Medical Engineering Requires Long-Term Approach

First there was Brexit, trade wars and structural change in key industries, now it's the corona pandemic. Up to now the machine tool manufacturers have only been marginally affected by the economic setbacks, but they are now facing increasing threats. Medical engineering readily springs to mind when it comes to markets that still hold growth potential. But is there any point in even consid-ering moving in this direction in the short term? Niklas Kuczaty, Managing Director of the VDMA's Medical Technology Working Group, is somewhat sceptical: "Medical engi-neering is a very complex industry. Those looking to gain a foothold need to show com-mitment and determination – and above all staying power – before any investment will pay off."

 At present, medical engineering represents something of a unicorn in the German in-dustrial landscape. It requires high innovativity and investment levels, but enjoys rising demand that is not dependent on economic cycles, and remains steady and reliable even in times of corona. But where there is light, there is inevitably also shade. Scarcely any other industry is so heavily regulated. The bar has been raised once again in the form of the new European Medical Device Regulation (MDR). Machine tools used for the production of implants and surgical instruments or for micro-milled prosthesis geometries, for example, must offer maximum precision and reliability.

Quality assurance plays a decisive role here. When it comes to health, there is no room for compromise. "Anyone looking to enter the medical engineering sector needs to know what they're getting into," emphasises Christian Rotsch, Head of the Medical En-gineering Department at the Fraunhofer Institute for Machine Tools and Forming Tech-nology (IWU), Dresden/Chemnitz. He regards ISO 9001 certification as a basic require-ment. Fraunhofer IWU itself is ISO 9001-certified and it also holds ISO 13485 quality management certification for medical devices.

Focus on manufacturing processes and materials

The Fraunhofer IWU Institute is involved in numerous medical engineering projects. Its main emphasis is on manufacturing processes and materials, but also on biomechan-ics and on translating project results into clinical treatments. Interdisciplinary coopera-tion is crucial. One of its key areas is the development of technology for cutting, ablat-ing and forming processes in precision and micro manufacturing. In addition, it is carrying out research into bone-like structures which can be produced from cellular structures, for example from metal foam or with the aid of generative manufacturing processes. There are attempts to enhance material properties through solid forming. Additive manufacturing methods are increasingly being deployed to create customised, patient-specific implants. Nevertheless, Rotsch sees no threat here to the wide range of conventional methods: "Machining and the corresponding machine tools will still be needed in the future," he points out.

The projects on which the Chemnitz scientists are working involve both medium-sized and large-scale machine tool manufacturers. Christian Rotsch sees very good pro-spects for SMEs to enjoy success with special solutions and machines, for example in the field of microprocessing and finishing. Complete process chains are also in de-mand, especially involving robotic support, which Rotsch sees as a "lucrative field with great potential in terms of demand".

Maximum quality through reliable processes

One such example is Exeron, based in Oberndorf am Neckar – a system supplier of die-sinking EDM and high-speed milling machines. It joined forces with Erowa (Büren, Switzerland) and Certa Systems (Nuremberg, Germany), to develop a combined-pro-cess automation cell for Aesculap (Tuttlingen, Germany), a subsidiary of the B. Braun

Group and manufacturer of surgical, orthopaedic and interventional vascular medical products. Aesculap's challenge is that the required component geometries are some-times so small, complex and angled that they can no longer be milled and have to be sink eroded instead. In addition, manual retooling processes always pose the risk of in-accuracies creeping in. The desired accuracy was achieved through Exeron's manufac-turing combination of milling, die-sinking EDM, cleaning and measuring; Erowa's zero-point clamping system which increases precision and speed; and Certa Systems' pro-cess control system which provides automation within the manufacturing network.

According to Udo Baur, Sales Manager for Germany and Europe at Exeron, it is crucial to adapt to the special needs of this sensitive industry and also to be prepared to offer unusual solutions or other special services. This includes providing support for product releases. The automation cell was initially commissioned at Exeron but not handed over to Aesculap until after the product release. "We know our customers and their stringent demands," says Baur, "and we have the know-how and the machines to meet these." 

Special requirements require tailor-made solutions

Christian Thiele, Press Spokesman at Hartmetall-Werkzeugfabrik Paul Horn, also re-ports on the highly specialised requirements for materials, machining systems and tool solutions. "Experience from other industries is only transferable to a certain extent," he says. Horn is active in specific fields, offering specialised and unique tool solutions in the whirling of bone screws, for example. The precision tool manufacturer was able to significantly increase tool life by internally cooling the whirling tool while simultaneously preventing the risk of chip accumulation. Whirling is used in medical engineering to pro-duce high-precision and dimensionally stable bone screws made of titanium and stain-less steel. Horn also offers special solutions for surgical instrument machining in the form of specially ground milling tools or special milling cutters with a high milling depth and very narrow cutting width for surgical forceps. The company is also conducting re-search into cutter coating solutions for medical engineering materials and into cutting conditions for medical products. Christian Thiele also emphasises the great importance of quality management, which is essential for the manufacture of sophisticated medical products.

Costs for medical devices continuing to rise

IWU expert Christian Rotsch fears that the cost of new medical engineering products will increase dramatically in the future. The Medical Device Regulation requirements are a source of increasing economic pressure for the manufacturers of medical de-vices, which they are passing on to machine manufacturers and suppliers. Neverthe-less, Rotsch is convinced that it will remain worthwhile for machine tool manufacturers and suppliers to enter the medical engineering market. He believes that, if the post-pro-cessing stage can be automated, additive processes will give rise to new ideas through the integration of new functions and the trend away from mass-produced towards cus-tomised products. However, the most important success factor for companies always remains their response to the regulatory aspects and quality assurance.

Paul Horn has been involved in medical engineering for many years, and the sector's share of total sales is likely to increase in the future. Automotive and medical engineer-ing have traditionally been the strongest pillars of the company, but medical engineer-ing is currently proving to be a stable market for the metalworking company. The co-rona crisis has generated a number of short-term and urgent enquiries, such as the recent example of a customer who approached Paul Horn with machining problems in the production of components for a heart-lung machine. Paul Horn is maintaining oper-ations in all areas, which will allow it to react quickly and effectively. However, it's im-portant to realise, says Thiele, that there is no decline in the demand for tools used in the manufacture of implants and hip joints, for example; they are simply out of the lime-light at the moment.

VDMA expert Niklas Kuczaty is also convinced of the strong growth prospects for medi-cal engineering, even if they are not expected to reach the volume of the automotive industry. Furthermore, the sector is much less dependent on economic cycles. In any case, companies that decide to enter the market have to realise that they will be invest-ing for at least two to three years before seeing any success. Yet, as Kuczaty points out, taking such a long-term approach will eventually pay off. Maybe not immediately, but perhaps in time for the next crisis. 

Author: Cornelia Gewiehs, freelance journalist, Rotenburg (Wümme)