Digitisation: a major trend in medical technology

New developments in the ‘mega-trend’ of digitisation will be a feature of COMPAMED 2016, which takes place in Düsseldorf on 14-17 November alongside the world's largest medical trade fair, MEDICA 2016.

3D printing is one of the developments set to revolutionise medical technology

Digitisation presents great opportunities for the healthcare sector in an increasingly ageing society in which a growing number people suffer from chronic illnesses, according to the German Medical Association BVMed. Digitisation can help diseases to be detected earlier, the duration of hospital stays to be reduced and people's mobility to be extended with the aid of tele-medicine, apps or care robots.

The healthcare and medical technology industries are talking more and more about digitisation, the Internet of Things and Industry 4.0, because these topics have become highly relevant to suppliers who work with medical technology providers.

New developments in the ‘mega-trend’ of digitisation will be key features at COMPAMED 2016, the leading international industry platform for suppliers to the medical technology industry. COMPAMED will take place in Düsseldorf from 14 to 17 November, where more than 750 exhibitors will be celebrating its 25th anniversary in Halls 8a and 8b, alongside the world's largest medical trade fair – MEDICA 2016.

‘The medical technology sector is dominated by small and medium-sized businesses, and they are finding it difficult to identify the potential that networked factories have to offer,’ suggests Dr Jens Nitsche, Director Research & Development at consulting firm Ingenics. The situation, however, appears to be changing, as the IVAM Microtechnology Network, which represents small and medium-sized businesses in particular, has discovered: ‘Mobile health applications, the Internet of Things, wearables and smart implants and textiles are playing an increasingly significant role in the product market that IVAM serves,’ says Mona Okroy-Hellweg, IVAM spokesperson. The Network will again be hosting around 50 companies at its joint stand in Hall 8a at COMPAMED.

The newly founded Information Technology Society (ITG) within the VDE, the German Association for Electrical, Electronic & Information Technologies, expects that ‘user-oriented, secure, dynamic systems in the healthcare sector’ will in future use interoperable sensors and actuators on patients to capture and digitise data relating to such parameters as weight, blood pressure, temperature, activity and ECGs and then transfer them via the intranet or Internet. This will enable the recording of the progress of patients' well-being in different environments.

Mobile applications that deliver health services through mobile communications devices are on the rise

The captured data will make it possible to create and deliver services via the intranet or Internet and provide recommendations for action, such as exercise or medication. They will also detect which measures helped improve the health condition. This would, for example, allow a service generated from the collected health data to assess the success of interventions on the basis of medical criteria (guidelines) and so provide the best possible therapy.

‘Such services would use interoperable interfaces to connect the various manufacturer-independent components and devices to smart mobile devices,’ explains Johannes Dehm, standardisation expert for medical technology at the VDE. ‘In the next stage, performance-assessment software would continuously analyse the progress of measures and improve the healthcare that is being provided.’

The digitised transformation of different types of data generated by different sensors and actuators would, in compliance with the telematics infrastructure (data security), allow these systems to inform all involved along the healthcare chain about important parameters – in almost real time.

Without a doubt, mobile applications that deliver health services through mobile communications devices are on the rise. Health apps are becoming more and more popular. There are around 100,000 apps alone in the narrower field of healthcare that are also being marketed increasingly by medical-technology companies. Almost half a million products are available through app stores and the number of downloads exceeded the three-billion mark in 2015 – a figure that has doubled in just two years.

A survey by the Bertelsmann Foundation found that 30% of people in Germany have already installed health apps on their smartphones. The BVMed has found that they are employed for improving health competence, providing analyses, gaining new findings and awareness, indirect interventions through the continuous recording and analysis of health-related information, on-line courses, the documentation of health and illness histories, the organisation and management of processes as well as the purchase and delivery through on-line pharmacies.

At COMPAMED, Sensirion will be presenting the world's smallest differential pressure sensor, which will be ideally suited for such mobile applications, particularly in the field of respiration. The SDP3x works with the latest generation of CMOSens sensor chips and lies at the heart of Sensirion's new sensor platform for measuring differential pressure and mass air flow.

The Sensation SDP3X sensor is likely to be employed in medical devices such as intelligent inhalers

The digital component's size of only 5x8x5mm will allow it to be installed in devices that previously did not have the space for sensors to be fitted. The small sensor will also make it possible to significantly reduce the size of existing devices. Besides its minimum dimensions, the SDP3x differential pressure sensor offers outstanding precision and long-term stability as well as being free from zero-point drift. That makes it ideally suited for measuring flow behaviours in bypass configurations. The new sensor is likely to be employed in medical devices used for home care, in portable medical devices and intelligent inhalers.

3D printing set to revolutionise medical technology

3D printing is one of the developments set to revolutionise medical technology. The LightFlex research project, for instance, which is being carried out by the Fraunhofer Institute for Production Technology (IPT) in cooperation with a variety of industrial partners, is an example of how the process is changing the field. It is a project aimed at manufacturing medical prostheses using a combination of 3D printing and fibre-composite technologies.

Fibre-reinforced injection-moulded components are associated with one great disadvantage: it is very difficult to adapt them to individual wishes and requirements and it is usually only possible to produce them in large quantities because the corresponding tools are expensive and inflexible. For these reasons injection-moulded components are increasingly being replaced by ones produced with the help of additive manufacturing. 3D printing makes it possible to individualise and functionalise almost any component before it is combined with a thermoplastic fibre-composite plastic to help it achieve the required loadbearing capacities. Since 2004, the market for additive manufacturing has been growing by around 20% per year (source: Wohlers Report 2016); this strong growth, also driven by medical-technology applications, is expected to continue in future years.

International growth market: flow cytometry

The international market for flow cytometry has grown by more than 10% a year over the last five years and market volumes are forecast to continue to expand to reach €5bn by the year 2020. This growth is being driven by the increasing demand for single-cell analyses – for instance in personalised cancer therapy.

‘Liquid biopsies’ represent a promising approach for diagnostics, monitoring and individualised therapy in the field of cancer treatment. This type of biopsy permits cancer-associated biomarkers to be detected in conventional blood samples. These include freely circulating tumour cells (CTCs), circulating tumour DNA (ctDNA) and exosomes. The subsequent Next Generation Sequencing and sequence analyses of the biomarkers' nucleic acids will consequently permit individualised therapies.

It is against this backdrop that the Fraunhofer Institute for Chemical Technology – Institute for Micro-technology Mainz (ITC-IMM), which is working within the Ci3 lead cluster, has developed the CTCelect device for extracting single tumour cells from full blood and storing them in the wells of mictrotiter plates. The device spans the arc between sampling and single-cell analysis, achieving very high target-cell yields (> 75%) and very high target-cell purities.

Automation allows great reproducibility to be achieved, which initially will be ideal for tumour research and then later for use in therapy management within the framework of personalised medicine. In 2014, the ICT-IMM was able to positively validate all the significant components within the CTCelect system so that system integration could then follow in 2015.

‘The CTCelect system, our platform technology for processing and analysing samples within the scope of liquid biopsies will be the highlight among our exhibits at this year's COMPAMED,’ explains Dr Michael Baßler, who is responsible for the system at the ITC-IMM.

Ultra-short pulse lasers as tools for materials processing

Light as a tool remains an ongoing topic of interest at COMPAMED. Micreon is a leading contract manufacturer and technology consultant for microprocessing using ultra-short pulse lasers that operate in the picosecond and femtosecond ranges. Working with these types of laser permits processing qualities to be achieved that are significantly higher than those that can be realized with conventional laser technologies.

Ultrashort pulse lasers are characterised by the fact that the energy is concentrated locally in the solid material to such an extent that it is possible to directly ionise it without damaging the surrounding areas. Micreon has focused its laser micro-machining processes on precision cutting, micro grilling and structuring. The quality of the cut edges and insignificant damage to the component material are just two aspects that deliver great benefits to the production of stents made from biopolymers.

Last year COMPAMED welcomed a record 18,800 visitors, and many product developers, production managers and purchasing decision-makers are again expected at this year's event.

One of the highlights for visitors will be attendance at the two established forums. The COMPAMED High-Tech Forum, which is being organised by IVAM, will be staging an entire session focusing on wearable electronics, while the COMPAMED Suppliers Forum by DeviceMed will be presenting ‘Benefits and challenges of 3D printing’ and ‘Industry 4.0 and medical technology: New business models for manufacturers’, among other things.