Manufacturers pivot to support COVID-19 response
Not long after COVID-19 became recognised as a major global health crisis, governments from around the world have turned to various industries to shore up the vital supplies of medical equipment and consumables that are so desperately needed to save lives and protect public health.
Not since World War Two have we seen such a demand on these industries to provide vital supplies to support the “war effort”. But as many countries have declared states of national emergency, as they fight the war against Coronavirus, the analogy is apt. During World War Two, however, industries were asked to switch to making items that were not too dissimilar to their traditional manufactured products.
For example, silk garment manufacturers switched to manufacturing parachutes, steel makers produced ammunition cases, engineering firms switched to guns and automakers to tanks, and arguably, they had more time to do it. Today, however, we need those ventilators, hand sanitisers, face masks and other personal protective equipment in great quantities now. Indeed, President Trumps recent invoking of the Defence Production Act to compel manufacturers to switch to producing medical supplies is an example as to how seriously these measures are being taken.
While some manufacturers are switching to making more familiar products, such as Zara, the fashion apparel manufacturer, who is switching production to medical scrubs, and several skin-care manufacturers (and also Brewers and Distillers!) to hand sanitisers, others are pivoting to completely new types of products. In the UK, for example, Dyson the domestic appliance manufacturer is switching to manufacturing thousands of medical ventilators.
Even the Mercedes Formula One team is ramping up to produce thousands of Continuous Positive Airway Pressure creating devices (CPAP) subject to regulatory approval. Further afield, Foxconn the Chinese makers of iPhone started manufacturing surgical masks, and in the US General Motors is also turning to medical ventilators. The list continues to grow on a daily basis.
What these manufacturers have is not just the manufacturing expertise in related disciplines such as precision engineering, but also specialist equipment and facilities such as clean rooms. But such pivots, especially when performed virtually overnight is no mean feat. It is simply not a case of just switching from making one component to another by adjusting some machine settings. There is a much wider set of implications.
Production and quality personnel are moving to completely unfamiliar territory. Take the Mercedes F1 team as an example. There is a whole world of difference between making engine gearbox components to making medical CPAP devices. Failure of the former loses them a race or two, failure in the latter cost’s lives.
For medical device manufacturers, the environment they operate in is strictly regulated and new devices can take months, if not years, to achieve the regulatory approvals and validations needed to start shipping those products on to the market. And during the production process, the need for quality assurance and auditing is paramount. While government agencies are indeed fast-tracking these approvals, that does not mean that quality standards can be relaxed - otherwise lives are also at risk.
Another factor is the exponential change in production volume. Again, using the Mercedes F1 team example, they have stated that they could produce up to 1,000 CPAP devices per day. The consequential scalp-up in monitoring manufacturing process, quality inspection, testing and recording of quality data is equally challenging.
Added to that is the unfamiliarity of working with new materials and components from new suppliers. Not only will these require new certification and qualification processes to be performed, but monitoring the characteristics of these new raw materials, their performance throughout the conversion process, and their impact on the quality and safety of finished goods will also be new territory, where the hand of experience is absent.
What these manufacturers do have to help to address these challenges are the availability of advanced technologies such as data analytics, manufacturing and quality intelligence solutions that can be rapidly adopted to support these new products and manufacturing processes. The importance of such solutions should not be overlooked. Pivoting to wholly new, and often alien products is one thing, but pivoting to wholly new quality and manufacturing processes is another. But these challenges can be overcome if manufacturers, government, regulatory agencies and technology companies all come together with a common goal. Across the industry, we have the technology, capability, skill and expertise to make this work. We just need to have the collective resolve to make it happen now.
By Jason Chester, Director of Global Channel Programs, InfinityQS
The challenges to vaccine distribution affecting everyone
While it is comforting to know that vaccines against COVID-19 are showing remarkable efficacy, the world still faces intractable challenges with vaccine distribution. Specifically, the sheer number of vaccines required and the complexity of global supply chains are sure to present problems we have neither experienced nor even imagined.
Current projections estimate that we could need 12-15 billion doses of vaccine, but the largest vaccine manufacturers produce less than half this volume in a year. To understand the scale of the problem, imagine stacking one billion pennies – you would have a stack that is 950 miles high. Now, think of that times ten. This is a massive problem that one nation can’t solve alone.
Even if we have a vaccine – can we make enough? Based on current projections, Pfizer expects to produce up to 1.3 billion doses this year. Moderna is working to expand its capacity to one billion units this year. Serum Institute of India, the world’s largest vaccine producer, is likely to produce 60% of the 3 billion doses committed by AstraZeneca, Johnson & Johnson and Sanofi. This leaves us about 7 billion doses short.
Expanding vaccine production for most regions in the world is complicated and time-consuming. Unlike many traditional manufacturing operations that can expand relatively quickly and with limited regulation, pharmaceutical production must meet current good manufacturing practice (CGMP) guidelines. So, not only does it take time to transition from R&D to commercial manufacturing, but it could also take an additional six months to achieve CGMP certification.
The problem becomes even more complex when considering the co-products required. Glass vials and syringes are just two of the most essential co-products needed to produce a vaccine. Last year, before COVID-19, global demand for glass vials was 12 billion. Even if it is safe to dispense ten doses per vial, there is certain to be significant pressure on world supply of the materials needed to package and distribute a vaccine.
It is imperative drug manufacturers and their raw material suppliers have clear visibility of production plans and raw material availability if there is any hope of optimizing scarce resources and maximising production yield.
It is widely known by now that temperature is a critical factor for the COVID-19 vaccine. Even the regions with the most developed logistics infrastructures and resources needed to support a cold-chain network are sure to struggle with distribution.
For the United States alone, State and local health agencies have determined distribution costs will exceed $8.4 billion, including $3 billion for workforce recruitment and training; $1.2 billion for cold-chain, $1 billion vaccination sites and $0.5 billion IT upgrades.
The complexity of the problem increases further when considering countries such as India that do not have cold-chain logistics networks that meet vaccine requirements. Despite India’s network of 28,000 cold-chain units, none are capable of transporting vaccines below -25°Celsius. While India’s Serum Institute has licensed to manufacture AstraZeneca’s vaccine, which can reportedly be stored in standard refrigerated environments, even a regular vaccine cold chain poses major challenges.
Furthermore, security will undoubtedly become a significant concern that global authorities must address with a coordinated solution. According to the Pharmaceutical Security Institute, theft and counterfeiting of pharmaceutical products rose nearly 70% over the past five years. As with any valuable and scarce product, counterfeits will emerge. Suppliers and producers are actively working on innovative approaches to limit black-market interference. Corning, for example, is equipping vials with black-light verification to curb counterfeiting.
Clearly, this is a global problem that will require an unprecedented level of collaboration and coordination.
Disconnected information systems
While it is unreasonable to expect every country around the world will suddenly adopt a standard technology that would provide immediate, accurate and available information for everyone, it is not unreasonable to think that we can align on a standard taxonomy that can serve as a Rosetta Stone for collaboration.
A shared view of the situation (inventory, raw materials, delivery, defects) will provide every nation with the necessary information to make life-saving decisions, such as resource pooling, stock allocations and population coverage.
By allowing one central authority, such as the World Health Organization, to organize and align global leaders to a single collaboration standard, such as GS1, and a standard sharing protocol, such as DSCSA, then every supply chain participant will have the ability to predict, plan and execute in a way that maximises global health.
Political influence and social equality
As if we don’t have enough stress and churn in today’s geopolitical environment, we must now include the challenge of “vaccine nationalism.” While this might not appear to be a supply chain problem, per se, it is a critical challenge that will hinge on supply chain capabilities.
In response to the critical supply issues the world experienced with SARS-CoV-2, the World Health Organization, Gavi, the Vaccine Alliance and the Coalition for Epidemic Preparedness Innovations (CEPI) formed Covax: a coalition dedicated to equitable distribution of 2 billion doses of approved vaccines to its 172 member countries. Covax is currently facilitating a purchasing pool and has made commitments to buy massive quantities of approved vaccines when they become available.
However, several political powerhouse countries, such as the United States and Russia, are not participating. Instead, they are striking bilateral deals with drug manufacturers – essentially, competing with the rest of the world to secure a national supply. Allocating scarce resources is never easy, but when availability could mean the difference between life and death, it becomes almost impossible.
Global production, distribution and social equality present dependent yet conflicting realities that will demand global supply chains provide complete transparency and an immutable chain of custody imperative to vaccine distribution.
The technology is available today – we just need to use it. We have the ability to track every batch, pallet, box, vile and dose along the supply chain. We have the ability to know with absolute certainty that the vaccine is approved, where and when it was manufactured, how it was handled and whether it was compromised at any point in the supply chain. Modern blockchain technologies should be applied so that every nation, institution, regulator, doctor and patient can have confidence in knowing that they are making an impact in eradicating COVID-19.