At 11.11.2021 from 15:00 - 20:00 you can expect exciting lectures on the topic "Safety-integrated implants for the future". You will learn, for example, which materials are optimally suited for implants and how hearing implants enable brain maturation. Afterwards, you will gain insights into our various research laboratories and learn more exciting news about our research work. You can arrange this virtual tour individually in terms of time and content. You will also have the opportunity to ask our experts questions.

To ensure that your implant also lasts a lifetime and is characterized by a high level of safety, we are conducting research in the "Lower Saxony Center for Biomedical Engineering, Implant Research and Development" (NIFE) in interdisciplinary teams to develop new implants with increased compatibility and functionality - from A for aorta to Z for tooth, from the cellular level to the entire organ, using the body's own and artificial materials. Safety-relevant concepts from the engineering sciences, such as those used in aviation to increase safety, are being researched for the first time for medicine by the scientists in the "Safety-Integrated and Infection-Reactive Implants" (SIIRI) research network, which is funded by the German Research Foundation (DFG), in order to make your implants safer as well.

Download the schedule of events here down.

Here you can register for the event log on.

Professor Dr. Andrea Hoffmann received the second teaching award in the category "Biosciences" on 20.10.2021 during the AStA summer party. This was awarded to her by the student body for her module "Adult Stem Cells in Regenerative Medicine". This lecture is offered for students of biochemistry of the MHH as well as for bachelor students of biology and life science of the LUH.

Twelve million euros for new Collaborative Research Center/Transregio led by MHH in cooperation with Leibniz Universität Hannover and other partners

A major success for medical research in Hannover: The German Research Foundation (DFG) is funding the new Transregional Collaborative Research Center TRR 298 on implants with around twelve million euros over the next four years. Under the leadership of Hannover Medical School (MHH), MHH physicians will work together with engineering and natural scientists from Leibniz Universität Hannover (LUH) to develop the implants of tomorrow. "On the one hand, this shows how powerful medical research is at the MHH," emphasizes MHH President Professor Dr. Michael Manns, "on the other hand, we have once again demonstrated how successfully the cooperations between the universities and research institutes of our metropolitan region are developing. Our already close cooperation with Leibniz Universität Hannover (LUH) is thus placed on an even firmer footing. I would like to thank all those involved for their commitment."

Intelligent implants of tomorrow

In the research network "Safety-integrated and infection-reactive implants" (SIIRI), which is headed by Professor Dr. Meike Stiesch, director of the MHH Clinic for Dental Prosthetics and Biomedical Materials Science, a completely new approach to implant research is being taken. "For the first time, we want to research safety-relevant concepts from the engineering sciences, such as those used in aviation to increase safety, for medicine," explains Professor Stiesch.

Researchers from a wide range of disciplines want to work together to develop intelligent implant systems for dentistry and orthopedics, as well as hearing implants, which for the first time will use state-of-the-art technology to allow continuous monitoring of implant function and thus early detection of complications such as infections. This will enable early therapeutic intervention to combat these infections, some of which can be life-threatening. However, the scientists want to go even further in this collaboration: "We are developing intelligent implant systems that can independently initiate early repair and thus healing via cell-based, chemical and physical so-called closed-loop systems," adds the professor.

Close cooperation of the different disciplines

The interdisciplinary and innovative concept has been made possible by the close cooperation of dentists, physicians, engineers, natural and social scientists. The nucleus for this interdisciplinary research is the NIFE (Lower Saxony Center for Implant Research and Development), which has been established in the Medical Park Hannover as an internationally visible research institute, achieving top results in experimental research and bringing them into clinical application for various organ systems.

In the Transregional Collaborative Research Center, more than 150 scientists from the MHH, Leibniz Universität Hannover, the Helmholtz Center for Infection Research in Braunschweig, the Technical University of Braunschweig and the University of Music, Drama and Media (HMTMH) will conduct joint research on the development of new implants to increase patient safety.

"This extremely challenging task can only be tackled jointly between the institutions involved. The engineering and medical expertise of the project partners complement each other perfectly for this purpose," emphasizes co-spokesman Professor Dr. Hans Jürgen Maier, head of the Institute of Materials Science at Leibniz University. Leibniz University scientists from the fields of mechanical engineering, chemistry and physics are involved, contributing expertise from materials science and sensor technology, among others.

Furthermore, another innovative approach in this research network is that not only the interfaces between technology and biology are explored, but also the patient perspective is included in all research and development steps from the very beginning. Research into the doctor-patient interaction will contribute significantly to a further increase in future implant and thus patient safety.

SERVICE:

More information please contact Professor Dr. Meike Stiesch, stiesch.meike@mh-hannover.de, telephone (0511) 532-4773.

DFG priority program funds four MHH projects with 1.6 million euros

For people with severe lung diseases, transplantation of a healthy organ is often the only chance of survival. But donor lungs are in short supply. A new artificial lung could provide a remedy. Since 2017, the German Research Foundation (DFG) has been supporting this scientific approach with its Priority Program SPP 2014 "Towards an implantable lung". The aim is to develop an artificial lung that can be permanently implanted as an alternative to a donor organ. Hannover Medical School (MHH), Europe's largest lung transplant center, is also involved in the nationwide research network. The DFG is now funding the work of the Hannover scientists for a further three years with more than 1.6 million euros.

ECMO support is not a permanent solution

At the MHH, research is being conducted on a so-called biohybrid lung. It is based on extracorporeal membrane oxygenation (ECMO), in which the blood is passed through hollow plastic fibers that act as "artificial alveoli" for gas exchange. This lung support system is already being used clinically - for example, to provide oxygen to patients in intensive care units who are severely ill with COVID-19. "So far, however, we have only been able to bridge lung function for a certain time with ECMO, because the blood forms clots when it comes into contact with the artificial surfaces and clogs the tubes," explains Dr. Bettina Wiegmann, who heads three of the four MHH projects at the Lower Saxony Center for Biomedical Engineering, Implant Research and Development (NIFE). The scientist wants to prevent this thrombus formation by populating the surfaces of the gas exchange membranes, the blood pump and the tubes with special, vessel-lining endothelial cells. "These endothelial cells, which are not endogenous to the body, are also genetically modified in such a way that they are virtually invisible to the patient's immune system and are therefore not recognized as foreign and fought against," explains the cardiac surgeon and emergency physician.

Large area with the smallest possible volume

The next step is to test whether the endothelial cells adhere firmly enough to the artificial surfaces and withstand the frictional stress caused by the blood flow. The membranes must also be further developed in such a way that, while providing the largest possible surface area for gas exchange, the volume of the artificial organ nevertheless remains as small and effective as possible, as is the case with the human lung. In the human lung, about 100 to 140 square meters of breathing surface are packed into 300 million alveoli to save space. Another requirement is the shape of the ECMO device, which must be modified during the development of the biohybrid lung so that it can be optimally implanted in the body. "We cannot insert a square box into a patient's chest," the scientist explains.

However, the scientist not only focuses on breathing, but also on kidney function. Because patients who have severe lung disease and require an ECMO machine usually also have an increased risk of acute kidney failure, they also require machine dialysis in addition to lung replacement therapy. Until now, these two procedures have been done with separate machines, which increases the risk of infection and thrombosis, among other things. The scientist is working to combine lung and kidney support in a single device. "This so-called lung-kidney crosstalk is another aspect for the development of an individualized implantable lung," Dr. Wiegmann emphasizes.

Develop different prototypes

Once all remaining problems have been solved, various prototypes of the biohybrid lung will first be tested under laboratory conditions using artificially generated blood circuits. In a next step, they will then be tested first as a respiratory acute aid and later as a permanent lung alternative in animal models. However, the researcher believes that it will be several years before the artificial lungs can be transplanted into the human body.

The DFG Priority Program SPP 2014 funds a total of ten projects nationwide. The Rhenish-Westphalian Technical University (RWTH) and the University Hospital Aachen are in charge. The MHH is involved with four projects. Three projects are headed by Dr. Bettina Wiegmann - one of them in cooperation with Professor Dr. Constanca Ferreira de Figueiredo from the Institute of Transfusion Medicine and Transplant Engineering. A fourth is located at the Leibniz Research Laboratories for Biotechnology and Artificial Organs (LEBAO) under the direction of Dr. Ruth Olmer.

SERVICE:

For further information, please contact Dr. Bettina Wiegmann, wiegmann.bettina@mh-hannover.de, telephone (0511) 532-1408.

A team consisting of students from LUH and MHH, who spent a year researching synthetic biology, implant research and modeling at the Lower Saxony Center for Biomedical Engineering, Implant Research and Development (NIFE), was awarded a prize for their concept for a biosensor in this year's iGEM competition.

Every year, around 250 international student groups present their projects in the field of synthetic biology as part of the iGEM competition. 16 students* from LUH and MHH under the guidance of Prof. Dr. Heisterkamp and Dr. Kalies presented their project at the competition days in mid-November. The team was awarded a gold medal for their sensor concept and nominated for a special prize. All team members participated in the competition for the first time.

The team at NIFE has developed a cell-based sensor designed to detect inflammatory toxins. The origin of these toxins are bacterial colonies that settle on the implant surface after the insertion of medical implants. Such toxins can trigger serious diseases. With the sensor, the team enables a non-invasive detection of the bacterial colonies and thus increases the chance for a successful therapy.

The students also thought extensively about science communication and systems modeling in synthetic biology. As a result, a board game for students was created that teaches the basics of cell biology in a playful way. Other students developed a numerical model to simulate bacterial colonies.

The project is described in detail on the team's website (https://2020.igem.org/Team:Hannover) documented. For the first time, a project from Hannover was awarded a gold medal. Previously, LUH students* from Hannover took part in the competition in 2014 and 2016.

Below, the iGEM team from Hannover 2020.

From left to right Back row: Thorben Klamt, Timm Landes, Jan Mairose, Lara Gentemann, David Theidel, George Dati, Jonas Scholz.

From left to right front row: Anna- Charleen Wessel, Lisan Püttmann, Louise Schaar, Pia Peppermüller, Sören Donath, Celine Beckhausen, Fiene Daniel, Stefan Kalies.

Not pictured: Alexander Heisterkamp, Laura Wesche, Manmeet Singh.

The program includes a lecture on arteriosclerosis - from the outside in by Prof. Haverich as well as " Hands-on research":

Read the report at www.presse-club-hannover.de.Previous

Every hip counts

The central implant registry is intended to increase safety for patients.

It was a scandal: In 2010, it became known to the general public that the French manufacturer Poly Implant had been producing inferior breast implants for years. As a result, hundreds of women had to have the silicone-containing, often defective preparations removed.

Poly Implant revealed gaps in the control system of medical devices that are only gradually being closed. As recently as the end of 2018, a network of journalists discovered the "Implant Files": gaps in the approval of implants, without which modern high-performance medicine is inconceivable. Pacemakers, vascular prostheses, stents, cochlear and retinal implants: there is hardly an area in which medical devices cannot support or replace bodily functions.

"The legislator has now reacted to the abuses," says Prof. Henning Windhagen, Director of the Orthopedic Clinic of the Hannover Medical School (MHH) at the DIAKOVERE Annastift. He points to the significantly tightened approval procedure for medical devices at the EU level. Another advance is the current 16 voluntary implant registries for pacemakers and other implants maintained by medical societies more. "Products can remain in the patient's body for decades. Without registries, long-term effects are almost impossible to detect," says Windhagen.

A shining example is the Endoprostheses Register Germany (EPRD), established in 2012. According to Windhagen, almost 716 of 1,200 German hospitals that insert around 450,000 endoprostheses, i.e. artificial hip and knee joints, each year now report the data of patients - if they agree. "That's still 66.7 % of the implants inserted that are recorded in this way," says Windhagen.

The importance of data collection is shown by the more than 45,000 endoprosthetic operations performed each year in which, according to the EPRD, old implants are exchanged for new ones without the real reasons being known. Another example is thousands of hip replacements used until about 2010, in which the ball and joint alike were made of extremely hard cobalt chrome. "With the register, doctors would have been able to identify the problems with this design much earlier," Windhagen is certain.

His advice to patients: Only have operations performed in hospitals that report to the EPRD and are also part of the German Endoprosthetics Centers (EPC) network. Experts such as Windhagen believe that the statutory minimum volumes are not sufficient, not to mention the fact that hospitals tend to disregard them, as the German medical journal "Ärzteblatt" reported in June 2019.

"A single surgeon should be able to perform at least 50 operations a year, as specified in the EPCs, and at least 100 operations in the case of complicated procedures, for example due to congenital deformities," says Windhagen. Another advantage of the EPCs is the co-pilot concept: "A specialist must assist an experienced surgeon for two years before he or she can lead an operation," Windhagen explains.

In order to close the remaining gaps in the registration of implants, the establishment of a central registry based in Cologne is to start in 2020. It will merge the existing voluntary registries, cover additional implant groups and introduce a reporting requirement: Clinics will then have to report every "installation" of an implant and patients will have to agree to data transmission. "Ultimately, this is in the interest of patients," Windhagen says.

HAZ/NP Safety Weeks 07.11.2019

Dr. Manfred Elff was re-elected to the BVMed board for another 2 years at the BVMed general meeting in Berlin.

As a trade association, BVMed represents over 230 industrial and commercial companies in the medical technology sector. Among others, the 20 largest medical device manufacturers worldwide in the consumer goods sector are organized in BVMed. BVMed represents, among others, the areas of medical technology, implants, medical aids, homecare and dressings, as well as bio- and nanotechnologies.

On March 8, 2018, the Institute for Multiphase Processes at NIFE will organize the last event of the winter semester series HannoVersity under the title.
"Biomedical Engineering - What is that?"

With the new HannoVersity event series, Initiative Wissenschaft invites German and international students to "think outside the box".

The aim of the series is to gain insights into other research disciplines in a relaxed atmosphere at various locations in the city and at the universities, and to establish and expand international contacts and networks beyond one's own university life.

Advance registration for the event is mandatory and available by Feb. 28 at: rittinghaus@imp.uni-hannover.de

For more information on HannoVersity and the Initiative Wissenschaft, as well as on the program of the winter semester, please see here.

Bypasses from human cells could become an alternative to synthetic material in the future

It is a vision that may open up entirely new possibilities in the treatment of circulatory disorders: biologically compatible bypasses made from the patient's own cells. The bypasses grown in a bioreactor from blood and tissue cells are expected to be a significantly better tolerated alternative to conventional bypasses made from synthetic material.

An interdisciplinary team of researchers from Leibniz University is working on this at NIFE (Lower Saxony Center for Biomedical Engineering, Implant Research and Development) and has received the 2017 VDI Technology Award.

Circulatory disorders in the arteries can, in the worst case, lead to heart attack or stroke. In these cases, bypasses must be inserted urgently. In the case of vascular prostheses made of synthetic material such as Goretex, blood clotting must then be permanently reduced by medication, because otherwise there is a risk that the bypass will become clogged due to the material structure and there will be renewed vascular occlusion.

The anticoagulant drugs are not easy to use and can cause complications. Synthetic bypasses can also become infected. Venous autologous material that can be taken from patients elsewhere in the body and used is often not available in sufficient quantity and quality. There is therefore a great need for artificial vascular prostheses.

Research into bypasses made from animal material has been going on for a long time - but apart from ethical concerns, there have so far been problems with rejection and deposition processes. The scientists at Leibniz University are taking a different approach. They want to settle cells of the patient on a tubular scaffold structure made of synthetic material - a so-called scaffold. In a cultivation process in the bioreactor, a bypass develops from this, which can then be implanted. The scaffold is later degraded so that the vascular prosthesis consists only of the body's own material.

The scientists from the Institute of Technical Chemistry and the Institute of Microelectronic Systems jointly developed the technology for the cultivation. "Conditions in the bioreactor must mimic those in the human body," explains Prof. Cornelia Blume from the Institute of Technical Chemistry.

Heartbeat and blood pressure are simulated so that a bypass can be created in two to three weeks. "The further maturation process takes place in the body after implantation. The best bioreactor is the human being," she adds. The sensitive control and sensor technology as well as the monitoring via ultrasound - the bioreactor must hardly be opened during the process - were developed by Prof. Dr.-Ing. Holger Blume and his team from the Institute for Microelectronic Systems.

In the project, which is funded by the DFG, the researchers are working closely with Hannover Medical School and other partners. Applicability doesn't seem so far off: "We hope to be ready to test the bypasses in trials with sheep in about three years," says Prof. Cornelia Blume. This will be followed by the clinical phase with the approval process in humans.

Note to editors:

For further information, please contact Prof. Dr. med. Cornelia Blume from the Institute of Technical Chemistry by phone (+49 177 86 69 328) or E-mail gladly at your disposal.

Mechtild Freiin v. Münchhausen | idw - Science Information Service

More information:
http://www.uni-hannover.de

Wanka: Major project of the three Hanoverian universities unique in Germany - Federal Government and State of Lower Saxony bear lion's share of 60 million euros costs - Professors Bitter-Suermann and Welling awarded honorary doctorates
(From left) Professor Dr. Christopher Baum, Dr. Gerhard Greif, Professor Dr. Volker Epping, Mayor Thomas Hermann, Stephan Weil, Professor Dr. Johanna Wanka and Dr. Manfred Elff

Newly opened: The Lower Saxony Center for Biomedical Engineering, Implant Research and Development (NIFE) is a major joint biomedical engineering project of the three Hanover universities, which offers researchers and developers from all scientific fields an excellently equipped laboratory environment in the new building: The implants of tomorrow are to be developed here.

The Federal Minister of Education and Research, Johanna Wanka, highlighted the outstanding expertise of the Hannover site at the opening of NIFE on Thursday, May 26, 2016. "The Lower Saxony Center for Biomedical Engineering, Implant Research and Development, or NIFE for short, exemplifies the high innovative power of biomedical engineering research in Germany. With its focus on medical technology innovations at the interface between medicine, biology and engineering, it will contribute energetically to improving medical care," she said. "NIFE is unique throughout Germany."

Weil: National and international lighthouse project

Lower Saxony's Minister President Stephan Weil emphasized the international importance of the state capital Hannover as one of the leading locations for biomedical research and development. With the Biomedical Engineering Center, he said, the state government is following the research policy agenda of 2015 to focus funding in Lower Saxony on the major challenges in order to expand research strengths in future fields. He expects NIFE to be perceived in the future as a national and international beacon of biomedical engineering and implant research.

Weil said that the center should succeed in dovetailing basic research and potential clinical applications in the best possible way. This will also enable improved clinical care. The state thus supports the entire research from the development of new implants to their clinical application. Weil emphasized the corporate cooperations with NIFE, which would also give the location further impetus in economic terms.

280 scientists conduct research on 7,000 square meters

The construction and initial equipping of the new research center cost around 60 million euros, of which 53.8 million euros are financed in equal parts by the state of Lower Saxony and the federal government, and a further 6.5 million euros are financed by the Braukmann-Wittenberg Foundation for the cardiovascular area. The new building is located in the Medical Park on Stadtfelddamm, not far from the MHH. In a laboratory area of 7,000 square meters, around 280 researchers from Hannover Medical School (MHH), Leibniz Universität Hannover and the Stiftung Tierärztliche Hochschule Hannover will develop innovative implants and strategies in the fight against implant-associated infections.

"New avenues of implant technology are being explored here"

"Here in Hannover, an implant research center has been created that is unique in size and focus and will thus radiate far beyond Hannover's or Lower Saxony's borders. At the same time, the scientists involved guarantee, through their proven research excellence, for example in the REBIRTH and Hearing4all clusters of excellence, that new avenues of implant technology can be opened up for industry cooperation and, even more importantly, subsequently also in patient treatment," emphasized NIFE board spokesman Dr. Manfred Elff.

On behalf of the state capital Hannover, Mayor Thomas Hermann highlighted the close cooperation between no less than three Hannover universities. "Hannover has top achievements to offer in many scientific fields and especially in biomedicine, which are now being brought together in a unique way. With the new NIFE center in the Medical Park, Hannover as a location for science and medicine is getting a new highlight, not least thanks to funding from the federal and state governments."

Universities bundle their research competencies

The collaborative partners are pooling their research expertise in the new building. The MHH is contributing its research focus in the fields of biomedical engineering, regenerative medicine and immunology/infectiology. MHH President Professor Dr. Christopher Baum emphasizes the great importance of interdisciplinarity: "The MHH stands for quality and innovation. Implant research requires particularly extensive interdisciplinary cooperation. Therefore, the integration of NIFE into our campus creates excellent conditions for excellent science for the benefit of patients."

Leibniz Universität Hannover contributes its expertise in the fields of engineering and materials science. Professor Dr. Volker Epping, President of Leibniz Universität Hannover, praises the excellent cooperation between the universities at the Hannover site: "Biomedical engineering is assigned the status of a key technology, with an increasing demand for analytical, diagnostic, manufacturing and process engineering instruments due to the steadily growing market.

In order to meet the requirements of this promising market, cooperative collaboration across the disciplines is essential to solve the interdisciplinary tasks. In particular, the mechanical engineering department at Leibniz University and parts of the natural sciences contribute the necessary expertise from these areas to the network."

In addition, there are the biological test models of the Stiftung Tierärztliche Hochschule Hannover. "In cell culture and with animal models, our scientists test new procedures. Developments in human medicine often also benefit patients in veterinary medicine in the long term. Innovative implants in particular can improve our patients' treatment options," adds Dr. Gerhard Greif, President of the University of Veterinary Medicine Hannover Foundation.

Professors Bitter-Suermann and Welling awarded honorary doctorates

During the opening ceremony, Professors Dieter Bitter-Suermann and Herbert Welling were awarded honorary doctorates. Former MHH President Professor Dr. Bitter-Suermann received an honorary doctorate from Leibniz Universität Hannover for his services in building bridges between the natural sciences and medicine. Together with the then president of Leibniz University, Professor Dr. Erich Barke, he is considered one of the founding fathers of NIFE, who started the project of the joint research center eight years ago.

Professor Dr. Herbert Welling received an honorary doctorate from the MHH. The physicist had established laser research at the University of Hannover in 1970 and co-founded the Laser Zentrum Hannover in 1986.

Source: Press and Public Relations MHH, Photos: Kaiser

Economics Minister Lies and Science Minister Heinen-Kljajić awarded the prize of the Lower Saxony Innovation Network.

The 1st place was awarded to the cooperation of Ordermed GmbH (Buchholz in der Nordheide), BioRegioN (Hannover), Hannover Medical School and the Lower Saxony Center for Biomedical Engineering, Implant Research and Development (NIFE), for the development of the electronic implant ID card ImplantCard.

A pilot project for the application of this ID card will start at MHH in early May 2016.

Copyright: Photo: WWW.SCHEFFEN.DE

Chemistry professor at Leibniz Universität Hannover receives award for interdisciplinary teaching and research

Professor Thomas Scheper from the Institute of Technical Chemistry at Leibniz Universität Hannover was awarded the 2014 Lower Saxony Science Prize on Wednesday, October 15, 2014. The award recognizes Scheper for his commitment to interdisciplinary research in the field of tissue engineering and biomedicine, as well as for his contributions to the internationalization of teaching and studies. The prize is endowed with 25,000 euros.

Scheper's research work in the field of tissue engineering and in biomedical engineering led to the approval of the project "Biofabrication for NIFE (Lower Saxony Center for Biomedical Engineering, Implant Research and Development)", which is funded by the state of Lower Saxony. In this project, competences of different institutes of Hanoverian universities (MHH, HMTMH and Leibniz Universität Hannover) in the field of medicine, natural and engineering sciences are bundled. The area of participatory research is particularly important here: scientists want to research both the effect and acceptance of their own work on the population. "The point is not only to conduct interdisciplinary research, but also to pay attention to the fears or wishes of potential beneficiaries at an early stage and to respond to them," says the chemist, who has taught at Leibniz Universität since 1995.

In the area of teaching, Prof. Thomas Scheper designed the first consecutive bachelor's and master's degree program "Life Science - Cells and Molecules" in Lower Saxony. By initiating the student exchange between Leibniz Universität Hannover and the Technion in Haifa/Israel, Scheper has made a significant contribution to internationalization in teaching. In the meantime, this exchange program has been established and extended to other universities in Lower Saxony. The goal is to send ten to twelve students to Israel each year. The professor would like to donate a large part of his prize money to this project.

The Lower Saxony Science Prize is awarded to scientists at a university or college in Lower Saxony. The award is given to persons who have held a professorship for a certain period of time and who have made special achievements in, for example, cross-university research focuses, cooperation with non-university research institutions, developments in teaching and studies, or the like.

Source: (Leibniz Universität Hannover, Mechthild Freiin von Münchhausen)

In order to better translate medical ideas and scientific findings into the practice of patient care, physicians and scientists must consider the issues of patent application, approval, clinical trials and transfer to reimbursement systems at an early stage. This was made clear by the experts at the BVMed special event "Translation: Science and economy - a contradiction?" on May 27, 2014 at the Medical Park in Hannover.

One challenge is to gear research more closely to the needs of patient care. Researchers must not only publish their results, but also patent them. And they must include economic expertise at an early stage. An important aspect of successful "translation" is the transfer of knowledge about regulatory requirements and clinical trials. At the beginning of a translation process, there must be precise goal setting and planning of the process, the experts say. Other success factors include a strategy for reimbursement, professional study planning to generate evidence, and a strategy regarding market access, marketing and distribution channels. It is also important to win key customers in the medical profession early on who support the product, and to identify comparative therapies in order to prove the benefits of the innovations.

Ingelore Herring from the Lower Saxony Ministry of Economics emphasized the importance of medical technology for the state of Lower Saxony. The state is very well positioned in materials, laser and implant research in particular. The challenge, he said, is to align research more closely with demand and then translate the research results into successful start-ups. Success factors include cooperation platforms in the clinical field and the establishment of technology centers in the vicinity of scientific institutions. The goal of the Medical Park in Hanover, where the conference was held, is to bring science and companies "door to door" to cross-fertilize each other, Hering said. She also suggested breaking down the national medical technology strategy process to the state level.

Dr. Manfred W. Elff presented the Lower Saxony Center for Biomedical Engineering, Implant Research and Development (NIFE) in Hannover. Elff is chairman of the center's board and also a BVMed board member and managing director of Biotronik in Berlin, a manufacturer of pacemakers. The center was founded in November 2008 as a joint scientific institution of Hannover Medical School (MHH), Leibniz University, the University of Veterinary Medicine and the Laser Zentrum Hannover, in order to bundle the competencies of implant research at one location. Numerous facilities are being built in the vicinity of the MHH to locate research and industry side by side.

Thom Rasche, partner at Earlybird Venture Capital, introduced financing aspects. Venture capital is equity capital provided by public and private financiers to invest in good ideas. Venture capital is thus a "seed financier" for young start-ups. The funds are usually limited to ten years. It is important to assess whether the idea is marketable and whether the idea providers have the management skills to turn it into a commercial reality. The "first money" to start a company is sufficiently available in Germany, for example through the High-Tech-Gründerfonds. There are problems with the second financing phase of 15 to 20 million euros to bring the innovation into practice. Rasche appealed to German clinical research to think not only about publications but also about patent applications. "Research should be more closely intertwined with economic expertise as well. Business people need to be involved early on to make good research results marketable," Rasche said.

The culture between physicians and industry must be further developed and improved in Germany, demanded Prof. Dr. Axel Haverich, Medical Director of the Clinic for Thoracic, Cardiac and Vascular Surgery at Hannover Medical School. Doctors should have just as little fear of contact as researchers. This is a lengthy development process. Researchers, for example, not only have to publish, but also have to patent. Haverich cited the topic of "tissue engineering" as an example of innovations from clinical practice that are implemented with the help of industry. This involves tissue cultivation using autologous cells on a matrix. In Hanover, for example, heart valves that grow with the patient are being developed. They are based on the body's own cells and thus belong to individualized medicine. "However, the regulatory requirements in Germany are not geared to these innovations," Haverich said. Haverich pleaded for new cooperation formats to bring researchers, clinicians, industry and regulators to the same table - with the common goal of "getting innovations on the road."

The translational alliance "TRAIN" in Lower Saxony was presented by the researcher Prof. Dr. Ulrich Kalinke in front of. He is Executive Director of the TWINCORE Center for Experimental and Clinical Infection Research in Hannover. The goal of the regional competence network is to identify and develop good ideas from basic research. "TWINCORE bridges the gap between basic research and clinical application," says Kalinke. Before know-how can be pooled, however, a good infrastructure is needed, for example through the construction of innovation centers. Networks include the Clinical Research Center (CRC) or the Biomolecular Drug Center (BMWZ). "Enormous opportunities are developing here," says the researcher optimistically. An important aspect of successful translation is the transfer of knowledge about regulatory requirements and clinical trials.

The concept of the Clinical Research Center Hannover (CRC) as part of the TRAIN network introduced Prof. Dr. Norbert Krug . He is Medical Director at the Fraunhofer Institute for Toxicology and Experimental Medicine. The CRC is intended to be a "professional test center" for early-phase clinical studies to transfer research results into clinical practice. It is important, he said, that subjects feel comfortable at the center and are treated well so that they can successfully participate in the study over a four-week period. The center also has hotel-style overnight accommodations for relatives for this purpose. Numerous specialized medical tests can also be performed at the CRC. The "synergistic use of infrastructure" at the CSC includes outpatient clinics, research stations, a biobank, laboratories and imaging to enable regulatory studies to be conducted in the future. It will also be an event center and meeting place for scientists, Krug said.

How can research results be better implemented? Support for technology transfer is provided by Dr. Christian A. Stein, Managing Director of Ascenion in Munich. One important aspect: patenting the idea. Stein recommended talking to experts early on and not pre-publishing the idea at congresses. "After publication, patent protection is no longer possible," the expert said. A technology transfer office helps the researcher or physician draft an invention disclosure and file the patent application, he said. Substances and new compositions of matter, uses, biochemical processes or methods, production processes, diagnostic processes or software with a technical character can be patented. Scientific theories, discoveries, algorithms, software without a technical character, but also clinical treatments - in contrast to the USA - cannot be patented. The patent can be the starting point for business start-ups, licenses or cooperations. A sale leads to the complete transfer of the rights.

Successful company founders presented case studies "from idea to medical product" from the Medical Park in Hanover:

Prof. Dr. Moritz N. Wente, Chief Medical Officer of Aesculap in Tuttlingen, used the example of the drug-eluting balloon catheter (DEB) to illustrate that the path from the idea to the patient can be complex and lengthy. In this specific case, it took nine years. The starting point was university research. Once the technology had been developed, the next steps were proof of efficacy in animal experiments, clinical testing, the CE approval process for a combination product, and finally CE approval for the product. An increasing problem, he said, is the shortage of young scientists, not only in the medical field but also in the engineering field. Wente therefore presented various models for promoting young talent. For example, he said, Aesculap cooperates with the Tuttlingen university campus to bring young people to the region for training. The "Industry on Campus Professor" program helps to bridge the gap between university and company. In this program, students rotate between working half-time in the company and half-time on a research project.

A second industry view presented Dr. Jürgen O. Böhm, Chief Executive Officer and Medical Director of Xenios in Heilbronn. The company specializes in extracorporeal circulation. The subsidiary medos develops solutions for cardiac surgery and cardiotechnology with a modular heart-lung machine system. The subsidiary Novalung develops products for interventional lung support. Precise goal setting and planning of the process is indispensable at the beginning of a translation process. A critical phase, especially for medium-sized companies, is the approval phase, which involves numerous imponderables. In addition, the requirements for proof of benefit and thus for study planning are increasing.

Peter Hartung from the engineering service provider Seleon clarified that the approval process for medical devices is very complex. This includes, among other things, an early benefit, feasibility and cost-effectiveness assessment, the definition of requirements, proof of function and safety, and proof of clinical effectiveness. For complex devices, the requirements from applicable standards are extensive. The requirements for clinical evaluation and testing of medical devices have increased steadily in recent years. Hartung recommended that a clinical evaluation be carried out at the very beginning of product development. The European Medical Device Regulation currently under discussion would mean more bureaucracy and higher costs for manufacturers without creating more patient safety.

Not every invention is an innovation that helps people, he argued. Dr. Jan Helfrich, a management consultant at the health insurance company DAK-Gesundheit in Hamburg. Therefore, the requirements for the benefit assessment of medical devices must be increased. A comparison with standard therapy is desirable. The clinical study must be supplemented by health services research under everyday conditions. "We need a real benefit assessment from the patient's perspective in the reality of care and pricing based on the added benefit," Dr. Helfrich said. He also called for rapid testing of innovations under study conditions in centers. In this way, an unchecked expansion of services with dubious quality could be counteracted.

The BVMed conference was moderated by the medical journalist Renate Harrington from Hamburg

(Source: BVmed)

You can find more pictures of the event under the following link

http://www.bvmed.de/de/bvmed/mediathek/bilder-veranstaltungen/translation-wissenschaft-und-oekonomie

Science Minister: New 61 million euro research center is another milestone / Focus on biomedical technology and implants

At the topping-out ceremony of the Lower Saxony Center for Biomedical Engineering, Implant Research and Development (NIFE), Gabriele Heinen-Kljajić, Minister for Science and Culture of Lower Saxony, emphasized the international importance of the state capital Hannover as one of the leading locations for biomedical research and development. "Biomedical engineering and implant research has been a focus of Hannover's universities and the Hannover Laser Center for more than ten years. The ambitious program of the Lower Saxony Center for Biomedical Engineering makes Hannover an international heavyweight in the promising research field of implant research," the minister said at the topping-out ceremony on Thursday.

The construction and initial equipping of the new research center will cost around 61 million euros, of which 53.8 million euros will be financed in equal parts by the state of Lower Saxony and the federal government, and a further 6.5 million euros by the Braukmann-Wittenberg Foundation. The new building is being constructed in the Medical Park on Stadtfelddamm, not far from the MHH. In a laboratory space of 7,000 square meters, researchers from Hannover Medical School (MHH), Leibniz Universität Hannover, the Foundation of the University of Veterinary Medicine Hannover and the Laser Zentrum Hannover will develop innovative implants and strategies in the fight against implant-associated infections. "NIFE is a first-class focal point of interdisciplinary science and offers excellent opportunities for cross-university collaborations in a significant field of research. We are extremely pleased to soon be able to work in this new ambience," said Professor Dr. Christopher Baum, MHH President and Chief Scientific Officer.

NIFE is the first major joint biomedical engineering project of the three Hanover universities, which will offer researchers and developers from all scientific fields an excellently equipped laboratory environment in the new building. Collaborative research centers, the two clusters of excellence REBIRTH and Heraring4all, as well as new research projects, such as the Biofabrication for NIFE project funded by the Volkswagen Foundation, already demonstrate the excellent cooperation in implant research across disciplinary and university boundaries.

"Hannover and Lower Saxony can be proud to be able to launch such a lighthouse project of implant research as an important scientific and subsequently also economic factor here in the Medical Park," emphasized NIFE board spokesman Dr. Manfred Elff.

The collaborative partners are pooling their research expertise in the new building. The MHH is contributing its expertise in the main research areas of biomedical engineering, regenerative medicine and immunology/infectiology, Leibniz Universität Hannover is contributing its expertise in the fields of engineering and materials science, and there are also the biological test models of the Foundation of the University of Veterinary Medicine Hannover and the expertise of the Laser Zentrum Hannover. At present, the researchers are still spread across 18 institutes at eight locations throughout the Hannover region. From 2015, the 300 scientists - including 80 engineers and physicists - will then work under one roof at Stadtfelddamm.

Professor Dr. Erich Barke, Hans-Gerd Aper, Minister President David McAllister, Elke Breier, Professor Dr. Dieter Bitter-Suermann, Dr. Manfred Elff and Dr. Gerhard Greif

Minister President: New research center for 60 million euros is another milestone / Focus on biomedical technology and implants

At the groundbreaking ceremony for the new Lower Saxony Center for Biomedical Engineering, Implant Research and Development (NIFE) on Thursday (Dec. 20), Lower Saxony's Minister President David McAllister praised the cooperation between physicians and engineers for the benefit of patients. "With a total of 15 successful research buildings since 2007, Lower Saxony occupies a top position nationwide behind Baden-Württemberg and ahead of Bavaria," he continued. "The new building of the Lower Saxony Center for Biomedical Engineering, Implant Research and Development - NIFE - is also recognized and supported by the Science Council as a research building. This shows: Lower Saxony is successful in high-performance research. It is also proof of the good cooperation between our Ministry of Science and the universities. The new NIFE building is another milestone in this regard."

The cost of the new building is 60 million euros. The state of Lower Saxony and the federal government are each investing 27 million euros. The Minister President thanked the Brauckmann-Wittenberg-Herz Foundation, which is supporting the project with a further six million euros. In a laboratory area of 7,000 square meters, researchers from Hannover Medical School (MHH), Leibniz University Hannover, the Foundation of the University of Veterinary Medicine Hannover and the Laser Zentrum Hannover will develop innovative implants and strategies in the fight against implant-associated infections.

NIFE is the first major joint biomedical engineering project of the three Hanoverian universities. "It is the icing on the cake of a development that began more than ten years ago," said MHH President Professor Dr. Dieter Bitter-Suermann. Two collaborative research centers focusing on the development of biocompatible implants and the clusters of excellence "REBIRTH" on regenerative medicine and "Hearing4all" on hearing research are proof of the outstanding basic research expertise and collaboration in this field, he added. NIFE board spokesman Dr. Manfred Elff emphasized that the unique constellation of an internationally recognized profile of excellence in translational implant research will now also have its own address with the new building. "This will create - probably for the first time worldwide - the prerequisite here in Hannover for the development of innovative implants across many organ systems with significantly improved functionality and long-term compatibility," said Dr. Elff. 

The collaborative partners are pooling their research expertise in the new building, which has a total area of 13,200 square meters. The MHH is contributing its expertise in the research areas of biomedical engineering, regenerative medicine and immunology/infectiology, Leibniz Universität Hannover is contributing its expertise in the fields of engineering and material sciences, and there are also the biological test models of the Foundation of the University of Veterinary Medicine Hannover and the expertise of the Laser Zentrum Hannover. At present, the researchers are still spread across 18 institutes at eight locations throughout the Hannover region; from 2015, the 300 scientists - including 80 engineers and physicists - will then work under one roof at Stadtfelddamm. "This is unique in Germany, otherwise the Science Council would not have funded the project," Professor Dr. Bitter-Suermann emphasized. "This will give a new boost to application-oriented implant research."

V. i. S. d. P.: Press and Public Relations of the MHH  

The German Society for Biomedical Engineering (DGBMT) in the VDE has elected its new chairman for the term of office 2013 to 2015 in the course of its constituent board meeting on March 5, 2013 in Frankfurt am Main. The new chairman of the DGBMT is Prof. Prof. h.c.. Dr. med. Thomas Lenarz. Prof. Dr. med. Dipl.-Ing. Thomas Schmitz-Rode and Dr. Olaf Such were appointed to office as Vice Chairmen.

The DGBMT promotes cooperation between natural scientists, engineers and physicians in research, development, application and teaching. The aim is to support the exchange of knowledge in the various disciplines of biomedical engineering, to make greater use of synergies for future developments, and to accelerate the transfer of new technologies into medical applications. This work, which is important both for improving patient care and for Germany as a center of innovation, is made possible and continuously developed by the expert contributions and commitment of DGBMT members in the individual specialist committees, working groups, projects and initiatives of the professional society.

The board of the DGBMT is interdisciplinary and represents both the scientific-technical and the biological-medical disciplines. Representatives from research, clinical application and industry are equally represented on the DGBMT Board. The DGBMT Board for the years 2013 to 2015 is composed of nine experts:

For more information on the DGBMT Board of Directors, visit: www.dgbmt.de/vorstand

The DGBMT is part of the VDE network. With around 36,000 members, the VDE Verband der Elektrotechnik Elektronik Informationstechnik e.V. is one of the largest technical and scientific associations in Europe.

(Source:DGBMT)

Deeply impressed by her visit to the MHH in November 2012, the Chancellor reflected her impressions with the following sentences in her New Year's speech on Dec. 31, 2012:

"... To this end, I would like to tell you about two small medical miracles: I recently met a 10-year-old boy who was born almost deaf. Then he received a state-of-the-art implant. Today he can hear music and attend school without any problems.

I also met a young woman who has been living with a heart valve prosthesis that grows with her for three years. With it, she can do sports and lead a normal life.

These are small medical miracles. They are the success of our researchers. For the boy and the woman, research means his hearing and her heartbeat. It means everyday life and quality of life.

For our country, research means jobs. When we can do something others can't, we maintain and create prosperity..."

The German Chancellor visited the MHH on 27.11.2012. Lower Saxony's Minister President David McAllister had invited Dr. Angela Merkel to the university to show her the cutting-edge research and care it provides. MHH President Professor Dr. Dieter Bitter-Suermann guided the guests to the two clusters of excellence. 

Professor Dr. Thomas Lenarz and his team presented hearing research and care at the MHH. Professor Dr. Axel Haverich and his team showed the latest findings in regenerative medicine. Afterwards, the German Chancellor, the Minister President of Lower Saxony and the ministers Professor Dr. Johanna Wanka and Aygül Özkan discussed with scientists and young scientists. "I am very impressed by this jewel here in Hannover," said the Chancellor.

The Lower Saxony Center for Biomedical Engineering, Implant Research and Development is now called NIFE.

The Lower Saxony Center for Biomedical Engineering is once again fulfilling its pioneering role: In March, the International Interdisciplinary Alliance against Implant-Related Infections (I4A) was founded at the MHH - a European alliance that cooperates closely with the North American "Multidisciplinary Alliance against Implant-Related Infections".

"With our alliance, we want to advance research into the diagnosis and therapy of these infections in a targeted manner, define treatment approaches on an interdisciplinary basis, and discuss suitable strategies with representatives of industry and the healthcare system," emphasizes Professor Dr. Meike Stiesch, Scientific Director of the I4A Alliance and Director of the MHH Clinic for Dental Prosthetics and Biomedical Materials Science.

MHH Journal April 2012 Download (PDF)

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