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Materials Sustainability and ‘servicisation’


Shifting from a linear to a circular medical device economy means reshaping OEM business models. According to the authors of a recent study in Health Affairs, that is likely to mean a growth in performance-based or servicised approaches that sell the service or function that a product provides along with ongoing support and maintenance, rather than the product itself. Healthcare is particularly well-suited to servicisation because of the need for continuous, uninterrupted service and safe functioning. Servicisation has gained momentum in various industries because of the inherent material savings and the value it creates for both user and manufacturer. Rolls-Royce sells performance hours to airlines – not jet engines. Philips offers lighting as a service instead of selling physical bulbs and fixtures. In the health sector, GE sells product-service packages that include the purchase or use of medical imaging equipment along with product maintenance.


In all of these cases, companies have expanded their markets by avoiding high up- front capital equipment costs and are incentivised to ensure optimal durability for reuse and repurposing of spent components and materials, rather than excess consumption of newly manufactured ones. A case study of a product-service package approach to haemodialysis demonstrated a 50% reduction in overall costs and environmental impacts compared with business as usual. In the view of the authors, there are many short and long-term benefits to a


servicisation model, most notably the alignment of user and retailer incentives. Hospitals would receive higher-quality, durable, easy-to-clean medical devices, which are more desirable than single-use disposables manufactured for obsolescence. Use would be facilitated by technical support and product servicing. OEMs would design products and protocols to optimise reprocessing and repair, instead of engaging in anticompetitive manoeuvres with reprocessing vendors. Finally, by gaining visibility into the real-world use of their products, OEMs could observe malfunctions and inefficiencies in action and innovate in harmony with clinical needs. The incentive to extend product life and maintain product value at the highest level drives innovation,


encouraging optimal material selection and circular product design. Source: Health Affairs


but this is ultimately determined by a regulator: a reprocessed device must be demonstrably as safe and perform as well as the original.


“There is a broad misunderstanding that putting plastics in a landfill is bad because they don’t degrade. But actually, it’s better if they don’t degrade. When plastics degrade [in an incinerator] they release methane, and if you don’t collect the methane properly, that’s a greenhouse gas that is way worse than CO2 Robert Render, Ravago Recycling


by-device basis, but in future, it would be useful to have broader industry guidelines on reprocessing, says lead author of the Sustainability study Anna Schulte, of the Fraunhofer Institute for Environmental, Safety, and Energy Technology. For now, more research into the life cycle and circularity of different devices is needed. Vukelich estimates that there are currently around 300 different devices that have been cleared by the FDA and EU for reprocessing. In the US, medical reprocessing companies — third parties who reprocess devices for hospitals — save 4.6 million devices per year from landfill or incineration, amounting to approximately 935t of medical waste according to a report from Resources, Conservation, and Recycling.


What if a device must be single use? Sometimes, a device must be designed in a certain way for a certain use, meaning there is no choice but to dispose of it afterwards. If this is the case and the device is made of plastic, Render recommends working with a legal and well- designed landfill rather than sending the devices for incineration.


“There is a broad misunderstanding that putting plastics in a landfill is bad because they don’t degrade. But actually, it’s better if they don’t degrade,” he says. “When plastics degrade [in an incinerator] they release methane, and if you don’t collect the methane properly, that’s a greenhouse gas that is way worse than CO2


.” .”


Most SUDs that are reprocessed are medium- complexity and medium or high-criticality devices, such as catheters and surgical staplers that are materially rugged enough to survive the process of sterilisation or disinfection.


14,000t


Waste generated per day by US healthcare facilities.


HPRC 88


More expensive devices are also usually better candidates. “You wouldn’t reprocess a needle,” says Vukelich, “but you would reprocess an advanced surgical device.” The costs involved in getting FDA clearance for reprocessing, which may require R&D investment, are an important factor here. Whether and how many times a device can be reprocessed is currently determined on a device-


It would also be beneficial to choose a landfill that is as close as possible to the point where the device has been generated, to reduce the environmental impact of transport. The supply chain, including the production, transport, use and disposal of goods, is currently responsible for 71% of the healthcare industry’s greenhouse gas emissions, according to Healthcare without Harm and Arup. Awareness of the industry’s environmental impact is growing – and so is the willingness to address it. Within the past year, the HPRC has had a 25% increase in membership, while the commercial reprocessing industry is predicted to grow by 15.1% per year from 2020–26, as stated in a report by Global Market Insights. In 2019, it was valued at $1.4bn.


This speaks to a wider shift in thinking, away from the linear ‘take, make, waste’ mentality towards a focus on retaining value and usability for as long as possible. “How many cuts can umbilical cord scissors make, if it says ‘single use’?” asks Vukelich. “Does that mean one cut or three? If you can repurpose a product safely, it can make 30 cuts for different patients.” ●


Medical Device Developments / www.nsmedicaldevices.com


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