Challenges of software certification for startups in the medical technology industry

Nowadays, hospitals heavily rely on all sorts of medical devices to treat or diagnose patients. It is important to build trust in medical technology through standards and certificates. To ensure that they work in a safe and effective way, governments introduce legal regulations such as the Medical Devices Regulation (MDR). From a manufacturer's perspective, a large amount of technological documentation has to be completed. According to MDR, manufacturers are obliged to provide technical documentation containing a huge amount of research. Companies now have to have to budget for additional resources to learn about all requirements, create and maintain the documentation. The manufacturing costs are thus increasing, at the same time the offered value of the product remains unaltered. The time-to-market is also drastically delayed, therefore the revenue is delayed, and it leads to poor company performance.

From a startup perspective, we should research how obligations of the Regulation need to be fulfilled in order to place compliant devices on the market. Further, we want to take a look at the internal business processes of big and small companies and see how compliance with MDR is ensured. The following research questions are defined:

1. What are the main challenges of compliance?

2. Are there any processes already in place to deal with the challenges?

3. How can a startup bring a new product onto the market?

The main goal of this thesis is to conduct a market analysis and identify challenges, processes and strategies to ensure compliance with MDR. To answer the second question, semi-structured interviews should be conducted with small manufacturers, that have implemented the new requirements of MDR. We are interested in the solution process of the company to meet the regulations.

A poster ("Landkarte") is to be created that should contain a summarized overview of the main research topics and challenges, as well as the results of the research. It should contain the necessary process steps, measures and documents to successfully and efficiently develop a new compliant medical device from scratch. The poster should be able to serve as a guide for people unfamiliar with the subject.