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Manufacturing technology The FDA’s advanced manufacturing plan


“The Covid-19 pandemic has shown us that the existing manufacturing structures, with a small number of facilities fed by long and complex supply chains, can be disrupted. This has also been demonstrated in the aftermath of hurricanes in recent years. This can elevate risk and create shortages in the US. The reality is that it isn’t enough to just respond to the current pandemic. The FDA and industry have to accelerate the adoption of advanced and smart manufacturing technologies to strengthen the nation’s public health infrastructure. To this end, the FDA is creating a new collaboration with the National Institute of Standards and Technology (NIST) through a memorandum of understanding (MoU). This MoU is intended to increase US medical supply chain resilience and advanced domestic manufacturing of drugs, biological products and medical devices through adoption of 21st century manufacturing technologies. These include smart technologies, such as artificial intelligence and machine learning, and emerging manufacturing processes. The MoU signals alignment between senior leadership at both institutions in recognition of the importance of modernising regulatory frameworks as well as industry practices


to meet public health needs in the US.” Source: Stephen Hahn, former FDA commissioner


appalling labour and environmental standards in the country of origin of these products.” But health systems are realising that environmental commitments matter. The NHS, which is responsible for up to 5% of the UK’s carbon footprint, has committed to becoming ‘net zero’ for greenhouse gas emissions by 2040. Miller predicts that procurement teams in the UK and elsewhere will place more importance on their suppliers’ green credentials than they have in the past. Supply chain priorities may have changed across all industries because of the crisis. Consulting company McKinsey surveyed 400 companies about their procurement objectives and found the mood had shifted considerably. Executives previously rated increased productivity and minimised costs as the most important factors in purchasing decisions. But the unique circumstances of the pandemic have shown the value of agility and flexibility in operations. McKinsey’s Susan Lund summed it up well on the company’s October podcast. “We’ve spent 25 years creating these incredibly complicated, complex global supply chains. And they were designed for cost and efficiency, but without really a thought to what could go wrong along the way.”


Smarter manufacturing >60%


Manufacturers that plan to invest in smart digital technologies across the supply chain.


PA Consulting 64


The question for healthcare OEMs will be how they can stay competitive and even thrive when normal life resumes. Josh Blackmore, global healthcare market manager at M. Holland Company, which makes resins for the medical device industry, says the pandemic has driven many healthcare OEMs to move production closer to demand to improve flexibility and reduce stock-outs. But he believes there will be great opportunities for medtech companies post-Covid-19. “I predict a strong renaissance to occur for many industries including healthcare,” he says. “Many technologies such as


3D printing, telemedicine, wearables, point of care testing, artificial intelligence and robotics have received a huge boost in investment because of their performance in this extreme environment.” Some of these technologies (dubbed Industry 4.0) are primed to change manufacturing for good. “The coronavirus pandemic should be a wake-up call to the international manufacturing sector,” wrote the authors of a World Economic Forum report in June 2020. They suggested smarter manufacturing could help suppliers survive in a global marketplace, which will likely prioritise agile and flexible production systems. The FDA also seems convinced that Industry 4.0 methods will strengthen public health infrastructure in the US. In January 2021, it announced a partnership with the National Institute of Standards and Technology to develop and implement advanced manufacturing technologies. Modularisation will be one focus, so the same facility can seamlessly switch production from one pharmaceutical or device to another in a matter of hours. Adaptive process controls that use AI and computational models to boost the efficiency of manufacturing lines are another target of interest. Exploring new technologies could be a shrewd move for OEMs, agrees a report from PA Consulting. The company found that over 60% of manufacturers plan to invest in smart digital technologies, such as modular production lines, greater automation and use of data to improve planning and risk management, across the supply chain.


But the pandemic is not over yet. While the world crosses its fingers that vaccines will get it out of this mess, the future remains shrouded in uncertainty. At the time of writing, many of the world’s healthcare systems are running out of oxygen. Without a crystal ball, it is impossible for medical device manufacturers and health procurement teams to know what the new normal will look like and what opportunities they should harness when they get there. Plus, not all healthcare OEMs have weathered the same storm over the past year. Makers of ventilators and PPE have seen hugely increased demand, but other medical equipment manufacturers’ sales have slowed as surgeries were postponed while health systems battled the virus. It may be tempting for some companies to continue existing practice and hope for the best until Covid-19 is extinguished, but Miller cautions against burying heads in the sand. “There are multiple trajectories forward,” she says. “But if I was advising companies, I’d point to arguments about levelling the playing field for domestic manufacturers in ways that are supportive of economic opportunity for communities and environmental responsibility.” ●


Medical Device Developments / www.nsmedicaldevices.com


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