D4SMD

Context

The medical sector and more specifically medical devices, as regulated under the Medical Device Regulation (MDR), accounts for a significant share of global greenhouse gas emissions, chemical pollution, and waste. Despite a growing willingness within the medical sector to adopt more environmentally friendly solutions, compliance with regulatory requirements or guidelines that prioritize patient safety often complicates initiatives aligned with EU sustainability policies and frameworks. As a result, conflicting demands may arise for medical devices (e.g., integrating circular principles such as reusing/recyclable products can conflict with strict legislative hygiene and infection prevention requirements).

In this context, the design.nexus research group at Ghent University and Sirris, with the support of the innovation clusters Biovia (Health) and Catalisti (Chemistry and Plastics), are launching the collaborative COOCK+ project D4SMD project (i.e., Collective R&D and Collective Knowledge Dissemination).

Goals

The D4SMD project aims to develop a methodology and toolkit to guide companies along the medical device value chain in integrating sustainable solutions that reduce environmental impact, while still complying with applicable medical and sustainability legislation.

To achieve this, the following approach will be applied:

1. Clarify and translate the legal medical (MDR) and sustainability requirements (e.g., REACH, RoHS, Packaging Directive, Single Use Plastics Directive, WEEE, ESPR), including synergies and contradictions between them, in the context of medical products. This involves identifying what is already legally permitted, what is not, and where conflicts exist.

2. Link these requirements to ecodesign strategies (e.g., design for reprocessing and reuse, modularity, reversible joining techniques, design for recycling), and potential technical solutions (e.g., safer additives, biopolymers, recycled materials) so they can be integrated into their innovation and product development processes. Input from the chemical and plastics industries will be needed to assess technological and economic feasibility.

3. Support companies throughout the product development cycle by helping them evaluate and prioritize alternatives and make informed decisions related to their environmental and economic performance using simplified LCA (life cycle assessment) and TEA (techno-economic assessment) tools. 
   For instance, the tool will assist users as follows in their decision-making process: A user wants to explore whether it makes more sense to (a) increase the recycled content in secondary packaging used in hospitals or (b) use biopolymers instead of fossil-based polymers. The tool will inform the user about: 
   i. Whether both options are allowed under the MDR; 
   ii. Whether there are existing or upcoming laws that specify targets for recycled content or biopolymer content; 
   iii. The technical maturity of both options; 
   iv. The expected environmental impact and life cycle cost of both options.

4. Apply and validate the methodology and toolkit to four selected case studies. The final case studies will be defined based on input from participating companies in the user committee, and will cover a range of medical products from non-invasive homecare devices to invasive consumables used in hospitals.

Through this approach, the project will translate legislative and technological knowledge into practical sustainable solutions for industry via co-creation with all actors in the value chain. It aims to support chemical companies, medical device designers, and healthcare professionals in navigating complex—and sometimes conflicting—regulatory frameworks, while enabling the design and development of environmentally friendly medical products.