Medical Device Prototyping Services

ISO 13485-compliant prototyping for minimally invasive devices: from proof of concept to First-In-Human prototype.

Protomed is a medical device developement and prototyping company based in Strasbourg, France. We specialise in mechanical engineering and materials science of minimally invasive devices: delivery systems, multi-lumen catheters, endoscopic and laparoscopic accessories, and surgical instruments. ISO 13485-certified, we build prototypes that hold up under clinical scrutiny.

From a founder's first sketch to a pre-clinical prototype ready for animal testing, we cover the full development arc. And when a project calls for it, we move fast. Our fastest turnaround: project kick-off in 15 days, first functional prototype delivered in 3 weeks

3

weeks

Fastest delivery: first functional prototype from project kick-off

See what we prototype

Not sure if your concept is technically feasible? Start with a fixed-scope Innovation Sprint.

What we prototype

Mechanical and materials engineering only, no embedded electronics or medical software.

Our prototyping process: from PoC to submission-ready prototype

We work in four stages. The pace at each stage depends on your project's maturity, funding situation, and technical complexity. Some clients move through all four in months. Others need to pause between phases to raise capital. We adapt.

The frugal engineering approach

Before we build anything bespoke, we look for what already exists. We have used LEGO motors to validate a mechanism in a proof-of-concept. We have designed atraumatic tips with threaded connections so they screw onto the catheter body instead of being glued, because it means you can swap tips without scrapping the whole catheter. That kind of problem-solving comes from engineers who actually make things. It is the différence between a prototype that teaches you nothing and one that tells you exactly what to do next.

Our Protobrix platform extends this philosophy: a modular toolbox of components and validated sub-assemblies that shortens development cycles for common architectures in MIS device design.

Working on a delivery system or catheter? That is our core territory

Tell us what you are building, we will tell you how fast we can move.

Why work with us ?

Full in-house capability

CAD design, injection moulding, 3D printing (SLA + FDM),coating, rotomoulding, mechanical assembly all under one roof. A change identified in testing is implemented the same day.

MIS specialists, not generalists

We focus on biomechanics and materials for minimally invasive devices. We do not do electronics or software. That focus means we are very good at what we do and honest about what we do not.

European hub, Franco-German border

Strasbourg sits at the centre of European medtech. German and Swiss clients choose us because we combine European regulatory expertise with native German-speaking engineers and true cross-border proximity.

Who we work with?

Our clients range from surgeons with a clinical insight and no prototype, to R&D managers at hospital institutes arriving with a device in their bag, to startup founders preparing a seed round. What they share: a technically complex challenge in minimally invasive device development, and a need for a partner who will engage with the specifics and not hand them a generic process.
We work with medtech startups and spin-offs, university and hospital R&D teams, established device companies needing external prototyping capacity, and individual inventors at the earliest stages of development. We adapt to your stage, your budget, and your constraints. And when a project is genuinely outside our expertise, we say so and help you find who can do it.

Start your prototyping project

Tell us about your device. What phase you are at, what you have already built (if anything), and what you need to validate. We will respond within the week with an initial assessment of whether we are the right fit and if so, what a first engagement could look like.

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