New product development process in medical technology

In medical technology, it is not enough to simply develop a new product. It must also be clearly regulated how to proceed - and in such a way that the regulations in Europe (MDR, or ISO 13485) and the USA (FDA 21 CFR 820) are fulfilled. At the same time, this process should be understandable for everyone involved and feasible in everyday working life.

A leading international medical technology company wanted exactly that: to create a new product development process that could do both - be compliant and applicable. We were able to support this project: from the conceptualization of the "backbone", to the detailing in process and work instructions as well as templates, to the testing in pilot projects and the company-wide introduction with accompanying training.

The new process was developed together with internal experts from Development, Supply Chain and Regulatory Affairs. We have contributed our experience from our own work in R&D and from numerous projects for the development of product creation processes. The result is both technically sound and tailored to the needs of the organization.

This was not about a textbook model, but about specific questions:

• What roles and responsibilities are really needed? Which documents are necessary?
• How can the individual work steps be coordinated in a meaningful way? What are the interfaces to other processes, such as risk management or usability?
• What is absolutely necessary from a legal perspective - and what simply helps in everyday life?

We created some key documents ourselves, such as the role matrix and a glossary. We also supported the team with targeted moderation and our experience.

A standard-compliant process was thus developed. To find out whether the new process also works in practice, we tested it in three real development projects:

1. an "as if" simulation of an already completed project with an existing product file

2. application in an ongoing project in the requirements phase

3. the real "lifting" of a product file for a simple medical product

We methodically accompanied the pilots and evaluated the findings together with the team. What worked well? Where were there problems in the application? Based on this experience, the process was sharpened in a targeted manner - pragmatically and in a way that could be connected.

Parallel to refining the process, we have developed a two-stage training concept:

1. Read and Understand: employees were required to read and understand the key process instructions.
2. classroom training or eLearning: we conveyed the ideas behind the process on site (or digitally) - key discussions from the development team, typical application scenarios, deliberately without going into too much detail.

This second part in particular was crucial to increasing acceptance of the new process. The training sessions were supplemented by regular consultations with managers. This ensured that the process was not only formally introduced, but actually understood and practiced.

The new process is now in use in the company. It meets the legal requirements and is being used in practice. Initial ideas for increasing efficiency - for example in documentation using generative AI - are already being pursued, but have so far only played a minor role.

This project has shown: Even in highly regulated industries such as medical technology, processes can be developed that are both legally compliant and suitable for everyday use - if those involved are involved at an early stage.

It is not enough for a product development process to be formally correct - it has to prove itself in everyday working life. Only then is it truly connectable. And only then can typical application problems be avoided - and the number of anomalies in the next audit be reduced.