Medical Device Prototyping

Medical device prototyping builds physical versions of a device to test form, function and safety before design freeze. It runs from early looks-like models through functional engineering builds to design-verification units made from production-equivalent materials and processes, which are the ones regulators care about.

Our team prices each build by its process stage and the device's complexity class. A looks-like model is part of Concept Design (stage 2), typically $2,000 to $25,000. A functional electromechanical prototype is Alpha Prototyping & Testing (stage 6), typically $2,000 to $30,000.

A design verification build in production-equivalent materials is Beta Prototype (stage 7), typically $1,000 to $30,000. Ranges are labor only.

Regulated medical devices, connected products with app and cloud backends, and large automated or industrial systems often run above Class D, because certification, regulatory documentation and software sit outside these ranges. Our team quotes them stage by stage after Stage 1.

Early models use standard SLA and FDM resins. Functional builds move to engineering thermoplastics such as PC, ABS, PEEK and USP Class VI silicones, plus stainless steel and titanium for anything load-bearing or implantable. Patient-contact prototypes should use materials with an existing biocompatibility history so ISO 10993 testing later is not a surprise.

Exploratory prototypes do not, and forcing design controls onto early concept work slows learning for no benefit. Once you enter design inputs and verification, the work falls under 21 CFR 820.30 design controls and should be produced under an ISO 13485 quality system with a documented design history file.

A first functional prototype usually takes 6 to 12 weeks. Verification builds add 8 to 16 weeks because of documentation, supplier qualification and test scheduling. Sterilization validation and biocompatibility testing usually run in parallel and set the critical path.