Medical Device Design Agency Germany – Eckstein Design

Medical device design is a discipline of its own. Here, technological complexity, regulatory requirements, and the highest expectations for use safety meet – and today's design flaw becomes tomorrow's use error in the OR. Eckstein Design develops medical devices that resolve this tension: user-centred, standards-compliant, and visually convincing. From radiation therapy systems and surgical instruments to portable organ transporters, we have realised products that perform in clinical practice and differentiate their manufacturers in the market.

As a medical device design agency based in Germany, we bring German engineering precision together with deep MedTech experience. Our interdisciplinary team of designers and engineers guides MedTech companies, start-ups, and development leads from the first idea to series release – across the DACH region and internationally. With more than 300 serial products, over 50 design awards, and references such as Brainlab, Wisap, VDW, and 3M, we are among the most experienced partners for medical design in Germany.

Medical technology is undergoing a paradigm shift. Users now expect a diagnostic device or an OR control to offer the same operating quality they know from their smartphone – self-explanatory, responsive, no manual required. Disappointing that expectation risks not only frustration but use errors. And in medical technology, use errors are a safety risk.

User experience therefore carries the same weight in medical technology as technological performance. A device that works intuitively under the pressure of clinical routine is used more safely, accepted more quickly, and operated incorrectly less often. This is not a soft factor: studies such as McKinsey's Business Value of Design demonstrate the link between design competence and business success – and medical technology was one of the three industries McKinsey studied to prove it.

For us, medical design is therefore a strategic tool. It brings use safety, usability, and market differentiation together – turning a technically strong product into one that people trust.

Medical device design begins with the question of what role a product plays in clinical routine – and ends with a solution that is safe, standards-compliant, manufacturable, and visually convincing. We cover the entire path.

Good medical device design does not happen in a regulatory vacuum. Considering requirements only at the end of development means paying with expensive correction loops. We therefore design so that regulatory requirements are built in from the start – and we are clear about one thing: we do not replace regulatory consulting. We are your design agency that thinks in regulatory terms. For companies entering the European market, our MDR-aware, CE-marking-ready design process is a distinct advantage.

IEC 62366-1 – usability engineering

IEC 62366-1:2015+A1:2020 describes the process by which manufacturers analyse, specify, develop, and evaluate the usability of a medical device as it relates to safety. It is recognised as the generally acknowledged state of the art. This is where our hands-on competence lies: user-centred design with documented formative and summative evaluations.

MDR (EU) 2017/745

The Medical Device Regulation requires, in Annex I, Section 5, that risks related to ergonomic features and the intended use environment be reduced – taking into account the knowledge, experience, and physical conditions of intended users. What the MDR means for product design, we translate into concrete design decisions.

ISO 13485, FDA awareness, and the Design History File

We know the demands of quality management to ISO 13485 and work so that our design process fits cleanly into your QM structures. We also bring experience with FDA-relevant projects – the X-Therma TimeSeal received an FDA Breakthrough Device Designation. A well-run design process delivers the evidence the Design History File requires almost by itself.

Our experience ranges from Class I to Class III medical technology. This breadth is not coincidence but method: good design principles transfer. The fields that occupy us most right now are shown in our Lab/Med/Dental trends.

Developing a medical device follows a structured path. We interlock design, engineering, and strategy across all four phases – not sequentially, but iteratively.

Phase 1 – Concept & Feasibility

We clarify clinical need, use context, and feasibility. Early concepts and models make assumptions testable before development costs arise.

Phase 2 – Design & Development

Form, interface, and construction emerge together. Usability requirements per IEC 62366-1 are built in from the start, while manufacturability and material choice are developed in parallel.

Phase 3 – Verification & Validation

Formative and summative evaluations confirm that the design meets its requirements. We deliver the usability evidence that feeds into the Design History File.

Phase 4 – Commercialisation

Design transfer, series support, and post-market feedback close the loop. More on our design process.

Every project has its own challenge. What connects them: a clear clinical starting point, a user-centred process, and a result that proves itself in the care setting.

Medical technology is a core competence here, not a niche – for more than 15 years. Design and engineering work under one roof, without interface losses between separate service providers. Managing Director Stefan Eckstein brings design and ethical authority as a Red Dot juror and project lead of the VDID Codex. Add an interdisciplinary team with medical technology expertise and references such as Brainlab, Wisap, VDW, and 3M. We work across Germany and internationally, with established remote processes and the CET time zone making collaboration efficient regardless of location. Our roots in industrial design and our medical design studio combine technical depth with design quality.