Swiss Medtech Report 2012 - Medtech Switzerland

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Invention Product Development 22 Manufacturing Facts & Figures Marketing & Market Access Regulation & Healthcare Navigating the regulatory jungle Funding & Financing The Swiss medtech market is traditionally characterized by fast time to market. With increasing regulatory and safety requirements, however, this is changing. Swissmedic, the supervisory authority, addresses this fact by providing information, training and recommendations and consulting firms such as ISS support companies in the efficient management of authorization procedures and quality controls. On its passage through the development, manufacturing and delivery chain, a medical device has to meet countless requirementst to protect patients and users. For marketing authorization alone, there are numerous provisions on the tolerability of materials (biocompatibility), functionality, quality and sterility to be complied with. For example, cleanroom requirements for assembly or the safety of packaging for items such as syringes are subject to validation by specific tests. Sticking on a Band-Aid is not associated with the same risks as the use of walkers or even a cardiac pacemaker. When a medical device is scrutinized in terms of compliance for marketing purposes, it is subject to requirements, the stringency of which is dependent on its risk class. The potential risk is also a factor which determines how it is tested in humans. For example, clinical trials with implants must fulfill the highest scientific and ethical criteria, as well as statutory requirements in terms of patient information and insurance coverage for injuries. 10,000 PaGEs OF DOCUMENTaTION Whether for the development, composition or functionality of a product and for liability reasons as well, all relevant information must be meticulously documented in manuals and regularly updated. Depending on the risk class up to 10,000 pages may be required for technical and clinical documentation. In addition, manufacturers of products on the market are obliged to maintain a system for product surveillance. In this system, information on safety, quality, stability and performance of medical de - vi c es in actual use must be collected and evaluated. Here traceability is becoming ever more critical. It serves as proof of quality and allows for the efficient recall of products. Serious adverse events and measures taken to correct them must be reported by manufacturers and users to Swissmedic, the Swiss authorization and regulatory authority for therapeutic products, and/or coordinated with it. Some 1,800 reports on medical devices are registered annually, i.e. nearly twice as many as in 2005. The largest increase was recorded between 2009 and 2010, resulting from the revision of the Swiss Regulation on Medical Devices (Medizinprodukteverordnung). Through implementation of the changes to European law, this entailed, among other things, the reclassification of a few surgicalinvasive products from Risk Class IIa to Class III. Besides erroneous classifications, the most frequent causes of undesirable events are labeling and packaging problems, incorrect product descriptions and software errors. Once the corrections carried out, they are published by Swissmedic, which also issues safety alerts on its own, for example if a manufacturer is faced with bankruptcy. CONsCIENTIOUs MaNUFaCTURERs “In principle, the manufacturers take their responsibilities seriously. The surveillance system works, and the SIRIS implant register provides another valuable instrument for quality control,” says Karoline Mathys, a member of Swissmedic’s Management Board. Hans-Jörg Riedwyl, CEO of Integrated Scientific Services (ISS) AG, also stresses that Swiss medtech companies have a strong tradition of quality and safety consciousness with respect to patients. For this reason, he cannot imagine cases of fraud, such as that of the PIP implants in France. INNOvaTION-FRIENDLY sWITZERLaND “With a time to authorization of only a few months – in contrast to Japan where it takes up to two years – Switzerland offers an environment that is conducive to innovation. It often serves as a test market for international companies before they enter other countries,” says Ulrich Hofer, head of Regulatory Affairs & Science at ISS. Despite years of effort to achieve the global harmonization of laws covering
medical devices, there are still very different regulatory systems and hurdles to overcome. In the USA the federal government’s Food and Drug Administration, the FDA, controls the market and developing medtech countries, such as Brazil or China, barricade themselves against foreign companies by tightening conditions for authorization. “As a result of increasing global integration and the development of new technologies, such as in the nano range, changes in the regulatory environment are accelerating,” according to Riedwyl. Following incidents with defective products, regulations are being strengthened worldwide, entailing a correspon d ing increase in administrative expenses. From the validation of the production process to the conformity certificate for authorization the costs per product run from four to six figures. REGULaTORY aFFaIRs aRE TOP PRI- ORITY “In view of the growing complexity of the requirements, a good knowledge of the laws and directives is needed,” emphasizes Mathys. It is here that Swissmedic provides information, training and regular recommendations. In order for a company to make its way through the thicket of important regulations, the subject should be part of the business strategy from the start and should be handled Between quality demands and cost pressures by management. A start-up must bear this in mind even before the development of its first product, and must train employees to deal with it. Larger companies recruit a regulatory affairs officer and quality manager or form their own departments. On the other hand, small and midsized companies will, for financial reasons or due to a lack of medical knowledge, have to seek other solutions. This is all the more so since, as with pharmaceutical products, any review of efficacy requires ever increasing clinical know-how. sTREaMLINED QUaLITY MaNaGE- MENT Companies like ISS can provide support in the form of specialized advice and software to small and midsized companies and so help them build a streamlined quality management structure for rapid market entry. “ISO Standard 13485 for the design and manufacture of medical devices already offers an efficient basis for certification,” says Hofer. Given well-prepared documentation, the pro - cess for entry into as many markets as possible can be reduced significantly. In addition, thanks to the know-how provided by specialists, classification into a higher risk class, or recalls of a medical device can be prevented, which represents a great cost saving to the company concerned. Switzerland, with its healthcare system, its number of hospitals and physicians, but also its use of medical technology, is a world leader. High-value services have always had top priority. But with increasing cost pressures, solutions are being sought to increase quality and efficiency, an area in which medtech users and manufacturers must work together closely. Today Switzerland has more than 310 hospitals, of which at least 130 are for acute care, more than 180 specialized clinics and more than 1,500 care facilities. In addition, medical devices are sold via 10,000 doctors’ practices and laboratories, as well as over 1,700 pharmacies. The hospital sector is the biggest customer, buying goods and services to the tune of approx. CHF 6.8 billion annually. Of this, a large part consists of medical technology. Among the medical consumables used are bandages, syringes and surgical instruments, as well as implants, which comprise about a third of the total. Aside from this, hospitals on the scale of the Hirslanden Group use thousands of devices and systems, primarily in diagnostic imaging. HIGH DENsITY OF CaRE IN sWITZER- LaND Healthcare in Switzerland is at a very high level. In the OECD list, Switzerland occupies fourth place, with over 40 hospitals per million inhabitants. It shares second place with Germany when it comes to limiting the length of hospital stays. It also holds fourth place in the number of practicing physicians, and is number one in number of nursing personnel. The high density of care comes at a price. According to forecasts by KOF, the Swiss Economic Institute (ETH-Konjunkturforschungsstelle), dated November 2011 the Swiss healthcare system will cost CHF 1.7 to 2 billion more than in the previous year. According to the OECD, healthcare costs, at 11.4 percent of gross domestic product, are two percent over the 23
Page 1 and 2: Swiss Medtech Report.
Page 3 and 4: INTRODUCTION Switzerland, like many
Page 5 and 6: INNOvaTIONs FORIMTECH SA is a leadi
Page 7 and 8: ering the solutions they need to ru
Page 9 and 10: CENDREs+MéTaUx sa Cendres+Métaux,
Page 11 and 12: flects the product language and cor
Page 13 and 14: sURFaCE TECHNOLOGY KKS Ultraschall
Page 15 and 16: focused on achieving a high level o
Page 17 and 18: ZIEMER GROUP Founded in 1998 in the
Page 19 and 20: from the competition by supplying a
Page 21: sWIss MaDE Switzerland is the world
Page 25 and 26: sUPPORT Financing of young technolo
Page 27 and 28: The start-up financing phase funds
Page 29 and 30: HOTsPOT Switzerland boasts one of t
Page 31 and 32: Source: Data from the Swiss Medical
Page 33 and 34: Source: Swiss members of Medical Cl
Page 44: Publishers of the Swiss Medtech Rep

Swiss Medtech Report 2012 - Medtech Switzerland

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