Agile Product Development in Medical Technology

Faster, cheaper and one hundred percent compliant. Medical technology companies have to overcome enormous challenges regarding their product development processes. These challenges can rarely be tackled with traditional approaches like the waterfall method, as they are too expensive, too slow and rather far-fetched for the present needs.

This is where the management framework Scrum enters the stage. While it may have become popular in the mid-90s in the software industry, Scrum has by now found its way into the medical technology sector. The main reason is that Scrum simplifies the requirements analysis while dismantling the complexity of product development into manageable cycles – for hardware as well as software or PEMS. Furthermore, as proven by the AAMI TIR45, the agile approach complies with the framework of existing regulations.

How does Boris Gloger Consulting work?

Agile product development safeguards the uniqueness of your organisation, while preparing you for the increasingly dynamic market of medical technology. Our overall goal as consultants is to make ourselves redundant as quickly as possible. It is you and your employees who should work, produce and live in an agile way. This is something we cannot do for you. However, we can help you with it.

We start with the necessary foundation. From the the first moment onwards, we create a shared understanding of the impact of Scrum for the organisation together with all involved parties (from development teams to top management) by using simple pictures, methods and techniques. It is important to us that the management plays an active role from the very beginning by being involved in making the necessary decisions and actively engaged in learning what it feels like to work with Scrum. It is necessary to engage everyone due to the fact that all levels of the organisation need to start trusting this new method of working.

With the implementation of Scrum, you will notice how job descriptions and employees’ tasks will change over time. Employees will start defining their new roles by themselves and not stick to the ones stated in their job description. Gradually, we bring in certain engineering practices, such as Continuous Delivery, and make sure to integrate the suppliers. It is fascinating to note how – after a while – the entire organisation starts to think about the new way of working.

Our Services

  • Consulting and coaching: conception and guidance during Scrum implementations
  • Basic training/ technical trainings like GIT/JIRA
  • Consulting for Scrum in IVD or RUO environments
  • We provide Product Owners and ScrumMasters

Scrum Board

Whitepaper & Case Studies

3 reasons for agile product development in the field of medical technology

The generation of new, revolutionary ideas has never been a problem for the medical technology sector in German-speaking countries. However, cost pressure and rigorous competition are starting to force highly innovative companies to deliver in shorter cycles.

It is difficult for companies to develop cheaper products faster while complying to strict regulations which demand top-quality technologies. Agile development frameworks, such as Scrum, can be the answer for this problem.

Nevertheless, this industry is facing bigger challenges than ever before.

» download whitepaper – English version


  • Roche PVT GmbH, Waiblingen, Deutschland
  • Qiagen Instruments AG, Halle, Deutschland