Build trust in quality and reliability into healthcare manufacturing to drive a societal transition to a circular economy

Courtney Soulsby, Sector Development Director, Global Healthcare, BSI examines the regulatory, infrastructure, and trust barriers slowing adoption, while emphasising the importance of sustainable innovation, recycling, reuse, and patient-safe circular solutions to build a more environmentally responsible healthcare ecosystem. 

According to the WHO, an estimated 16 billion injections are administered worldwide each year, yet not all the needles and syringes are properly disposed of afterwards. In fact, like many parts of our economy, the healthcare sector generates large volumes of waste and consumes significant resources. It also operates under strict regulatory, sterilization, and safety requirements that often favour disposable materials. Hospitals, clinics, and social care centres within India rely heavily on single use plastics, disposable personal protective equipment, injectables, and primary packaging – much of which evidence shows ends up in incineration or landfill. 

Pressure to reduce environmental impact is increasing, with increasing recognition of this in healthcare systems procurement, environmental pollution regulation, and government sustainability reporting requirements (i.e. BRSR), as well as of ensuring the long-term security of supply of critical healthcare products and auxiliary items. Efforts are emerging to implement circular strategies, such as Zero Waste to Landfill sustainability targets, efforts towards full circularity of drug delivery devices, reprocessing plastic materials, reuse of solvents, and improved pharmaceutical waste management. Nevertheless, the transition remains imbalanced, shaped by regulatory variation, and perceived risk.  

What’s positive, however, is that there is general recognition amongst people and patients that this trend needs to change. In BSI’s 2025 global study, The Tipping Point: Building Trust in the Circularity Economy, a third of respondents overall agreed they would trust repurposed medical equipment as much as new, indicating caution, but also that education and safety protocols may be needed. Whilst the concept may not always be familiar to people, the need to shift to a model that incorporates reuse, repair and recycling is recognized. 

India is actively transitioning towards a circular economy through various government initiatives – such as the soon-to-be-launched circular economy policy and the ‘One Nation, One Mission: End Plastic Pollution’ campaign, as well as the plastics EPR (Extended producer Responsibility). While this represents positive progress, taking circular action is not necessarily simple for healthcare organizations. 

The healthcare and life sciences industry is immersed in innovation, consistently pushing the boundaries of what is possible. Amidst these advancements, sustainability is seen as both an enabler and inhibitor to innovation, leading manufacturers to strike a balance between doing what is right to be environmentally responsible, ensuring patient safety, and being economically responsible by ensuring their products are available and accessible. 

Regulation and customer requirements

One of the biggest barriers to circularity in the MedTech, pharmaceutical and healthcare sectors is around the regulatory environment. To design for reuse or recyclability, manufacturers may face regulatory uncertainty of what will be deemed an acceptable change, as well as conflicting national requirements and potential increased for regulatory re-approval costs. Alignment of regulatory frameworks and their subsequent requirements need to be applicable to all stakeholders engaging in circular economy across the sector, not just the life sciences manufacturers. The development of international consensus-based standards – such as the BS 8887 series Design for manufacture, assembly, disassembly and end-of-life processing (MADE) or BS EN ISO 22526-2:2021 Plastics. Carbon and environmental footprint of biobased plastics – to support linkage between regulatory requirements and environmental outcomes can help mitigate these risks.

Infrastructure 

Another barrier to circularity within the healthcare sector is around the lack of infrastructure to manage waste streams effectively or for outbound reverse logistics. This puts an increased burden on the capacity of industrial sterilizer providers who are asked to terminally sterilise these products for healthcare facilities. Poor separation of clinical, hazardous and recyclable waste in clinical setting reduces the feasibility of decontamination, recovery and reuse. 

Additionally, take-back schemes involve the collection of specific drug delivery devices (i.e. insulin pens), as identified by the manufacturer or materials recovery service provider, from patients directly. Currently each scheme involves a different process, increasing patient engagement and awareness for returning used drug delivery devices, involving local postal logistics companies for collection, and finally pharmacies to include and advertise collection bins. A recent report from ISO and IEC – two standards entities that serve as critical backbones to the Medical Device Regulation – recommended a new standard to be developed on medical devices safe take-back and recycling of medical device.  Guidance outlining best practices to implement successful take-back programmes could also be beneficial here. 

Perception of risk

Even where reuse is technically safe and approved, healthcare professionals may be hesitant to adopt reprocessed or circular products due to perceived sterilization or health risks. Product liability concerns for and lack of incentives towards manufacturers can also deter innovation for circular products.

According to our study, 46% and 40% of people respectively ranked a lack of trust in quality and reliability, and a lack of trust in sterilization and decontamination as top three concerns that may prevent them from adopting circular behaviour. Yet, 60% said that where safe and sterile to do so, medical devices and equipment, such as insulin pens, injectables, or even large imaging equipment such as MRIs, should prioritize design to enable future reuse, refurbishment, remanufacturing and recycling, even if this increases costs.

Moving to a circular economy will undoubtedly require significant disruption and a fundamental rethinking of economic models. It will mean transforming how we construct the economy, so that the upfront costs of circularity – for example healthcare manufacturers adopting eco-design principles for new ways of making products, or the creation of takeback schemes – are not prohibitive. But the appetite for doing so is there, both from patients concerned about environmental impact and healthcare organizations that rely on resources that may become scarce if things do not change. Promisingly, 86% agree circularity should be a priority for businesses and governments in addressing environmental challenges (88% in the pharmaceutical and MedTech sectors). 

We will not shift to a circular economy overnight. Partly, that’s because not everything is in place to do so, such as recycling infrastructure or regulatory pathways. Partly, it’s because the linear economic model is ingrained and behaviour change is notoriously complex. Yet there’s little doubt people understand the purpose of circularity and the need to preserve resources rather than pollute the planet. 

Ultimately, quality and safety – along with, unsurprisingly, cost – are the critical dealbreakers when it comes to the circular economy. Healthcare manufacturers must consider the entire lifecycle of a product – from design, to measurement and end of life – and then build trust into their products so that there is confidence circular is just as good, if not better. In doing so, we can accelerate progress from our centuries-old, wasteful linear economy to one based on reuse, repair and recycling.

BSICourtney Soulsbyenvironmentalsustainable
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