INDUSTRY REPORT
Medical Technology 

HIGH TECH CARE FOR PATIENTS

An inflamed tooth root – it is not so long ago that this diagnosis would have inevitably led to the loss of the tooth. Today, root canal treatment usually helps. Even in the case of the one in every three or four root canals, which has grown at a 90° angle, and is therefore very difficult to reach using conventional dental instruments, endodontists can still put an end to the pain here using special equipment and save the tooth.

Have you ever experienced this? If so – even though you probably did not notice at the time – you were surrounded by a range of medical products during your treatment. The chair you were lying in, the lamp above you, a spray of analgesic, a surgical microscope and the various implements are all examples of products from an industry that has developed rapidly in recent years and has a promising economic outlook that is set to continue – the medical technology industry.

An Industry with Product Diversity
Behind this is a separate industry, which produces a huge range of different products. These range from swabs, catheters and dressings, which are manufactured in large quantities and end up in the trash can after a single use, to large devices such as CT scanners. The surgeon’s classic tools – stainless steel instruments – are as much medical products as are anesthesia machines, which send patients into the land of dreams during operations, using a precisely dosed gas mixture.

Manufacturers are constantly developing this multitude of products and adapting them to the requirements of the healthcare industry. What is needed is defined both by medical professionals and, to an increasingly greater extent, the commercial requirements of the hospitals and their sources of funding. Solutions and ideas, which enable patients to be treated quickly and, ideally, result in a speedy recovery, are currently very much in demand as they will help keep under control the rising costs of healthcare.

Global Growth in Demand for Medical Products
Healthcare systems in the industrialized world are already very well developed. However, lifestyle choices in these countries are causing an increase in diseases of civilization, such as cardiovascular diseases and diabetes. At the same time, the proportion of old people in the population is growing. Most of these patients have more than one medical condition and are in increasing need of medical support. In many less-industrialized or non-industrialized countries, the healthcare systems are currently being developed. Instead of products of the highest technical level it is, rather, much more simple equipment that is needed, which is more affordable, easier to maintain and simpler to operate. Products suitable for the financial capabilities of newly industrialized countries are also in demand. Overall, the demand for medical products is growing.

Many manufacturers are medium-sized businesses but, of course, global corporations are also represented in the industry. They all work on the development and production of their products with qualified suppliers. Manufacturers and suppliers together must comply with strict legal requirements. These serve to protect patients and regulate, in detail, what evidence must be provided on the effects, safety and risks of the product.

Strict Legal Requirements for Manufacturers and Suppliers
The requirements are not identical in the different regions of the world – be it the USA or China, South America or Europe. In Europe, for example, the new Medical Device Regulation (MDR) came into effect in 2017 and has kept the industry busy ever since. Manufacturers must implement the requirements of the MDR within a transition period of a few years. The list of changes is long and includes the requirement for every medical product to be uniquely identified (Unique Device Identification, or UDI). A similar regulation, which aims to make it easier to trace individual products in the event of problems, was gradually introduced in the USA a couple of years ago.

To make this type of labeling possible, manufacturers of medical products need to arrange their companies from a technical and organizational perspective so that they can provide this data to a central database in the correct form for every single product. They need to permanently identify every product with a unique code that can be read by people and machines and can be found on every piece of packaging film, secondary packaging and the box.

The tip of the cannula is extremely fine and free of burrs to ensure that the active ingredient can reach the patient’s tissue relatively painlessly.

Extremely fine metal structures known as stents dilate constricted vessels.

Many Product Ideas Come from Doctors
Care and quality are not only required when identifying the products – they are essential for all activities in the medical technology industry. Despite the many requirements that must be observed, there is still room for new products and ideas, which can be used to treat a wide range of diseases. According to information from the German industry association, BVMed, taking a structured approach to ideas from users is particularly important for companies. For 52 percent of medical products, the ideas for new products and procedures originally come from doctors and nurses or caregivers.

New approaches are also being developed in the field of biological and technical research. One example of this is regenerative medicine, which suffered for a while as the expectations for the possibilities it offered were much too high. How about using a replacement made from a patient’s own cells instead of a transplant? Could organs perhaps simply be printed instead of having to wait for a donor kidney?

Science has not yet come this far and, according to skeptics, perhaps never will. Printing cells in a hydrogel is one thing, but permanently providing these cells with vessels, in the same way as in natural tissue, involves very different challenges. Minor cartilage defects in the knee, however, can already be treated in this way.
Technical Advances Drive the Medical Technology Industry Forward
Developments in other industry branches also spur on medical technology. Modern materials from metal and plastic to ceramic are used, modified and refined into high-performance materials, which have special and sometimes new properties, such as an antimicrobial effect, which creates unfavorable conditions for microorganisms.

However, the industry is focusing on the future not just in terms of materials. Factory workshops in which implants are manufactured, or components are produced in injection molding processes, are equipped with computer-controlled machines that are as state-of-the-art as those in the automotive industry. Precisely positioned laser beams cut out extremely fine metal structures for vessel-supporting stents. 3D printing is also being adopted in all its various forms – whether to achieve porous bone-like structures in implants or to produce plastic scaffolding, on which cells for regenerative therapy grow particularly well. Data exchange between medical devices has also begun – with all the associated opportunities and risks known from discussions about digitalization and Industry 4.0.

In the past: In the 17th century, a skilled blacksmith created an iron corset for a child suffering from spinal curvature.

Today: Cast from the multi-component adhesive Metak, this partially rigid, partially flexible corset supports the deformed spine of scoliosis patients in the right places.

Medicine Has Also Entered the Digital Age
IT in medicine is one of the future topics that will enable new products and different approaches to patient care. Today, x-rays are sent as files to the radiologist, who receives and analyzes data from various hospitals. RFID chips can be used to identify where surgical instruments are located, and if and when they have been sterilized. Cables under the operating table will disappear when the foot control can send its instructions wirelessly. Sensors in hospital beds report whether a patient is lying down, sitting on the edge of the mattress, or has left the bed completely. Miniaturized, chip-sized laboratories are designed to analyze blood samples in tiny channels and enable rapid diagnosis in the patient’s room. Vital signs such as pulse or blood pressure are recorded, collected on a smart phone, analyzed by an app and made available to the patients or their doctor. Yet, the imagination of developers is far from exhausted with these few examples.

Further Growth to Come
All these trends provide the conditions for further development of the high-tech industry of medical technology. The market researchers of EvaluateMedTech, which is based in London, predict annual growth of the global market for medical technology of around 5 percent for the coming years. The size of the market will therefore be worth approximately USD 530 billion by 2022. According to information from the German industry association Spectaris, it can be expected that “the German market, which is highly innovative, well positioned and internationally competitive, will benefit from this development at least proportionally.” One of the key success factors will be to successfully meet the challenges and opportunities arising from the digitalization of healthcare and to master the transition to being a provider of digital and integrated healthcare solutions.

PLASTICS IN MEDICAL TECHNOLOGY

CPAP machines ensure that the brain is sufficiently supplied with oxygen, even for patients who suffer from sleep apnea. The flexible plastic used for the masks makes wearing them more comfortable.

Plastic has been used as a material in many, and extremely varied segments of medical technology. Plastics are processed into petri dishes for laboratories, molded into disposable syringes or blood bags, and used to produce flexible masks for artificial respiration. Anybody who uses a CPAP machine for air supply at night so that the brain can be adequately supplied with oxygen, despite sleep apnea, appreciates it when there is nothing pressing around their nose or mouth.

Millions of medical products are shrink-wrapped or packaged in plastic containers and sterilized by exposure to radiation or ethylene oxide. This is an additional stress that the product and packaging materials must withstand in the long term without showing signs of discoloration, cracks, or other signs of premature aging.

A Matter of Properties
Different material properties, which can be fulfilled by various plastics, are required depending on the application. Sometimes, the focus is on resistance to chemicals, which can play a major role in in-vitro diagnostics. Other times the focus is on biocompatibility for use in or on the body, as is the case for catheters. Where extreme forces are at work – as experienced by implants in the spinal area, for example – particularly resistant materials such as PEEK are required. For artificial joints, in which different components slide against each other with every movement, cross-linked polyethylene materials have made great advances as there is hardly any abrasion.

Forming an Image of the Patient
A key argument for plastics are the various possibilities for processing and shaping them. Injection molding performed by automated machines is just as well established in medical technology as it is in other industry branches, and clean-room equipment is often used for the production of sensitive products. A fascinating medical application of 3D printing, which is becoming increasingly common, is the reproduction of an individual patient’s vascular layout or skeleton. The information obtained before an operation using imaging techniques can then be printed out in preparation for surgery. 3D printing processes have even been developed for liquid silicone.

Perhaps more unusual is the fiber-reinforced carbon from the field of lightweight construction, which is used in car manufacturing, the rotor blades of wind turbines and high-performance bicycle frames. This material also appears in medical technology – wheelchairs, crutches, ortheses and prostheses are all made from this lightweight, resilient material. Manufacturers have also been relying on it for years in the production of operating tables and x-ray machine linings, where both the stability and the transparency of the material for x-rays play a major role.

The specialist journal medicine & technology regularly reports on developments in the medical technology industry, with a focus on engineering expertise in components, materials and processes.
www.medicine-technology.com

Photos © pgottschalk, Gino Santa Maria, Zarathustra, sokko_natalia – fotolia.com, Deutsches Medizinhistorisches Museum Ingolstadt, Fraunhofer LBF