Myopic medicine17 May 2019
In order to achieve sustainability in manufacturing operations, it needs to be incorporated in all stages of the supply chain. One key aspect is obtaining sustainable components from eligible suppliers. Recently, this topic has gained greater attention from industry and academia. Ben Wicks from Team Consulting speaks to Emma Green about the status of sustainability within medical device manufacturing.
Discussion of sustainability is increasing in all sectors. Loosely defined as the ability to meet the present needs of an industry without compromising those of future generations, its principles have not been readily adopted by most OEMs. This is largely because in relation to the wealth and gravity of other factors to consider within medical device manufacturing, it pales into insignificance.
This is certainly the view of Ben Wicks, a medtech consultant with over 20 years’ experience in the industry. With a background in microbiology, immunology and virology, as well as a PhD in clinical biochemistry, he certainly isn’t short of credentials. He also isn’t afraid of holding back in a discussion about sustainability within medical device manufacturing.
“For much of the industry, I don’t think sustainability is very important,” he says. “We’ve got a ton of other regulation to worry about, everyone is concerned with FDA and the European notifying bodies because they hold the key to you having a product on sale or not. Sustainability is not in their world or in their remit.”
Although legislation on sustainability is currently lacking, this may change in the near future. Wicks remains unconcerned about this possibility, however. “I suspect it will start becoming something you’re asked to think about, and we are seeing and hearing patient groups and industry start to get it on the table for discussion,” he admits. “But it’s still often an almost inconsequential issue.”
In light of this context, it is thus unsurprising that, unlike other sectors, the industry has been reluctant to embrace sustainability. The responsibility to ensure patient safety has also been a large contributor. “We are focused on trying to save people’s lives –right here, right now,” Wicks says. “Rightly or wrongly as an industry, we think that we have a higher calling.
That allows us to think that we don’t have to care about it.”
Sustainability is not uniformly rejected but it remains low on the agenda for most companies, especially when developing novel products, where time and money are particularly pertinent factors. “It’s just very far down on the list, particularly if you’re developing something new and clever,” says Wicks. “Bringing it successfully to market is the most important thing, whether it slightly damages the planet or not, or some of the parts could be recycled but aren’t at the moment, just doesn’t come into your thinking.”
For more established devices, there is greater openness to exploring sustainability. “If your product is mature and the risks are low and well understood, then you can turn your attention to sustainability,” explains Wicks. “And why wouldn’t I think about reducing its carbon footprint? I benefit, I’ll save some money and the user will be happier.”
Fix the flaws of perception
It’s not just the perception of sustainability that hinders its implementation; there are also a number of practical considerations when attempting to integrate its principles into the manufacturing process. “For many people in the industry, we’re sweating bringing the product to market, and once we have brought it to market, it’s difficult to make changes to the product without doing a ton of reverification,” Wicks explains. “If it’s just the secondary packaging, I might be able to cope with that. But if I’ve got a complex medical device and want to change its primary packaging, I might have to reverify my sterilisation or my stability trials, and that might cost several million pounds.” This means that any benefit to sustainability is likely outweighed by the hassle of successfully achieving it.
This is in stark contrast with direct-to-consumer products where sustainability is not only high on the priority list but also much more feasible to implement. “For a consumer product, you think ‘Well, if I can just save 20% of the packaging by a bit of a change here and there... bish, bash, bosh, off you go and do it. You get the product out there, everything continues and you’re happy, but you just can’t often do that in the medical device industry.”
For Wicks, and many others in the industry, sustainability is perceived as a luxury, an expensive indulgence that often isn’t deemed worthy of consideration. “Sustainability is in everyone’s thinking in the developed world, and during design and development, you’d give it a thought,” says Wicks. “In a sense, it’s in people’s minds but it’s always down the priority list, certainly with complex devices.”
The average global temperature increased during 1880–2012.
If sustainability was on the agenda, selecting a sustainable supplier would be an important step in the process. However, for Wicks, as with manufacturing in general, it remains a relative footnote when making a decision. “I think about if they’ve got a high-quality system, if they’re reliable, if they’ll continue to give me parts that work and can ensure that the end device means that patients get better and don’t get worse,” says Wicks. “Sustainability hardly makes it onto that checklist for supplier selection.”
The rise in sea levels 1901–2010.
The status sphere
The low status of sustainability within the industry is also driven by the relative lack of consequences if its principles are not adhered to. “You screwing it up, if that product fails and people die, lawsuits fly around, products come off the market, companies go bust,” says Wicks. “Nobody loses their job or dies if I use a printed circuit board that wasn’t as recyclable as another one.”
It’s clear that from a purely business perspective, sustainability just does not come into the equation. “It’s not like someone running off with a commercial advantage saying ‘look at our devices, they’re all biodegradable,’” says Wicks. “That just isn’t a thing.”
Nevertheless, there are small indicators of change in the industry, such as batteries in disposable goods. “Nowadays you would expect a disposable medical device that has a battery in it for you to be able to take the battery out in accordance with the Waste Electrical and Electronic Equipment Directive,” says Wicks. “There are examples where, in the past, you’d have not cared about getting the batteries out before you chucked the device away, but now you have to because that’s standard practice.” One rare case where sustainability did become more important was the use of propellant in metered-dose inhalers (MDIs). “They originally used chlorofluorocarbons as propellants, which have a serious ozone-depleting effect,” explains Wicks. These were discontinued in January 1996, except in a few rare cases.
A new class of propellant, called hydrofluoroalkanes took over, which was much more environmentally friendly. However, they are certainly not carbon-neutral. “These are way better but they are still a serious greenhouse gas contributor,” says Wicks. For large companies, the use of these propellants contributes a significant amount to their overall carbon footprint.
There are currently discussions about moving to an alternative propellant, but manufactures are reluctant to make any changes unless it becomes mandatory. “The industry doesn’t want to make the switch if it can help it because it will be a pain to do all the reverification and revalidation,” says Wicks. “Nobody wants to spend the time or money, or cause potential risk to their patients.”
Although clearly unlikely to immediately jump to the top of the priority list for OEMs, public perception looks set to be a future driver of sustainability within the industry. “We are seeing patients and users, such as healthcare professionals, starting to recognise these issues,” admits Wicks. “But even though they say that, as a device developer, it’s a secondary or tertiary issue. Ultimately, if this device doesn’t work safely, it might not be commercially viable or, worse still, it might harm someone. Of course, that is not okay.”
Despite the reluctance from industry to embrace sustainability, it is likely that small steps will continue to happen, largely driven by legislation. “I would expect that within the coming years, we’ll see a nod towards sustainability from the regulator,” says Wicks. “But it’s never going to be high on their priority list.”