA-facing regulatory submissions. She also supports investors, acquirers, and partners through regulatory due diligence and technology transfer assessments, bringing the same structured, evidence-based approach to transactional contexts as to development programs.

At Webster MedTech Consulting, Caroline works as a collaborative partner, meeting teams where they are and clarifying what matters most at each stage of development. She helps organizations anticipate regulatory and technical risks early, align today's engineering decisions with tomorrow's regulatory and scalability goals, and build development strategies that support both innovation and compliance. Helping teams achieve that alignment is not only her expertise, it is the core of her work.