Medical Device Sustainability – in the EU and Germany

Sustainability is ubiquitous these days. Nevertheless, it seems to be taking hold more slowly in the medical technology sector than in other sectors. This shouldn’t be that surprising given the number of regulations medical devices have to comply with before they are allowed on the market. But do these requirements really stand in the way of sustainability?

This article will look at what medical device manufacturers need to consider and what options they have for making their devices more sustainable.

1. Sustainability: what does it mean?

a) The term “sustainability” and where it comes from

A lot of people associate sustainability with protecting the environment only. Responsible stewardship of the planet is indeed an important part of the concept, but sustainability involves far more than just environmental considerations.

In 1987, the United Nations Brundtland Commission defined sustainable development as 

c) Why sustainability is booming

Everyone has been talking about “sustainability” in recent years. The finite nature of our resources and current lifestyles is becoming increasingly apparent. Sustainable products and sustainable business practices offer the best insurance against systems that will stop functioning in just a few years because they lack a foundation.

However, sustainability is also in vogue for reasons beyond purely rational considerations. Companies emblazon the label everywhere for PR reasons. A lot of subsidies and investments are no longer available these days without a sustainability strategy. Sustainability also drives innovation. For example, the search for environmentally friendly materials has often resulted in materials that are better tolerated and, as a result, more suitable for medical applications. 

2. What constitutes sustainability in medical technology?

The trend towards sustainability has not yet had a significant impact on the medical technology sector. Nevertheless, the sector, which has to consider a huge range of interests, could benefit from it massively.

The industry association MedTech Europe has summarized what constitutes sustainability in medical technology as follows:

When it comes to medical devices, sustainability can be achieved at several different levels.

a) Supply chains

Companies can use the ESG criteria as a guide to ensuring the sustainability of their supply chains.

• Environment
• Social
• Governance

These criteria say that companies should comply with environmental, human rights and health standards throughout their entire supply and value chains.

Legal basis for supply chain sustainability

Germany

German passed its Lieferkettengesetz in 2021. It establishes that companies are responsible for their entire supply chains, although the extent of this responsibility is graded according to the level of influence they can exert. The Lieferkettengesetz will apply to companies with more than 3,000 employees from 2023, and from 2024 to companies with more than 1,000 employees. Its scope will be reviewed again after 2024. 

Under the Lieferkettengesetz, companies are responsible for their entire supply chain – all the way from the raw materials to the finished products. However, their obligations are tiered according to the level of control the company has over a particular area. The levels are:

• Own business area
• Direct suppliers
• Indirect suppliers

The actions required by the law are also determined by:

• The nature and extent of the business activities
• The company's ability to influence the party responsible for any breaches
• The typical expected severity of a breach
• The nature of the company's contribution to the cause of a breach

Companies must take the following measures both in their own business area and in relation to their direct suppliers:

• Issue a policy statement on its human rights strategy
• Risk analysis: perform a risk analysis to identify violations of human rights
• Risk management (including preventive measures and remedial actions) to avert potential violations of human rights
• Establish a complaint mechanism
• Publish transparent reports

In the case of indirect suppliers, in contrast, the due diligence obligations only apply on an ad hoc basis and only if the company becomes aware of as possible violation. In that case, the company must:

• Carry out a risk analysis
• Implement a strategy to minimize and prevent the violations
• Enforce appropriate preventive measures aimed at the party responsible

Europe

The EU has published a draft for a European supply chain directive. However, it has not been passed yet and has been significantly watered down since the original draft.
Once the directive is passed, the German regulations may have to be adapted. However, only where they protect the legally protected rights less than the European regulations. And that doesn’t look likely at the moment.

b) Medical devices 

Medical devices themselves can be made (more) sustainable in a variety of ways. For example, they can consume less energy, be made using sustainable low-emission production processes and with sustainable materials, lower material use or less packaging, or have longer lifetimes.

Sustainable materials for medical devices

The choice of materials has a big impact on the sustainability of a medical device. In a lot of cases, more sustainable materials even improve the device's tolerability for patients because, for example, fewer harmful substances are used in their production. Sustainability aspects should be incorporated into the device's design right from the start, so that as few materials as possible are used in production (and those that are used are as well-tolerated as possible), and so that recycling options can be created.

Criteria for sustainable materials include:

• Resource efficiency and low-emission production
• Renewability
• Working conditions for mining, processing, transport, etc.
• Transport routes
• Degradability or reusability

Example of sustainable alternative materials:

Alternatives to conventional plastics include the biopolymers polyhydroxyalkanoates (PHA), which do not cause allergic reactions and are degradable in the body, and polylactide (PLA), a plastic derived from corn starch that is also more readily biodegradable than plastics made from crude oil.

Substances can’t always be replaced

Nevertheless, it is not always possible to use sustainable alternative materials in medical technology. More sustainable alternatives must meet the same criteria as the original product. They must also first be tested, including for biocompatibility, which often involves animal testing.

Sustainable materials must meet the following criteria:

• Stable against mechanical and thermal stresses
• Easy to clean, disinfect and sterilize
• Biocompatible
• Reproducible in terms of production
• Other properties, depending on the type of use

If sustainable materials are not safe or their performance is not good enough, they are not a real alternative.

There are sustainable alternative materials – if you look for them

Nevertheless, in many cases, more sustainable options can be found for common, problematic materials. These might be products with an inherently better life cycle assessment and social balance because, for example, they are produced from indigenous plants, or are products that have been mined and transported sustainably, or are recycled materials.

However, these materials are often not used for image reasons as much as due to regulatory issues. For a lot of people, having “new” equipment made of solid and tried and tested materials seems more valuable. Alternative materials also have to be researched first and possibly tested for safety and performance, which involves time and costs. 

Packaging

EU Directive 94/62/EC in conjunction with Directive 2018/852 demands a significant reduction in packaging waste from 2025. An EU-wide “plastics tax” has been planned for non-recycled materials since 2021.

Medical device manufacturers face several challenges as a result. A lot of devices, such as needles and catheters, have to be packaged sterile, which often produces a lot of waste. The options for substituting or reducing the materials used is often limited due to the sterility requirements. 

Other manufacturers can switch to reusable materials or make their packaging as mono-material a possible, which makes it easier to recycle. However, new packaging potentially involving less waste generally also means a design change, which means testing and re-certification by a notified body. And notified bodies are already stretched thin by the introduction of the MDR. For this reason, the industry association BVMed, pleaded for medical device manufacturers to be exempted from the plastics tax in its position paper for the Bundestag elections (in German).

There is, at least, a provision in EU Directive 94/62/EC on the reduction of packaging waste that would enable a special regulation for medical technology. It is found in Article 20 of Directive 94/62/EC, which has been amended to read as follows:

Lifetime

The lifetime also has a major influence on the sustainability of devices. Longer lifetimes with as few servicing requirements as possible generally result in a more positive life cycle assessment, as fewer devices have to be produced. 

c) Use and disposal

In a lot of cases, the same sustainable use, disposal and recycling strategies that are used for other products can also be used for medical devices. How sustainable the disposal or reuse of the device is, depends on the choice of materials, the production method and the type of device.

Circular economy

A circular economy has to be the aim if we are serious about sustainability. In a perfect circular economy, there is no waste at all. All resources always flow back into the product cycle.

In the case of medical devices, this can be achieved through reprocessing as well as through recycling. This is particularly important in markets where “new” medical devices are simply too expensive. ISO 17664 provides some guidelines for the processing of medical devices.

Single-use devices

However, when it comes to single-use medical devices, for example syringes that are also contaminated with blood or other body fluids, they generally have to be disposed of under special conditions.

But even single-use devices can be reprocessed in some situations. Article 17 of the MDR establishes the basic principles for this. It states that individual EU member states must regulate whether or not they permit the reprocessing of single-use medical devices. In Germany, this option is governed by Section 8(4) and (5) of the MPBetreibV-E. 

d) Corporate structure

Corporate structures and processes also need to be designed sustainably. Corporate sustainability means:

• Having an economically forward-looking management (will investments also pay off in the future?)
• Looking after employee welfare (health, prosperity, training opportunities, equality)
• Reducing the company's environmental footprint (reducing emissions by reducing business travel and using energy-efficient equipment, printing fewer documents, implementing sustainable production, etc.)

A recent study by the digital association Bitkom(in German) showed that digitizing companies, among other things, could save a fifth of corporate CO2 emissions.

Sustainability regulations

In addition to the sustainability requirements mentioned previously, companies are also subject to the provisions of, for example, procurement law (e.g., the EU's Government Procurement Agreement (Directive 2014/24/EU), GPA for short) or transparency requirements (e.g., Directive 2014/95/EU).

A proposed EU directive on sustainability reporting from 2021 also envisages an expansion of reporting obligations. This directive wouldn’t just expand the scope of the reporting obligations, it would also mean they apply to small and medium-sized enterprises (SMEs) from 2023.

3. Do safety and costs conflict with sustainability?

Some companies would like to implement more sustainability but worry that the safety of their medical devices will suffer and that their costs will increase as a result.

Safety sets limits to sustainability

The options for sustainability vary greatly from medical device to medical device. When people's safety is at stake, (environmental) sustainability takes a back seat. This is reflected in regulatory requirements and is, ultimately, also compatible with the idea of sustainability itself. After all, the UN’s understanding of sustainability includes public health aspects alongside the environmental aspects. There are, therefore, various legally protected rights that have to be weighed against one another. If there isn’t a more environmentally friendly alternative that is just as safe and performs just as well as the existing material or device, the less environmentally friendly alternative has to do. The legally protected right to human life wins out in this case.

This is particularly apparent when it comes to single-use medical devices – if hygiene considerations prevent reuse or reprocessing, the device must be disposed of. It is also worth noting that medical devices and IVDs are explicitly excluded from some of the regulations, for example, Article 2(4)(g) of Directive 2012/19/EC (prevention of electrical and electronic waste).

But: There is a risk of hiding behind the argument of “we just can't do any better.” There are often several ways of achieving the same level of safety with less harm to the environment or without inhumane working conditions. A good example of this is the alternatives to conventional plastic described above. 

To find these alternatives, enough money had to be invested in the research and development of the products and systems. And sometimes what is needed is a major systemic shake-up, for example, towards compatible device components or new disposal systems. Where there’s a will, there’s often a way.

Costs

A lot of companies shy away from the potential costs of improving their sustainability:

What sustainability can cost:

• The costs of switching to more sustainable processes (research, co-ordination (employing a sustainability manager is worth considering), acquisition of new equipment and software, etc.)
• Higher product and procurement costs
• Higher production costs, e.g., if production is onshored or methods with lower emissions are used

But sustainability doesn't just have costs. In some circumstances, it can help companies increase their revenue:

How sustainability can make companies money:

• It’s almost impossible to obtain investment and subsidies without fixed sustainability targets
• Companies can save a lot of money through recycling and reprocessing
• A reduction in energy and material requirements can also reduce costs
• Sustainable management makes companies fit for the future
• Young talent is more likely to choose to work for sustainable companies
• Sustainability is a winning argument in marketing

In a lot of cases, customers are willing to pay higher prices for more sustainable products. However, it’s difficult to tell how much this also applies in the medical technology sector, as the customers are often commercial enterprises. Nevertheless, in the vast majority of cases, medical devices also end up with the end users, the patients. Whether higher prices can potentially be passed on to them or not is primarily a question of good communication.

4. Five tips for newcomers to sustainability

Sustainability is generally easier to implement at startups than established companies because startups can tailor their strategies right from the start. Nevertheless, even long-established medtech giants and medium-sized companies can no longer avoid having a sustainability strategy. For those new to sustainability, here are some tips:

Tip 1: Include sustainability in your corporate strategy

Sustainability should be part of your corporate strategy and, therefore, touch every aspect of the company. As with many other transformation processes, the shift to sustainability will fail if it is made half-heartedly.

A holistic approach has the advantage that processes can be coordinated. Investors are also starting to see the importance of a sustainable corporate strategy. And if you approach sustainability holistically and seriously, you can definitely incorporate it effectively into your marketing strategy. 

Tip 2: Setting SDG priorities

The UN has adopted 17 SDGs. So that’s 17 possible ways to approach sustainability. Ideally, of course, you would take all 17 SDGs into account in the long run. But that can be overwhelming, especially at the start. So, set priorities. Select a few SDGs that you can focus on first. In the field of medical technology, socially oriented SDGs such as health, equality, prosperity, education, etc. are particularly good ones to start off with. Then you can gradually add the other aspects.

Tip 3: Appoint a sustainability manager

The entire economy is in the middle of a transition toward greater sustainability. A lot is still up in the air. This means that manufacturers don’t just have to make changes to their own company and devices, they also have to keep an eye on the latest research and changing business climate. 

These tasks are less likely to get lost in the day-to-day stresses of running a business if there is a designated person at the company responsible for them. Sustainability managers can oversee transformation processes, bring all the necessary stakeholders to the table, and ensure that companies are always up to date with the latest opportunities. However, a designated sustainability position should not lead to an increase in internal bureaucracy. 

Tip 4: Consider end-of-life use at the design stage

You should be thinking about how to make a new device as sustainable as possible even in the design phase.

Aspects you should think about:

• Which materials are being used?
• Where do they come from (supply chains)?
• Where and how is the device produced?
• How can you best combine safety, performance and sustainability?
• What happens to the device at the end of its life? Can it be recycled or disposed of in an environmentally friendly way?

Tip 5: Discover new markets

There are markets where either medical devices are too expensive or they don’t have the production materials we have in Europe. These are the markets with the biggest potential for sustainable medical devices. In these markets, for example, medical devices made from recycled materials or re-processed medical devices can make an enormous difference – and may even ensure that people who would otherwise not have access to medical devices do have access to them. Designing medical devices for these markets can ultimately help everyone – manufacturers, medical personnel and users.

5. Conclusion

The term “sustainability” is often associated with stereotypes – both positive and negative. Regardless of where you stand ideologically, given the increasing scarcity of resources and ever stricter laws, virtually every company will have to get to grips with sustainability in the future. The medtech sector is no exception.

The regulatory requirements governing safety and performance still have to be followed, particularly in the case of medical devices. Where these two aspects are at risk, environmental sustainability considerations may have to take a back seat. But regulatory requirements cannot be used as an excuse. There are many different ways of being sustainable and it can even help drive innovation.

We would like to thank Rainer Schultheis, science journalist and CEO of Saphenus Medical Technology for important input to this article.