Packaging, supply & logistics
break to struggling private sector managers. If, for instance, a particular component is proving difficult to source, Pratt says that bodies like the FDA may want to intervene – by working with manufacturers to expedite approvals or validations necessary to adapt to an upstream supply disruption. One example, she says, is if a company “needs to identify an alternative supplier or reconfigure their device to utilise inputs that are available.” In fact, there’s evidence that such flexibility can prove useful in the real world. At the height of the pandemic, the FDA stated that hospitals could repurpose machines as ventilators and that manufacturing blueprints could be tweaked if necessary. In practice, the FDA saw batteries as a prime target for modifications here, while even suggesting that Bluetooth could be integrated for monitoring patients at a safe distance.
The CHIPS Act and its UK equivalent are both examples of state-run schemes that aim to strengthen medical supply chains.
association is to speak to external stakeholders, like the government and other partners in the healthcare supply chain.”
In the first instance, this certainly seems reasonable considering the successes of the DPA. More to the point, you can easily trace this spirit of collaboration if you examine the AdvaMed white paper in detail. Consider, by way of example, those queue-busting green lanes. To thrive, the authorities inevitably need to cut red tape, even as they trust shipping manifests to match imports. It’s a similar story around another AdvaMed recommendation: the ‘long-term prioritisation’ of medtech needs.
“First and foremost, the major consequence of these supply chain issues is the potential disruption in the delivery of patient care. If medtech companies are unable to manufacture and deliver these life-saving devices to hospitals and clinics, patients will lose access to the care they need.”
Scott Whitaker
Without a top-down understanding of what doctors and patients require, after all, it’ll obviously be tough for individual factories to react. Enforcement of the DPA is clearly one option here. “A lesser tool,” Pratt continues, “could be that the government reaches out to suppliers, to urge them to prioritise the medical device industry or certain medical device companies.” As Pratt notes, a well- placed letter from the White House can do much to prod stakeholders in the right direction. If the awesome power of the state can be coercive, however, it can equally provide a
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Deal or no deal? It seems clear, in short, that a genuine solution to the medical sector’s woes involves an intimate dance between the public and private spheres. But for that to happen, they obviously need some way to communicate. AdvaMed is at the centre of these developments, too. Unveiled last year and led by the Administration for Strategic Preparedness and Response of the US Department of Health and Human Services, the Joint Supply Chain Resilience Working Group brings together almost 180 experts from across medical life – all united in sharpening the healthcare supply chain. AdvaMed, for its part, sits on the new group’s executive committee, while Pratt believes that similar schemes are destined to follow. At the same time, Whitaker makes the case for greater state intervention at the international level. As he puts it: “AdvaMed is working with the US government to make the case around the importance that coordination with partners and allies is essential to enhance trade in areas that support our supply chain resilience.” Once again, there are signs this is occurring already. As far as semiconductor chips are concerned, the EU and US have jointly launched an ‘early warning’ mechanism for supply chain shortages, and promised to share information on the support offered to domestic manufacturers. That’s shadowed by other bilateral agreements. In April, the US secretary of commerce and her South Korean counterpart pledged to keep the protectionist implications of the CHIPS Act as clear as possible. Diplomacy of this kind surely makes sense. Especially with the rising bullishness of China and the relative economic decline of the Western alliance through the end of this century, Washington will need all the friends it can get – for the sake of the country’s medical sector and countless other industries. ●
Medical Device Developments /
www.nsmedicaldevices.com
mpohodzhay/
Shutterstock.com
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