Creating a Circular Eco-System for Medical Devices: Eco-Design

As discussed in our previous blog, sustainability focuses on the overarching principles for addressing three main pillars: environment, economy, and society. It is industry agnostic and culturally neutral, meaning that it applies to everyone, everywhere. This is the first in a series of blogs highlighting different aspects of these pillars as they pertain to and impact on the healthcare and medical device industries.

While it may seem that sustainability, circular economy, and eco-design are the latest fad buzz words, they are in fact concepts that have been evolving and maturing since the late 20th to early 21st centuries.

The impact of industrial processes on the natural environment has been a growing concern for environmental economists, industrialists, regulators, and your normal everyday eco-citizens, going back to the 1990s when work began on what we know today as circular economy principles, including the development of product lifecycles and the concept of sustainable design.

This was followed by the development of policies and initiatives aimed at reducing waste, improving resource efficiency, and fostering sustainability being adopted in the 2000s; the proliferation of regulations in 2010s; and now global agreements, coalitions, and agendas emphasising the need for worldwide adoption of circular practices to combat climate change and resource depletion.

Circular economy is generally defined as an economic model that focuses on minimizing waste and maximizing the value of resources through principles such as eco-design, re-use, remanufacturing, and materials recovery. Each of these has a unique set of challenges, requirements, impacts, and regulations associated with them. Some are more easily applied than others; and not all of them will be relevant to every medical device. BS 8001:2017, Framework for implementing the principles of the circular economy in organizations. Guide provides a framework for implementing circular economy principles within organizations.

Eco-design, also called Design for Environment (DoE), Design for Life (DfL), and Green Design, is the principal of rethinking the design of a medical device to consider the entire product lifecycle in order to minimize environmental impact, extend the lifespan, and make re-use or materials recovery easier. This lifecycle design approach involves designing products to be easily disassembled, repaired, and upgraded, extending their useful life, and reducing the reliance on plastics.

When applying eco-design principles to medical devices, manufacturers should consider the following design aspects to ensure the products are sustainable, safe, and effective throughout their lifecycle. Read more about incorporating eco-design in BS EN ISO 14006:2020, Environmental management systems. Guidelines for incorporating ecodesign.

Material selection

Use biocompatible, non-toxic, and environmentally friendly materials

Reduce the use of hazardous substances

Consider recyclable or biodegradable options

• BS EN 16751:2016, Bio-based products.Sustainability criteria

Energy efficiency

Design devices to be energy efficient in both manufacturing and operation processes

Incorporate low-energy technologies and components

• PD IEC/TR 62726:2014, Guidance on quantifying greenhouse gas emission reductions from the baseline for electrical and electronic products and systems

Product lifecycle management

Consider the entire lifecycle of the device, from raw material to end-of-life treatments

• BS 8887-3:2018, Design for manufacture, assembly, disassembly and end-of-life processing (MADE) - Guide to choosing an appropriate end-of-life design strategy

Implement lifecycle assessments (LCA) to identify and mitigate environmental impacts

• BS EN ISO 14040:2006+A1:2020, Environmental management. Life cycle assessment. Principles and framework

Modular design

Design devices in a modular way to facilitate easy repair, upgrade, and replacement of parts

Enable disassembly for recycling or reprocessing of components

• BS 8887-1:2006, Design for manufacture, assembly, disassembly and end-of-life processing (MADE) — General concepts, process and requirements

Durability & reliability

Ensure devices are durable and optimise the operational use life to reduce the frequency of replacements

Design for reliability to minimize the need for repairs and reduce waste

• BS 8887-240:2011, Design for manufacture, assembly, disassembly and end-of-life processing (MADE) - Reconditioning

Minimization of waste

Aim to reduce waste generated during manufacturing and at the end-of-life

Design for minimal packaging and use recyclable or reusable packaging material

• BS EN 13429:2004, Packaging. Reuse
• PD CEN/TR 14520:2007, Packaging. Reuse. Methods for assessing the performance of a reuse system
• PD ISO/TR 17098:2013, Packaging material recycling. Report on substances and materials which may impede recycling

Eco-design is the starting point for developing a new generation of medical devices, healthcare products and technologies that are sustainable, effective, and safe. These principles can also be applied to the redesign of existing devices and products to make them more sustainable. It is not feasible for every medical device to be 100% sustainable, but there are actions that can be taken to decrease its environmental impact and improve its circularity.

Other key aspects that will be highlighted individually in upcoming blogs include remanufacturing, end-of-life management, and transitioning from a single-use to reuse model.

In addition to the standards identified earlier, there are several more standards available to help manufacturers design, or re-design (if applicable), their devices to be more environmentally friendly, without negatively impacting their efficacy or the safety of the patient.