Services · Phase 3
Design engineering and development for medical devices and combination products.
Develop the mechanisms, systems, requirements, prototypes, and technical solutions that turn product concepts into manufacturable, regulated products — with design controls and risk management integrated from day one.
When teams call us in
- A platform program needs an architecture call before downstream work commits.
- A novel mechanism — pump, valve, optical path, microfluidic system — needs cross-functional engineering judgment to close the cheaper-faster trade space.
- Design-controls artifacts and engineering reality have drifted apart and need to be re-aligned.
- Manufacturing readiness is uncertain and the design needs a hard DFM pass before tooling investment.
How we approach it
- System-level architecture first, with explicit subsystem interfaces and an integration plan.
- Requirements developed alongside design — design inputs engineering can actually verify.
- Design-for-reliability and FMEA driven by ISO 14971 hazard analysis, not done as a parallel exercise.
- Verification strategy designed up front, not improvised under a milestone.
Typical deliverables
- System architecture and trade studies.
- Mechanical, fluidic, optical, and systems design.
- System and subsystem requirements decomposition.
- Engineering prototypes and breadboards tied to design verification.
- FMEA aligned to ISO 14971 risk management.
- Verification strategy, protocols, and design output package.
Frequently asked questions
- What disciplines does design engineering cover?
- Mechanical, optical, fluidics, and systems engineering for instruments, consumables, and combination products — with adjacent fluency in firmware, software, and biology/chemistry interfaces. The principals have led design engineering at unit volumes ranging from prototype quantities through hundreds of thousands of units per year.
- Can you take a program from concept through verification?
- Yes. System architecture, breadboard and prototype, design-for-reliability, FMEA, GD&T, and verification protocols — coordinated with the design controls and risk management workstreams so design controls produce real evidence rather than retrospective documentation.
- How are requirements developed and traced?
- Requirements are developed alongside design rather than waterfalled in front of it. Design inputs trace from user needs and use specification through subsystem requirements, into design outputs, and onward to verification protocols. The traceability is structured for ISO 13485 / 21 CFR 820 design controls from the start, not bolted on later.
- Do you work with internal teams or external partners?
- Both. We embed with internal engineering when the program needs senior technical leadership in the room. We also work alongside contract manufacturers and design houses when the program is run by external partners and the firm needs an independent technical owner.
Working on a design engineering challenge?
Engagements typically start with a scoping call to map where the program is in the lifecycle and the decision you are facing.