Medical technology is at a turning point. The sector, which has relied on plastics as an indispensable component of its products for decades, is now facing one of the greatest challenges of modern industry: How can the use of plastics be made sustainable without jeopardising patient safety or product quality? This question will not only shape the industry, but also the way in which medical products are developed and used in the future.
However, the good news is that the path to more sustainable medical technology is by no means impossible – but it does require determined adaptation to new regulatory requirements, in-depth innovation and, last but not least, a bold view of the future. Seleon has developed a framework that holistically demonstrates how sustainable development in medical technology can succeed in practice.
New challenges, new opportunities – with an expanded compliance process
It’s no longer a secret: regulations are becoming ever more numerous and increasingly complex. The PPWR is a prime example of this. Substance regulations in particular raise questions that go beyond simply “Are we allowed to use this substance?”. Today, it is more a question of how and in what context a material can be used without violating the increasingly strict regulations. Material compliance is no longer an optional extra – it has become a decisive competitive factor.
However, it is not enough to simply respond to regulatory requirements. Companies must also increasingly keep an eye on customer requirements. According to a study by Vamstar, the influence of ESG criteria on tenders is now unmistakable. Environmentally friendly packaging, CO₂-neutral production and recyclable materials are no longer “nice to have”, but “must haves” in the eyes of many buyers. The impact of these new requirements is serious: in countries such as France and Spain, environmental and sustainability criteria can account for up to 10% of the tender evaluation. In the Nordic countries, this proportion is as high as 30%. A clear wake-up call for all companies that want to position themselves not just as suppliers, but as pioneers of a green future.
The growing requirements call for an expansion of the compliance process to track the impact of new requirements and improve tender management. Communication channels between procurement, regulatory affairs and product development need to be integrated to ensure customised and compliant products.
The cost of change: where can you save, where can you invest?
But how can companies successfully manage this change without jeopardising their economic stability? The key lies in making the right calculations. Adjustments that make a product more sustainable cost money – that is undeniable. But this is precisely where the new framework comes in. Because long-term investment in sustainable solutions must be seen not only as a cost factor, but also as added value.
The less obvious but no less important factors must also be taken into account: How much are companies already losing as a result of the new ESG procurement criteria if they do not focus on sustainable solutions in good time? What potential savings can be made through waste reduction, material reduction and energy savings? And not to forget: What impact will the extended manufacturer obligations have on overall costs?
Today, companies not only have to calculate within their own organisation, but also take into account the wider social and economic context. An ESG score can influence access to financing opportunities, for example, and thus become a decisive competitive advantage. Seleon’s framework proposes a new process that takes all these aspects into account – and thus serves as a valuable basis for strategic decisions.
The product impact: Where to start?
But where exactly do you have to start to enable sustainable product development? An important method that helps to evaluate the environmental impact of a product is the Life Cycle Assessment (LCA). With an LCA, the most effective levers in sustainable product development can be identified – and the necessary customer information can be provided at the same time.
What is important here is a standard for medical technology that specifies the content of ISO 14040 Environmental management – Life cycle assessment – Principles and framework and ISO 14044 Environmental management – Life cycle assessment – Requirements and guidelines, so that the information on product impact is comparable between different manufacturers and can be used for customer communication.
Defining product requirements: The ESG requirements workshop
An important step in the early development phase is the implementation of an ESG requirements workshop. In this workshop, all the information collected is collated and translated into specific product requirements. Appropriate measures can be argued through the prior value calculation.
Among other things, this process makes it possible to rethink material requirements and utilise the potential of eco-design principles. Many of the material requirements used today are relics from the past and can be narrowed down by analysing the requirements. Here it is important to sharpen the focus and think ahead.
Best practices: From lighthouse project to systematic application
Successful projects and innovations should be used as lighthouse projects to build a best practice database. This database can serve as a valuable resource for collecting and passing on experience with sustainable solutions. The application of eco-design principles should not only be demanded, but also actively trained.
In the development itself, conventional materials are often used because the implementation of new materials appears to be too costly. A systematic total cost calculation, which weighs up the benefits of new materials against the initial costs, enables companies to better utilise the advantages of new approaches. A database of alternative materials can help to support a well-founded total cost calculation and link the requirements from the extended compliance process. This makes the transition to sustainable solutions tangible and practicable.
This framework makes sustainable medical device development not only theoretically tangible, but also practically realisable. It requires the industry not only to adapt to new regulations, but also to undergo a comprehensive reorientation – away from traditional ways of thinking and towards future-orientated medical device development.
seleon supports you in this task by setting up your compliance, operating tender management, carrying out value calculations, expanding your development process for the future and supporting your team with hands-on projects.
Please note that all details and listings are not intended to be exhaustive, are without guarantee and are for information purposes only.