Packaging, supply and logistics
Bix and Couling believe more attention is being paid to the role that packaging can play in the delivery of care.
opening [the packaging] and making the transfer?” It’s because of this, in part at least, that the FDA released guidance on the issue of human interactions back in 2016, and has updated it since too. The guidance was developed to assist the industry in following appropriate human factors and usability engineering processes to maximise the likelihood that new medical devices are safe and effective, and to minimise potential use errors that can result in harm. Couling believes the guidance caused a snowball effect for device manufacturers and their packaging teams. Until recently, he says, few included packaging as part of their validation process, including the aseptic presentation part of it. “But I think that’s where we’re heading,” he adds. “When we’re in the ideation phase – not even close to any type of validation verification – we’re getting feedback from surgeons that’s starting to incorporate packaging within it.” For some time now, there has been criticism that device packaging is too often considered at the wrong part of the design process – the end. Couling agrees this has been the case, but he’s confident this is changing. He says packaging development is a long process, meaning there’s no reason it has to be considered at the latter stages. In fact, it can prove a critical part of a device’s development in itself. “We can release rapid representative prototypes to collect feedback to be able to incorporate packaging, so that we’re not an afterthought,” he says. “I do see it heading that way. The human factors guidance has allowed us to get involved early, and to be able to collect user feedback on their needs early in the development process.”
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Stifling innovation is bad for business The medical device packaging industry is big, and getting bigger still. Growing at around 6.9% annually, it’s set to be worth more than $50bn by the end of the decade. That, if nothing else, illustrates the growing importance many are placing on good, effective solutions. The increasing awareness human interactions with packaging have on the end product will continue to mature – and about time, according to Bix. “It’s a natural evolution of our discipline, and I hope an elevation of it too,” she says. “Because when you just take that basic approach and don’t add value for the end user, you doom yourself to a commodity playing field, where you’re just beating the price out of your product or your package.” This, she warns, is not only bad for healthcare, but it also stifles innovation. There’s one final thought that Bix shares, and it’s regarding the barriers to traceability when it comes to understanding where HAIs originated – in the US at least. Whether or not an unintended human interaction with a device was the cause of an infection has long been a question. “If you look at independent variables, things that impact outcomes, there’s a real disconnect in terms of being able to identify what all the factors are, down to the packaging.”
She argues that until healthcare is awash with data, it will face challenges in defeating HAIs. “Some people may not want that, because maybe they don’t want to be culpable for the infection,” she adds. “But I personally think that we need some kind of consistent electronic health record, where we can look at what’s going into those health outcomes. I think that would drive a lot of improvements in terms of cost and efficiency – but that’s been discussed for years.” ●
Medical Device Developments /
www.nsmedicaldevices.com
Kseniya Oniskevych/
Shutterstock.com
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