The medical technology sector is a fast-growing industry. With its help, the lives of many people can be improved or even saved. For good reasons, the development of new digital medical products and applications is significantly more complex than in most other industries. The highest quality standards are essential for the safe operation of a medical application. 

Digital software solutions must meet a variety of legal and regulatory requirements for quality assurance, usability, and risk control so that they can achieve certain approvals or certifications for market launch and ongoing distribution. Medical applications undergo a strictly regulated process during their development, in which each step must be evaluated and documented in compliance with standards. In addition to data security issues, which require confidentiality, integrity and availability, the stability and reliability of the software is also crucial here.

Even the methodology with which software is developed can have a significant influence on the quality of the software. Long development cycles with irregular tests and deployments invariably bring with them a high susceptibility to errors. Bugs that only become apparent after weeks or even months of development are difficult to fix. Cumbersome workarounds carry the threat of undesirable side effects. The risk of introducing further bugs or overlooking existing ones is high. While all of this may be extremely annoying in conventional applications, it is absolutely unacceptable in medical technology products. In the best case, the product fails certification; in the worst case, people get hurt.

How can errors in the software be avoided to the greatest possible extent during the development phase? An key factor here is the right choice of methodology. Extreme programming and DevOps are particularly suitable for the development of medical software products: Every development step, no matter how small, is deployed and tested automatically by the development team using a dedicated test and deployment (CI/CD) infrastructure. Errors in the code can be detected and corrected immediately. Feedback gained in this way is incorporated directly into the development process. This not only increases the speed at which software is developed, but also has a significant impact on its quality. Extreme programming makes it possible to build prototypes quickly in short iterations (rapid prototyping). The stability and reliability of software products and features required for medical devices are always guaranteed. Both Extreme Programming and DevOps improve the quality of software, reduce the time to market for new products and increase the efficiency and productivity of the development team.

With the consistent use of pair programming, the code is continuously reviewed using the dual control principle; errors are detected much more reliably and quickly. Problems can be solved more easily when two people are involved in problem solving. In addition, the entire team shares responsibility for the code and follows a common coding standard. This increases code quality, reduces errors, and simplifies code documentation and traceability.

The development team must be able to organize itself and respond quickly to feedback. Team and organizational structures must therefore be (re)designed in a way that enables the development team to provide fast feedback loops and the greatest possible scope for reaction. Since the development team in the medical field has to comply with strict regulations during development, it must be able to make independent decisions according to the best-practice approach in order to find simple but functional solutions for the product or feature within the framework of the specifications. If the team has to fight against rigid architecture specifications from decision-makers outside the team, software quality inevitably suffers.

Conclusion: The DevOps mindset and the consistent use of Extreme Programming practices offers development teams and companies significant advantages over traditional and rigid waterfall methods. Strict regulations can be successfully accommodated with the best practice approach without sacrificing software quality. Open coding standards enable easier documentation and traceability of code, facilitating the implementation of regulatory requirements. The dual control principle and an automated deployment and test infrastructure minimize the risk of errors during development. Products reach market maturity faster. Teams work more effectively - which not least has an effect on the satisfaction of the team and thus in turn on the software quality.