The trend towards personalised medical care, demographic developments and digitalisation constitutes an important driver towards technological advances in the fields of medical technology and healthcare. Health policies and cost pressures are also pushing progress forward. The field of medical technology has in particular given the micro-technology industry a huge boost with its demand for corresponding solutions. Nearly two-thirds of micro-technology companies in Europe supply products, technologies and services to the medical technology and healthcare sectors … they represent the most important sales market for almost 20% of these firms. The share of companies that supply primarily to the market for medical technology will increase by another 5% in the next three years. This is what the IVAM Fachverband für Mikrotechnik (IVAM Association for Microtechnology) has found in its annual survey of economic data from companies and research institutions operating in the field of microtechnology in Europe.
Microtechnology will therefore also be playing a major role at the COMPAMED 2017, which is the leading international trade fair for supplies to the medical-manufacturing sector. It will be taking place in Düsseldorf alongside the MEDICA 2017 – the world’s leading medical trade fair – from 13 to 16 November. “Besides digital transformation that has affected all sectors, the miniaturisation of components for creating increasingly handier and lighter product applications also constitutes an overarching technology trend,” says Joachim Schäfer, Managing Director at the Messe Düsseldorf. Since its launch 25 years ago, COMPAMED has developed into the No. 1 platform for suppliers to the medical technology industry and will this year again be counting almost 800 exhibitors in Halls 8a and 8b (MEDICA: approximately 5,000 exhibitors) at Düsseldorf’s exhibition centre.
The ‘High-tech for Medical Devices’ product market with around 700 square metres and more than 50 companies and institutions (Hall 8a) is again fully booked and is being organised as in every year by the IVAM Fachverband für Mikrotechnik as a special showcase for microsystems destined for medical technology applications.
Measuring blood pressure without cuffs
One important application is the field of so-called ‘wearables’, mobile, almost entirely concealed and very comfortable systems for recording and analysing vital parameters in everyday situations and transferring them to medical experts. The continuous recording of so-called peripheral photoplethysmograms will in future provide valuable information about a person’s health. The information recorded includes the pulse and arterial oxygen saturation, heart-rate variability, respiratory rates and data about vascular stiffness and signs of rising or falling blood pressures. Elevated blood pressure is currently one of the most serious risk factors for cardiovascular disease which – according to the Deutsche Hochdruckliga (German Hypertension League) – affects around 35 million people in Germany alone. The disease is often detected too late because its symptoms are not always apparent. The consequences are in particular stroke, heart disease, kidney failure and dementia.
Against this backdrop, the possibility of tracking blood pressure continuously without the need for cuffs is one of the most important innovations at this year’s COMPAMED. A team of scientists around project manager Dr Hans-Georg Ortlepp at the CiS Forschungsinstitut für Mikrosensorik (CiS Research Institute for Microsensors) developed the sensor for this application along with the sophisticated method of analysis. “The necessary raw data is taken from the shape of the pulse wave and its behaviour over time. It is essential in medically relevant applications that the sensor signals are of a high quality and that suitable mathematical algorithms are employed for data analysis,” explains Ortlepp. CiS has already been working for a good decade on miniaturised multispectral photoplethysmography sensors that are integrated into silicon. The tiny sensors are placed in the outer ear canal and are individually adapted to patients. It is very important that the high-tech components are comfortable to wear as it is this aspect that decides acceptance by users. It is possible to equip the sensors with up to four LEDs that utilise different wave lengths to enable additional vital parameters and data from different depths of tissue to be measured besides blood pressure thus making it possible to eliminate movement artefacts from the signals.
Administering active ingredients into instead of under the skin
The Hahn-Schickard-Gesellschaft für angewandte Forschung (Hahn-Schickard Association for Applied Research) has also dedicated itself intensively to researching, developing and manufacturing in the field of technology for microsystems. It cooperates with the Verapido Medical GmbH spin-off in the development and production of equipment, systems and technologies that allow active ingredients to be administered into instead of under the skin. Studies have shown that active ingredients introduced intradermally are available at considerably faster speeds than those administered subcutaneously and are consequently able to develop a more efficient effect. It has also been proved that such biotech molecules as insulin, antibodies, proteins and hormones are absorbed into the body much more quickly when they have been administered intradermally.
Active ingredients that are injected into the skin are also able to influence the immune system more efficiently and specifically. “Clinical studies have shown that up to 90% of the injected dose can be saved with intradermal administration while achieving the same or even better effect than injecting into muscle,” emphasised Dr Markus Clemenz, Managing Director at Verapido Medical. The company is working on micro-needle technology and micro cannula that are injected precisely into the dermis – a layer of skin that is located just under its surface. Only the top layer of skin is penetrated which makes it a minimal invasive procedure. “Our scope of developments range from patch-based micro-needle arrays through intradermal administration equipment with fixed or variable depth settings for injections and infusions to drug-metering systems for (time-delayed) chronotherapy without the need for any electronics,” says Clemens. Verapido is anticipating that intradermal injections will become clinical state-of-the-art in the future.
CorTec is going to be exhibiting at the COMPAMED for the second time. This young company that specialises in medical technology is working on the next generation of active implants. It is developing and producing implanted electrodes for drain-outs and stimulation in the central and peripheral nervous systems. CorTec is also manufacturing encapsulated casings to support high-channel applications. Electrodes and encapsulated casings will possess between 32 and more than 200 channels and thus more drain-outs than comparable products. “CorTec’s technology combines innovative solutions for design, layout and working with materials that are already tried-and-tested in the field of medical technology – particularly with high numbers of channels. We are thus making applications and therapies possible that were previously impossible to address in this way,” explains Dr Martin Schüttler, CTO and CEO at CorTec.
Its patented ‘AirRay’ electrode technology has enabled CorTec to overcome the current limitations when working with electrodes through innovative and highly precise manufacturing conditions. This makes smaller dimensions for contact diameters from up to 25 µm possible which in turns means that it is possible to significantly increase packing densities in electrode arrays. This will allow the quality of data acquisition to be improved many times over. The electrodes also possess excellent electrochemical properties. Platinum-iridium or MP35N (nickel-cobalt alloy) may be used to make the electrodes, optionally with high-performance coatings, to further improve the delivery of stimulation impulses to the biological tissue. It is also possible to adapt the electrode’s mechanical properties to individual needs.
Communicating with implants via high-frequency or infrared technologies
In addition to its ‘AirRay’ electrode technology, CorTec’s portfolio also includes such other products for manufacturing active implants as a ceramics-based hermetic encapsulated casing. The use of thick-film technology here allows hundreds of electrical throughputs to be realised – entirely in contrast to conventional encapsulated casings. The ceramics-based encapsulated casings by CorTec are also permeable to electromagnetic waves which in turn means that it is possible to communicate with implants using high-frequency and infrared technologies and to transmit energy wirelessly. The ceramic encapsulated casings have been optimised to the extent that they are able to withstand the mechanical loads that have, for instance, been specified for cochlear implants. CorTec Brain Interchange has combined all these components into a single system that is able to measure and analyse neuronal activity and so is able to stimulate the nervous system as required. This so-called closed-loop functionality opens up a wide range of possible applications for individual and needs-based neural treatments. The system’s scope of applications range from controlling assistance systems for paralysed patients through needs-based deep-brain stimulation to rehabilitation for stroke patients and epilepsy intervention. The first system prototypes are currently undergoing preclinical trials. Initial clinical pilot studies are in preparation.
Additive procedures for personalised implants
Another topic that has been becoming more and more important at the COMPAMED are additive procedures. The IKTS Fraunhofer Institut has developed ‘bone from the printer’. It has been designed to be used to repair defects in facial areas or bones damaged by tumours that have metastasised. In such conditions, the patients’ quality of life is considerably restricted because the bones can suddenly break without the application of any external forces. Ceramic bone implants that have been adapted to the precise millimetre to the patient’s anatomy would be able to potentially alleviate patients’ suffering. The ceramic implant by IKTS is being manufactured in two stages: The ceramic casing is printed in 3D which is then filled with a ceramic foam. The additive manufacturing of the shell allows the piece to be adapted to the patient’s specific skeletal structure and the porous foam filling enables porosity to be adapted specifically to the patient. The foam facilitates cell growth while it is also biologically active and resistant to pressure. It is this combination of procedures and materials that create the great benefits that the new solution delivers. “We work with such commercially available materials as hydroxylapatite and tricalcium phosphate and are now initiating the biological testing phases for our substances,” explains Dr Matthias Ahlhelm, Project Manager at IKTS.
Microstructures from 3D printers
Multiphoton Optics is also active in the field of 3D printing. This company is producing a high-precision 3D printing platform (‘LithoProf3D’) and software (‘LithoSoft3D’) for the additive and subtractive manufacturing of randomly shaped structures that are realised either in the full or on surfaces of materials. The technology supports the high-precision manufacturing of optical 3D interconnects, aspherical or free-form microopitics as well as biomedical products such as scaffolds for tissue engineering, microfluidic cells and drug-delivery structures. Multiphoton Optics only recently demonstrated the opportunities presented by 3D printing platforms by manufacturing this stack of microstructures. The stacks resemble the optical component of an endoscope and they consist of five different individual freely shaped lenses and other structures thus creating a total of 10 differently shaped surfaces. “Microoptical structures are increasingly becoming the core components for highly integrated technical medical systems. We shall be presenting exhibits at the COMPAMED that will also demonstrate how well our process performs in this area,” says Felix Kiesel, Director of Sales at Multiphon Optics.
The ‘Cobra’ line of products by Silicon Microstructures (SMI) Inc. – the first commercially available pressure sensor with a connected cable that fits into instruments with a French-scale diameter – will be another highlight at the COMPAMED 2017. The French scale is used in the field of medicine to indicate the outer diameter of cannula and catheters where three on the scale is equal to one millimetre. The sensors are small (220 micrometers wide), stable and smart as well as temperature-compensated; digital and amplified analogue versions are available. SMI will be presenting how this sensor array is able to reduce risks with urodynamics, endourology, cardiology, emergency surgery, brain-pressure monitoring and other processes.
The world of small and smallest solutions for medical technology therefore remains a subject that will remain important to the COMPAMED in Düsseldorf and, as previously, it is also going to be presented and explored within the scope of the IVAM’s COMPAMED HIGHTEC FORUM in Hall 8a. Besides microsystems technology, the focus this year will be on nanotechnologies, production technologies and process control. Specialists will also be presenting parallel talks about current developments along the entire process chain of medical technology at the COMPAMED SUPPLIERS FORUM, which is being organised by the DeviceMed magazine in Hall 8b. This year, the event will be focusing on digitalisation, wearables, 3D printing and regulations.