By Erdmann Solutions…
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Embracing the Circular Model in Pharma and Medtech
The pharmaceutical and medical device industries are showing increased interest in Circular Economy concepts as paths to greater sustainability. This series of three articles summarizes Erdmann Solutions’ experiences in this field with the design of take-back programs and reusable devices, along with the design consultancy’s assessment of what the future may hold.
In this initial article, we examine what’s involved in Circular Thinking and the concept’s implications for life sciences.
Circularity – what is it?
Perhaps the best definition of the Circular Economy comes from the Ellen MacArthur Foundation as “a system where materials never become waste and (where) products and materials are kept in circulation through processes like maintenance, reuse, refurbishment, remanufacture, recycling, and composting.”
The Foundation stresses that the most important single benefit of circularity in the fight against climate change, loss of biodiversity, pollution, and resource scarcity “is to decouple economic activity and growth from the consumption of finite resources.”1
A subsidiary principle of the Circular Economy is Device Circularity. This means retaining the highest value of products and materials by keeping them in circulation, ideally as functioning products or, failing that, as components or raw materials. “This way, nothing is wasted, and the intrinsic value of products and materials is retained.”2
In the life sciences context, ‘device circularity’ refers to the design, production, use, and disposal of pharma and medical devices in ways that maximize their lifecycle.
Being circular
Based on Erdmann Solutions’ experiences with life science and academic partners, device circularity can be manifested in several ways. The first important step is that manufacturers take whole life responsibility for their products. This can for example mean instituting a take-back program to retrieve used devices from patients or healthcare facilities. This ideally allows the whole device to be refurbished and re-used. As a second best, it can be recycled for its raw materials, as a more readily accessible solution.
This demands collection and transport expertise and infrastructure and thus pharma companies must partner with specialists with collection infrastructure, those capable of processing, cleaning, and refilling used devices (aseptically where necessary), or with recycling facilities. Neither the logistics nor recycling parts of the process are within the remit of a life science company, but it is possible to bring refurbishment in-house.
The ‘purest’ forms from a design perspective are more modular concepts in which components can be replaced individually and longer service life and reusability are ‘built in’. With an injection device, for example, the consumables (ampoule and needle) should have minimal material and size. They should be easily inserted into a durable user-friendly housing, which is then also easy to return to the cycle.
‘Design for disassembly’ is a new discipline we are having to learn, incorporating features such as integrated plastic grades and releasable (but still secure) connections between components.
Circularity also can be manifested upstream in selecting sustainable (biocompatible and biodegradable) and recyclable materials when designing products to reduce their overall environmental impact. This is an area that requires intervention by regulators to standardize different plastic grades and harmonize their monomaterial forms and coloring within CE standards. In the new paradigm, recyclable plastics no longer need to be ‘as good as possible’ but ‘as good as necessary’.
Design for circularity also demands attention to the manufacturing process to reduce waste generation, such as minimizing scrap during production, as well as to the overall supply chain to reduce excess inventory.
Pharma companies may need to invest in innovative technologies that support circularity, such as advanced reuse and recycling techniques, smart packaging that monitors device use and expiration, and digital platforms for tracking and managing individual devices.
There are also a series of supporting actions that need to be taken as part of a thorough transition to Circularity. These start with Lifecycle Assessments (LCAs) to quantify the environmental impact of devices throughout their entire lifecycle, from raw material extraction to end-of-life disposal. This helps in making informed decisions to improve sustainability. The Regulatory Affairs team will need to extend their efforts to consider that the circularity program complies with the guidelines that are already emerging from the FDA, EMA and the local EPR (Extended Producer’s Responsibility) processes.
Change communication for new behaviors needs to support all this. These communications can involve collaboration with other companies, healthcare providers, and agencies to create cohesive systems for circular practices and with employees, consumers, and other stakeholders to drive the uptake of circular economy initiatives.
Why Circularity?
Based on current experiences, Erdmann Solutions can highlight several key reasons for life sciences industries to embrace Circularity.
One bottom-line benefit of the circular economy is potential new revenue streams from refurbished devices and recycling programs. A further economic bonus is greater supply chain resilience from reduced dependence on raw material suppliers and manufacturers.
Other benefits, less easy to quantify at this stage, include the positive impact on overall workflows of eliminating extraneous outputs and rationalizing design and material choices.
A further subsidiary gain is the increasing knowledge of carbon footprint evaluation and reduction that is implicit in circular thinking. This will become increasingly core to business operations as time goes on, as will the increased data management expertise that comes from handling complex just in time delivery and collection programs.
Perhaps the most important motivation, though, is the wish to ‘future-proof’ the business against emerging environmental regulations and greater risks of resource and other shocks in an increasingly stressed world.
It certainly seems to be the view of the public that green is the way to go, and it emerged very strongly in our market research that consumers and distributers are increasingly looking for eco credentials in the products and services they favor. Circularity of devices is a prime route for pharma companies to meet these stakeholder expectations and by so doing to differentiate themselves from the competition.
Corporate Social Responsibility (CSR) may have gained something of a reputation as a mere ‘box ticking’ exercise but its more meaningful manifestation as ESG (Environmental Social Governance) objectives is important. In the final instance, companies need to take responsibility for delivering sustainable businesses for the welfare of all stakeholders. CSR and ESG formalize that contract with society, as well as the technicalities of controlling risks related to operations, supply chain and investments. Circularity fits into both agendas, along with the constant need to motivate Stakeholder Engagement among employees, consumers, and investors.
Maybe the most significant long-term benefit of embracing the Circular Economy is the change in overall mindsets that is required. Circularity involves holistic thinking and streamlining processes at every level, both of which are great for the organization’s overall culture of innovation, ‘Kaizen’ continual improvement, and its operational efficiency.
In future articles, we will examine the other important aspects of the Circular Economy:
- The Challenges of Circularity: the main issues to be overcome in adopting this model.
- Moving to Circularity: The main steps involved in reaching an implementable action plan.
References
- Ellen MacArthur Foundation. 2017. Circular Economy Introduction. https://www.ellenmacarthurfoundation.org/topics/circular-economy-introduction/overview.
- Ellen MacArthur Foundation. 2019. Circulate Products and Materials. https://www.ellenmacarthurfoundation.org/circulate-products-and-materials.
Resources
Click on Novo Nordisk Global: Introducing ReMed™: Driving change to avoid plastic waste to learn more.
Click on Johnson & Johnson Sustainability for current best practice.
Click on Johnson & Johnson Environmental Sustainability to learn more.
Click on European Federation of Pharmaceutical Industries and Associations: EFPIA White Paper on Circular Economy for suggested guidelines.
Click on Pharma Manufacturing Magazine: Pharma’s shift towards a circular economy for further information.
Click on From Idea to Innovation for more on Erdmann Solutions.
Device circularity is increasingly driven by market demand on the part of patients and doctors.
The Circular Economy Approach as applied to Medtech and Pharma, with refurbishment of components as a separate loop within the Use part of the cycle, supplementing new production.
Circular thinking can deliver a series of business benefits, ranging from enhanced durability of products and services to driving innovation.
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