How to Integrate Sustainability into Device Developments to Optimize Impact

How can companies better integrate sustainability throughout the development process?  

Carol: Prepare early; integrate sustainability into the process before the need really hits. The refinements you can make after figuring out the design and packaging are likely to have minimal sustainability impact. However, if (before the program begins) you ensure the right processes and suppliers are in place, you position yourself to make decisions that will have a meaningful impact on the sustainability of the final product.

Fran: In drug delivery device development, there are often tight constraints on time, budget and resources – the device cannot delay a drug trial or commercial launch. If you can set up a sustainability strategy in advance and establish how it will be integrated into development, you won’t find yourself asking those questions when your team is already stretched or you’ve got an impending deadline. 

"If the patient needs to travel to the pharmacy to collect their medication, then how they choose to get there will form part of the overall environmental impact of the product. There may be a way to change where the product is shipped to in order to improve sustainability."

What does this look like in practice?

Fran: It’s about understanding your high-level aims for improving environmental impact alongside your corporate sustainability strategy and quantifying what that means on an individual development project level. For example, if carbon footprint is a key metric for you, how much better does your next device need to be than the previous one? Does it also need to be lower than that of a competitor device or lower than the impact of using a competitor therapy? You can then include the appropriate targets in your high-level design documentation at the start of development, along with your target product profile, risk management plan and so on. That will naturally filter into your requirements documentation, risk documentation and the design itself. Considering this early on allows sustainability-related goals to be included seamlessly without adding a significant burden to the concept generation and development process. 

It’s also important to understand which tools and techniques you can give your device team to help them design and make decisions with sustainability in mind. For example, a comprehensive life cycle assessment (LCA) calculator will allow quantitative comparison of the environmental impact of products. You may also want to have a less involved version to allow quicker assessment of concepts.

 

What lessons can pharma learn from other industries that have made real strides in sustainability?

Fran: The consumer sector is a good example of an industry that’s further along the sustainability journey than we are in the medical space. The environmental regulations on consumer goods and packaging are much tighter than those currently facing drug delivery devices. Through our work in the consumer space, we have seen those companies go through the process (and sometimes pain) of interpreting relevant regulations and redesigning on-market products when required.

We have seen regulations result in the need for rapid redesign of products or their packaging to meet new requirements. Seeing how regulations have progressed in the consumer sector may give us a map of how those regulations will progress in healthcare. This can help us focus our efforts in the short-, medium- and long-term. For example, regulations may initially focus on things that do not directly impact the product’s function, such as packaging, before impacting the products themselves. Other focus areas are expected to be electronic and plastic waste. A key takeaway is that we need to be proactive, rather than reactive, in our developments to ensure that new regulations do not derail ongoing or future programs.

We can also learn from the consumer sector how important it is to collaborate with partners and vendors, and even competitors, to achieve sustainability targets. It is difficult for any company to have a significant sustainability impact on its own. For example, in a circular economy, we rely on everyone involved throughout the device lifecycle to play their part in recovering and reusing materials and energy. We need to work across the whole supply chain and, ideally, across the whole industry to make the maximum impact. 

"Requirements or targets focused on environmental sustainability should drive consideration of the environment without undermining patient safety, outcomes, or the broader set of sustainable development goals."

Are there opportunities to improve the sustainability of drug delivery devices that people aren't thinking about?  

Fran: We talk a lot about the physical device or the components that device designers work on – like the plastics and electronics – but the environmental impact of the combination product is much greater than this. One technique we use is called system mapping, where we identify all the stakeholders who might interact with the product or device and use this to identify opportunities to improve sustainability. For example, if the patient needs to travel to the pharmacy to collect their medication, then how they choose to get there will form part of the overall environmental impact of the product. There may be a way to change where the product is shipped to in order to improve sustainability. We need to think more broadly than just the device and its packaging. 

Carol: Another potential approach to reduce environmental impact could be including multi-month supply in a single package and/or shipping directly to the user. However, this could have regulatory or payer coverage implications that also need to be managed.

We also need to think about feature benefits and trade-offs. If we add connectivity to a device, one impact may be improved (for example, user experience, medication reminders and adherence tracking), but the new product may not meet your sustainability goals at first glance. However, if you look beyond the device lifecycle, improved adherence may lead to more positive patient outcomes, reducing hospital admissions and the corresponding environmental impact that in-clinic care would involve. There is, therefore, a trade-off between short- and long-term impacts that can be difficult to quantify, made even more complex when impacts other than carbon footprint are considered (for example, resource depletion or eutrophication potential). This links back to the need for tools to estimate overall impact across key metrics to help make these design decisions.

 

How does thinking about the environment as a stakeholder impact decision-making? 

Fran: The idea is to have the environment on our minds as we set up our development programs. We include relevant environmental considerations in our list of requirements and key risks. Having our environmental targets written down makes it easier to remember when making design decisions or developing new concepts. By including the environment as a key stakeholder throughout, you are prompted to make conscious decisions about sustainability.

"Sustainability is a team sport."

How can we ensure we are not improving sustainability at the cost of patient safety and outcomes?

Carol: Although our discussion today has focused on environmental impact, safety and efficacy need to continue to be the priority when developing medical products. Improving access to effective healthcare is integral to the broader definition of “sustainability,” as outlined by the United Nations’ 17 Sustainable Development Goals. This encompasses good health, well-being, and reduced inequalities. Requirements or targets focused on environmental sustainability should drive consideration of the environment without undermining patient safety, outcomes, or the broader set of sustainable development goals.

Fran: An example of this may be reducing carbon footprint while maintaining a consistent user experience. On a device level, you can look for more sustainable ways to meet the same key functions by changing what happens to the product outside of the user’s hands. For example,  improving transportation and distribution can improve sustainability without the patient experiencing any change at all. 

 

What key factors should be driving our approach?

Fran: Sustainability is a team sport. We need to collaborate across whole supply chains and industries to optimize our effectiveness. While individual companies can take strides and improve their impact, everyone will be better off if we can collaborate and share what we learn.

Carol: When making data-led decisions to improve product sustainability, the data we rely on is crucial, just as it is for all other aspects of medical device design. Our research needs to encompass the full range of regions and demographics to ensure that our data can support sustainable development for all populations.

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