COMPAMED is continuing on its road to success

There is a lot of potential for optimising treatment processes in optical methods

In parallel to the world’s largest trade fair, the MEDICA, with more than 4,800 exhibitors, the COMPAMED in Düsseldorf, the largest and most important international supplier trade fair for medical technology is continuing on its road to success. With 724 exhibitors, it was also able to reach a new record this year. The interest of professional visitors is also great. From a total of almost 130,000 professional visitors that came to the MEDICA 2014 (underway: 12 – 15/11) and to the COMPAMED (underway: 12 – 14/11), around 17,000 flowed into the halls of the COMPAMED (halls 8a and 8b). This time, one trend emphasis there included optical methods, which for years now have been entering into the equipment and product market in the medical technology industry and have been increasingly becoming a key “guarantee of success”.

“Among other things, a reason for this includes the continuously growing requirements for accuracy and precision that can be effectively met with the aid of optics, photonics and lasers,” confirmed Dr. Thomas R. Dietrich, managing director of the IVAM association for microtechnology. Furthermore, optical processes, by means of minimally invasive diagnostics or imaging, for example, have proven to be particularly patient friendly. Therefore, optical micro-components have in the meantime become indispensable for the production of diagnostic equipment, which is successful on the market. A new development of the Fraunhofer Institute for Ceramic Technology and Systems (IKTS) impressively shows this by indicating to doctors in only 90 seconds if prostate tissue is cancerous or not. Up until now, laboratory technicians had to prepare razor-thin tissue sections from biopsy samples – cumbersome work that takes at least an entire day of effort. Afterwards, the samples get passed on to a pathologist, who examines them under a microscope – frequently with unclear results since differentiating between benign and malignant tissue is difficult, even for experienced doctors. In the future, this examination will be simpler, more precise and quicker: “The doctor lays the extracted tissue sample onto a supporting platelet, inserts this into the device, presses a button, and obtains a reliable indication of if the tissue is benign or malignant within one and a half minutes,” explained Dr. Jörg Opitz, scientist at IKTS. “The method is based on the auto-fluorescence emitted by human tissue because it contains fluorophore,” Dr. Jörg Opitz further explained. These molecules light up for a short time if a certain type of light falls on them. At the beginning of the measurement, an intermittent laser pulse stimulates the fluorophores, which in turn emit light themselves. How the fluorescent radiation decreases is different in the case of benign or malignant tissue and this is the key to the new “flash analysis”, for which there is already a prototype unit available. It has already passed two clinical trials successfully.

The measurement system “µsurf expert” is also based on optical effects, having been presented at the COMPAMED, among other things, by the company NanoFocus for the detection of surface roughness. “Our device works like a 3D microscope. An optic filter in the optical path ensures that only beams from the focal point are depicted,” explained Dr. Jürgen Valentin, chief technical officer at NanoFocus AG. Particularly concerning joint implants, there are special requirements with regard to medical compatibility, durability and wear. The optical-confocal 3D surface metrology by NanoFocus is suitable for surface analysis as well as production control and product development. Thereby, metal, plastic and ceramic surfaces alike are reliably registered, and scratches, surface imperfections or surface roughness values are displayed as colour-highlighted topographies.

Lenses based on a model of the human eye

At the COMPAMED, the Swiss company, optotune, presented, among other things, quick, focus-variable lenses for 3D microscopy for the field of ophthalmology, making diverse bio-imaging applications possible. “The array of applications ranges from confocal microscopy to multiphoton imaging, all the way to optical coherence tomography,” said Dr. David Leuenberger delightedly, sales manager at optotune. The adaptive optical components made of elastic polymers are based upon an imitation of the human eye and could result in a revolution. By applying an electrical voltage, it is possible vary the curvature of the soft lenses. In this way, optical systems become smaller, more inexpensive and quicker. In the case of certain applications, it is possible to reach up to 30 volume scans per second.

Road map for the standardisation of point-of-care diagnostics

With the German standardisation road map “Mobile Diagnostic Systems”, the Association for electrical engineering, electronics and information technology (VDE) has pointed out the special significance of “point-of-care testing”. That applies to countries such as Germany with highly developed medical care because people are getting older and older, lack of doctors in the countryside is increasing – by 2021, 42 percent of all general physicians are going to retire – and patients do not want to wait for days for a diagnosis. On the other hand, in emerging nations, the route to the nearest doctor or laboratory is frequently very far – here, it is hardly possible to come again after a few days. Thanks to mobile diagnostics, the time span involved to get results, which takes between one and five days, can be reduced to 15 to 30 minutes. “In addition, the related equipment has to be small and mobile, be able to be used in a decentralised manner, as well as be easy to operate,” explained Dr. Joerg Schickdanz, managing director of QIAGEN Lake Constance. With the road map, the harmonising the standardisation process should be set into motion in order to clarify technical and legal issues. Without question, the individual measurement of samples, omitting laborious sample preparation, and the direct available of measurement results lead to various fields of application, ranging from the operating theatre to patients performing measurements on themselves in a household environment. Of course, until it reaches that point, there are still a lot of technological and regulatory challenges to overcome in the area of method development, validation and verification. The outbreak of Ebola has shown how urgent point-of-care solutions are needed. Examination of the potentially ill would be ideal at airports within a period of 30 minutes for example. Currently, travellers who are suspected of having the disease have to spend three days in quarantine.

Innovative back training with wearables

Wearables are also a topic that is gaining in significance, meaning measurement technology worn on the body that has particularly been used to determine vital parameters. In this field, the make-to-order manufacturers Cicor and Hocoma have started a new chapter. Hocoma is a global market leader in the development, manufacturing and marketing of robotic and sensor-based equipment for functional movement therapy. The training device, Valedo, detects the movement of the torso with the aid of two Bluetooth sensors and transfers the data into a gaming world. “In this way, the test subjects obtain real-time feedback on if they have done the exercise correctly,” said Monica Thomann, responsible for marketing and communication at Cicor. Each sensor uses a 3D gyroscope, a 3D accelerometer and a 3D magnetometer to detect movement on a 360-degree basis. At the third Devicemed award ceremony, with this development, Cicor won the prize in the customer-manufacturing category. “Up until now, it was relatively difficult for competitors here. Therefore, we are pleased with the increase of more good submissions, particularly in the area of make-to-order production that is gaining more and more significance in the medical technology field,” commented Peter Reinhardt, editor in chief of the trade magazine Devicemed that had bequeathed the award during the COMPAMED.

In light of this, Gerresheimer Medical Plastic Systems has established pilot production at its technical competence centre. Pharmaceutical and medical technological products go through a long and complex approval process, for which small quantities have to be produced for clinical samples or stability batches, etc. For all small-batch production runs, there are eleven injection-moulding machines available with a closing force of 65 to 420 tons, among which there are 2 two-component injection moulding machines weighing 120 to 200 tonnes. In addition, there are project-specific assembly systems, such as joining machines, gluing devices or systems for ultrasonic welding. In addition, there is a class-8 clean room. A management execution system (MES) ensures the efficient, quick and economic production. “Small batch production makes development samples and clinical samples, all the way to small series, also in small quantities between 500 and 1000 pieces,” explained Ulf Kirschner, key account manager at Gerrresheimer Medical Plastic Systems. Weak points are recognised in the project early on, can be optimised during the development process, and these optimisations can flow into the series.

Packaging machines are getting more and more intelligent

In the case of packaging for the pharmaceutical and medical technology industry, all-round concepts are also in demand. The company Harro Höfliger offers solutions along these lines. “Within a small area, we link filling, dosing and assembly technologies and combine them with sealing and laminating processes,” commented Dieter Haberzettl, division leader for diagnostics at Harro Höfliger Verpackungsmaschinen GmbH. Based upon the technology platform “Varioflex”, the company creates customer-specific solutions that also meet various clean room requirements. Thanks to their flexible concept, the machines are also suitable for companies that require packages for new developments and want to establish corresponding processes.

Progress can frequently be found in the little things: Weidmann Medical Technology has developed containers for laboratory samples with an RFID chip integrated inside of them. The so-called tubes make contact-free data acquisition possible along with seamless traceability. “Processes with bar-code labels or dot-matrix coding had frequently been associated with difficulties up until this point. Therefore, we have embedded chips into the material of the tubes,” emphasised Kurt Eggmann, director of sales and marketing at Weidmann. The RFID elements are capable of saving, updating and overwriting larger amounts of data. In addition, they can resist temperatures as low as minus 20°C. This is an advantage since many sensitive samples have to be stored in a refrigerated environment.

There is still a lot of research required for 3D printing in the field of medical technology

Hearing devices that are custom manufactured for individual patients by means of 3D printing are already available on the market in large quantities. “Also in the field of dentistry, 3D printing has already reached the point of being implemented in production,” confirmed Carlos Carvalho, in charge of process and material development at envisionTEC. It cannot be said that the company is not involved. After all, it supplies the 3D bioplotter, a related unit that can process a variety of biomaterials – ranging from soft hydrogels to polymer melts, all the way to hard ceramics and metals. In addition, there are two versions for production and one version without the frills for development. At the COMPAMED 2014, the 3D bioplotter was bequeathed the Ad-hoc Award by the Devicemed editorial staff for the very first time. “For example, we use thermoplastic synthetic materials for products that should be capable of being metabolised by the body within three to six months as well as ceramic pastes for those that should dissolve within the body only after two to three years,” commented Carvalho. The body’s own cells can be dissolved in hydrogels. This is an approach to printing “spare parts” for the human body. “In the near future, we will be capable of printing bone material and also skin over the medium-term. In 20 to 30 years, it may be then possible to produce organs in the way,” predicted Carvalho. Currently, the 3D printing hype in the medical technology industry has somewhat faded away – a lot of this is still stuck in the research stage and has just started to spread at universities. Nevertheless, already today, it can be determined that the topic of 3D printing will be grabbing attention repeatedly at the COMPAMED in the years to come.

The next COMPAMED is taking place from 16 to 19 November 2015 – over a period of four days for the first time (being held at the exact same times as the worlds largest medical trade fair, the MEDICA) and in the future always over the days running from Monday to Thursday.