Sustainability FAQ

Q: Why is sustainability important in medical device development and manufacturing?

A: Sustainability is a critical consideration for medical device developers and manufacturers due to its impact on the environment and future profitability. As healthcare contributes to a significant portion of global carbon emissions, embracing sustainability is essential. Manufacturers must integrate sustainability factors into their design processes as in future sustainability might become a regulatory requirement and market access issue. Currently in certain regions such as the NHS, procurement may require the carbon calculation and sustainability certification of your device to place it on the suppliers list. Implying that some preferred providers might lose their placement on the suppliers list if they do not align with the NHS Net Zero strategies for Medical Devices.

Q: What is the current state of sustainability in the MedTech industry?

A: Globally, healthcare contributes to 4.4% of carbon dioxide equivalent emissions. Europe has around 33,000 medical device manufacturers, with a €140 billion market value. The UK’s NHS, as a case study, exemplifies the push for sustainability, with medical equipment accounting for 10% of its carbon footprint. Initiatives like the NHS Net Zero plan focus on efficiency, low-carbon solutions, and decarbonizing suppliers’ processes.

Q: How does sustainability impact medical device manufacturers?

A: Sustainability may in future become a regulatory requirement. Currently manufacturers may only consider carbon footprint and end-of-life considerations. But it actually involves a full lifecycle approach such as reducing emissions, energy, water usage, and material waste throughout the device’s lifecycle. The impact for compliant manufacturers go beyond being environmentally friendly, it can also attract consumers, reduce costs, enhance investor appeal, and improve brand competitiveness.

Q: What are the key goals of sustainability in medical technology, as defined by industry associations?

A: MedTech Europe and WHO identifies key sustainability goals as good health and well-being, responsible consumption and production, climate action, and partnerships. These goals guide the industry toward more sustainable practices and products.

Q: How can medical devices be designed to be more sustainable?

A: Sustainability can be integrated during the ‘design phase’ of the medical device design by using green energy sources, energy-efficient manufacturing processes, sustainable materials, and streamlined packaging. A starting point would be to incorporate sustainability fields into your design history file (DHF) to manage your materials list and processes. Devices should be designed for recyclability, durability, and reduced material consumption. Design choices at each stage impact the device’s long-term sustainability. Standard templates can also be obtained from CLIN-r+.

Q: How do materials impact the sustainability of medical devices?

A: The choice of materials significantly affects a device’s sustainability. Sustainable materials should consider factors like resource efficiency, renewability, working conditions, transport routes, and degradability. Designing for recyclability and reusability while meeting safety standards is essential for sustainability.

Q: How does sustainability impact the manufacturing process?

A: Sustainability considerations extend to the manufacturing process. Using green energy, energy-efficient processes, and reevaluating supply chains can reduce energy and water use. New manufacturing technologies can minimize waste and enhance productivity. Disassembly and reassembly ease recycling and reuse.

Q: Why is packaging important for sustainability?

A: Packaging is crucial in sustainability efforts, especially with regulatory changes demanding reduced packaging waste. Medical devices often require sterile packaging, making sustainability more challenging. Reusable, mono-material, or innovative packaging can minimize waste. Companies should explore eco-friendly and recyclable packaging materials.

Q: How does distribution impact sustainability?

A: Distribution affects the carbon footprint. Manufacturers can minimize transportation distance, energy use, and warehousing impact. Efficient logistics, sustainable supply chains, and electric vehicles contribute to reducing environmental effects.

Q: How can medical device manufacturers address end-of-life sustainability?

A: Sustainability considerations extend to device disposal. Manufacturers can explore options like switching to reusable devices, recycling materials, and transitioning from single-use to reusable components. The goal is to minimize waste and create a circular economy.

Q: What are the financial implications of incorporating sustainability into medical device manufacturing?

A: While implementing sustainability measures might involve costs initially, there are potential benefits. Investment attractiveness, cost savings from recycling, energy, and material reduction, and improved marketing appeal are among the advantages. Sustainability also prepares companies for future regulatory changes.

Q: Is there ISO standards to guide sustainability planning for medical device manufacturing?

A: There is not yet an ISO standards that specifically tackles sustainability for Medical Devices. It may be in future that the QMS or risk management process may include sustainability workflows and assessments. Currently ISO standards like ISO 14001 (Environmental Management System) and ISO 50001 (Energy Management System) provide frameworks to integrate sustainability practices into operations. These standards help manage environmental impacts, energy efficiency, and compliance with regulations.

Q: What is lifecycle analysis, and why is it important?

A: Lifecycle analysis (LCA) assesses environmental impacts across a device’s entire lifecycle, from raw materials to disposal. It’s essential for understanding and minimizing the ecological footprint of medical devices. LCA informs decisions related to material selection, production processes, use, and end-of-life management.

Q: How can organisations address sustainability in their clinical assessments?

A: The environmental cost impacts a devices benefit-risk assessment, hence it both impacts on your risk management report (RMR) and your clinical evaluation report. This is due to sustainability impacting health determinants and climate change-related risks. Sustainability should be factored into risk assessments. If the environmental impact exceeds the device’s healthcare benefits, it will make the devices benefit-risk profile unfavorable which does not conform to the EU MDR GSPR needs leading to CE mark not being awarded or being withdrawn. Various GSPR apply but specifically I would lead to a non-conformity against GSPR 4 which focuses on the device when used under the conditions and for the purposes intended, which should not compromise the safety of patients, users, or where applicable, other persons. It states that side-effects/hazards related to the device must constitute an acceptable risk when weighed against the benefits to the patient.

Q: How do social and environmental factors relate to sustainability in medical devices?

A: Climate change affects determinants of health, leading to additional fatalities and health issues. Risk assessments should consider a device’s environmental impact. If the environmental effects overshadow the healthcare benefits, the device’s significance might be reduced.

Q: How can manufacturers implement sustainability in their operations?

A: Currently ISO standards like ISO 14001 (Environmental Management System) and ISO 50001 (Energy Management System) provide frameworks to integrate sustainability practices into operations. To integrate sustainability, manufacturers should also consider local regulations such as Health and safety regulations.

Q: What is material and substance management, and why is it crucial for sustainability?

A: Material and substance management involves identifying and managing significant environmental aspects of materials used in production and operations. It’s essential for complying with environmental regulations and reducing environmental impact.

Q: How can medical device manufacturers stay informed about sustainability trends and standards?

A: Manufacturers should stay updated with emerging sustainability trends and ISO standards. Regularly checking industry updates, attending conferences, and engaging with sustainability experts can help manufacturers adapt to changes effectively. Organisations should proactively assess their operations, design processes, and environmental impact. By aligning with sustainability trends and incorporating them into their strategies, companies can prepare for regulatory changes and market demands. Contracting in CLIN-r+ to assist with your initial sustainability planning can help beyond earmarking ISO accreditation needed for your operations to actively look at you medical devices to create a gap analysis how to create a second generation device’s full lifecycle more sustainable.

Q: What is the ultimate goal of sustainability efforts in medical device manufacturing?

A: The ultimate goal is to create a circular economy where resources are consistently reused and waste is minimized. Sustainability practices should extend beyond production to every stage of a device’s lifecycle, contributing to a healthier environment and future generations.