Embracing Circularity in the Medical Device Industry

The MedTech industry is at a critical crossroad in its sustainability journey. While innovation has helped to bring state-of-the-art technologies to healthcare, the continued use of non-recyclable materials and the significant increase in single-use devices are undermining efforts to support sustainability efforts by medical device manufacturers. What's needed is a more holistic approach to product development efforts that integrates innovative approaches across the entire life cycle of medical products.

In this article, we explore the concept of circularity and the potential benefits that its application can bring to medical devices. We'll also discuss the various barriers and challenges facing device manufacturers in their efforts to adopt a "circular mindset," as well as potential solutions that can not only foster innovation and improve sustainability results but also strengthen the economic performance and value of device manufacturers and stakeholders.

What is Circularity and Why Is It Important?

At its most basic level, circularity presents an approach to economic activity that is fundamentally different from the traditional "make-use-dispose" linear model, in which resources are processed into products that are used and then disposed of at the end of their useful life. Instead, according to the Ellen MacArthur Foundation, a global non-profit dedicated to creating what it calls a "circular economy," economic activity based on circularity adheres to the following three principles:

• Eliminate waste and pollution from product design.
• Extend the longevity of material use and/or reuse products and materials.
• Regenerate natural resources and systems used in the process.

Embracing the concept of circularity is not just about reducing the negative environmental impacts associated with linear economic activity. It's also about making economic systems more resilient and less susceptible to resources and material shortages. Ultimately, applying the concept of circularity can lead to the development of innovative practices that can also improve an organization's financial performance as well as its competitive position in the global marketplace.

The Impact of Healthcare-Related Waste

Despite its central role in supporting the health and well-being of the world's population, the healthcare industry is a major source of environmental waste. According to a recent report issued by the UC Santa Barbara's Bren School of Environmental Management, the U.S. healthcare industry alone generates approximately six million tons of environmental waste every year, an amount equal to the entire annual environmental waste production of the country of India.

A major source of waste generation in healthcare is the expanded application of single-use medical devices, which grew exponentially during the COVID-19 pandemic. According to a 2023 report by global tax and advisory firm Ernst & Young, an estimated 90% of medical devices waste can be traced back to single-use devices or their components.

Environmental waste generated by the disposal of healthcare-related devices, materials and activities directly contributes to global greenhouse gas emissions and pollution. An article in Harvard Medicine Magazine estimates that between 4.4 and 5.2% of the world's greenhouse gas emissions are directly traceable to the healthcare sector, a percentage greater than that of the aviation industry, which generates between two and five percent. Single-use medical devices and the manufacturing processes used to build them also have a sizeable carbon footprint, further contributing to greenhouse gas emissions in the healthcare industry.

But even more important is the potential health impact of medical waste itself. The World Health Organization has determined that approximately 15% of healthcare-related waste is considered hazardous because of biological, chemical, or radioactive contamination. Proximity to hazardous medical waste can also inadvertently place underserved populations at greater health risks, due to insufficient or poor waste disposal practices.

Enabling safety, compliance and sustainability for medical innovation

The Current State of Circularity in Medical Devices

In light of these troubling trends, the MedTech industry is stepping up its efforts to identify new and innovative solutions that not only address environmental and health concerns associated with the production, use, and disposal of medical devices, but that simultaneously support the more efficient use of resources and materials.

A paper published in the journal Science Direct in 2024 presents a detailed review of nearly 100 scientific articles on the subject of circularity and medical devices. Of the more than 1400 active devices discussed in those articles, developers or manufacturers of 346 of those devices (about 25%) integrated at least one circular strategy into their efforts.

The previously cited Ernst & Young report identifies three separate areas of focus by medical device developers and manufacturers, as follows:

• Redesign-Increasingly, MedTech companies are looking for ways to redesign their medical devices, for example, using bio-based materials in place of plastics in single-use devices to reduce the environmental impact attributable to their disposal. Other redesign options include incorporating modular components and materials that are easier to disassemble and replace, thereby eliminating the need to dispose of the entire device.
• Reuse-In addition to the use of more sustainable materials in place of plastics, medical device developers and manufacturers are also evaluating the use of recycled or reusable materials in single-use devices. The E&Y report cites the application of this strategy in prolonging the anticipated useful life of catheters.
• Refurbish-Especially in the case of high-value equipment and instruments, such as MRI and ultrasound imaging equipment, medical device companies are exploring options for retrofitting and/or refurbishing equipment. This option focuses on replacing only those components that are defective, thereby reducing or eliminating the need to replace the entire system.

Each of these areas of focus adopt one or more of the principles that define circularity, combining efforts to improve sustainability while also supporting the more efficient and cost-effective use of materials. And, from an industry perspective, circularity helps to reduce reliance on many previously critical materials, thereby making essential supply chains more resilient.

Barriers to Developing More Sustainable Medical Devices

However, despite the widespread benefits of adopting a circular approach in the development of medical devices, there are a number of barriers and challenges that are impeding progress in the MedTech industry's circularity journey.

As discussed in the Science Direct article, there are several prominent barriers confronting developers and manufacturers that are considering ways to integrate circularity into their efforts. These barriers include:

• Safey concerns, such as: 1) safety, infection, and contamination risks; 2) a primary focus on clinical outcomes that run counter to circularity; and 3) careless adherence to decontamination methods. (Example: "Healthcare providers are concerned that reused devices could still be contaminate, putting patients at risk")
• Technological barriers, like: 1) device or material characteristics that are not suitable for circular strategies; 2) a primary focus on the quality and function of a medical device; and 3) challenges in updating circular devices. (Example: "The materials we use are chosen for their strength, which makes them incompatible with reuse in many cases.")
• Systemic concerns, including: 1) practical difficulties in collection and separation logistics; 2) inherent challenges in moving away from a linear approach; 3) scalability issues and a potential scarcity of materials and other resources. (Example: "Our industry infrastructure is not yet positioned to actively support widespread recycling efforts.")
• Regulatory issues, especially those that: 1) complicate the regulatory review process; 2) address data privacy issues; and 3) impact product warranty considerations. (Example: "Disclosing our specific circularity strategies and methods could compromise our intellectual property rights.")
• Financial considerations, such as: 1) financial objectives and constraints of various stakeholder groups; 2) device market valuation and its impact; and 3) constraints on new market entrants. (Example: "Embracing circularity can be especially challenging for start-up companies with innovative ideas but limited resources."
• Social barriers, like: 1) lack of buyer awareness about the benefits of the circular economy; 2) confusion about terminology; and 3) a lack of trust that impedes acceptance. (For example: "Many in the healthcare system are either unaware of the benefits of circularity, or unconvinced that a circular approach is worth the effort.")

These barriers and other challenges are enough to deter many medical device developers and manufacturers from exploring circularity options. Yet, those that fail to evaluate how to integrate innovative sustainability-enabling practices into their business model lose valuable market credibility as well as opportunities to increase efficiency and profitability.

Overcoming Sustainability Challenges and Embracing Circularity

For medical device developers and manufacturers seeking to embrace a circular mindset, successfully navigating the path to circularity can seem overwhelming. But your organization's circularity efforts can begin by applying some simple concepts and strategies that are already gaining traction in the MedTech industry.

The "redesign, reuse, refurbish" circularity concepts currently being adopted by many MedTech companies offers a useful framework for medical device developers and manufacturers beginning their circularity journey. These concepts generally align with the strategies identified in the review of scientific articles previously cited, which include:

• Refuse-Evaluate the development of new devices that eliminate other less environmentally-sustainable devices;
• Rethink-Explore the development of devices that offer multiple functions in a single device, or that can be shared among multiple users;
• Reduce-Identify ways to reduce the use of materials and energy consumption;
• Reuse-Where possible, reuse devices for multiple use cycles following decontamination; and
• Remanufacture-Design devices that can be remanufactured at their anticipated end of life.

To apply these circularity concepts and strategies, device developers and manufacturers can begin by reviewing their current practices to identify potential opportunities to apply one or more of these strategies. Then, based on the findings of that initial review, they can then initiate pilot projects to evaluate the feasibility of implementing these strategies in practice. Finally, with real-world data in hand, developers and manufacturers can confidently move forward to implementing their circularity initiatives at scale.

How UL Can Support Your Circularity Journey

Beyond developing a circularity strategy, MedTech companies seeking to embrace circularity should also consider how best to measure the impact of their efforts in connection with both their sustainability objectives and their economic value, as well as verifying the objectivity and transparency of their assessment.

To support these efforts, UL Solutions has developed UL 3600, the Standard for Measuring and Reporting Circular Economy Aspects of Products, Sites and Organizations, a pioneering standard for measuring product circularity. At the heart of the standard are detailed methods for measuring circularity, which are then used to calculate a circularity rating for each of several individual performance metrics. These ratings are then averaged into a single, composite circularity score.

The individual performance metrics and the final circularity score are presented in a comprehensive Circularity Facts™ Report that provides a detailed visual representation of the organization's circularity efforts. By measuring both product inputs and end-of-life outputs, UL 3600 supports your efforts to validate your circularity initiatives and your commitment to circular economy principles.

In addition to UL 3600, UL Solutions also provides environmental claims validations (ECVs) in connection with a suite of individual circularity standards. These standards include UL 2809 (recycled content), UL 9797 (biobased content), UL 1497 (biodegradability and compostability of managed waste disposal methods), and UL 2485 (recyclability of paper-based products). These standards can support efforts to directly evaluate specific circularity initiatives, thereby contributing to your circularity progress.

A world-leader in safety science, UL Solutions is your trusted partner in your efforts to integrate circularity concepts into your operations, helping you to achieve your circular economy vision.

The MedTech industry has a tremendous opportunity to make a meaningful difference in efforts to address global sustainability issues that will impact us now, and in the decades to come. Adopting the foundational concepts of the circular economy can not only support an organization's sustainability efforts but can help strengthen its economic performance and value, while also building shareholder support and confidence.

Within UL Solutions we provide a broad portfolio of offerings to all the medical device industries. This includes certification, Approved/Notified Body and consultancy services. In order to protect and prevent any conflict of interest, perception of conflict of interest and protection of both our brand and our customers brand, we have processes in place to identify and manage any potential conflicts of interest and maintain impartiality. UL Solutions is unable to provide consultancy services to EU MDD, MDR or IVDD Notified Body, UKCA MD Approved Body or MDSAP Customers.