In the cycle of progress: sustainable medical technology and the challenges facing the sector

However, there is more than just CO2 emissions. According to Dr. Christian Schulz, Managing Director of the German Alliance on Climate Change and Health, our planetary health, i.e. the interplay between human health and the well-being of the planet, is increasingly threatened by environmental pollution, overuse of resources and climate change. "By exceeding more and more planetary boundaries, the living conditions for humans are deteriorating everywhere," Dr. Schulz explains.

Dr. Christian Schulz, German Alliance on Climate Change and Health

Circular economy in medical technology

In medical technology, circular economy means transforming the life cycle of devices and products into a sustainable cycle. It is about reducing waste production, the design of medical devices, giving them a second chance and finally integrating their materials into a new rhythm of recycling.

By adopting sustainable practices such as extending the life of medical devices, promoting reprocessing and recycling materials, the medical technology sector can be environmentally responsible and have a positive impact on global health. This approach enables the reduction of waste and environmental impact. According to "Abfallmanager Medizin", hospitals are already the fifth largest waste producers in Germany counting 4.8 million tons of waste per year.

"In order to create a sustainable cycle, aspects such as the easy dismantling of components to be treated separately, for example rare-earth-containing motors and batteries, or the minimal use of disposable products and packaging materials must be considered," says Dr. Romy Auerbach, project manager for medical technology at the IWKS Fraunhofer Research Institution for Materials Recycling and Resource Strategies.

 
Dr. Romy Auerbach, IWKS Fraunhofer Research Institution

Complex regulatory requirements for medical technology

However, compliance with various regulations is required in order to drive forward a rethink in terms of sustainability. Regulation requires the implementation of standard quality and safety standards in many areas and is a growing challenge for manufacturers. "Medical devices are subject to approval in accordance with the Medical Device Regulation (2017/745/EU)," explains Dr. Auerbach. "This means that a new approval process has to be started for the smallest changes to existing products, which can sometimes take years."

The MDR (Medical Device Regulation), for example, contains regulations on the safety and performance of medical devices in the EU. It requires comprehensive consideration of environmental aspects throughout their entire life cycle. There are further barriers, for example in the reprocessing of disposable products such as tweezers and scissors, which are largely used in the care sector. Experts from the IWKS estimate that such products generate around 22 million disposable steel items in Germany every year. The steel used, which contains around 18% chromium, can be recovered in high quality and reused as a pure raw material.

"However, there are challenges, e.g. when implementing the reprocessing of single-use devices: According to paragraph 8 section 6 of the MPBetreibV (Medical Devices Operator Ordinance) in conjunction with Article 17 section 5 of the MDR, for example, it is necessary for external assessments to be carried out by a recognized Notified Body. However, there currently is no notified body in Europe that has registered for the task of certifying reprocessed single-use devices. This means that an implementation is therefore not even possible here," says sustainability expert Clara Allonge from the German Medical Technology Association BVMed.

In summary, the MDR results in high regulatory requirements that entail costs and obligations for manufacturers in the medical technology sector. "Overall, the medtech industry is already very strictly regulated by the MDR. The associated resource expenditure and the additional bureaucratic burden of sustainability-related regulation tie up considerable capacities. The regulatory requirements of the MDR are accompanied by multi-year cycles for the development, registration and validation of product and packaging solutions. We need better consideration of existing requirements and at least a sufficient implementation period for new requirements," says Clara Allonge. 

For example, there are new requirements under EU Directive 94/62/EC in conjunction with Directive 2018/852, which are intended to raise the targets for the recycling of packaging waste. According to the Johner Institute, however, the options for replacing or reducing packaging material are limited in the case of needles or catheters, for example, which require sterile packaging. Biovox, a start-up supplier of recyclable bioplastics, saves up to 85% CO2 by using bio-based plastics that can also be recycled. This means they can be reused in a closed loop in medical technology products. "Our plastics are not only sustainable, but also safe," says Biovox founder Carmen Rommel. "We have tested them for biocompatibility under the same standards and procedures as plastics currently in use. This allows us to solve the plastic problem."

The European Green Deal and the industry's responsibility

The European Green Deal is another ambitious initiative that aims to make the European Union the first climate-neutral continent by 2050. This has implications for the industry. For example, the Green Deal emphasizes the importance of a circular economy in which products are to be reprocessed and recycled after use.

In medical technology, devices should therefore be designed in such a way that they can be easily dismantled and reusable materials need to be recovered. The ecological footprint of their products should also be minimized. This is to be achieved by using environmentally friendly materials, resource-efficient production and the use of renewable energies.

"The Green Deal aims to make Europe the first climate-neutral continent. One thing is clear: modern medical technologies serve people and their healthcare. And their production and distribution must also keep people's livelihoods in mind and fully respect their rights. But of course, medical technology also has an ecological footprint. The industry wants to reduce this. The particularly sensitive balancing of interests is essential here, as the safety of patients and users is at stake. The industry is therefore already working intensively on sustainable alternatives without compromising care," says Allonge.

 
Frank Detering, Wild Design

Durability as the key to ecological and economic efficiency

Designing for durability is a practice through which medical technology can promote sustainability. This approach to product design aims to create medical devices that have an extended lifespan. This involves the use of high-quality, durable materials and the integration of design features that allow certain components to be easily replaced or repaired without having to replace the entire device. According to Frank Detering, graduate designer at WILD DESIGN, a German medical design agency, the most important requirement is to always keep sustainability aspects in mind when designing medical devices. "About 15 years ago, for example, I was involved in the development of a surgical combination instrument for cutting and coagulation. This was unique at the time when it was introduced, because until then there were only single-use products as an alternative. The most important design contribution is to create long-lasting products, i.e. a design and design language that would not be recognizable as outdated after just a few years. This awareness has gradually set in when it comes to materials and packaging," says Detering.

Hermann Achenbach, Head of Sustainability and Circular Economy at the SKZ Plastics Center, explains the importance of durable appliance design: "Of course, it is fundamentally important that plastic parts are easy to separate. Adhesive joints, for example, should be avoided as they are often difficult to separate and cause contamination. There are also other joining methods that simplify separation. When designing, care must be taken to ensure that the devices can be dismantled in such a way that contamination from glass, metals, fibers, wood, paper, pigments, additives or flame retardants does not occur." In this way, appliances can be dismantled more easily after use and replaced if necessary.

Hermann Achenbach, SKZ Plastics Center

Another promising trend is the increased use of modular components. These not only make maintenance easier, but also allow specific parts to be updated or repaired without having to take the entire appliance out of service. This not only helps to extend the service life, but also minimizes electronic waste and reduces the consumption of resources.

Another innovative approach is to integrate advanced diagnostic and monitoring technologies that allow potential problems to be identified at an early stage. This enables preventative maintenance measures to be taken before more serious damage occurs, thus promoting the sustainability of medical devices.

By implementing such methods, the medical technology industry can not only improve its environmental footprint, but also achieve economic benefits through longer service life and reduced operating costs. According to software provider Praxedo, the maintenance of equipment, in particular, is a significant cost factor for hospitals. These costs can be significantly reduced with preventive maintenance.

Shaping the future of medical devices through reprocessing

Device design aimed at easy disassembly and reprocessing also promotes sustainability. Clear labelling and standardized modules facilitate the recycling process. To support this approach, manufacturers could rely on take-back systems that enable users to easily return devices at the end of their service life.

The ElektroG law of March 16, 2005, which regulates the take-back and environmentally friendly disposal of electrical appliances, for example, also implements European regulations on avoiding waste and conserving resources.

"Medical devices with electrical or electronic components, for example, are considered electrical appliances and fall under the regulations of the ElektroG legislation. This means that retailers and manufacturers are obliged to take them back and recycle them. This is partly also the case with large medical devices when refurbishing them so that they can be reintroduced to the market or used as spare parts," explains Dr. Auerbach. "This reduces the volume of waste and aims to recover marketable fractions from metals and plastics."

Conserving resources through effective material recycling

Medical devices can be designed in such a way that they can be effectively dismantled in order to recover valuable materials and return them to the production cycle. A crucial aspect of this approach is the implementation of efficient recycling processes. This requires not only technological innovation, but also collaboration between manufacturers, recycling service providers and regulators. Romy Auerbach explains these processes: "Recycling processes for waste electrical and electronic equipment include various shredding methods, screening, sifting, magnetic separation processes and sensor-based sorting. For example, Fraunhofer IWKS is developing new separation and sorting processes, also by using AI, to make material separation even more efficient for such products." The dismantling of the devices must therefore be precise in order to enable the effective recovery of materials such as valuable metals, plastics and electronic components. "And in sorting plants, plastics can then be detected using near-infrared spectroscopy, for example, and then sorted out using pneumatic nozzles. There are many other sorting technologies that can sort plastics in an even more differentiated way. With AI pattern recognition methods, sorting robots or even markers that are incorporated into the plastics, very specific types of plastic can be sorted in a targeted manner," adds Achenbach.

 
Jens Fernis, AHN Biotechnology

"The principles of sustainability and environmental responsibility can already be embodied in packaging. We take into account the most environmentally friendly processes with the overarching goal of avoiding as much plastic as possible," says Jens Fernis, Sales Director at AHN Biotechnology. "This is done, for example, by using space-saving dispenser towers during transportation, which not only represent a sustainable solution for reducing plastic, but also reduce transportation costs and fuel emissions. Our cardboard cryogenic storage boxes are also the perfect solution for the sustainable organization and preservation of samples; they are designed for extremely low temperatures and excellent thermal stability without the use of plastics."

A changing industry

It is clear that medical technology is facing groundbreaking changes. This will also be a key topic at MedtecLIVE, which takes place in Stuttgart from June 18 to 20, 2024. "In view of the increasingly fast-changing and complex requirements and solutions, MedtecLIVE will focus on sustainability and the circular economy. MedtecLIVE offers a platform for presenting innovative solutions and engaging in constructive dialog on how the industry can work together to overcome the challenges of the circular economy in order to shape a sustainable future," says Christopher Boss, Managing Director of MedtecLIVE GmbH and Executive Director of the event.

Christopher Boss, MedtecLIVE GmbH