COMPAMED continues its successful course – suppliers significantly advance development in the diagnostics sector

The COMPAMED in Düsseldorf, the world's most important and largest supplier trade fair for medical technology, continues its successful course in parallel with the MEDICA, the world's largest medical trade fair with more than 4,800 exhibitors. This year, it again set a new record with 724 exhibitors. The interest from trade visitors remains high. Of the nearly 130,000 trade visitors attending MEDICA 2014 (November 12–15) and COMPAMED (November 12–14), around 17,000 flocked to the halls of COMPAMED (Halls 8a and 8b). This time, a trend focus was on optical processes, which have been making inroads into the device and product markets of the medical technology industry for years and are increasingly becoming a central "success guarantee".

"Among other reasons, this is due to steadily increasing demands for accuracy and precision, which are particularly effectively achieved with the help of optics, photonics, and lasers," confirms Dr. Thomas R. Dietrich, Managing Director of the Professional Association for Microtechnology IVAM. Furthermore, optical methods have proven to be especially patient-friendly, for example through minimally invasive diagnostics or in imaging. Optical microcomponents are now indispensable for the manufacture of diagnostic devices that are successful on the market. An impressive example is a new development from the Fraunhofer Institute for Ceramic Technologies and Systems (IKTS), which shows doctors in just 90 seconds whether prostate tissue is affected by carcinoma or not. Previously, laboratory technicians had to prepare ultra-thin tissue sections from biopsies – a tedious task that takes at least a day. Afterwards, the samples are examined under a microscope by a pathologist – often with uncertain results, because distinguishing between benign or malignant tissue changes is difficult even for experienced doctors. In the future, the examination will be simpler, more precise, and faster: "The doctor places the extracted tissue sample on a slide, inserts it into the device, presses a button – and within one and a half minutes, receives a reliable statement whether the tissue is benign or malignant," explains Dr. Jörg Opitz, scientist at IKTS. The method is based on auto-fluorescence, which human tissue emits because it contains fluorophores. These molecules glow briefly when illuminated with a specific light. At the start of the measurement, a calibrated laser pulse excites the fluorophores, which in turn emit light. How this fluorescence decreases differs between benign and malignant tissue, and is the key to the new "flash analysis," for which a prototype device already exists. Two clinical studies have already been successfully completed.

The measurement system "µsurf expert," also based on optical effects, was presented by the company NanoFocus, among others, for roughness measurement of implants at COMPAMED. "Our device works like a 3D microscope. An optical filter in the beam path ensures that only rays from the focal point are imaged," explains Dr. Jürgen Valentin, Technology Director of NanoFocus AG. Special requirements are placed on joint implants concerning medical compatibility, durability, and wear. NanoFocus's optical confocal 3D surface measurement technology is suitable for surface analysis as well as for production control and product development. Metal, plastic, and ceramic surfaces are reliably captured, and scratches, surface defects, or roughness values are displayed as color-coded topographies.

Lenses modeled after the human eye

Among other applications in ophthalmology, the Swiss company optotune presented fast, focus-variable lenses for 3D microscopy at COMPAMED, enabling a variety of bio-imaging applications. "The range of applications extends from confocal microscopy to multiphoton imaging to optical coherence tomography," says Dr. David Leuenberger, Sales Manager at optotune. The adaptive optical components made from elastic polymers are modeled after the human eye and could revolutionize the field. By applying an electrical voltage, it is possible to vary the curvature of the soft lenses. Optical systems become smaller, more affordable, and faster. For certain applications, up to 30 volume scans per second are achievable.

Roadmap for standardization of point-of-care diagnostics

With the German standardization roadmap "Mobile Diagnostic Systems," the Association for Electrical, Electronic & Information Technologies (VDE) highlighted the importance of "Point-of-Care Testing." This applies to countries like Germany with highly developed healthcare, as people are aging, the shortage of doctors in rural areas is increasing – by 2021, 42 percent of all general practitioners will retire – and patients no longer want to wait days for a diagnosis. On the other hand, in emerging countries, the routes to the nearest doctor or laboratory are often very long – making it difficult to return after just a few days. Thanks to mobile diagnostics, the time from sample collection to results, which currently takes between one and five days, is to be reduced to 15 to 30 minutes. "To achieve this, devices must be small and mobile, deployable in decentralized settings, and easy to operate," explains Dr. Jörg Schickdanz, Managing Director of QIAGEN Lake Constance. The roadmap aims to initiate harmonization of standards to clarify technical and legal issues. Undoubtedly, the individual sample measurement, the elimination of elaborate sample preparation, and the immediate availability of results open up many fields of application, from operating rooms to self-testing at home. However, many technological and regulatory hurdles in method development, validation, and verification still need to be overcome. The urgent need for point-of-care solutions was demonstrated by the Ebola outbreak: testing potentially infected individuals at airports within just 30 minutes would be ideal. Currently, travelers suspected of being ill must undergo three days of quarantine.

Innovative feedback training with wearables

An increasingly important topic is wearables – body-worn measurement technology, which so far has mainly been used for vital parameter monitoring. A new chapter has been opened in this area by contract manufacturer Cicor and Hocoma. Hocoma is a global market leader in the development, manufacturing, and marketing of robotic and sensor-based devices for functional movement therapy. The training device Valedo captures torso movement using two Bluetooth sensors and transmits the data into a gaming environment. "Participants receive real-time feedback on whether they performed the exercise correctly," says Monika Thomann, responsible for marketing and communications at Cicor. Each sensor uses a 3D gyroscope, a 3D accelerometer, and a 3D magnetometer to capture movement in full 360 degrees. With this development, Cicor won the third Devicemed Award in the Contract Manufacturing category. "So far, applicants have found it relatively difficult, so we are pleased with the increasing number of good submissions, especially in contract manufacturing, which is gaining more importance in medical technology," says Peter Reinhardt, Editor-in-Chief of the trade magazine Devicemed, which awarded the prize during COMPAMED.

Against this background, Gerresheimer Medical Plastic Systems has established a pilot production in series quality at its Technical Competence Center. Pharmaceutical and medical products undergo a lengthy approval process, often requiring small batch productions as clinical prototypes or stability batches, etc. For "small batch production," eleven injection molding machines with clamping forces from 65 to 420 tons are available, including two two-component injection molding machines of 120 and 200 tons. Additionally, project-specific assembly equipment such as pick-and-place machines, bonding stations, or ultrasonic welding systems are available. There is also a Class 8 cleanroom. A Manufacturing Execution System (MES) ensures efficient, fast, and economical production. "Small batch production enables development and clinical prototypes up to small series in quantities between 500 and 1,000 units," explains Ulf Kirschner, Key Account Manager at Gerresheimer Medical Plastic Systems. Weak points are identified early in the project, can be optimized during development, and integrated into the series production.

Packaging machines becoming increasingly "intelligent"

Comprehensive concepts are also in demand for packaging in the pharmaceutical and medical technology industries. The company Harro Höfliger offers solutions in this regard. "We combine filling, dosing, and assembly technology in a compact space and integrate them with sealing and lamination processes," says Dieter Haberzettl, Division Leader Diagnostics at Harro Höfliger Packaging Machines. Based on the "Varioflex" technology platform, the company creates customized solutions that also meet various cleanroom conditions. Thanks to their flexible design, the machines are suitable for companies that need packaging for new developments and want to establish corresponding processes.

Progress often also lies in small details: Weidmann Medical Technology has developed containers for laboratory samples with integrated RFID chips. The so-called tubes enable contactless data collection and seamless traceability. "Previous procedures with barcode labels or dot-matrix coding often encountered difficulties, so we embedded the chips into the material of the tubes," emphasizes Kurt Eggmann, Director of Sales and Marketing at Weidmann. The RFID elements can store, update, and overwrite larger data volumes. They also withstand temperatures down to minus 20°C. An advantage, as many sensitive samples need to be stored refrigerated.

Much research still needed for 3D printing in medical technology

The next COMPAMED will take place from November 16 to 19, 2015 – for the first time over four days (completely parallel to the world's largest medical trade fair MEDICA) and will always be held from Monday to Thursday in the future.