The DGBMT is not a (registered) association, which distinguishes it from many other medical technical societies. It was founded independently of any federations in 1961 and later joined VDE in 2001. Since then, the DGBMT has no longer been a separate legal entity, but in every other sense it remains independent. It has its own members’ assembly, its own bylaws and its own electoral regulations. VDE only gets involved in “formal legal issues”, such as cooperation contracts.
As with every other technical society, it’s the individual members who define the character of the DGBMT. Its large number of personal memberships distinguishes the DGBMT from other federations such as BVMed and Spectaris, which also work on similar topics. “The members of federations are industrial corporations, and so federations tend to pursue industrial politics,” says Dr. Schlötelburg. “In our case, our personal members elect the management board. We’re a neutral technological platform driven by technical and medical expertise.”
The DGBMT has about 1,600 personal members. The largest group consists of engineers from the fields of medical technology, biomedical engineering, information technology and physics. These technical developers come from universities and applied research institutions. They are flanked by their colleagues from medical technology companies, who make up the second largest group of members. There are also members from medical practice, as well as from technology-related subjects such as anesthesia; ear, nose and throat medicine; surgery; cardiology and, of course, radiology. They are joined by staff from various authorities, employees from notified bodies and people involved in mediator organizations.
It’s a mixed bunch, in other words, which is something the DGBMT takes pride in. “We’re an interdisciplinary network that deals with medical technology and biomedical engineering in a supporting capacity on several different levels,” Dr. Schlötelburg explains. Interdisciplinarity needs to be organized well. That's why the nine-member DGBMT management board adheres strictly to its set quotas: there are always three board members from the academic world, three from companies and three from medical practice. Its annual conferences – major events that draw up to 1,000 participants and even continued during the pandemic – also serve as showcases for interdisciplinary cooperation.
Medicine and technology: finding a common language
The DGBMT features 23 technical committees. One of the largest is the Biosignals committee, which publishes the Signals for Life podcast. The committee specializes in measurable signals in the human body, from bioimpedance to ECGs. It’s all about developing sensor technology and its clinical applications, which is a perfect example of how nothing is possible without interdisciplinarity. However, Dr. Schlötelburg admits that this isn’t always easy. “Finding a common language is a real challenge,” he concedes. That applies not only to the interface between technology and medicine, but between academic and commercial research, as well. Not to mention to connections with information technology: “We had a network project with IT experts and engineers where we’d had something like ten sessions and still hadn’t managed to define a space where everyone was talking about the same issue.” It’s also difficult to find the staff resources on the clinical side. Those who perform operations can only do research in their spare time. “Finding time when you can link up with those people can be difficult,” Dr. Schlötelburg points out.
Another area of focus for the DGBMT is the EU Medical Device Regulation (MDR). “That has changed everything – not only in the industry, but also in research,” Dr. Schlötelburg adds. Longer development cycles mean that a new concept for patenting is needed. There are always new hurdles for clinical research to overcome, and entire catalogs of standards also have to be adapted to the MDR. The DGBMT provides support with position papers and recommendations for companies, research institutions and politicians. It’s not easy to be heard by the latter. “Another special thing about the DGBMT is that we have three places we can reach out to: the health ministry, the research ministry and the economic ministry. It’s always been a challenge to get them all on the same page,” says Dr. Karsten Seidl, the chairman of the DGBMT. In the area of digitalization, data protection and data security are major issues. Access to digital healthcare data for research purposes is high on the agenda due in no small part to the Health Data Use Act (GDNG). And then there’s always the regulatory landscape in the field of artificial intelligence. On this subject, the notified bodies in Germany have announced that they believe continuously learning AI systems cannot be certified as medical products. Is that true? The DGBMT sees one possibility: “We’re providing specific guidance on how certification under the applicable MDR could be structured. That's been a really important topic in the last few months.”
AI, scarce resources, a lack of specialists
The MDR and digitalization (including AI) will continue to keep the DGBMT and its 1,600 members busy in the coming years, just like the long approval times that urgently need to be reduced. At the end of September in Duisburg, Germany, the 57th DGBMT annual conference had some specific figures in store for its attendees: until just recently, the general wisdom held that it takes about 10 years for a breakthrough innovation to become an approved medical product. At the moment, though, it tends to be more like 15 years. “If that figure rises to 20 years, it’s game over,” declares Dr. Schlötelburg. Experts have been emigrating to the USA for many years. “In the past, people always said they were thinking about it. Nowadays, they’re all already there.”
The DGBMT on its own won’t be able to make Europe attractive again as a center of medical technology. But it can certainly make a contribution. The DGBMT can also take credit for the postponement of important MDR deadlines, which was the focus of concerted efforts from many sides. How can this technical society continue to improve? According to Dr. Schlötelburg, by achieving even greater interdisciplinarity and doing even more to incorporate expert circles, particularly in medicine. One particular platform that is constantly growing in importance in this regard is the Association of the Scientific Medical Societies (AWMF), where the DGBMT has been an associate member since 2007. Requests for comments are always arriving at the door of the DGBMT via the AWMF. Bottlenecks in the supply of medical products are a current example. The borderlands where clinical medicine, medical technology and politics meet are a busy place in times of scarce resources, a lack of specialists and increasingly intelligent software. As usual, the DGBMT is right in the thick of it.
Philipp Grätzel von Grätz works as a freelance journalist in Berlin and makes connections between topics relating to medicine and technology.