Auditors Ernst & Young presented its latest "Pulse of the Industry" medical technology report as guests of BioRegio STERN Management GmbH and the Medical Valley Hechingen Academy at the Villa Eugenia in Hechingen on Wednesday, 30 March. The annual report provides figures and detailed analyses on the performance of an industry that continues to be highly successful, yet needs to face up to new challenges.
There was no telling tales in the great hall of the Villa Eugenia in Hechingen, which was filled to almost the last seat. And this was despite Christian O. Erbe, President of the Chamber of Commerce and Industry (IHK) in Reutlingen and Managing Partner of ERBE Elektromedizin GmbH in Tübingen, quoting from the most important work by the brothers Jacob and Wilhelm Grimm: the "Deutsches Wörterbuch" (German diction-ary). Addressing an audience of more than 80 guests from business and politics, he cited the definition of a "Klaster" from this work: "That which comes together in a tight and compact form". Drawing on this, he described the extremely successful medtech cluster in the Neckar-Alb region – a cluster characterised by a particularly tightly meshed network of research activities and companies. "We have the perfect environment here, from basic research and prototype construction to marketing," said Erbe in his presentation "Expertise and the inventive mind – medical technology in the Neckar-Alb region".
The actual presentation of the medical technology report also highlighted the par-ticularly effective network in the Neckar-Alb medtech cluster. As well as BioRegio STERN Management GmbH and the Medical Valley Hechingen Academy, the event was also at-tended by the Verein zur Förderung der Biotechnologie und Medizintechnik e.V. (Society for the Promotion of Biotechnology and Medical Technology), the MITT Centre of Competence for Minimally Invasive Medicine & Technology Tübingen-Tuttlingen, and the Chamber of Commerce and Industry (IHK) in Reutlingen.Prof. Christa Schröder from Albstadt-Sigmaringen University and Friedrichsdorf-based consultant Dr. Rainer Canenbley spoke about "Regulatory requirements for combi-nations of medical products and pharmaceuticals" and "Clinical testing for medical prod-ucts". Both are established experts in regulatory affairs, i.e. the licensing of pharmaceuti-cals and medical products. The standards and processes are in themselves already highly exacting. However, when working with combinations of medical products and pharmaceu-ticals – or "advanced therapies" – in areas such as tissue engineering and cell and gene therapy, the challenges for entrepreneurs are virtually insurmountable and may prevent a successful market launch. Both speakers agreed that "early inclusion of regulatory exper-tise is vital to assess all needs from the outset". BioRegio STERN Management GmbH is already pursuing this approach and has recently started to offer initial consultations on li-censing matters for entrepreneurs and company founders in the region's life sciences sector.Heinrich Christen, EMEIA Medical Devices Leader and partner in Ernst & Young Ltd., who had travelled from Zurich for the report presentation, stressed that "this is the world's only report that maps economic events in medical technology". It has been pub-lished annually since 2009 under the title "Pulse of the Industry" and provides detailed analyses of global perspectives and current capabilities in the industry. It is now regarded as obligatory reading among entrepreneurs, researchers and decision-makers. The global crisis has not left this industry unscathed either, but the effects have been felt primarily in the U.S. Looking at necessary savings measures, Christen pointed out that "companies are still carrying excess weight that they can shed to become leaner." The number of employees at European medtech companies has remained virtually constant.In terms of the number of medtech companies, Germany is in third place in the European economic region after the United Kingdom and Israel, with 120 in the STERN BioRegion alone. The companies are predominantly active in the orthopaedic / cardiovas-cular product sectors and remain well positioned. Unlike the U.S., which recorded growth of just one percent, European medtech companies achieved growth of eight percent. Spending on research and development in this region has also risen by four percent. Yet Europeans, too, are faced with a series of challenges – the dynamics of international markets, changes to state regulations and sharp increases in cost, price and competitive pressures.