Medical device product development from concept to production

We define the clinical need, intended use and likely classification before drawing anything.

• Intended-use statement and indications
• Predicate device scan and pathway options
• Preliminary hazard analysis
• Budget and timeline modelled against the pathway

Multiple concept directions tested against real workflow, not a showroom.

• Concept CAD and ergonomics studies
• Formative usability sessions
• Material and sterilization shortlist
• Design inputs frozen

The device becomes real in target materials, with test coupons for the claims you need.

• Production-intent CAD and drawings
• Functional prototypes for bench testing
• Tolerance and sealing validation
• Biocompatibility material dossier started

Tooling, fixtures and a documented build so the first units are reproducible.

• Tooling and fixture design
• Pilot run with build records
• Inspection and acceptance criteria
• Supplier qualification support

Bridge production while volume ramps, with a change process that keeps the file intact.

• Short-run manufacturing
• Controlled engineering changes
• Cost-down on the consumable
• Scale-up to a contract manufacturer

Class I devices with no electronics commonly run in the tens of thousands through design and prototyping. Class II devices with electronics, biocompatibility testing and a 510(k) pathway are typically a multi-hundred-thousand-dollar program across all parties. We scope in phases so you can stop, pivot or raise between them.

Six to twelve months from concept to verified prototype is realistic for a straightforward Class II device. Regulatory review, clinical evidence and tooling extend beyond that. Sterilization and biocompatibility testing are the two schedule items that most often surprise first-time teams.

We produce the design and engineering evidence a submission relies on - design history documentation, verification data, risk analysis, human factors records - and work alongside your regulatory consultant. We do not act as your regulatory agent of record.

Yes. Many clients start with a proof-of-concept or a functional prototype to test a mechanism, secure a grant or run a clinical conversation, then decide whether to continue into a regulated program.

Regularly. We have supported Phase I and Direct-to-Phase-II SBIR awards, and we can scope work to fit a specific award budget and reporting period.

Yes. Our short-run manufacturing line builds clinical and pilot quantities with build records, so trial units and production units come from the same documented process.