Quality counts ...

"Active, invasive or implanted...?" These are terms of the three classes that have to be distinguished in medical products. "We want to be able to accompany the entire life cycle, including in-house product development and production," said representatives of the Institute for Human Centered Engineering (Hu-CE) at the Bern University of Applied Sciences (BFH). After all, the safety and health of patients are at stake. Ensuring this is mandatory for medical devices. The directives are strict, harmonised throughout Europe and accordingly require continuous quality control. Consequently, a certified quality management system is essential.

"Application-oriented" research in concrete terms
For manufacturers of medical devices, the ISO-13485 standard should be a matter of course in this context. But for an educational institute like the BFH? We asked Prof. Dr. Marcel Jacomet, Head of HuCE, about the most important reasons for the decision to obtain this certification. First of all, Marcel Jacomet refers to the role of universities of applied sciences: As is well known, their task is to provide practical training on the one hand and application-oriented research on the other at university level. "For me, application-oriented research in medical technology means that the Institute for Human Centered Engineering HuCE and the Bern University of Applied Sciences seek to be close to SMEs and conduct research together with them," says Jacomet. It is important that the engineers and doctors at the institute do not just "do research at the green table", but work together in teams with partners from industry and hospitals on medical issues and develop technical solutions. "At HuCE, we are particularly interested in implementing the solutions we find in med-tech devices, i.e. from prototype design to verification and validation," explains Prof. Jacomet. "Thus, it was obvious to me to breathe life into the term 'application-oriented' research, to introduce a quality management system and thus to have the Institute HuCE certified according to ISO-13485."

Complex certification
This was followed by the - for a university probably unique - certification process. The Bern University of Applied Sciences is now the first university in continental Europe to be awarded the ISO 13485 certificate. The path to this certification was not always easy, as Marcel Jacomet also admits. "The effort required to introduce the quality management system was clearly higher than expected. This is not only due to the numerous quality processes that had to be defined, but it was also necessary to sharpen the quality awareness of the young researchers in their daily research and development tasks." The field of "medical products" alone is complex: there are three product classes, depending on their effect on the human body. A stethoscope or a wheelchair have a low risk potential and are assigned to group 1. Products with a medium to increased risk, such as contact lenses, hearing aids or X-ray machines, fall under group 2. Cardiac pacemakers or knee prostheses, on the other hand, are classified in the 3rd class. These medical products therefore have the highest risk potential. So what exactly has to be proven for certification? There are various steps involved, as Marcel Jacomet explains: "Based on a first class 2a medtech device project, the team at HuCE has already completed the feasibility study, device development and device verification in parallel with the research. Design verification is well advanced and well on track, so that a first series of devices can be used in the planned clinical trial at Inselspital before the end of the year.

Separate subgroup created
Proving the conformity of the quality management system proved to be - as I said - time-consuming. So did the institute also have to make adjustments to meet the requirements? Yes, says Marcel Jacomet: "The Institute for Human Cognitive Engineering HuCE carries out applied research and development in six specialist disciplines with a focus on medtech applications. It would be overkill to involve our 70 or so researchers at the Institute in the introduction of quality management. We have therefore created a sub-group at the Institute, HuCE-microCert, which is certified in accordance with ISO-13485 and also operates a qualified class 7 medtech clean room. Depending on the objectives of a medtech project, individual researchers from the HuCE Institute are assigned to HuCE-microCert for the duration of the project and trained in accordance with the quality standard," explains the institute director. One of the conditions was that the HuCE-microCert research group and the medtech clean room should be operated in a separate location from the UAS training, which is why the corresponding space was rented at the Switzerland Innovation Park (SIP Biel) and the rooms - office, R&D, clean room - were set up.

Access to the European market
With the certification obtained, the HuCE is a valuable research and development partner for SMEs in medical technology. To what extent has the certification already had an economic impact? "The effort and therefore the costs involved in the decision to have the Institute certified at the Bern University of Applied Sciences in accordance with the ISO 13485 quality standard were secondary," says Marcel Jacomet. The primary goal is to follow up the principle of conducting application-oriented research with action. The first cooperative ventures with industry and hospitals have already materialized, which would hardly have come to fruition without the HuCE's quality management system or the clean room. And since educational institutes are in competition with each other, especially in the area of application-oriented research - also internationally - the ISO 13485 certification can be an advantage for the BFH. It facilitates access to the European market. And last but not least, the HuCE sees itself increasingly as a partner for SMEs: "In applied research, it is important to really understand the needs of SMEs," says Marcel Jacomet, "This certainly begins with the clear description of a problem from industry, but it often only becomes really exciting when you also understand the consequences and the boundary conditions created by a solution approach found for the implementation of a product idea. By involving HuCE researchers, engineers and doctors in medical technology, development and manufacturing processes, valuable experience is gained which further increases the attractiveness of our university of applied sciences graduates for SMEs."