Projects in Brazil

The acronym "NUTES", which may not sound very scientific at first glance, stands for "Núcleo de Tecnologias Estratégicas em Saúde", meaning “Center for Strategic Technologies in Health Care“. The establishment of this center is being funded by the Brazilian government. The choice of location fell on Campina Grande in the state of Paraíba in order to promote the state development. The goal is to improve the quality of software-intensive medical products. This goal also envisions that the center shall perform the certification of software intensive medical products.

In Brazil, the certification of medical products was introduced by the Brazilian Ministry of Health in 1993. Since then, the certification process for hardware has been improved significantly, but software as an integral part of modern medical products has not been taken into account yet in the certifications performed today. Including software in safety-oriented development does not only mean developing software safely, but also means, in particular, developing safe software. In other words: If you want to develop software in a structured and engineering-style manner, there is no escaping the topic of risk management of software-intensive systems. General due diligence and international standards such as IEC 62304 cover this by demanding a structured process and by also referring to ISO 14971, which demands systematic risk management.

In order to master this challenge, the project partner relies on Fraunhofer IESE, which is considered as an important competence carrier in the area of software and systems engineering for medical products and is one of the leading institutes when it comes to the risk management of software-intensive systems.

The task of the scientists and engineers of IESE is to package the requirements on the development and certification of software-intensive medical products within a relatively short project duration in such way that NUTES will be enabled to certify software in accordance with the state of the practice and pertinent standards.

However, there are not only technical issues that must be mastered in the context of this project. The cultural differences and the distance to the customer also constitute interesting additional conditions for the project. Thanks to several Brazilian scientists working at Fraunhofer IESE, there are no difficulties in overcoming these challenges. At IESE, collaboration between staff from different nationalities and cultures is rather the norm than the exception.

"In the NUTES project, issues must be dealt with effectively and efficiently", says project leader Sören Kemmann. This also includes that the goal is not only to answer the question of "What" must be done, but also to look at the "Why" and the "How". Previous projects have shown, for example, that providing guidance to a company on how to reflect on its own on the topic of "standard-conformant development" has increased flexibility and efficiency when it comes to implementation in the company. Effectiveness and efficiency also mean that we are not striving to provide off-the-shelf solutions, but rather that results are delivered that are adapted individually and precisely to the needs of the project partner. This is the only way to avoid iterations for adaptations and rework right from the start.