Embedding sustainable principles in the design of drug delivery devices
Alex Fong, Insights and Sustainability Lead at Owen Mumford, explores how life-cycle assessment (LCA) is transforming the design of drug delivery devices. With single-use auto-injectors generating 400g CO₂e per unit, Fong presents innovative approaches to reduce environmental impact while maintaining critical safety standards.
Alex Fong
The drug delivery devices market is growing rapidly, largely driven by the rising prevalence of chronic diseases, technological advancements and the growth in biologics. Disorders such as cardiovascular disease, diabetes and cancer, for example, are now being treated with targeted drug administration – and the growing biopharmaceutical market means drug delivery devices are set to play an increasingly important role in supporting health and wellbeing.
However, the current model for designing, producing and distributing single-use auto-injectors and other combination products – as well as handling their end-of-life processing – is leading to missed opportunities to embrace circularity and the principles of sustainability.
In fact, there is currently no process or industry methodology in the UK or globally to facilitate the return, disassembly, and reintegration of these devices into the manufacturing and supply chains, including the pharmaceutical industry and healthcare systems.
Without concerted efforts to reduce the environmental impact of drug delivery devices across their life cycle – whilst maintaining patient safety and working within the current and future regulatory landscape – there is a risk that natural resources will be irrevocably depleted and carbon emissions will not be reduced.
Why not reuse?
According to Owen Mumford’s analysis, a single-use, disposable auto-injector/pen has a carbon footprint of approximately 400g CO₂e. In contrast, a reusable and remanufacturable auto-injector could potentially reduce this footprint to 19g CO₂e. Clearly, this is the direction the industry needs to move in.
However, in the meantime, manufacturers must also meet clinical demand for delivery devices and pre-filled syringes. This means we must assess the environmental impact of these devices and whether this impact can be meaningfully reduced, as we transition to more sustainable solutions.
Additionally, as one article on this topic notes, “When evaluating whether reusability saves on carbon footprint or cost in the long term, device manufacturers also need to understand the carbon costs of different scenarios. Generally, the overall sustainability of a reusable system will depend on a balance between the complexity of the disposable elements and the reusable element, as well as the number of uses over its lifetime. Modelling tools can be an effective way to identify where this “sweet spot” lies for reuse.”[i]
LCA: The key to effective emissions reduction
The drug delivery device industry operates in a complex global value chain, with numerous opportunities to reduce environmental impact. That is why life-cycle assessment (LCA) holds the key to an effective response. It has become an essential methodology to evaluate those opportunities and maximise sustainability whilst avoiding knock-on adverse effects elsewhere in the supply chain.
It is crucial to think about sustainability from the very beginning of a product’s life cycle, when a device can be designed with reuse or recyclability at end of life in mind. This includes minimising the complexity of materials and embedding sustainability practices into the manufacturing process. The middle stage of the life cycle covers distribution, with opportunities to optimise packaging and distribution networks and collect data on the impact of the process. At the end of a product’s life, waste can be decreased through the use of collaborative programmes involving the recovery and reuse or disposal of devices and materials.
Conducting LCAs is complex, especially as some seemingly obvious decisions over sustainability may have negative consequences in the supply chain. To help with these challenges, Owen Mumford has developed a life-cycle-based eco-design tool, allowing manufacturers to autonomously model any product concept across any supply chain, from conception to disposal.
Guarding against unintended consequences
The tool enables Owen Mumford to quickly estimate the baseline impact for each of its products – giving greater understanding of the sustainability aspects of entire product lines. A detailed overview of the carbon footprint of current products can be created by building scenarios that take into account the market for existing products and their distribution routes and supply chains.
When developing new products, the LCA tool makes it possible to build scenarios to examine a variety of product concepts and configurations. Multiple device characteristics can be assessed – including component weights, material choice and supply, manufacturing location, packaging, transportation and end-of-life scenarios. It is then possible to review the effects of any changes to the characteristics to see if they improve the overall sustainability ‘score’. As well as providing a quick assessment of any likely sustainability improvement, this helps guard against potential unintended consequences – known as ‘environmental burden shifting’.
Safely reducing impact
Operating within a highly regulated industry, drug delivery devices have to provide a safe and efficient means of delivering prescribed medication to patients. They must be robust and operate as intended throughout their whole life – and they need to provide simple, intuitive interfaces to enable patients to use them with minimal training.
Any modifications for improved sustainability performance must not affect these parameters. This is why material choices are limited to approved ‘medical grade’ options that have been rigorously tested for biocompatibility, sterility and zero chemical leaching, and why recycled materials are not an option for drug delivery device designers.
However, considering the environmental impact at all stages of device development can help ensure sustainability plays a valuable part in driving innovation – optimising size, weight and functionality, driving energy-efficient manufacturing methods, pushing forward innovative part design and maximising device life, as well as challenging the business models involved in getting the devices to market and persuading users to rethink how they interact with their devices so that they are not simply thrown away. Creating products that are easier and cheaper to recycle, for example, means making sure they are easy to disassemble.
The choice of recycling method for a product is also a balancing act. Although highest value recycling is usually the aim, the reality in terms of processing material may rule it out as the most sustainable solution. Attention may need to switch to the ‘next best’ point of value, with products recycled as components or assemblies, or to the ‘least best’ point of value – devices recycled as raw materials.
Often, these design changes come with added benefits. Simplifying design, optimising device size and reducing packaging all have the added benefit of reducing waste and transportation costs. The replacement of metal components with suitable polymers can also significantly reduce the carbon impact of processing and shipping without compromising the device itself.
Designing for circularity right from the start of a project is key – addressing, up front, questions about the product’s end of life. Disruptive thinking at an early stage of the design process can have far-reaching environmental repercussions. Flexing the drug delivery device brief around the state of the drug product supplied, for example, can pay huge dividends. If a drug can be lyophilised (freeze dried) and then recombined through the device at the point of administration, the sustainability gains could extend throughout the supply chain thanks to a longer shelf life, increased stability, and the ability to transport and store at room temperature.[ii]
Refreshing design decisions
Pushing beyond the boundaries and challenging decisions throughout the design and development process can reduce the environmental impact of a drug delivery device whilst optimising the design in all other ways. The use of an LCA ensures designs and material choices can be compared right from the start to enable informed decision making early in the development journey. Ultimately this benefits manufacturers, healthcare systems, patients – and the planet.
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References
[i] ONdrugDelivery. (2024). REUSABLE VERSUS SINGLE-USE DEVICES: TRADE-OFFS IN IMPROVING SUSTAINABILITY. https://www.ondrugdelivery.com/reusable-versus-single-use-devices-trade-offs-in-improving-sustainability/
[ii] Broughton. (2023). Lyophilized products: The benefits of freeze drying to increase product shelf-life and stability. https://www.broughton-group.com/blog/lyophilized-products-the-benefits-of-freeze-drying-to-increase-product-shelf-life-and-stability#:~:text=It%20involves%20freezing%20a%20product,primary%20drying%2C%20and%20secondary%20drying.
