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Issue 30, September 2012
bulletMedical Technologies Made in Germany
bulletInnovation: ReinHeart - A Technical Alternative to Heart Transplantation
bulletHyperPLUS: A New Sensor System for Long-Term Blood Pressure Monitoring
bulletLIFEBRIDGE Provides Portable Life Support
bulletOpportunities and Challenges in the German Medical Technology Field: Interview with Dr. Ute Brauer
bulletGermany's Medical Valley: Medical Technology for Tomorrow's Health Care
article1Medical Technologies Made in Germany
Worldwide, the medical technology market amounts to 220 billion euros. As Europe's leading medtech business location, Germany ranks third, behind the U.S. and Japan. In terms of new patent registrations, German manufacturers are second after the U.S.

According to the March 2012 Medtech Industry Report of the German Medical Technology Association BVMed, the total revenue of medical technology manufacturing in Germany increased by 9.4% to 20 billion euros in 2010. Medical technology manufacturers in Germany are mainly medium-sized companies and make approx. one third of their sales from devices that are less than three years old. As well as being a major export force (the German medical technology industry export rate is 60 to 65%), medical technologies made in Germany are known for  their innovative strengths. Trend areas include imaging systems, prostheses and implants, telemedicine and model-based therapy, operational and interventional devices and systems, in-vitro diagnostics, as well as device and system networking. To learn more, click here.  

Research and development for the ReinHeart artificial heart, this issue's Innovation of the Month, for example, combines mechanical hydraulic models with innovative software simulations. A recent article in German Research, the magazine of the German Research Foundation (DFG), explains how.

article2Innovation: ReinHeart - A Technical Alternative to Heart Transplantation

According to a 2011 World Health Organization report, cardiovascular diseases are the leading cause of death and disability. For some patients, the last resort for end-stage heart failure is transplantation. Due to a deficit in donor organs, the average waiting time exceeds one year. The ReinHeart total artificial heart (TAH) device may provide a technical alternative to heart transplants. Compared to current TAH devices, ReinHeart is designed to be fully implanted into the patient's chest and to last longer without external equipment, thus providing the patient with increased mobility and quality of life.

Developed at the Institute of Applied Medical Engineering, an institute of the RWTH Aachen University, ReinHeart is built to replace the human heart. It consists of three main components: two diaphragm pump chambers with inlet and outlet valves, and the drive unit. The inlets of the pump chambers are connected to the natural atria, the upper two heart chambers, while the outlets are connected to the aorta and the pulmonary artery. The drive unit is a specially developed direct, linear, battery-fueled motor which provides a significant increase in durability. The ReinHeart development project is funded by the European Union, the state of North Rhine-Westphalia (grant id: 005-GW01-206B) and the Erich and Hanna Klessmann Foundation. Clinical studies are expected in 2015. Visit www.reinheart.de for more information.

article3HyperPLUS: A New Sensor System for Long-Term Blood Pressure Monitoring

Hypertension and heart failure are two of the main diseases affecting today's global population. In Germany alone, more than ten million people suffer from high blood pressure. Ten percent of these hypertension patients require surveillance, of which ten percent need long-term blood pressure monitoring. Currently available systems, such as blood pressure cuffs for ambulant and at-home use, are unable to provide continuous measurements, restrict the patient's daily activities and sleep and are prone to failure. Due to its miniature design and fully implantable, battery-free functionality, the HyperPLUS sensor system is suitable for long-term intravascular blood pressure monitoring. With a sampling rate of 30Hz, the sensor provides precise information on blood pressure, body temperature, heart rhythm and possible anomalies, while enabling full mobility for the patient.

The sensor system is composed of an implantable part, consisting of a miniscule sensor tip connected to a transponder, and an external read-out module. The sensor tip is placed directly inside a femoral artery while the extravasal transponder is placed under the patient's skin. Worn outside of the patient's body, on a belt, for example, the read-out module then telemetrically exchanges energy and data with the transponder. The HyperPLUS sensor system is being developed at the RWTH Aachen Institute of Applied Medical Engineering (AME), in the Department of Cardiovascular Engineering (CVE) and the Institute of Materials in Electrical Engineering. It will be presented in October 2012 at the Transcatheter Cardiovascular Therapeutics (TCT) Conference in Miami, Florida. For more information, click here.

article4LIFEBRIDGE Provides Portable Life Support

September 29, 2012, is World Heart Day. Despite increased global awareness and prevention efforts, the World Health Organization predicts that by 2030, 23.6 million people will die from heart disease. Cardiovascular diseases affect women and men equally. Even children are heart patients. Heart attacks and acute cardiovascular failure can occur at any moment. While it is possible for heart-lung machines (HLMs) to replace vital heart and lung functions to ensure blood and oxygen flow, conventional HLMs can only be used in hospitals due to their large, heavy, and complex size. The German LIFEBRIDGE Medizintechnik AG has developed the world's first CE-certified and FDA-approved portable extracorporeal life support system. Designed for use outside of the surgery room, at only 38.5 lbs. (17.5 kg), the LIFEBRIDGE device has set new technological standards in invasive emergency medicine, allowing attending physicians to provide cardio-pulmonary support instantaneously. LIFEBRIDGE has been selected as a landmark in the prestigious Germany-Land of Ideas  campaign. The award ceremony will take place at the LIFEBRIDGE headquarters in Ampfing, Germany, on October 17, 2012.  For more information, click here.

Photo: LIFEBRIDGE Medizintechnik AG

DR. Ute Brauer
article5Opportunities and Challenges in the German Medical Technology Field: Interview with Dr. Ute Brauer

Medical advances, demographic changes, competitive pressures, and heavily regulated markets are transforming the medical technology innovation system in Germany. On October 20, 2011, German State Secretaries Dr. Georg Schütte (Federal Ministry of Education and Research, BMBF), Thomas Ilka (Federal Ministry of Health) and Ernst Burgbacher (Federal Ministry of Economics and Technology) appointed high-ranking policy makers, representatives of industry, science, and health care to the Steering Committee of the national strategy process "Innovations in Medical Technology." With the goal to accelerate the innovation process and enhance patient care, the Committee convenes more than 100 experts in five working groups to develop recommendations for future medical technology innovation policy.  

Dr. Ute Brauer is one of the Steering Committee members. As the Chief Medical Officer and Senior Vice President Medical Scientific Affairs at B. Braun Melsungen AG, Dr. Brauer brings vast experience in the medical technology field, both from a physician's as well as from an industry perspective. In this GCRI interview, she talks about the opportunities and challenges in Germany's medical technology field, the changes in its innovation system, and which developments will create lead markets. To read the interview, click here.

Medical Valley Logo
article6Germany's Medical Valley: Medical Technology for Tomorrow's Health Care

Health care and medical technology have a long tradition in the Medical Valley European Metropolitan Region Nuremberg (EMN). The first German ether anesthesia was administered in Erlangen and Wilhelm Röntgen invented the x-ray in Würzburg in 1895. Today, the Medical Valley EMN is one of the world's leading clusters in the medical engineering sector, with a strong focus on diagnostic imaging, intelligent sensors, treatment systems, ophthalmology, and horizontal innovations for product and process optimization. It is home to highly specialized research facilities, global players, like Siemens AG Healthcare Sector and Biotronik, as well as many small and medium-sized innovative startup companies that are cooperating with world-renowned health research facilities to find solutions to current and future health care challenges. This exceptional concentration of stakeholders, combined with the competitive positions of individual players in the global market, provides the basis for quickly and efficiently turning ideas into products, processes, and services.

Announced by the German Federal Ministry of Education and Research (BMBF) as one of Germany's 15 leading-edge clusters, Medical Valley EMN also serves as the national cluster of excellence in medical technology. To date, the cluster encompasses 180 medical technology companies with approx. 16,000 employees, 40 hospitals that treat more than half a million patients per year, and 20 independent research institutes that work in the medical technology field. In academia, more than 60 departments and professorships at universities and universities of applied sciences focus on medical technology research and teaching.