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.

A looks-like model typically costs $2,000 to $8,000. A functional electromechanical prototype runs $15,000 to $60,000. Design-verification builds using production-equivalent materials and documented processes commonly run $50,000 to $200,000 because each unit must be traceable.

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.