Medical Device Development: Concept to Manufacturing

Medical Device Development: Concept to Manufacturing

Full-cycle medical device engineering from the first requirement to a design your contract manufacturer can build. One team covers discovery, electronics, firmware, mechanics, prototypes and design transfer, working under an ISO 13485:2016 certified quality system. 220 medical devices developed since 2015, Class I to Class III.

How a program runs: discovery (requirements, intended use, architecture, risk inputs and a phase plan with an hours ceiling), a proof of concept on the riskiest physics question, electronics, firmware and mechanics designed in parallel, functional prototypes and a golden sample, verification support and clinical builds, then design for manufacturing and transfer.

Typical sizes: small projects take 2,000 to 3,000 engineering hours (6 to 12 months), mid-size 5,000 to 6,000 hours (about a year), large programs such as ventilators or glucose monitors 10,000 to 30,000 hours. One published rate of $125 per hour, and the budget and timeline for each phase are agreed before work starts. If something we designed doesn't work as specified, we fix it at our cost.