Balancing Sustainability With Patient Safety In Medical Device Design

By Maggie Chan, Ramsay Black, and Emanuel Wasson, PA Consulting

Medical device manufacturers have traditionally focused on designing devices that are safe and effective to use. This will continue to be the main concern, but there is now more pressure on manufacturers to make devices that combine safety and effectiveness with sustainability. PA Consulting’s Reimagining sustainable medtech report shows leaders the steps that they can take to design for sustainability when developing medical devices, based on research that was conducted into the sustainability impact of six continuous glucose monitors (CGMs), as a real-life example. The pressure comes from increasing regulatory requirements but also from public opinion. Consumers of medical devices are becoming more alert and critical for the sustainability of the products they use.

Increased Legislation On Sustainability Of Medical Devices

The focus on environmental impact has been progressively strengthened within the medical devices industry in the last 20+ years. Both EU MDR 2017/745¹ and IVDR 2017/746² incorporate environmental elements into the medical device life cycle implicitly, along with EU regulations and directives to provide additional guidance on hazardous substances and waste management in promoting sustainability, reducing environmental impact, and fostering a more circular economy throughout the medical device life cycle.

While EU MDR and IVDR primarily focus on patient safety and efficacy of the devices, they incorporate the environmental aspects throughout the device life cycle indirectly, from materials selection to device design, manufacturing, packaging, labeling, and waste management. GSPR (MDR Annex I 14.7) requires manufacturers to “identify and test procedures and measures as a result of which their devices can be safely disposed after use” and provide it with the instruction for use (IFU).

Directives such as the Waste Electrical and Electronic Equipment (WEEE) Directive,³ the Restriction of Hazardous Substances (RoHS) Directive,⁴ and the Registration, Evaluation, Authorisation, and Restriction of Chemicals (REACH) Regulation⁵ provide comprehensive guidance for medical device manufacturers to promote resource efficiency and advance the transition to a greener economy.

The WEEE directive, enacted in 2003 and revised in 2012, imposes obligations on medical devices manufacturers, distributors, and consumers to ensure the proper collection, recycling, and disposal of electronic equipment. Specifically, the directive requires member states to establish collection systems for electronic waste, enabling consumers to return devices at the end of their life cycle. Manufacturers are responsible for financing and participating in this collection and recycling scheme, ensuring that discarded devices are managed in an environmentally responsible manner. It aims to minimize environmental pollution and resource depletion associated with improper disposal practices.

The RoHS Directive is another key directive on sustainability. The directive, which was revised in 2011, restricts the use of certain hazardous substances in the manufacturing of electrical and electronic equipment. It prohibits the presence of lead, mercury, cadmium, hexavalent chromium, polybrominated biphenyls (PBB), and polybrominated diphenyl ethers (PBDE) above specified thresholds in covered products. Manufacturers are required to ensure compliance with these substance restrictions through rigorous testing and documentation processes. It is mandatory for medical device manufacturers with products sold in the EU to comply with this directive.

In addition, the REACH regulation provides a comprehensive framework to manage risk associated with medical devices. It requires medical device manufacturers to register with the European Chemicals Agency (ECHA) if they produce or import substances in quantities exceeding 1 ton per year. The regulation also authorizes ECHA to evaluate substances of concern and impose restrictions on their use if deemed necessary to protect human health and the environment. This registration provides transparency, which then promotes safe and sustainable use of chemicals in medical device manufacturing. While neither EU MDR or IVDR explicitly references any other regulations or directives, medical device manufacturers are required to follow national or local laws on disposal and recycling.

Guidance/Best Practices On Design For Sustainability

Safety and efficacy are the foremost considerations for medical device development. Sustainable device design should be considered from the beginning of the product development life cycle. However, the conversation on medtech sustainability has focused on the packaging and distribution of the device, rather than the environmental impact of the device itself.

When considering sustainability as part of the device's design process, several approaches can be applied.

Most obvious is the decision whether a device should be single-use or reusable. Although reusability is considered the more sustainable solution, there are several caveats. Reusable devices can require exhaustive energy and material consumption to prevent contamination. To safely reuse a device, it must be collected, cleaned, repackaged, and re-sterilized and, in some cases, redistributed. In many cases, the environmental impacts of the switch from single-use to reusable devices will outweigh the benefits due to the additional transport, cleaning chemicals, energy, and packaging required. The full life cycle of the product must be carefully considered when assessing and maximizing the sustainability of medical devices. Similarly, device sustainability and safety are also dependent on the intended use of the device. Implantable devices and devices intended for long-term usage will remain single-use as there is no benefit to be gained from reusability.

However, with all devices, end-of-life and disposal processes need to be considered for the safety of the patient, user, and environment. Almost all devices or specific components will need to be retired in the future. Specific disposal mechanisms may be required for a device or its components (e.g., needles) because of potential biohazard risks and electrical safety concerns (e.g., batteries). And while many aspects of a sustainable device design and manufacturing life cycle have been well documented, recent innovations in relevant supply chains have caused a new focus for manufacturers. This has even been codified within the EU MDR – GSPR related to disposal.

There has been a shift in the medtech industry’s perceptions and implementation of sustainable supply chains. In response to the COVID-19 pandemic, we’ve seen life sciences manufacturers diversifying and localizing their supply and distribution partners as a precautionary measure. One way that companies are trying to balance costs and profits is by using sustainable packaging and services. For instance, medtech companies have been trying to decide how to ensure their products are delivered right on time (avoiding costly, expedited shipping fees), at predictive volumes (lowering associated CO₂ emissions and transportation costs with fewer freights), and in reusable or biodegradable packaging (reducing cost of new packaging or penalties for excessive pollution). Proof of sustainability also has become a compelling characteristic for winning tenders with hospitals or other life sciences partners (e.g., pharmaceutical companies looking for device partners).

Unfortunately, user perception of sustainability does not often match reality. A perception of high product quality can drive users to believe a device is or should be reusable, when in fact that would not be practical from a manufacturing or performance angle. This may also be referred to as “greenwashing,” where unsustainable practices are hidden behind a sustainable-appearing surface (e.g., earth tones, eco-friendly language, or aesthetics). Truly sustainable designs must recognize these user beliefs and demonstrate sustainability metrics to users and regulators through KPIs and evidence.

Sustainability Vs. Risk Management

Medical device manufacturers are required to minimize the risk to patients and clinicians as far as possible by design. This typically results in product and packaging material selections that provide the safest possible device, with maximum profitability for the manufacturer. Historically, little to no consideration has been given to the environmental impact of the materials and processes used.

Medical device manufacturers are under ever-increasing pressure to improve the sustainability of their devices – from regulators, customers and patients. They must find ways to reduce environmental impact, while maintaining the key priority of patient and clinician safety. Up to now, it has been easy for a manufacturer to dismiss the high environmental impact of a device by claiming that it is necessary for device safety. But when other manufacturers find more sustainable ways to achieve the same outcome, regulators will be hesitant to approve new designs with less sustainability. Manufacturers must act now, making sustainability a priority from the outset – or risk rejection by the regulators.

However: patient and clinician safety will always be the number one priority. Sustainability must never come at the expense of device safety and effectiveness. For example, moving from a single-use to a reusable device brings the potential for additional risks. In this case, the risks associated with cleaning and re-sterilizing the device may be significant, as well as the risk to any clinical staff handling a used device. Another example is material selection. For many consumer products, changing to a more sustainable material can be relatively straightforward, with no impact on user safety and no regulatory requirements. The safety and effectiveness requirements of a medical device makes even this seemingly minor change extremely challenging. For example, changing to a more sustainable packaging material can have a major impact on risk. Does the more sustainable material have the same sterile barrier properties? Does it react with the device or cause degradation of it? Does it have the same shelf-life? Does it offer the same level of protection against environmental factors? All of these and more must be considered, and the device manufacturer is still obliged to reduce risks as far as possible.

Sustainability Assessment: Product Life Cycle

As with all products, improving the sustainability of a medical device is not straightforward. Determining the carbon footprint of a device is just one way of identifying opportunities to reduce the environmental impact over the whole device life cycle. Life cycle considerations can include raw material selection, manufacturing techniques, use of natural resources, type of packaging materials, impact of disposal, e.g., incineration, and supply chain efficiency.

Trends In Pharma Compared To Medical Devices

Where for medical devices the risk management focuses on the safety of the user or patient and on the preservation of the functionality of the device during its entire life cycle, the trend in pharma is moving toward protection of both patient and the environment.

EU MDR pushes manufacturers to design medical devices that don’t contain any hazardous substances, but, again, this is from the perspective of protecting the patient, less so the environment (see EU MDR Annex I, GSPR 10.4). Only the requirement listed in Annex I, the General Safety and Performance Requirements (GSPR 14.7), relates to identifying ways of safe disposal of the device.

The proposed pharmaceutical legislation in the EU, however, requires drug manufacturers to provide an environmental risk assessment as part of the marketing authorization submission, focusing on avoiding or limiting the emissions to air, water, and soil. The risk mitigation measures should address the entire life cycle of medicines, from manufacturing to use and disposal of the drug.

Similarly, in the U.S. the FDA requires an environmental assessment for most drug applications, with a number of categorical exclusions (21 CFR 25.31). It is, in most cases, not required for a medical devices submission, only when there is no “similar” device type on the market.

For combination products, manufacturers need to be compliant with both the medical devices legislation for the device part, and drug legislation for the drug part. It is not clear yet whether the new pharma legislation in the EU will require the device part of a combination product to be part of the environmental risk assessment.

Competitive Advantage With Product That Is More Sustainable

With the public becoming more conscious of the environment, the pressure for more sustainability for medical devices is increasing. Medical device manufacturers must build in sustainable practices and approaches to device design now to stay competitive in the market.

References

1. EU MDR 2017/745 Regulation - 2017/745 - EN - Medical Device Regulation - EUR-Lex (europa.eu)
2. EU MDR 2017/746 Regulation - 2017/746 - EN - Medical Device Regulation - EUR-Lex (europa.eu)
3. Waste Electrical and Electronic Equipment (WEEE) Directive EUR-Lex - 02012L0019-20180704 - EN - EUR-Lex (europa.eu)
4. Restriction of Hazardous Substances (RoHS) Directive EUR-Lex - 02011L0065-20160715 - EN - EUR-Lex (europa.eu)
5. Registration, Evaluation, Authorisation, and Restriction of Chemicals (REACH) Regulation Regulation - 1907/2006 - EN - REACH - EUR-Lex (europa.eu)

About The Authors:

Maggie Chan is a life sciences and regulatory expert at PA Consulting. She focuses on leading process and operation improvement for medical device and pharmaceutical companies. She has led labeling remediation and e-labeling process design projects in compliance with global medical devices regulation for both implantable and non-implantable medical devices. She has been supporting companies by building capabilities and designing processes to ensure they comply with ISO 13485, EU MDR, 21 CFR, etc., in line with the product portfolio. She has a Master of Science in law from Northwestern Pritzker School of Law in the U.S. and a BS in biology.

Ramsay Black is a mechanical engineer at PA Consulting, specializing in creating novel medical devices and bringing them to market. He has broad experience in the design, development, testing and regulatory aspects of the medical device industry. Ramsay has a background in product design engineering, with an MEng from Glasgow University and Glasgow School of Art.

Emanuel Wasson is a medtech expert at PA Consulting with a niche on product development and business model design. He has experience in product management, development, procurement, growth strategy, and capability design across the pharmaceutical and medical device sectors. He has a MSE in bioengineering innovation and design from Johns Hopkins University and a BS in biomechanical engineering from Marquette University.