Medical Device Design & Development Services

Not sure where to start? A fixed-scope feasibility study clarifies what your device needs before committing to full development.

Five development phases

Medical device development under ISO 13485 follows a defined arc. We master all five phases. We step in at whichever one you need, and we stay as long as we are useful.

The flexible partnership model

Medical device development projects may run 5 to 8 years. Some stop for funding. Some get acquired. They restart. We do not sell a fixed engagement model, we act as the complement your team needs at each phase.

→ No internal R&D team? We cover the full development arc from user needs to design transfer.

→ Strong engineering team but gaps in regulatory documentation? We fill them without taking over the project.

→ Stuck on a specific technical problem? We solve it and hand back.

→ Need dedicated engineering capacity near surgical expertise? We have had client engineers embedded in our IHU offices for extended periods.

We enter where we can make a difference. When a client hands us a brief we think could be improved, we say so because getting the design right at phase 2 is always cheaper than fixing it at phase 4.

Not a methodology.

IEC 62366-1 (Usability Engineering for Medical Devices) is a regulatory requirement in Europe and the US. It exists because a technically flawless device can be dangerous if its use is ambiguous or prone to error. We treat usability as a design constraint from day one:

· Design inputs written from the user's perspective.

· Prototypes evaluated by future users before the design is frozen.

· Use error analysis integrated into our ISO 14971 risk management process.

· When a surgeon picks up a prototype and hesitates, we treat that as a design problem, not a training problem.

A culture.

We design for humans who do not always read manuals, who work under pressure, and who will not adapt their technique to a device that does not feel right. That constraint produces better engineering.

Protomed - design philosophy

ISO 13485 design controls: built in, not bolted on

Our five-phase development method is built around ISO 13485 design control requirements. An in-house quality manager oversees this from the start. The DHF is built in parallel with engineering.

Design and Development Plan maintained throughout

Design inputs documented, reviewed, and approved before concept work begins.

Design outputs traceable to design inputs.

Phase-gate design reviews, documented with action tracking.

Design changes controlled, risk-assessed, and recorded.

Complete Design History File (DHF) maintained for every project.

Why protomed for medical device design & developement?

Engineering with clinical context

We are located inside the IHU Strasbourg. We observe surgical procedures, test prototypes with real surgical teams, and integrate clinical feedback into design iterations. Most engineering firms do not have this access.

We assess briefs with a fresh eye. When we see a decision that will create problems downstream, we raise it and explain why.

Honest design partnership

Flexible engagement model

Full project ownership or targeted support on a specific phase. We adapt to your team structure, funding stage, and constraints.

Start your design & development project

Tell us where you are. What you have already defined, what remains open, and where you need engineering support. We respond within 48 hours.

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