After COMPAMED, the international leading event for suppliers of medical technology, could only be held digitally due to the pandemic last year, it will now be held as an in-person event again at the fairgrounds in Düsseldorf, Germany from November 15 – 18, 2021 - concurrently with MEDICA, the world leading medical trade fair. About 500 registered exhibitors prove that there is a high level of interest from medical technology suppliers, which is a huge step towards reaching normality again. In accordance with the hybrid event concept, significant program components such as the COMPAMED HIGH-TECH FORUM from the IVAM International Microtechnology Business Network (which specifically focuses 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 which can be accessed by purchasing the relevant ticket. In contrast to the previous years, COMPAMED will be held in Halls 13 and 14 this year (instead of Halls 8a and 8b). By moving the event to new halls, Messe Düsseldorf is meeting the wishes of the federal state government of North Rhine-Westphalia to ensure that they can continue to use the north area of the fairgrounds for activities in conjunction with the COVID-19 vaccination campaign.

Both the omnipresent COVID-19 pandemic and its consequences will provide much food for thought: "Due to the impact of the COVID crisis, supply bottlenecks have occurred: air and sea 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", explains Dr. Thomas R. Dietrich, CEO of the IVAM International Microtechnology Business Network. Raw materials and individual components were also scarce because the industry recovered more quickly than many suppliers expected. However, this will return to normal within a short period of time.

Computer chips were in short supply during the crisis because medical technology suppliers in particular suddenly 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, internationalization of the economy would still be expedient, as the global supply chains could not be maintained, which is not constructive. European manufacturers need the option to produce at a lower cost in other countries in order to remain competitive. These producing countries, in turn, need European customers in order 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.

One topic continues to cause a big stir...

Another topic also caused great unrest in the industry: On May 26, 2021, the new European Medical Device Regulation (MDR) and the new Regulation on In-Vitro Diagnostic Medical Devices (IVDR) came into force. As the trade magazine Devicemed points out in a long review article, companies are ready, but 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 MDR will add costs of 5 – 10% of their annual revenue and 13 percent even believe it will be over 10% of their revenue.

The companies' dissatisfaction with the powers that be in Brussels is also mounting in other aspects: 75% want clearer specifications from the EU Commission, 50% want more specialist support and 30% want training or information events. "The survey results show that the EU MDR continues to be very challenging, expensive and time-consuming for companies", states Veronika Schweighart, COO at Climedo Health. 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. In addition, the "notified bodies" must undergo a new designation procedure, which has not yet been finalized. Furthermore, the IVDR covers a broader scope than the previous directive and entails higher and also new requirements for companies and monitoring bodies in many areas. This will provide plenty of topics for discussion at COMPAMED 2021.

The Medical Device Regulation: as tough as cold fusion?

The COMPAMED SUPPLIERS' FORUM (in Hall 14) also picks up on this topic in its series of talks. "Often, when dealing with the MDR or the IVDR, one has the impression that we're working on cold fusion or rocket science. The basics for all of the points stated above are lacking. I cannot yet say which of the three topics will be resolved first, but at the very least, we can all be better informed on the MDR and IVDR. There were many difficult aspects, but also well-solved issues – complicated guidance, which is a contradiction in itself, and clever solutions", summarizes Stefan Bolleininger, CEO of the consulting firm be-on-quality. His presentation (on November 17) will show concrete examples from everyday consulting work and solution options for various problem scenarios. This concerns, for example, the handling of non-harmonized standards or what is considered to be state of the art.

Current developments throughout the entire process chain

Beyond that, the COMPAMED SUPPLIERS' FORUM also has a lot to offer in terms of content. Current developments along the entire process chain will be presented in a practical manner: Mechanical and electronic components will be the focus of the expert presentations, as will innovative materials, manufacturing processes, all types of contract manufacturing, design and usability aspects, and quality assurance. Keynote speeches on new markets complete the diverse program. Other key topics include additive manufacturing, electronics and regulatory affairs.

Dr. Benedikt Janny, who as Managing Director of USE-Ing. is responsible for usability engineering and user research, reports on the human-centered development of medical technology 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 on in the product development process and implementing them in the innovations. The keynote speech (on November 15) explores which regulatory requirements are applicable for usability engineering and the opportunities that exist to establish human-centered development processes and to create actual added value for the product user by increasing usability within the scope of user-centered innovations. The usability engineering process is closely linked with quality management and the requirements engineering process. As an expert, Dr. Janny, will indicate which types of use-based risks exist and are to be analyzed in the course of the product development process. In addition, the question of which prototypes companies can generate without great cost and effort in order to validate their medical products with real users at an early stage is also explored.

Additive manufacturing for patient-specific implants

Additive manufacturing and robotics remain exciting themes in medical technology. Toolcraft AG considers itself a pioneer of future-oriented technology such as additive manufacturing and in the construction of individual robot cells. As a partner for complete solutions, the company offers the entire process chain, from the concept and manufacturing to qualified precision components using additive manufacturing, machining and injection molding, electrical discharge machining and mold making. Within the scope of robotics, customized, 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 November 15) at the COMPAMED SUPPLIERS' FORUM and detail the advantages of additive manufacturing using a wide variety of application cases for medical technology. For example, Toolcraft AG uses additive manufacturing to make custom implants for individual patients. Furthermore, this mid-sized company has developed an automated complete solution for manufacturing and packaging a cerumen filter for hearing aids (which protects against contamination with ear wax and moisture).

Holger Frank, CEO of Mechatronic, will address the theme "The potential of the IoT in medical technology – using the example of the AED" in his forum speech (which is also on November 15). An AED is an automated external defibrillator, a portable medical device that can also be used by people without medical training. "In terms of the future development of important IT technology, 80% of all those surveyed assume that the Internet of Things will play an important role, according to a study by PwC", explains Holger Frank. Mechatronic delivers important devices for IoT developments in the medical field which enable communication between the device and the cloud. In essence, two solutions are possible: the device and communication are either integrated into one system or into separate units. An important factor for all versions is the question of which radiocommunication standard they need to be certified with. These vary throughout Europe and the USA and also differ based on the country one is based in. Large countries such as China, Russia and Canada also have their own standards. Mechatronic strongly advocates AEDs that perform a daily self-test and has developed hardware to monitor the test status via a cloud solution. The background to this is that around 30% of devices in public spaces do not work because maintenance and service are not done right.

The many highlights of IVAM in Hall 13

The IVAM International Microtechnology Business Network is again 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 of them coming from Europe. The technology 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 accompanying international presentations on all four days of the trade show and will also present a broad range of topics in 2021. These include, in particular, next-generation printed electronics and highly integrated diagnostics, "Equipment Manufacturer meets Component Manufacturer", laser and photonic applications, smart sensor solutions and microfluidics options for challenges in point-of-care diagnostics and 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 most frequently cited as a cause of death in the industrialized 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-eclampsia). The sensor developed at the CiS Forschungsinstitut für Mikrosensorik (CiS Research Institute for Microsensors) can be worn in the ear, which, in addition to numerous physiological advantages for signal quality and signal stability, means that it is comfortable to wear throughout the day. In addition to blood pressure, it can record many other vital signs such as heart rate, heart rate variability and blood oxygen levels.

Within the scope of the COMPAMED HIGH-TECH Forum, Dr. Martin Schädel, Head of the MOEMS Division at the CiS Forschungsinstitut für Mikrosensorik, will give a lecture on this development

High-tech communication between the body and modern IT

With its next-generation electrode design, CorTec creates new pathways for communication between the body's own electric signals and modern information technology. This young medical technology company specializes in developing efficient technology for active implants for recording over long periods of time and stimulation of neuronal activity. The technology comprises customized components such as electrodes for derivation and stimulation within the central and peripheral nervous systems. With its patented 'AirRay' electrode technology, CorTec overcomes previous limitations in the electrode field through flexibly adaptable mechanical properties 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.

For example, the components can help locate the epileptogenic focus to be surgically removed in certain types of epilepsy patients. 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 world first when they participate in COMPAMED 2021 together – the first 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 now also offers an appropriate machine solution for stoma producers. The main advantage is that it brings two separate converting processes together in one line. Process stations that could previously only be operated in cycles were developed for this line.

Innovative microtechnology that serves the pharmaceutical industry

Another example of high-tech that conclusively demonstrates the expertise of the COMPAMED exhibitors are the micro annular gear pumps from the manufacturer HNP Mikrosysteme. Microencapsulation is also becoming increasingly important in the pharmaceutical industry. Precise dosing techniques which can dose miniscule quantities are a prerequisite for manufacturing and processing APIs (Active Pharmaceutical Ingredients). The production of these APIs is demanding because the watery to oily substances have to be processed very delicately. Microencapsulation is the perfect procedure to protect these active substances from premature release and thus preserve their biological activity. The capsules are made of polymers or inorganic material. Depending on the permeability and degradability of the capsules, the active ingredients are released at a gradual rate. A continuous release makes therapy with medication easier to tolerate and simpler to handle. The delivery rates of the quantities range from a few microlites per minute to 140 ml/min. The precision of the delivery rate is crucial for the quality of the capsules; the tolerance for this is only plus/minus 1%. Micro annular gear pumps from HNP Mikrosysteme are used for this challenging task. The pumps can be heated or can be fitted with an additional reduction gear for the smallest quantities.

For information about COMPAMED 2021 visit: https://www.compamed-tradefair.com

Dates for COMPAMED 2021 and MEDICA 2021: November 15 - 18 at the fairgrounds in Düsseldorf, Germany

Opening times: 10:00 am - 6:00 pm

Author: Klaus Jopp, freelance technical writer for science and technology (Hamburg, Germany)