Owen Mumford’s Head of Insight Alex Fong, and Business Development Manager Olivia Houselander speak on how to clear a path to sustainable single-use drug delivery devices.
Traditionally, drug delivery devices have relied heavily on single-use plastics to ensure safe, effective administration of medication to patients. Recycled materials are not currently an option as material choices are limited to medical-grade options that have undergone rigorous testing for aspects such as biocompatibility with the drug, sterility and zero chemical leaching.
However, increasing pressure from regulators and consumers alike is leading to medical device manufacturers making environmental concerns a greater priority. The journey towards a greener, more sustainable future is turning the spotlight on single-use devices for delivering drugs to patients.
The journey towards a greener, more sustainable future is turning the spotlight on single-use devices for delivering drugs to patients.
But it’s a delicate balancing act – any move towards sustainability has to take into account the needs of patients and the financial pressures facing healthcare organisations. And, in the meantime, healthcare systems around the world need regular supplies of delivery devices and pre-filled syringes right now to meet clinical demands.
This means a transition plan is required to map out the pathway to sustainability – given that it will take the industry a number of years to move to truly sustainable alternatives that can be delivered at scale. Suppliers and buyers will need to adopt a collaborative approach to manage the transition and ensure the best clinical and patient outcomes.
Research is well under way into potential substitute materials for petroleum-derived plastics used in most drug delivery devices. But there are no easy answers. Biodegradable options, for example, have been under consideration. But biodegradability can sometimes affect the stability of drugs in pre-filled pharmaceutical products. The focus has therefore switched to creating reusable drug delivery products that can be easily remanufactured, with a disposable element that can be easily recycled.
That is where ‘sustainability by design’ comes in – in the short term, it is likely to be the fastest route to environmental improvements. It involves building sustainability considerations into product design and engineering. Ease
of disassembly, for example, will have a major impact on recycling costs and methods. Creating a smaller, simpler device with less packaging will reduce waste and the impact of transportation. And having different products sharing the same raw materials and production methods will save on cost and waste, as well as giving more flexibility on the production line.
Careful consideration at the design stage can also help reduce the amount of single-use plastic associated with each treatment using a disposable device, without affecting safe and effective usability. And removing metal components from a design can also help reduce the carbon footprint, as the processing and shipping of metals has a greater environmental impact than polymers.
The key to success is approaching sustainable product design by examining the whole product lifecycle – not just the standalone product. That means thinking about everything from concept development, material selection, and design and engineering to manufacturing, packaging, transportation, sales, product use and end-of-life disposal. In each case, things like energy efficiency, environmental impact, material usage and recycling need to be evaluated.
The key to success is approaching sustainable product design by examining the whole product lifecycle - not just the standalone product.
But, even with sustainable design, most drug delivery devices are likely to need a disposable element for some time to come – to meet regulatory, safety and hygiene requirements. For connected devices, disposable electronics would not be financially viable or environmentally acceptable. So a simple interface is required between the two component sections to ensure functionality and efficacy are not impaired.
Biosimilar interchangeability also has to be taken into account, with the cost benefits of a change in drug formulation or drug delivery device weighed against the effects on the patient experience. The most straightforward option in these circumstances is likely to be a disposable device as this will avoid the regulatory complications of interchangeability status. But, of course, this is not the most sustainable choice.
With so many competing factors on the path to sustainability, collaboration between buyer and supplier will be needed more than ever to deliver optimised products that tick the desired boxes. It is a balancing act, but strong and transparent partnerships promote ongoing refinement, as we continue to innovate and find better solutions.