This is a comprehensive service agreement that manages not only initial procurement, but also replacement, ongoing management, maintenance and disposal of medical equipment, as well as coordination of user trainings. Siemens will be managing and supporting around 6,000 pieces of medical equipment for almost all departments in the hospital, ranging from diagnostic imaging, laboratory diagnostics, anesthetics, audiology and intensive care.

Under the vendor-independent agreement, Siemens will manage differing equipment suppliers, with the aim of integrating them into the hospital workflow to optimize the quality of care and to ensure best technologies are available to the patients. The contract runs for a period of 15 years and includes management of planned replacement of the equipment with updated technology. In December 2011, Siemens commenced with the first phase of the 100 million AUD capital investment program which will see the first major items being procured. These include advanced computed tomography scanners, magnetic resonance systems, and other imaging equipment.

The Fiona Stanley Hospital is scheduled to open in April 2014 and will be Western Australia’s premier tertiary hospital, providing 783 beds and employing more than 5,000 people.

In operating theatres the welfare of the patient is in many respects “on the knife’s edge”:
The Professional Association of German Anaesthetists (Der Berufsverband Deutscher Anästhesisten – BDA) maintains a country-wide Incident Reporting System, that records safety-related incidents in anaesthesia, intensive care, emergency medicine and pain therapy and anonymously publishes them in the CIRS Medical Anaesthesiology (CIRS-AINS) system. Each month a new case is selected and discussed. Some typical examples: the misplacing of electrodes during ECG diagnosis or functional defects of a defibrillator in a cardiological emergency.

While the case numbers are disturbing, incidents cannot always be attributed to user errors. In approximately one third of all known cases, technical deficiencies of the clinical equipment are the trigger, according to experts from the Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte – BfArM).

The Institute in Bonn is concerned not only with the licensing of drugs, but also medical device risk assessment. The authority has been regularly informing for years on recall campaigns or measures for change by manufacturers. In the last year alone, there were 866 incidents, in the previous year a mere 722. The spectrum ranges from too weak a holding function of screw extraction instruments through loose contacts in stationary pump drive units to sudden current outages in implantable neurostimulators.

Prof. Thomas Schmitz-Rode

For developers and manufacturers of surgical equipment, malfunctioning products can be a bitter blow. After all, doctors and surgical teams are reliant on the safety features of their instruments and apparatus. “Medical technology can contribute a lot towards patient care and safety,” states Professor Thomas Schmitz-Rode, Director of the Institute of Applied Medical Technology at RWTH Aachen and Chairman of the German Society for Biomedical Technology in the Association for Electrotechnological, Electronic and Information Technologies (VDE). But how can modern medical technology increase patient safety?

Michael Meyer, Head of Market Services, Healthcare Sector at Siemens considers high quality standards to be the deciding factor for better patient care: “Medical technology must be absolutely reliable and optimally support the work processes of hospital doctors at an attractive cost-benefit ratio.” At Siemens Healthcare that means reducing stress factors in work processes, rapid analysis of results during the procedure and diagnostic methods that are appropriate to requirements.

According to Alexander Steffen, Director of Medical & Pharma at User Interface Design (UID), putting medical devices through a Usability Engineering Process and a Risk Management Process is critical to a higher degree of safety in surgery. “The increasing functional diversity of equipment is limited, especially if the user can no longer cope,” Steffen adds.

Alexander Steffen

Usability is a competitive factor also
An initial firewall against aberrations is provided by the industry-specific regulations of the German Standards Institute (DIN). The DIN EN 60601-1-6 and EN 62366 guidelines already oblige manufacturers of medical devices and in vitro diagnostics to carry out and record Usability Engineering and Risk Management to comply with standards. However, this is not just a legal requirement – Usability is increasingly becoming a critical sales factor. “With user-friendly products companies can differentiate themselves much more from their competitors,” explains Steffen.
The benefits of usability measures that are applied at a very early stage in the development of a product cannot be rejected out of hand. “We know that users who perceive a medical device to be practical also have a better subjective impression of safety,” says Steffen.

Anything and everything that facilitates the operation of a piece of equipment is practical: a clear display without complicated menu or a uniform operating design with intuitive user interface. A practical design reduces the risk of operator error for users, patients and support staff. At the same time, a well thought-through design of buttons and screens increases the quality of the product. Poorly-calibrated infusion pumps, damaged tubes or endoscopy systems that malfunction are finally becoming a thing of the past.

There are no accurate figures on deficiencies in the usability of medical devices. However, the market potential for so-called Medical Safety Design is high: “Many manufacturers are only just starting to understand how much they can benefit from the early association of risk management and the usability process in development,” Steffen says. Usability is not a irksome burden, the UID consultant stresses.

Interaction between man and machine
With regard to greater competitiveness and better patient safety, a great deal can be achieved by the smooth interaction between man and machine. The Agaplesion Diakonie Hospital in Hamburg has created the technical conditions to assess and control the images from surgical field cameras, ultrasound equipment, microscopes and operating room cameras via a central touch-screen, during surgery or an investigation. All the important information such as images, videos and pre-investigation data is available to the surgical team on monitors, outside the operating theatre as well. In difficult procedures and without further expenditure other in-house doctors can be involved and advise (see interview on pages 26 /27).

The trend to greater usability and the increasing inter-operability of the range of surgical equipment is noticeable in many places. The patient table in the operating room has long since advanced to become a multifunctional platform with almost unlimited possibilities for configuration. High-performance drives move the bed at the press of a button to any position desired according to the patient’s ergonomic characteristics. In addition, the patient can be accurately positioned down to the nearest micrometre, so that even difficult minimally-invasive procedures can’t go wrong.

Harald Völker

“Technical standards of surgery are improving all the time and modern medical technology enables new treatment methods and applications, increasing the level of safety,” says Harald Völker, Head of the Medical Technology Division at the Trumpf group. For this reason, Trumpf constructors have always based their designs around the patients, for example in the case of operating tables. “The tables are highly technical and enable numerous application-specific settings for safe, standardised procedures,” Völker stresses. Thanks to modern information technology, there are programmable warning signals for surgical staff that indicate if a setting was not optimal. Special positioning cushions contribute towards pressure ulcer prevention and keep the patients secure and stable.

According to Völker, medical technology that is user-friendly and adapted to the needs of staff and patients combines safe working with greater efficiency during surgery. Shorter time spent in hospital without time-consuming double investigations reduce costs: “New appliances support process optimization,” Völker stresses. The Trumpf manager considers the greatest benefit to be the harmonization of interfaces between pieces of equipment: “The operating interface of each individual product and the interplay between different pieces of equipment are becoming increasingly important,” Völker admits. Custom-made robot technologies which are appearing in every newly-designed operating theatre also offer better surgery outcomes and greater patient safety. More than forty DaVinci robot systems are in use in urology clinics between Hamburg and Munich. As the largest centre internationally specializing in the surgical treatment of prostate carcinoma, the Martini clinic at Hamburg-Eppendorf University Hospital (UKE) has over the last year put a second latest-generation DaVinci system into service in highly-complex minimally invasive prostatectomy.

Prof. Dr. Alexander Haese

The treating physicians wish to carry out over 500 prostate operations per year using the robot-assisted system. “The new DaVinci robot enables both high-precision and minimally-invasive prostate surgery. Blood loss during surgery is low and healing rapid and relatively pain-free,” states Prof. Dr. Alexander Haese, senior consultant at the Martini Clinic and the first surgeon in Hamburg to use the DaVinci robot.

Besides the DaVinci prostatectomy with most up-to-date telemanipulator technology, there are additional approaches that help to reduce stress in surgery and hence ensure patient well-being. For a long time the anaesthetist determined the amount of anaesthetic during a procedure based on general standards and his own experience. With its Smart Pilot View, the Drägerwerk company in Lübeck has created a software environment that enables a two-dimensional representation of calculated current anaesthetic levels and the planned course of anaesthesia.

It is based on a current patient model, and calculates the interaction of the active substance groups and the resultant current and planned depth of anaesthesia of a patient. With this information, the anaesthetist is able to maintain the composition and dosage of medication at the required level over the course of the intervention. According to company data, this results in a considerably gentler course of anaesthesia for the patient.
Andreas Beuthner

Mrs. Holt has more than 30 years of experience in world-class manufacturing companies in various sales, business management and executive roles. She worked for 23 years in numerous positions at Monsanto Company culminating as vice president of its spinoff company Solutia before joining PPG in 2003. She became a member of Spartech’s Board of Directors in 2005. Prior to joining Spartech as CEO, she served as Senior Vice President of PPG’s Glass and Fiber Glass division where she was responsible for $2 billion of global sales of glass and fiber glass products into a broad set of end-use markets including commercial and residential construction, renewable energy, automotive, energy infrastructure, appliance and consumer products.

“Victoria brings immense talent, wisdom, versatility and practical knowledge to Watlow’s Board,” said Peter Desloge, Chairman and CEO of Watlow. “The skills she has developed over the course of three-plus decades at world-class manufacturing companies will make her a great contributor. We welcome her to the Watlow family.”

Watlow designs and manufactures industrial heaters, temperature sensors, controllers and supporting software as well as assemblies – all of the components of a thermal system. The company partners with its customers to optimize thermal performance, decrease design time and improve efficiency of their products and applications.

Watlow brings its experience to numerous industries, including semiconductor processing, environmental chambers, energy processes, diesel emissions, medical and foodservice equipment.

Since 1922, Watlow has grown in product capability, market experience and global reach. The company holds more than 200 patents and employs 2,000 employees working in nine manufacturing facilities and three technology centers in the United States, Mexico, Europe and Asia. Watlow also has sales offices in 15 countries around the world. The company continues to grow, while the commitment remains the same – to provide its customers with superior products and services for their individual needs.
www.watlow.com

Japan has one of the largest markets for medical technology in the world. In 2010, according to the Ministry of Health (MHLW), volume was approx. 2.3 trillion yen (19.7 billion Euro; average rate of exchange in 2010: 1 Euro = 116.58 yen). Compared with the previous year, this was an increase of 6.4%. Based on the results of the first six months (production + imports: 1.3 thousand billion yen, – 4.9%), the market would seem to have shrunk in 2011.

Even so, it is expected that the years to come will see a high demand for medical technology. This view is based on an ageing Japanese population, technical progress and rising expectations of medical care. Foreign companies in particular could benefit from this, as Japan covers a considerable part of its needs through imports.

Set against this, some factors could impact negatively on the demand for medtech. For example, the market research institute Junicon cites the scarcity of doctors in some specialist fields, the complicated distribution system and the adjustment of reimbursement rates for equipment. The government undertakes the latter every two years. In September 2011, however, the US office of the Japan External Trade Organization (JETRO) still regarded the local reimbursement system for most devices as thoroughly attractive. From a European perspective, according to an article in the journal Eurobiz, there is progress in the reimbursement of certain innovative technologies, yet this is tempered by the inordinate time it still takes to get devices licensed. Accordingly, this dampens the interest of many foreign suppliers in the Japanese market and also leads to a “medical device gap”. Because of this, it is felt that Japanese patients do not reap the benefit of advances in medical technology.

However, Japanese hospitals are generally well equipped with new diagnostic techniques, such as computer tomography scanners (CT) and magnetic resonance imagers (MRI). For example, in 2008 the country had 43.1 MRI units per 1 million inhabitants, far in excess of the 12.0 units, which is the OECD average.

In the short term, the attention of Japan’s healthcare sector is devoted mainly to restoring institutions in northeastern Japan, which suffered as a result of the devastating tsunami of 11 March 2011. According to information released at the end of May 2011, in the three most seriously affected prefectures Iwate, Miyagi and Fukushima, only 80 of the 380 hospitals survived the disaster unscathed for example. Part of the money has presumably been earmarked in special budgets in the 2011 fiscal year. In the third supplementary budget alone, approx. 9 thousand billion yen was set aside for reconstruction work of this type. In other parts of Japan, too, institutions are being built or modernised, although the hospital sector as a whole is subject to stiff financial pressures. According to press reports in June 2011, several university hospitals in Tokyo are planning to invest “some 10 billion yen” (su hyaku oku en) in extension and conversion work. As well as the strengthening of earthquake defences, new research centres (for example Keio University: regenerative medicine) and intensive care wards, among other things, are said to be under discussion. Another project is the demolition and reconstruction of the municipal hospital in Sumiyoshi (Osaka). According to information released at the end of June 2011, the total budget there runs to approx. 4.9 billion yen. Of this, 900 million yen is scheduled for new medical technology and 400 million yen for information systems.

In 2008 (latest OECD figures), Japan spent 8.5% of its gross domestic product (GDP) on healthcare. This was 1% less than the OECD average. In the next few years, the rate is set to rise rapidly owing to demographic and technical developments. McKinsey, the corporate consultants, estimates that healthcare costs could climb to three times the 2005 level by the year 2035, which means that a GDP rate of 13.5% is on the cards. Thus the urgency to cut back on healthcare funded by the public purse, more than 81% of all such expenditure. At the end of 2011 the government discussed hiking consumer tax in two stages from the current 5% to 10% by 2015. The increased revenues were to be used exclusively in connection with social security payments.

Japan regards medicine overall as a central pillar of its international competitive edge and has adopted the accelerated technological development of devices and drugs and also medical care tourism into its “New Growth Strategy” of June 2010. By 2020, the government intends to create a market for medical, nursing and healthcare services with a volume totalling 50 thousand billion yen. Specialisations will include regenerative medicine (especially stem cells), and cancer and allergy research. To coordinate this, an “Office for the Encouragement of Medical Innovation” was set up, led by the head of the Cabinet Office and composed of representatives of science, politics and commerce.

Cloud computing is growing
Development in the coming years will focus particularly on forging links between the medical sector and information and communication technology. Cloud computing especially, i.e. data storage on servers outside the user’s own institution, is a very active field. In 2010, Seed Planning, the market research institute, valued the domestic market volume for medical cloud computing as less than 10 billion yen. By 2020, that is likely to rise to almost 193 billion yen.

The Japanese medtech industry is very fragmented. According to the MHLW, there were approx. 1,440 manufacturers in 2010. Of these, 42.8% generated average monthly sales of less than 1 million yen. At the upper end, 27 companies achieved mean monthly sales of more than 1 billion yen. Important Japanese manufacturers include Olympus, Terumo, Toshiba Medical Systems and Hitachi Medical. Siemens, GE Healthcare and Philips Medical Systems are some of the key foreign suppliers on the market. Examples of German companies operating in Japan are Dräger Medical Japan, B. Braun Aesculap Japan and Fresenius Medical Care. The main areas of domestic production have remained relatively constant for years. In 2010, the largest sectors were devices and accessories for treatment purposes (25.0%), diagnostic imaging systems (16.0%) and “devices supporting or replacing organic functions”, such as artificial joints and heart pacemakers (13.4%).

Japan imports considerable amounts of medical technology – the official total for 2010 was approximately 1.05 thousand billion yen. Just under 69% was for devices supporting or replacing organic functions, instruments and devices for treatment purposes and ophthalmological devices and equipment. At 51.0%, the US was the most important source country. This was followed by Ireland (10.9%), Germany (8.4%) and the People’s Republic of China at 4.0%. German suppliers are particularly strong in imaging systems and orthopaedic technology.
Dr. Detlef Rehn,  Germany Trade & Invest, Tokyo

Business practice: Good personal relations are very important
The distribution structures in Japan are very complicated and rather opaque. Small and medium-sized foreign companies with no representative office in Japan generally work together with an importer. Good personal relations with decision-makers, generally doctors, are a very important success factor. There are three or even more dealership levels between manufacturers and end customers.

The licensing process for medtech devices in Japan is complex. An importer must have its import products assessed with regard to its hazard class (Class 1: only a low patient risk; Class 4: very high risk). In most cases, the Pharmaceuticals and Medical Devices Agency (http://www.pmda.go.jp) issues the approval. In addition, the importer itself must also be in possession of a licence (‘kyoka’). All this can take a lot of time. The government is keen to shorten the time periods, though progress in this area is very slow.

The legal basis for the licensing procedure is the Pharmaceutical Affairs Law of the MHLW. In addition, there are additional regulations to be observed for each product. Information on this can be found in the JETRO Report Handbook for Industrial Products Import Regulations 2009 (http://www.jetro.go.jp/en/reports/regulations/pdf/industrial2009e_1007p.pdf). The importation of medical technology to Japan is free of import duty. However, 5% Consumption Tax, a type of VAT, is payable on the invoice value (cif).

The medical technology market in Taiwan has been expanding for years. With a growth rate of just under 12.8%, the island nation reached new heights in 2010 to the tune of 79.5 billion new Taiwanese dollars (NT$, EUR 1.9 billion, average rate of exchange in 2010: 1 Euro = 41.7 NT$). With a look to 2011, the Industrial Economics and Knowledge Centre (IEK) estimated the volume at 85 billion NT$, representing an increase of 6.9%.

The Taiwanese medical technology market will continue to be dependent on imports of products from foreign producers. Imports have been exceeding 65% for years. Even if local manufacturers broaden their supply capacity and competitive edge, the range of products they can produce will still be limited and remain unable to cover the country’s needs for the foreseeable future. In 2010, domestic production was valued at 66.2 billion NT$ (+17% against 2009). However, production is thought to have grown at a somewhat more moderate rate again in 2011 and was estimated by the IEK at approximately 72 billion NT$ (+8.9%). The majority of local medtech production is destined for export.

Almost three quarters of locally manufactured medtech products is intended for end consumers. As a result, the strong demand for diagnostic and treatment equipment for use in hospitals has to be covered by imports. The main customers are the country’s 530 hospitals and 19,370 medical centres (medical practices and outpatient clinics). Beyond that, there are 321 care homes (with 21,733 beds), 1,002 retirement homes (50,641 beds) and 466 home care organizations.

Given that the Taiwanese population continues to age, the demand for medical technology will continue to grow. According to a forecast of the DGBAS (Directorate-General of Budget, Accounting and Statistics), by 2020 16% of the population could be older than 65 (and by 2040 as many as 31%). There will be a greater incidence of chronic illnesses requiring more care services. Consequently, it is logical to conclude that demand for equipment for home use and for both outpatient and inpatient treatment will expand. Telemedicine will also gain in importance. In addition, the Taiwanese enjoy a rising standard of living and have ever higher expectations of good medical care. And the growth of medical tourism is another not insignificant factor intensifying the demand for the latest in medical technology.

By far the main cause of death due to illness in Taiwan is cancer. Lung and liver cancer are the most common types by a wide margin. Industry insiders claim that the greatest sales are likely to be achieved with medical technology products for the prevention and treatment of cancer, heart diseases, disorders of the vascular system, diabetes, high blood pressure and kidney and liver diseases.

Taiwan has a comprehensive national health insurance system known as the National Health Insurance (NHI). This means that the demand for medical services and ultimately also for medical technology is relatively stable and not heavily dependent on the purchasing power of patients, as opposed to many other countries. Even so, the public health insurance system needs to get to grips with mounting costs, not least in view of the country’s ageing population. In order to cut expenditures, one of the measures attempted by the Health Ministry is to keep the reimbursement of medical technology costs as low as possible.

Taiwan intends to develop medical tourism as a source of revenue. To this end, a special zone delivering premium level medical care will be created in the next four years near the international airport in Taoyuan. Patients will have to pay for services themselves. The main target group is affluent patients from the Chinese mainland.

Taiwan offers cost benefits
Medium-sized companies are the mainstay of Taiwan’s medical technology industry. Numbering over 500, the island’s companies employ a workforce of approx. 22,000. The producing companies work in the main to OEM and ODM contracts (Original Equipment Manufacturing/Original Design Manufacturing) and most of their production is for export. Some domestic companies are trying to establish their own brands.

The strengths of Taiwanese manufacturers lie in capitalizing on opportunities to cut costs in the production process and in knowledge transferred from the IT field for application in electronic components. Among the most competitive products are mechanical and electric wheelchairs, electronic thermometers, blood pressure and blood sugar gauges, hearing aids and contact lenses. At present, products for home use predominate in the product range. In 2011 the Economics Ministry announced its intention of launching a several-year programme promoting the local production of high-quality medical technology, i.e. ultrasound devices, digital X-ray machines and magnetic resonance imagers. Accordingly, the years 2011 to 2014 will see the establishment of research and development capacities, and then the associated commercial structures. The aim is to create at least two Taiwanese brands in this sector to take their place among the world’s ten largest providers.

Taiwanese imports of medical technology rose in 2010 by 15.6% to 53.5 billion NT$. IEK forecasts growth for 2011 of 7.6% to approx. 57.6 billion NT$. Exports made a great upward leap in 2010, rising by 24.1% to 40.2 billion NT$. According to the forecast, exports are still expected to rise in 2011 by 11.1% to 44.7 billion NT$. The main supplier countries continue to be the USA, Japan and Germany, followed in 2010 by the People’s Republic of China and the Republic of Korea.
Dr. Jürgen Maurer, Germany Trade & Invest, Taipei 

Foreign medtech companies need a suitable local agent
Since 2010, the Taiwanese medical technology market has been regulated by the recently formed Food and Drug Administration (FDA). In line with the US system, it specifies three risk classes. Good Manufacturing Practice (GMP) is mandatory for all medtech manufacturers as a quality assurance standard. Product safety (for both patients and staff) and environmental aspects are increasingly important factors in purchasing decision making.

In general, a foreign medtech company intending to import its products on to the Taiwanese market will need a suitable local agent. The only appropriate companies for this are dealers in or manufacturers of medical technology products. At present, the process from application to licence lasts approx. 100 days, says the FDA, if products are substantially similar to others on the Taiwanese market. The process for new products, however, is likely to take approx. 200 days. Product registration remains valid for five years. In principle, the Bureau of Standards, Metrology and Inspection (BSMI; http://www.bsmi.gov.tw) is for responsible for technical norms and standards. TÜV Rheinland Taiwan Ltd is a further contact for certification issues. (http://www.twn.tuv.com). The Directorate General of Customs (DGOC) provides information on import procedures and custom duty rates at http://eweb.customs.gov.tw.

Every year around five million patients worldwide need a bypass. Conventionally, blood vessels are taken from the patient, and then used to “mend” the damaged vessels. The older the person, however, the smaller the chance that their blood vessels will be viable. Scientists have made a start on tackling this problem, but are constrained by cost pressures in the healthcare system. Besides being compatible with the patient’s body and having a long service life, implants need to be storable and affordable. To avoid the implant causing problems, as well as being biocompatible, the basic material must still be smooth enough to prevent thrombosis developing. It must sustain blood pressure and be corrosion-resistant – after all, blood also contains a certain percentage of oxygen and chemically active substances.

“The basic scaffold for blood vessels is a matrix comprising various proteins such as collagen, whose structure is very similar in different mammals. In the same way as when we use human blood vessels, we assume that when animal bloods vessels are employed, specific rejection responses can be avoided after removing the original cells and implementing further process steps,” says Professor Ulrich Martin, Director of the Leibniz Research Laboratories for Biotechnology and Artificial Organs. In a next step, the patient’s cells then colonise this scaffold. Internal endothelial cells ensure that the vessel wall is sufficiently smooth, while muscle and external connective tissue cells ensure adequate resilience.

One big advantage of these scaffold structures is that the artificial vessels gradually transform in the body into completely natural tissue and therefore also have the ability to grow, which is extremely useful when performing surgery on children. The young start-up company Corlife, a spin-off of Hannover Medical University, is working in this field.

As part of their BioProfile BMPF programme, developers at Hechinger company JOTEC produced a collagen matrix with customised pores, which endothelium and muscles cells can colonise more easily. As isolated collagen is generally water-soluble, it can be cast in forms or flat to solidify. However, the collagen matrix initially needs to be supported by a polyester network in order to achieve the necessary stability. “As things stand at present, we have manufactured a reproducible matrix and carried out initial animal testing. Despite promising results, complex issues mean that the project has been put on ice in favour of other development projects. There are still some problems to be resolved, not least the logistics in terms of cell removal, cultivation and storability,” reports Dr. Kerstin Ragnitz (Bild), Marketing Director at JOTEC.

The scientists are working not only on collagen, but also elastin, an important component of natural tissue. The BMBF SynElast project is currently carrying out research on how elastin can be obtained in a soluble form that enables it to retain its unique 3D structure.

At present artificial blood vessels normally consist of knitted or interwoven artificial fibres, usually made of polyethylene terephthalate (PET, trade name Dacron) and expanded polytetrafluoroethylene (ePTFE, trade name Gore-Tex). Albumin, collagen or gelatin is used to make the artificial vessels blood-tight. However, only half of small blood vessels six to eight millimetres in diameter are still viable after five years. Prostheses filled with endothelial cells deliver better results, although these cells have to be properly seeded on these prostheses. On the other hand, a coating of modified biopolymers such as heparin also promotes colonisation by endothelial cells.

The key words are rapid prototyping
A shorter, automated production process is needed in order to bring down the cost of implants. The key words here are rapid prototyping, and two research teams have come up with similar solutions. Organovo, a spin-off from Missouri University, and a group of Fraunhofer institutes have both developed a sort of 3D inkjet printer, although the two teams use different “inks”.

Organovo uses modified stem cells and a hydrogel. The scientists have discovered that small cell clusters placed close together flow into each other and merge. A “drop of ink” consists of 10,000 to 30,000 cells. A second printer head deposits the sugar-based hydrogel, which acts as a scaffold. Once the structure is complete, it is left for a day or two before the hydrogel is removed.

The Fraunhofer team on the other hand “only” prints with one bio-ink made up of various polymers. Light solidifies these polyethylene glycol based plastics to create elastic walls. Multi-photon polymerisation by laser produces micrometer-sized structures. This method can also be used for inexpensive production of complex, fine-resolution structures.

The aim in both cases in to produce larger skin sections. “At present, artificial skin can already be cultivated automatically from adult stem cells. But from about one square centimetre upwards, there are problems with nutrient supply – nutrient solutions are no longer adequate,” explains Dr. Günter Tovar, Project Manager at Fraunhofer IBG (Institute for Interfacial Engineering and Biotechnology) and a partner in the new EU project artiVasc (Artificial Vascularised Scaffolds for 3D-Tissue Regeneration).

In this case too, the body cells have to accept the vessel matrix, which must be colonised by the appropriate cells to create a resilient vessel. The results will be used to provide replacement tissue for burns for example. Beiersdorf is now collaborating in the project to this end. Organovo is targeting pharmacological use and has made contact with Pfizer. The artiVasc project team also plans to develop a standardised process chain and has joined forces with KMS Automation, SYSMELEC and Vimecon automation experts.

Cellulose is another biocompatible material that has long been used in wound care. Gluconacetobacter xylinus bacteria produce high-yield, high-purity nanocellulose in sugary liquids. The resulting fibre network can have a 99 per cent water content, and thus forms a hydrogel. “Nanocellulose materials are easy to handle, because they keep their shape and can be stored for an almost unlimited time,” explains Professor Dieter Klemm, Chemicals Research Director at Jenpolymer Materials. Cellulose is also mechanically stable and according to Dieter Klemm (Bild), the bursting limit of vessel implants made from nanocellulose is 1,000 mm Hg.

When this material is used in the body, the body replaces the water with its own natural substances and cell colonisation then takes place in the body almost by itself. The first products made from nanocellulose, albeit only flat materials for wound care, are already on the market.

A number of large and small start-ups, spin-offs of well-known universities, are currently developing the basic technology. More and more large companies are expressing interest as production safety improves. However, it will still be some years before products such as artificial blood vessels and larger skin sections reach the market, as nearly all of these start-ups still have to run clinical trials.
Dr. Barbara Stumpp

ED-lights are on the increase at the surgeon’s workplace, according to manufacturers, but also in the opinion of Spectaris, the German high-tech industry association: “LED-light has cornered the market in surgical and investigational lighting in just a few years”, according to Tobias Weiler, Managing Director at Spectaris.

LED surgery lights are ahead of the competition for one simple reason: they combine high light emission with flexible design. The LED elements are arranged in such a way as to achieve almost shadow-free illumination of the surgical area. As light-emitting diodes produce virtually no heat, even at a light intensity of 160,000 Lux, the “cold” light also protects the tissues of the patient from drying out. In addition, light diodes require less current and have a longer life than halogen lamps.

According to Alexander Machill, Product Manager at Berchtold, the benefits of the latest F-generation in the company’s own Chromophare series surpass conventional light solutions: “By means of special reflector technology, we are already mixing the light in the reflector and creating a light field with excellent spectral properties”, says Machill. According to company data, the LED light multiplies in the reflector and causes intensive glare-free illumination at the place of use.

One additional plus factor is the selectable colour temperature with a colour rendering index of 96. The surgeon is able to select the exact light intensity and colour temperature with which he can clearly differentiate different tissue structures and colours. The advantage of adjustable light properties is noticeable in the surgical team’s improved efficiency and ability to concentrate. Tests have shown that the risk of concentration-related errors during a procedure decreases with the use of adjustable lighting systems.

For its operating design Berchtold relies on a touch-screen panel which controls all the functions of the LED lighting system. With a few movements of the hand, the doctor can adjust the light intensity and the size of the light field for both the main light as well as satellite lights. The flat bulbs are dimmable and can be moved freely in the operating room. The company places great store by the lamp structure, which does not disturb the laminar flow from the climate-controlled ceiling (which ensures a germ-free environment in the operating room) by turbulence. The light- emitting surface is made from glass, which is easier to clean than plastic.

Product developers at Trumpf Medical Systems have also recognized the importance of flat and efficient LED bulbs to freedom of movement in the operating room. In addition to a confined space version and a wall-mounted design, there is also a portable version of the current True Light 5000 series. The surgical lamp that is intended to provide additional lighting is mounted on a chassis with four wheels, but has the same features as the stationary light units.

The manufacturer from Ditzingen lists the advantages of light diodes for its medical technology product line. In order to achieve a uniform light at the operating area, the manufacturer bundles the individual light elements into a so-called multi-lens matrix. Each lens consists of a multitude of LEDs and none of the light is lost. This results in a uniform light field at the target site, with hardly any shadowing. According to the manufacturer’s data, the matrix lighting achieves a 25% increase in light compared with conventional lighting even at lower operating levels.

It is driven by the company’s own software – Adaptive Light Control (ALC) – which focuses each light segment electronically, measures the working distance to the surgical area and adjusts the position of the light segments by movement recognition. The lamp no longer needs to be directed by the surgeon, even if distances are changing frequently. Automatic adjustment of the viewing angle of the group of lenses ensures the best light conditions.

Modern lighting systems aren’t stand-alone devices but act as part of an integrated operating environment. They offer interfaces for connecting to OP control and expand the possibilities with integrated video systems for digital image transmission in high definition quality. Trumpf has developed its own video management system for the operating room, which manages the distribution of video signals, through the documentation of operations to communication with the world outside the operating theatre.

One response of conventional lighting technology to the success of LEDs can be found in glow discharge lamps. Besides its range of LED lights, Maquet also features the glow discharge lamp “G8 Evolution” in its product portfolio. The lamp produces a light intensity of 150,000 Lux at a power consumption of 85 Watt. At its core is the newly-developed electronic control gear “PlasmaTronic”. Together with the ELC (Electronic Light Control) the control unit guarantees dimmable, flicker-free lighting in the operation area.

The open ring light is designed in such a way that it produces less heat during surgery than conventional lighting. The top and bottom of the lamp reach a temperature of 35 degrees Celsius and therefore remain well below the conventional normal temperature of 70 degrees Celsius. According to company data, the surgery lights allow laminar air flows due to air conditioning to pass unhindered and hence reduce the risk of microbial invasion.

For documentation and telemedicine applications the lamp provides the use of a rotating camera with automatic focus and parallax correction. The software Intelligent Camera Control (ICC) focuses the camera at the touch of a button and automatically adjusts the parallax. The camera can rotate through 360 degrees, so that pictures of wounds can be taken from various perspectives.
Andreas Beuthner 

By integrating microsensors and electrically-conducting polymers into clothing, modern medical textiles can help for example to monitor a patient’s vital signs. Textile implants are increasingly being used in everyday surgery: stents, hernia meshes or vascular prostheses. Even artificial replacement corneas and skin are textile-based innovations such as novel cell carriers and external ear prostheses.

Besides the development of hollow textile fibres, into which active drug substances can be incorporated, textiles display their strengths in stents and other implants. Professor Stefan Jockenhövel, Head of the Cardiovascular Tissue Engineering Department at the Institute of Applied Medical Technology at RWTH (North Rhine-Westphalia Technical Institute) Aachen, researches into textile-reinforced heart implants. To increase the life-span of synthetic bypass prostheses, the medical technologists cultivate new blood vessels. They reinforce the gel-like blood vessels made from proteins in the body using a textile structure. This tissue matrix stabilises the living blood vessel, that functions like a normal human artery or vein.

“We are the first in the world to make textile-reinforced, biological vascular implants along these lines,” as Stefan Jockenhövel states. The only problem is that the combination of cultivated tissue and textile-reinforced supporting structure has not yet completed the clinical evaluation phase. However, initial preclinical studies have shown the superiority of the vital vascular prosthesis compared with the synthetic prostheses currently used in clinical practice. Jockenhövel estimates that the medical device will be licensed within two years. “We have the advantage in that we produce everything: from the new material to the finished implant, and we are also responsible for clinical registration,” states Jockenhövel.

Otto Bock Trias_Product

Long technology transfers from research results through to practical implementation are a thorn in the side of many participants in this industry. On average, the clinical testing and licensing procedures take over ten years. “That is clearly too long,” complains Klaus Jansen, Managing Director of the research association, Forschungskuratorium Textil e.V. However, progress cannot be halted by bureaucratic red tape. For orthopaedic sports specialists, prostheses made from light-weight carbon, a textile structure made from carbon fibres, has been the material of first choice for a long time. Top handicapped sportsmen and women achieve their personal bests when sprinting on high-tech artificial leg prostheses. Lightweight constructions based on carbon fibres can be found in the product portfolio of the prosthetics manufacturer Otto Bock. The `Trias´ foot prosthesis is an expensive technical replica of the foot with excellent biomechanical properties. Silk is a natural fibre that is also used therapeutically in the area of bone regeneration and wound healing as well as cardiovascular treatment. Start-up companies such as Munich-based Amsilk are involved in the production technology of an industrial spinning process which manufactures novel high-tech materials for any long high performance fibres from silk proteins. The biotechnologists at Amsilk are already working on fleeces, films and foils as well as coatings for implants.

Hypothermic Mat

The Aachen-based company Spintec Engineering manufactures various products from high-molecular silk protein obtained from specially-cultivated silk worms at their production plant. This is used to produce for example flexible membranes which display high stability and seam strength. Membrane thickness can be adjusted according to medical indication. Rate of degradation of the membranes in the human body can be adjusted during manufacture – which is ideal when combining them with bone replacement materials. Promising results from product development for medical applications also come from the area of trauma management. Two years ago, scientists from the German Wool Institute (DWI) managed to develop a non-adhesive wound dressing based on cellulose. The central idea is a sheer hydrogel coating, which together with various antimicrobial substances such as silver creates a microclimate that promotes wound healing. The dressings manufacturer Lohmann and Rauscher manufactures non-adhesive wound dressing coatings. One process that was adopted some time ago is the treatment of textile wound dressings with plasma ammonia, using a copolymer as the reactant. Together with embedded bioactive substances this creates a wound dressing that can be removed from the skin’s surface without leaving any residue.

Lohmann and Rauscher has been dealing with healing-promoting dressing materials for years that extract substances which promote inflammation during regeneration from the area of the wound. The bioactive collagen wound dressing “Suprasorb” for example is one of the pioneering medically-active wound dressings that promote rapid skin regeneration. A refined, highly-absorbent pore structure absorbs large quantities of fluid including substances that trigger inflammation.

Textile material is also the basis for a customized single surgical drape for transcatheter aortic valve implantation from Mölnlycke Health Care. The transparent side areas, comfort layer at skin contact points and the highly-absorbent material of the new Barrier Hybrid Cardiovascular Set is specially designed for minimally-invasive surgical implantation of an aortic valve. According to company data, approximately 100 hospitals already offer this system.
Andreas Beuthner

Measuring and analysing are the main requirements in many medical technology tasks: from the determination of gas pressure in ventilator equipment to the dynamic testing of implant components and measurement of their geometric characteristics – the processes are correspondingly diverse. Sensors are already able to directly record the stress on a leg prosthesis, while mini cameras, the size of a grain of salt, on the tip of an endoscope are able to deliver sharply-focussed images of the inside of the body.

Holger Bödecker

Although the majority of sensor manufacturers are active in branches of industry with a high turnover – the automobile industry first and foremost – demand is growing in the field of medical technology: “With the increasing use of modern sensors in medical technology, the trade fair is becoming increasingly significant in terms of providing a focal point for dialogue on innovative products between suppliers and users”, according to Holger Bödeker, Managing Director of AMA Service GmbH, a company belonging to the AMA Professional Association for Sensor Technology.

The trend is towards miniaturisation and integration. For example, when it comes to distance measurements, the measurement systems are becoming increasingly smaller and the diameter of a miniature encoder can be 18 millimetres with a resolution of 1600 impulses per revolution, while coating thickness measurement takes place in the nanometre range. When measuring individual layers of coating in a multi-layer coating of transparent, partially-absorbent layers, White Light Reflectance Spectroscopy (WLRS) delivers absolutely reliable results at low cost – previously, expensive measurement apparatus was required to do this.

When developing a new thermal membrane flow sensor, the company 2E Mechatronic was aiming for a space-saving design envelope with modular construction of the measuring cell. In collaboration with the Mikro- und Informationstechnik der Hahn-Schickard-Gesellschaft für angewandte Forschung (HSG-IMIT) (Institute for Micro and Information Technology), the Technologietransferzentrum MMA (Technology Transfer Centre) and the company Gruner, a silicon-based miniature system was produced that also detects the tiniest pressure differences. The measurement range is between zero and 15 millibar.

MID-Technology

At the heart of it all is an injection moulded interconnect device (MID). MIDs are mouldings with an integrated circuit. That means that the fluid connections are integrated in the MID and there is a direct connection between fluid channels and silicon chip. Not only does three-dimensional microchip configuration and connection technology lead to smaller components with optimal measurement characteristics, compared with 2-component injection moulding, MID technology also saves on assembly stages and therefore reduces the overall costs per measurement system.

3D-MID sets high quality standards
The Swiss electronics company Harting Mitronics has been producing MIDs for a long time. According to company information, medical technology is benefitting above all from the high quality standards of 3D-MID technology and from the combination of electronic and mechanical properties achievable with it in one component. Additional benefits of multifunctional 3D packages, according to head of marketing Michael Römer, include great design flexibility and favourable tool costs: “This makes MID technology competitive even with smaller batch sizes,” Römer says, as the Nuremberg trade fair approaches.

In addition to their industrial applications, the Halle-based firm Sonotec is also presenting its skills in medical technology. Among other things, the company has new clamp-on ultrasound sensors in its range, which rapidly, reliably and with no contact detect air bubbles in tubes and measuring chambers that have liquid flowing through them. The intelligent sensors have high reading stability in fluctuating environmental conditions. According to company data, the measurement cycle is 200 microseconds with a reaction time of one microsecond. “In any case, we guarantee detection of air bubbles with a minimum size of one third of the internal diameter of the tube”, says Peter Ködderitzsch, head of sales of medical devices and laboratory technology at Sonotec.

In addition to air bubble detection and flow measurement, chemical sensors and spectrometer measurement processes are in demand in medical technology. Vitro diagnostics and biological cell and DNA detection in particular are seeking better techniques that enable almost real-time blood or tissue analysis at point-of-care. Topics such as this are echoed in congresses that are taking place in parallel to the trade fair, such as the 14th International Meeting on Chemical Sensors (IMCS). One topic that is of particular interest to scientists travelling to the congress is medical technology of the future. “We are anticipating an expansion of this trend in the future and expect significantly more visitors from the field of medical technology,” says Bödeker. Spectrometers have become small and inexpensive with a relatively flexible structure, thanks to microsystem technology. Product versions can be found at the trade fair that offer a choice between greater throughput or higher resolution, for example. With the USB converter, up to 16 of its spectrometers can be configured via Ethernet with browser software, and the signals evaluated.

There are, in the meantime, micromechanical pressure sensors or temperature switches with digital output signals for a variety of measurement ranges. Of interest are pressure sensor modules that are also suitable for mobile applications, for example to monitor a patient‘s position. The crucial features are low current consumption and high long-term stability. Another capacitor pressure switch can be used in vacuum units on freeze-drying apparatus, in packaging machinery or autoclaves.

The most common scientific questions relate to the use of medical technology sensor applications. “It is primarily young, highly-innovative companies that focus on chemical sensor technology”, according to Bödeker. But many of the larger exhibitors also have product developments in their portfolio that are suited for medical technology. The professional association AMA is expecting further company start-ups in the future, frequently originating in the university arena: Bödeker feels that “intensive development activities in the area of science and the growing demand for medical technology will together create an attractive field for specialist company start-ups”.
Andreas Beuthner

Based in Tuttlingen, in the Swabian region of Germany, Synthes is a globally leading company in the development and production of implants and instruments for traumatology, spinal, oral and maxillofacial surgery. The company has set its sights on a particular goal – designing the production of medical instruments to be more flexible and more productive, while keeping within quality guidelines. Constantly recurring cycles in connection with small batch sizes is a key feature of production operations in Tuttlingen. In addition, in 2008, the company began producing complex rotational parts. This necessitated investment in a universal presetting and measuring machine to cover the dimensioning of both milling and lathing tools. The aim was to use this presetting and measuring machine to cut tooling times and error rates and increase machine run times measurably.

This procedure proved to be very complex and time-consuming, particularly with respect to tools for the long bed lathes, because the more intricate the rotational parts, the greater the importance of dimensioning and setting the centre height. This prevented the universal presetting and measuring machine from being employed for other tasks. This situation was plainly unsatisfactory, especially as Tuttlingen has approximately 15 machining centres for each of the 3-axis and 5-axis ranges and several complex long bed lathes and consequently a great many tools are in use. This situation prompted the Synthes decision-makers to invest in Zoller presetting and measuring machines. The types procured were a ‘venturion 450’ for milling tools and a ‘hyperion’ for lathing tools.

Today, a work folder is set up for each work order and a unique identification number is assigned to each tool. This means that all the relevant tool characteristics, such as overhangs for collision avoidance, parts lists for the tools etc. are clearly defined and stored. The actual tool data is measured and loaded on to a server by the Zoller presetting and measuring machines and then transmitted straight to each machine. Whereas in the past, tool presetting was carried out by each machine operator, these days tool trolleys are set up from the measurement and presetting room. This has made it possible to schedule almost all tool set up operations for non-productive times.

Error rate was cut by 80 percent
Wolfgang Ley, five-axis manager, describes the productivity gains achieved in the following terms, “This switch delivered huge time savings. For example, at present four to six tool trolleys can be set up with approximately 20 to 30 tools per shift in the measurement and presetting room. This is in addition to the tools that need to be replaced during continuous production because they’ve reached the end of their working lives or for other reasons. A further advantage was the cut in the error rate, because loading tool data straight on to the machines has definitely cut this by 80%.”

As regards long bed turning, even more time is saved than with milling tools. This is because the ‘hyperion’ presetting and measuring machine can preset tool data conveniently and reliably to the centre height, prepare the data and transfer it in seconds to the machine controls. Processes are reliable, reproducible and ensure compliance with all mandatory documentation requirements. 100% documentation of all stages in the process chain is naturally of great importance in medical technology. Over 60% of the products go to the parent group in the USA.

Walter Seeh und Wolfgang Ley

As Walter Seeh, production manager at Synthes Tuttlingen GmbH explained: “Product liability is taken very seriously in the USA. This makes evidential documentation on the entire production process an absolute must. One of the reasons why we have such a high regard for Zoller is that the presetting and measuring engineering of the tools is the first link in the process chain and thereby provides perfect conditions for dimensionally stable products with excellent surfaces. These are ideal conditions for the machine to deliver perfect parts right from the start.” Also – the consistent trend towards ever smaller instruments demands even greater standards of precision from production. Currently, geometric tolerances, angles and parallelisms are measured at below two hundredths of a millimetre.

The fact that in Tuttlingen the milling tools are preset and in perfect condition when they reach the machines and that down times between the previous and next work order have been cut appreciably is due in no small measure to the ‘venturion 450’. This is a presetting and measuring machine more or less custom-made for medical technology because it can be configured ideally to suit the production sequences in medical technology.

In Tuttlingen, Synthes produces approx. 700 articles in the 5-axis range and approx. 300 in the 3-axis range. A volume like this needs some management. However, skilled staff are practically unavailable, at least in the Tuttlingen area. This is why all relevant employees were involved in the development of the concept with the tool trolley, work card and installation of the Zoller presetting and measuring machines. There are obviously numerous reasons why the company opted for Zoller’s benchmark presetting and measuring machines. Firstly, it was the absolute precision and reliability of the machines and then the staff who have already had years of outstanding experience with Zoller. Other reasons are that operation is simple and service is known to be good.