• Strategies + Perspectives   Bringing Medtech closer to the patients

Bringing Medtech closer to the patients

Big trends cannot be stopped, and so-called personalised medicine is a case in point. Customised diagnosis and treatment paths are one of the main challenges facing industry, scientists and doctors around the world.
The solid growth environment is tempting some companies to jump into the medical technology market. “Rashly”, according to some market analysts; “spot on”, company managers boast. Regardless, the healthcare market is in flux and the pressure on medtech companies to adapt is growing as a result. Recognising the trends and handling them properly means being rewarded with lower costs and increased value added.
According to a current analyst assessment by Frost & Sullivan, the European market for personalised medicine is currently experiencing double digit growth, all the more remarkable for its relatively high starting level. This growth rate is expected to increase even further if more European governments promote personalised healthcare and it becomes a mainstream part of society.  

In the US, a powerful community of scientists and industry partners have already joined forces in the shape of the Personalised Medicine Coalition (PMC) in Washington and the Forum for Personalised Health Care, and last year they published a roadmap. Harvard Business School Professor Clayton Christensen concluded in this roadmap: “The time is ripe for a radical push of promising techniques, alternative business models and new value creation chains throughout the healthcare sector.”
International consultancy firm Bain & Company reaches the same conclusion in a current study on the healthcare market 2020. Its analysis shows that over the next ten years the medical technology and pharma market will become more compartmentalised and high-selling blockbuster products will become rarer. New trends, such as personalised medicine, will speed up this development (see interview on page 24).  

Expectations are high concerning new forms of diagnosis and treatment based on a better understanding of individual, disease-triggering factors at molecular level, and in the microcosmos of biological cells. The final report of the Forschungszentrums Jülich and the Fraunhofer Institute for System and Innovation Research on the future of personalised medicine published in 2009 confirmed that this innovative area of application is expanding and attracting an ever-growing number of players in the medical sector.  

The pharma industry and biotechnology are certainly two of the strongest drivers, but as the number of customised drugs and treatments grows, so too does the number of new procedures and systems. While initially it was the big medical technology and diagnostic companies, such as Roche, Sanofi, Quiagen and Siemens, expanding their activities in the field of large systems for imaging procedures or analysis and evaluation platforms for genetic and biochemical laboratory tests, now specialised manufacturers and niche providers are increasingly entering the picture. In the Aachen “Personalised Medicine” cluster alone, 40 partners from the region are working on six research and development projects. In the Greater Munich area, 130 small and medium medtech and biotech companies are focusing their efforts on technical life sciences. The prospects for new diagnosis and therapy methods are spurring on many medtech companies. Medtech suppliers and system manufacturers are forging ahead, seeing high research and development costs as an opportunity, rather than a drawback. “If you want to be part of progress you have to get to grips with molecular processes,” Aachen’s entrepreneurs said five years ago, as they entered the starting blocks. In order to avoid excessive innovation financing, smaller firms are cooperating with large companies or clinics. Collaborative projects spread the risks and create synergy effects that can be harnessed for new system concepts and component development.
“Personalised medicine now has a role to play at every stage of medical service provision, from early diagnosis screening to aftercare monitoring,“ says Bärbel Hünsing, Head of the Biotech and Life Sciences BU of the New Technologies Competence Centre at the Fraunhofer Institute for System and Innovation Research ISI in Karlsruhe.  

Paving the way for hybrid imaging
However, the Fraunhofer scientist is sceptical about whether the massive research and development expenditure on molecular diagnostics has translated into outpatient and inpatient treatment. “Nowadays, procedures are increasingly monitored for efficiency and are subject to more stringent cost and benefit analysis than they used to be,” says Hüsing. As a result, “many innovations are still on shaky ground.” Settlement of accounts for molecular test procedures with health insurance funds is also unclear in many cases. “That can be difficult,” Hüsing adds.  

In some areas of tissue engineering, measuring equipment and DNA sequencing machinery and molecular imaging, the breakthrough has been made. Siemens Healthcare has combined its Biograph mMR imaging system with molecular magnetic resonance and positron emission tomography (MR/PET), paving the way for hybrid imaging. PET detectors inside the body record the distribution of weak radioactive tracer deposits. Simultaneously, the MR tomograph produces high-resolution 3D images of the body area being examined and its anatomical environment. The two partial images are merged to produce photos indicating the site and size of dangerous tumour clusters.
The core philosophy behind patient-adapted medicine is reflected in the innovation strategies of many sector players. In artificial respiration for example. “Lung function monitoring can be used to develop therapy systems that continuously record information on the regional distribution of the respiratory air during the patient’s treatment, so that the therapy can then be adapted to meet the individual needs of the patient,” explains Eckhard Teschner, Product Manager for Electrical Impedance Tomography at Dräger Medical.  

Of course, this is all still in the future, but Dräger has already taken the first step towards automation with the smartcare function of its Evita respiration systems. A monitoring system now exists which uses electrical impedance tomography to show lung activity in real time. Conventional procedures have difficulty detecting unevenly distributed breathing gas in a diseased lung or distinguishing collapsed lung areas from areas that are still well ventilated. “Information on the regional distribution of ventilation opens up completely new prospects for customised respiration therapy,” says Teschner. The goal is a lung-protective respiration strategy that prevents negative impacts on the lung during machine respiration.  

The new Dräger Pulmovista 500 system delivers real time images and digital data on the ventilation of the ventral and dorsal lung regions. Its secret is a flexible belt fitted with 16 electrodes that is placed around the patient’s ribcage. The electrode belt continuously measures the bioelectrical properties of the lung tissue, and based on these measurements, software rapidly calculates the distribution of regional lung ventilation and changes in lung volume. Using these images, comprising up to 50 photos per second, the doctors track the respiration process live with all the main parameters, at present still manually adjusting the respiration pressure to the individual condition of the lung. In future, this too will be done automatically. “I firmly believe that the leading providers in the medical technology sector will continue developing these types of innovative approaches to patient-adapted technology,” states Teschner. 

A team from the Cardiovascular Technology (CVE) Teaching and Research Unit, Institute for Applied Medical Technology (AME) at the Helmholtz Institute in Aachen is also working intensively on patient-adapted technology. Result: A modular concept that can be used both as a heart-lung machine and for extracorporeal lung support. “The components are coordinated with one another in such a way that patient trauma is kept within limits and treatment costs reduced as a result,” says team member Georg Wagner. The so-called I³-Assist – Individual, Interactive, Integrated Cardiopulmonary Assist – consists of modular components that can be adjusted to the personal needs of the patient before surgery and during therapy. The system is suitable for mobile use and was developed in close cooperation between engineers from the Helmholtz Institute, doctors from the Clinics for Anaesthesiology and for Operative Intensive Medicine at the University Clinic of RWTH Aachen and the companies Medos Medizintechnik and Qcmed. 

Norbert Hültenschmidt, Global Head of Bain & Company’s Healthcare Practice Group, believes that clever product ideas are not the only answer to the changes in the healthcare sector. You also need to find a suitable business model and gear production to actual demand. “To continue working as a conventional innovator in future, you will need a sophisticated risk management system,” Hültenschmidt stresses. Market observers fear that international competition will lead to an increasingly fragmented market with high pressure on margins, coupled with increasing cost risk for new developments.
Andreas Beuthner   

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German Summary
Große Trends kann man nicht aufhalten. Das zeichnet sich gerade im Bereich der so genannten personalisierten Medizin ab. Auf den einzelnen Patienten zugeschnittene Diagnose- und Behandlungspfade gehören zu den großen Herausforderungen, die Industrie, Forscher und Mediziner weltweit umtreiben. Der deutschsprachige Beitrag ist nachzulesen auf www.meditec-international.com/medi0611cov