Built to Clear FDA: A Prototyping Framework That Works
Getting a medical device to FDA approval is not only about having a good idea – it's about knowing how much prototype is enough, walking the fine line between over- and under-developing.
Matthew Caius and William Conway-Vimier of Caius Medical, a medical software firm specializing in high-performance prototyping, will open with a crash course on the FDA landscape, then introduce a three-prototype framework for staying scoped to what regulators need — illustrated with a real client case study. They will close with a candid look at costs, which almost always run higher than founders expect.
Participants will gain guidance on how to:
Navigate the FDA approval landscape with practical, working knowledge
Apply a three-prototype framework to avoid over- or under-building
See the framework in action through a real case study
Set realistic expectations for the cost of FDA-ready prototyping
Matthew Caius
Caius Medical
William Conway-Vimier
Caius Medical
Matthew Caius is the founder of Caius Medical and has 5+ years of experience working with medical devices, particularly medical imaging technologies, across both academia and industry. Caius Medical helps medical technologies move from early concepts toward clinical use and has supported companies including Moonrise Medical, Corlibra, and Deep Breathe across AI-enabled imaging, software-as-a-medical-device, prototyping, verification and validation, and regulatory-aligned development. Matthew’s work focuses on bridging the gap between technical innovation and practical medical-device commercialization.
William Conway-Vimier is a biomedical engineer with Caius Medical, where he leads regulatory documentation and supports medical device submissions, design controls, and quality-system activities. His work focuses on translating technical development into the documentation and processes required for regulated medical devices, including requirements, risk management, verification and validation, and submission support. He also contributes to Caius Medical’s close collaboration with Western University on medical technology research and translation.
October 1, 2026 | 12:00 PM-1:00 PM
In-Person Attendance: JHTV - 1812 Ashland Ave, Baltimore, MD 21205
(lunch will be provided to those attending in person)
Virtual Attendance: Zoom (a link will be provided upon registration)
**Please note that our speakers will be joining us virtually**