Responses to pressing questions on the European Medical Device Regulation (MDR)

A lot is happening right now in medical technology. It can be attributed to the European Medical Device Regulation (MDR). As part of the 1st forum on risk management of medical products by DIETZ Consultants, Franz Josef Schmitt (Fresenius Medical Care Deutschland GmbH), Matthias Loch (Ottobock SE & Co. KGaA), Christof Schmeer (pfm medical ag), Jens Rosenstein and Manfred Ast (both B. Braun Melsungen AG) answered the questions of the moderator Gregor Heilmaier. The forum confirmed that the many small and medium-sized enterprises have to face major challenges right now so as to realise the imminent normative, official and legal requirements. The experts also answered pressing questions on standards, regulations and challenges in medial technology, the role of risk management and what the industry can learn from other industries like the Automotive industry.

Franz Josef Schmitt, how has the development of medicinal products changed over the recent years?

Schmitt: That is not at all easy. The systems have become increasingly complex. Software is always being integrated; the standards are becoming more and more strict and intensive. Sometimes it feels like one does not work for new developments at all, but only keeps developing to conform to norms.

At the 1st forum on risk management of medical products, what has been your perception and were there any special inspirations, which have reinforced this assessment?

Schmitt: It has certainly strengthened the lecture on MDR. It is really incredible what all it entails. We have already recognised a lot of that at Fresenius Medical Care. We are there to build a team to realise the requirements. We have already achieved a little, though we still have to bring it together in detail. That is one challenge, which has to be countered for a large company. But for a small company, I can hardly imagine that it will work.

Therefore, it remains exciting. Matthias Loch, what are the challenges faced by the industry in the development of medical products and what is it that especially must be taken into consideration?

Loch: I can only agree there with Mr. Schmitt. What exactly we are going to face in terms of standards and laws has not been defined precisely to an extent and must be defined more exactly and specific to a company. That is where I see a major challenge. Furthermore, we are also faced with the problem of finding or training personnel who can implement the innovations. For that, one must be tech savvy to promote developments, but also should keep the documentation up to date, which is mandatory.

Were there any special inspirations in the forum?

Loch: There have been new findings with respect to the new MDR requirements. As we primarily produce class 1 products, it is easier for us as compared to manufacturers of class 2 & 3 products. I think that a lot of smaller companies, who do not have the necessary means, are facing major challenges here to fulfil the new MDR standards.

Christof Schmeer, what is your opinion? What is the role of risk management in the development of medical products and what is the practical influence of standards and regulatory requirements on it?

Schmeer: Yes, what is the role of risk management? Let me put it this way: Years ago, we had the development, business and manufacturing processes and then parallel risk management. Not so any more. Today, we have risk management that covers the entire company. MDR is the first law wherein the legislator stipulates a risk management across all areas. That gives risk management a whole new importance with respect to development and the entire company.

Jens Rosenstein, what can development of medical products learn from other industries like Automotive with respect to risk management?

Rosenstein: We are very focussed on our norms and standards. A lot of standards now recommend: Take in a somewhat broader view; do not remain stuck at medical technology. For example, in case of white goods, we have discovered things that were very well specified; sometimes in great detail and even a little higher than the safety requirement.

Manfred Ast, you have been in the industry for 27 years. What is the role of companies like DIETZ Consultants, with its special know-how and its experience in FMEA and risk management, in the development of the industry?

Ast:I cannot speak about development of the industry. But speaking for us, I can say that we are not striving for an isolated solution. We also want to learn and integrate other experiences to carry out optimised FMEA. If we only take a look at ourselves, we cannot work optimally. We notice that in certain areas and have also picked it up from many discussions with DIETZ Consultants. There is one or another aspect, which we have already integrated and which helps us further.We need this experience and that is why we are here, besides other reasons. So that we can carry out discussions, share our experiences and have other experiences. I like that and we will continue to do that.

Franz Josef Schmitt, you have also been involved for a long time. What do you think. How can networks and events like the forum on risk management of medical products help in managing known and emerging risks in the digital age?

Schmitt:I have been involved for 10 years, also many years at FMEA forum of DIETZ Consultants in Osnabrück and I have selected the best for the user from these forums, in these years for the entire system that we have built up at Fresenius. As regards networking, I find that one can conduct dialogues very well during the forums themselves and can have an interchange of experiences. But nothing more actually happens after that. Even when people say that I will get back to you, no one mostly does. In your day-to-day business, you could certainly think more about it.

When one is attending such forums, one tends to think a little bit more freely in the future; how could one shape something? But daily implementation is also day-to-day business. And here in this respect, these forums and the information obtained from them are outstanding. One gets the best out for his own development.