Growing importance of risk management in medical technology

Medical technology is an important economic factor and an equally major employer in Germany. Around 1,250 companies employ more than 130,000 people and have recently generated sales of up to 30 billion euros per year. Above all, the medium-sized companies among Europe's leading German medical technology companies are currently facing a particular challenge: The industry is evolving rapidly courtesy of European Medical Device Regulation (MDR). DIETZ Consultants' 1st Forum for Risk Management in medical products has confirmed that many small and medium-sized companies in particular are yet to master major challenges in order to meet the normative, regulatory and legal requirements approaching.

"There is an enormous demand for knowledge in the implementation of risk management for medical products, especially in the light of new normative, legal and regulatory requirements and the implementation deadlines in the coming months and years," said Managing Director Winfried Dietz after the two-day forum with experts from different areas of medical technology in Nuremberg: "It has to be our goal to look for apt solutions for implementation of micro-companies along with the small and medium-sized companies." Since the requirements of MDR quickly develop into a challenge especially for them that they cannot handle alone. "The system has become increasingly complex. More and more software is being integrated, and normative specifications are becoming more and more comprehensive. "Sometimes it feels as if one no longer works for new developments, but only continues to advance as per the standards," said Franz Josef Schmitt of Fresenius Medical Care Deutschland GmbH as he summed up the discussions at the forum. Matthias Loch from Ottobock SE & Co. KGaA also takes a look at the subject matter of personnel and raises the question, "how can we find the qualified expertise necessary, push the development forward and at the same time complete all obligatory documentation?" It is rather obvious according to Christof Schmeer, pfm medical ag, that risk management will play a bigger role in the industry. "Years ago, we had development, business and manufacturing processes, and risk management running concurrently. The MDR is the first law in which the legislature stipulates risk management across all areas. This gives risk management a very different role in terms of development and the company as a whole."

DIETZ Consultants - the forum with the motto "Risk Management in Times of Change", has expanded its range of consultation and services for quality and risk management - with great success: Many participants from the fully booked event lauded the exciting, bespoke selection of topic and the highly professional level of the lectures, most of which rolled into a lively discussion. The productive meeting of minds continued in the framework of the forum as well. Many participants took the opportunity to expand their network and make new contacts. In certain cases indeed, concrete approaches for cooperation and regular exchange of ideas already seems to have emerged.

The foundation has been laid for a strong network, as already represented by the international FMEA Forum of DIETZ Consultants in other industries. Plans are already in place for further expansion right after the successful premiere. On May 14 and 15, 2019, the second Forum for Risk Management in Medical Products will take place in Nuremberg. "Our plan has worked out well," Dietz says happily. "Our forums bring together experts to impart knowledge. Together, we develop solutions and offer advice to the developers and manufacturers of medical products."