ENTWURFREICH
Medical Product Development – Playing by the Rules

Medical Product Development – Playing by the Rules

2024-01-15

MDR 2017/745/EU – CE – ISO 9241-210 / IEC 62366 / ISO 9001

Playing by the Rules

Following the rules is essential for a successful medical product. But knowing how to implement those rules — and push them to their limits — makes all the difference. Our multidisciplinary team at Entwurfreich is well versed in the relevant standards and regulations, guiding you through the complex regulatory landscape of the healthcare sector.

Our user-centered design process for medical products is based on IEC 62366 and enhanced with proven milestones and methods from practice. This guarantees a usability-oriented development process that ensures cost efficiency and on-time delivery.

Our Medical Design Process

Process

General Requirements

Planning

Planning holds a critical position in our process and is carried out meticulously by our entire team. In addition to trend and design analyses, the initial usability activities are mapped out for the whole project lifecycle.

Use Specifications

Analysis

First, the context of use is analyzed and users and user groups (intended users) are identified. Through various analytical methods — such as PCA analysis — potential interaction problems can already be detected at this stage. In parallel, markets and competitors are examined so that these insights can flow into the new development from the very beginning.

Analysis

Usability Specifications

Ideation

In this step, usage scenarios are created and initial foundational concepts are developed. The goal is to identify potential use errors and to prevent them early on by establishing inherent safety measures.

Usability Testing

Evaluation

Through early and iterative test cycles at a formative level, initial results can be tested cost-effectively. Potential problems can be identified at an early stage, contributing significantly to risk reduction by addressing issues during development rather than after.

Evaluation

Usability Implementation

Realisation

The USPs developed from the concepts are refined and interaction specifications are created. Prototypes are further developed and preparations for series production begin. Risk mitigation measures are defined.

Summative Evaluation

Release

This is where the final quality assurance review takes place. Concepts are assessed based on evaluation results and acceptance tests are conducted. The prototypes are refined to near-production quality and must meet all acceptance criteria.

Release

Risk Management

Documentation

Risk management is systematically integrated into every step of our work. The goal is to reduce risks during development. Through risk control measures, use errors are identified early and assessed, evaluated, and controlled through preventive actions. Our results can be directly incorporated into and documented in the risk management file.

Our Detailed Process

Download our Medical Design Process

Not Just Regulatory-Compliant Results

We develop designs holistically — from the perspective of the target audience, usability, and diverse manufacturing possibilities. Our experience and expertise enable us to create products that are not only regulatory-compliant, but also aesthetically appealing and innovative.

In our design development, we implement trends early, shape brand perception, and create desirability that sets our clients apart from the competition. Our multidisciplinary team combines creativity, innovation, and usability with a focus on production specifications and costs. This guarantees a manufacturable medical product even in the early phases of development.

Frequently Asked Questions

Yes, for over 10 years. We have developed medical devices from concept to market readiness — including dental microscopes, ventilators, surgical lights and health care wearables. Our process is based on IEC 62366.

Medical devices are subject to the EU Medical Device Regulation (MDR 2017/745). This means: usability engineering per IEC 62366, risk management, documented design validation and usability testing. We integrate these requirements into the design process from the start.

Like a classic design project — but with additional milestones: use context analysis, formative and summative usability tests, risk assessment and documentation for approval. We deliver results that can flow directly into the risk management file.