After COMPAMED, the international event for suppliers of medical technology, could only be held digitally due to the pandemic last year, it will now be held in-person again at Messe Düsseldorf from 15-18 November, in parallel with MEDICA.
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Almost 500 registrations from exhibitors shows the high level of interest from medtech suppliers, which is a huge step towards reaching normality again. As it’s a hybrid event, programme components such as the COMPAMED HIGH-TECH FORUM from the IVAM International Microtechnology Business Network which specifically focusses on the microtechnology and nanotechnology sectors and the COMPAMED SUPPLIERS’ FORUM from Devicemed, which covers the entire development and production sector in medical technology, will be offered as both online (as a live stream) and in-person events.
Both the COVID-19 pandemic and its consequences will provide much food for thought.
Dr. Thomas R. Dietrich, CEO of the IVAM International Microtechnology Business Network, said: “Due to the impact of the coronavirus, supply bottlenecks have occurred: flight and seaborne transportation cancellations have led to huge supply bottlenecks, particularly for electronic products. During the crisis, this was exacerbated by unnecessary stockpiling. Companies bought and stored more components than they needed to ensure that they were safe because they were scared of experiencing a shortfall in supply.” Raw materials and individual components were also scarce because the industry recovered quicker than many suppliers expected it to.
Computer chips were in short supply during the crisis because medtech suppliers needed far more of them. Dr. Meinrad Lugan, CEO of BVMed, recently put the situation into perspective: In many sectors, the issue was not shortages in terms of quantity, but instead distribution issues. Lugan notes that there was a “trend to make huge excess orders or multiple orders”. The resulting supply bottlenecks should be combated using “smart digital solutions based on existing eStandards.”
According to IVAM, internationalisation of the economy would still be expedient, as the global supply chains could not be maintained, which is the opposite of constructive. European manufacturers need the option to carry out production at a lower cost in other countries to remain competitive. These producing countries, in turn, need European customers to keep their own economies running. According to IVAM, there should, however, still be local supply chains for critical components – particularly for sensitive products that are important for basic care of the entire population, e.g. in the healthcare sector.
Another topic also triggered huge upheaval in the industry: On 26 May 2021, the new European Medical Device Regulation (MDR) and the equally new Regulation on In-Vitro Diagnostic Medical Devices (IVDR) came into force. As the long-read overview article on this subject in the Devicemed trade magazine states, the companies are prepared to take this on but are also clearly under pressure. According to a survey from the software company Climedo Health, 81% of the 115 companies surveyed from across Europe still find the MDR very challenging. The biggest hurdles are presented by an increase in the resources and costs needed, a lack of clarity and the requisite clinical testing. 31% estimate that the MDR will cause additional costs of 5 to 10% of their annual turnover to be levied, and 13% believe that these costs will amount to over 10% of their turnover. The companies’ dissatisfaction with the powers that be in Brussels is also mounting in other aspects: 75% wish for clearer specifications from the EU Commission, 50% want more specialist support and 30% want training or information events.
Veronika Schweighart, COO at Climedo Health, said: “The survey results show that the EU MDR continues to be very challenging, expensive and time-consuming for companies.”
The IVDR also increases effort and costs for companies. Along with new products, all approved products which are already available on the market need to undergo recertification in accordance with the regulation.
Current developments throughout the entire process chain
The COMPAMED SUPPLIERS’ FORUM has more to proffer. Current developments throughout the entire process chain will be presented in a hands-on manner: mechanical and electronic components have their moment in the spotlight in the expert talks, along with innovative basic materials, manufacturing processes, all types of contract manufacturing, design and usability aspects and quality assurance. Keynote speeches on new markets complete this diverse programme. Further focal themes include the additive manufacturing, electronic and regulatory affairs sectors.
Thus, Dr. Benedikt Janny, managing director of USE-Ing. and head of the user research and usability engineering division, reports on human-centred development of medtech products, better known as usability engineering: This is not only a regulatory obligation for medical device approval, but also offers medical device manufacturers the opportunity to differentiate themselves on the market by taking relevant user wishes into account early in the product development process and implementing them in the innovations. The keynote speech (on 15 November) explores which regulatory requirements are applicable for usability engineering and the opportunities that exist to establish human-centred development processes and to create actual added value for the product user by increasing usability within the scope of user-centred innovations.
Additive manufacturing for custom implants
Additive manufacturing and robotics remain exciting themes in medtech. Toolcraft AG sees itself as a pioneer of future-oriented technology such as additive manufacturing and in the construction of individual robot cells. The company offers the entire process chain, from the concept to manufacturing to qualified precision components using additive manufacturing, machining and injection moulding, electrical discharge machining and mould making. Within the scope of robotics, customised, fully programmed integrated solutions are implemented. Daniel Distler and Patrick Meyer (head of the robotics division and head of technical sales and distribution at Toolcraft) put their knowledge from over 30 years of experience in the industry to good use in their talk (on 15 November) at the COMPAMED SUPPLIERS’ FORUM and detail the advantages of additive manufacturing using a wide variety of application cases for medtech.
IVAM highlights in Hall 13
The IVAM International Microtechnology Business Network is one of the cooperation partners for and biggest exhibitors at COMPAMED. This year, 42 companies and institutes from nine nations are present on the joint stand (in Hall 13), with many hailing from Europe. The technology being represented includes diverse microcomponents (microelectronics, optronics, microoptics, microfluidics), sensors, actuators and sensor systems, micropumps, coatings, smart textiles and manufacturing and processing procedures, along with services. The COMPAMED HIGH-TECH FORUM (also in Hall 13) offers international presentations in accompaniment to the trade fair on each day of its four-day run and will present a wide range of themes in 2021 too. These include, in particular, printed electronics and highly integrated diagnostics for the next generation, “Equipment manufacturer meets component manufacturer,” laser and photonic applications, smart sensor solutions and microfluidic options to resolve challenges in point of care diagnostics and the life sciences.
Measuring blood pressure with an optical sensor
Highlights on the IVAM stand include new sensory developments. Conditions involving the cardiovascular system are among those which are most frequently cited as a cause of death in the industrialised nations. An important indicator for this is high blood pressure, which is currently still diagnosed and monitored by regularly taking blood pressure mechanically using an upper arm cuff. This method is uncomfortable and limits the patient in their daily activities, and, in comparison to other methods, only delivers a few selective measured values. An optical sensor can provide help here. This sensor, which works using the basic principle of photoplethysmography (PPG), records the fill level of the blood vessels in the skin over time. Using the contour curve (pulse waves) recorded in this manner, a patented procedure is used to identify relevant points in time to determine the cycle of the pressure wave in the aorta, which enables conclusions to be drawn on changes in central blood pressure. In addition to offering an alternative to classic cuff measurement, the process also gives a blood pressure result for each individual heartbeat. With this analysis of short-term and mid-term fluctuations, doctors expect to achieve a novel diagnostic approach for early detection of a variety of conditions in multiple different patient groups (e.g. pre-eclempsia).
Communication between the body and modern IT
With its electrode design, CorTec creates new pathways for communication between the body’s own electric signals and modern information technology. This young medtech company specialises in developing efficient technology for active implants for recording over long periods of time and stimulation of neuronal activity. The technology comprises customised components such as electrodes for derivation and stimulation within the central and peripheral nervous systems. Its patented AirRay electrode technology has enabled CorTec to overcome the current limitations when working with electrodes with mechanical properties that can be adapted flexibly and highly precise manufacturing conditions. The manufacturing process, using ultrashort pulse lasers, makes the technology highly reproducible even at very small dimensions of as little as 25 μm, and with a high density of electrical contacts. The flexibility of the technology enables a wide variety of product properties, such as thickness, the number of contacts, contact spacing and contact shape, and the total size of the electrode, to be modified.
The components can, for example, help localise the epileptogenic focus that needs to be removed using surgery in patients with certain types of epilepsy. CorTec’s aim is to be a leading partner in developing innovative therapies. In particular, the design flexibility of the AirRay electrode technology makes it into an important building block for the approach of communicating with the human nervous system and connecting it with artificial intelligence. This special electrode technology is, like the ceramics-based hermetic encapsulated casing, part of the CorTec Brain Interchange, a technology platform for innovative neurotherapy in a variety of fields of application such as epilepsy, Parkinson’s disease or bioelectronic medicine.
A world first for stoma care
Optima Life Science and Optima Automation will present a continuous manufacturing machine for stoma flanges. These are used as care products for artificial openings used to divert waste from the intestines (stoma). Thus, Optima Life Sciences offers an appropriate machine solution for stoma producers, bringing two separate converting processes together in one line. Process stations that could previously only be operated in cycles were developed for this line.
