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 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 over a decade of experience across medical device development, orthopedic implants, patient-matched devices, and advanced manufacturing, 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 varying from early stage and growth stage startups to established top orthopedics companies. Her background spans Class II and Class III devices, FDA-facing development initiatives, and regulatory pathways including FDA QSR and ISO 13485 systems, Custom Device Exemptions (520(b)), IDE, HDE, and PMA submissions.

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, supported design and manufacturing decisions for patient-specific implants, and guided programs from early concept through commercialization. Her approach emphasizes transparency, evidence-based decision-making, and a clear understanding of trade-offs so teams can move forward with confidence rather than uncertainty.

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.