COVID-19 critical supplies: the manufacturing repurposing challenge

By Carlos López-Gómez, Lucia Corsini, David Leal-Ayala and Smeeta Fokeer

April 2020

Key messages:

• Repurposing is a rapid response solution to address the global shortage of COVID-19 critical items that can save lives by using idle manufacturing capacity.
• Repurposing is in principle a temporary strategy, but one that can be expensive and fraught with challenges, explaining the limited results so far.
• Opportunities exist to leverage on proven designs and methods; starting from scratch or trying to ‘reinvent the wheel’ can lead to significant delays.
• Policy responses are essential to help manufacturers address repurposing challenges and facilitate the transition to the new “normal” after COVID-19.
• The development of a rapid repurposing roadmap, reflecting national priorities and context, could provide a coherent and holistic structure to support effective policy responses.

Summary:

As the global COVID-19 emergency continues to unfold, one urgent problem is the shortage of critical supplies such as masks, ventilator and test kits for both the healthcare sector and the wider population. Policy makers are calling for firms across manufacturing sectors to temporarily repurpose their production in order to increase global production capacity. Building on a recent study, this article reviews some of the key manufacturing challenges involved in repurposing and discusses potential ways to mitigate them.

Repurposing is necessary to manufacture life-saving products

The World Health Organization (WHO) has published a list of COVID-19 critical items facing global shortage, grouped into three categories (Table 1). Ideally, manufacturers would address the spike in demand by simply speeding and scaling up production. Despite efforts by companies to expand their current capacity, governments utilizing accumulated stockpiles, and people switching to substitutes, there is still a gap between the supply and demand of these essential products. The gap is likely to continue to grow before a vaccine against COVID-19 is found, hindering efforts to effectively fight the pandemic around the world.

Table 1: COVID-19 critical items and what might be repurposed

Note: List of critical items identified by WHO on 30 March 2020; examples of manufacturing facilities based on government communications and media reports.

Governments around the world are calling on manufacturers to temporarily repurpose their manufacturing lines to meet this shortfall. Japan is providing business subsidies to ramp up the production of masks; the UK has set up a “ventilator challenge” which aerospace, automotive and ICT firms have responded to; China is repurposing state-owned enterprises; and the US is issuing ventilator contracts to automotive firms. However, the repurposing journey is fraught with challenges.

Naturally, different levels of repurposing are required to manufacture COVID-19 critical items, depending on the items’ level of complexity. Repurposing to produce personal protective equipment (PPE) is less technically complex and can, in principle, be achieved quicker than the production, for example, of clinical care equipment such as complex ventilators.

In modern manufacturing, production processes are highly specialized and firms aim to maximize efficiency. Approaches such as lean manufacturing help manufacturers eliminate waste across the supply chain and continuously improve productivity. Whilst this can create highly efficient and profitable production, it also means that it is very difficult to switch to a new product line.

What challenges do manufacturers face when repurposing?

Despite widespread calls for a ‘wartime effort’ to tackle the current supply shortages, results so far have been limited. Goods from repurposed facilities have been rejected because they failed to meet required medical standards or were not sufficiently adapted for COVID-19 treatment. In the US, the state of New York announced that efforts by automotive manufacturers to produce ventilators would not arrive in time. In the UK, an order of ventilators produced in repurposed facilities by some of the most advanced automotive companies in the country has reportedly been cancelled by the government for not complying with the expected performance.

Why are these efforts falling short?

Under normal circumstances, firms follow well-established new product introduction (NPI) processes to develop an idea into a final product that can be manufactured at scale. NPI processes require substantial planning and resources to ensure compliance with industry standards, especially in highly regulated industries such as medical devices and pharmaceuticals. Repurposing, however, is not a conventional introduction of a new product but is intended as a temporary rapid response solution to meet a spike in demand by using idle manufacturing capacity. Hence, many of the NPI steps and processes need to be fast-tracked and, where possible, skipped. Manufacturers face significant challenges across the repurposing journey:

• Defining the business case. Assessing the risks of entering a new market is difficult when knowledge of the new manufacturing domain is incomplete and long-term demand is uncertain. Understandably, incumbent manufacturers may be reluctant to share their intellectual property out of fear of competition from new market entrants after the pandemic ends. Starting from scratch without proprietary information is a challenging prospect, particularly for the development of complex essential items such as ventilators. In addition, there may be concerns about overproduction if too many new entrants appear. Repurposing is expensive and firms are presently cash-poor.
• Determining feasibility. Firms must develop a preliminary design concept and assess its feasibility in light of their current knowledge and technological capabilities. Designing critical items, such as medical supplies, requires specialized skills that might not be readily available in entrant firms. Upskilling may be sufficient for low complexity products, however, partnerships must be formed to close the skills gap in the development of highly complex products. As well as designing new tooling for production, additional infrastructure is needed for handling and storing raw materials, as well as for packaging and outbound shipping.
• Developing a product. Concept level drawings and a bill of materials must be developed. Sourcing raw materials has proven to be a major challenge for manufacturers. New relationships need to be established with suppliers. Sudden spikes in demand for inputs have led to price increases. Since January, exports from China to all regions have declined, leading to shortages in essential parts . For example, the global supply of aluminium, pneumatic fitting and other important components for medical devices has been severely disrupted due to manufacturing shutdowns in China.
• Validating the repurposed product. Detailed production drawings need to be prepared prior to conducting failure mode analyses to identify any potential problems with product and process designs. Standards vary across regions; conformity assessments also vary depending on whether items are being produced for markets or government procurement/donation. Minimum specifications have been criticized by clinical experts for not providing adequate provisions and manufacturers have also expressed frustration at changes to these specifications. To verify the quality of the products, prototypes need to be produced and functional data validated. Once a design is finalized, creating the tooling and fixtures for complex products typically takes several weeks or even months.
• Implementing and scaling-up production. Production lines need to be built, calibrated, and sample production parts must be approved by various regulatory bodies. Manufacturers of medical devices need to be registered with the relevant regulators. Even if some regulations have been relaxed, complex medical devices such as ventilators must still comply with stringent standards. Meeting these standards requires a full clinical trial which is both lengthy and costly. Establishing a quality control system for mass production is another hurdle for scaling up production. Several new test runs may be required, and significant resources are needed to produce process documentation, establish safety controls, and verify the quality of supplies. It is clear that scaling-up production is not simply a technological challenge, but requires new organizational capabilities – from product design and manufacture to supply chain governance to regulation and testing. For this reason, repurposing remains challenging, even for technologically less complex items such as face masks.

Towards a rapid repurposing roadmap

With these manufacturing challenges in mind, Figure 1 proposes an indicative set of questions and activities to guide the development of a rapid repurposing roadmap. Roadmaps offer a coherent and holistic structure to support effective dialogue and communication between stakeholders. The approach is flexible and scalable, and can be customized by policymakers to suit many different strategic priorities and national contexts. While the structure presented in Figure 1 is by no means comprehensive, it illustrates how strategic planning tools might be employed to address manufacturing repurposing challenges.

Figure 1. Towards a Rapid Repurposing Roadmap for COVID-19

*‘Critical supplies’ includes first-response items such as protective personal equipment, diagnostic equipment, and clinical care equipment.

• Why repurpose. Repurposing is associated with the need to address shortages of COVID-19 critical supplies. Firms must balance project objectives and scope with long-term strategy and available budget. Quantifying these shortages is a complex task which requires the integration, continuous review and expert analysis of demand and supply data – from the healthcare sector, the scientific community, manufacturing industries and public authorities. The WHO has developed a suite of ‘surge calculators’ that can assist with this task. Policymakers also need to ensure that appropriate incentives and assurances are in place to make the business case attractive and dispel any concerns about overproduction.
• What to repurpose. Recent international experiences provide useful examples of manufacturing facilities that can be repurposed (Table 1), but policymakers need to have an understanding of the possibilities in their countries. Analysis of the current manufacturing base and direct dialogue with industry associations can help elicit a better understanding of the potential scope for repurposing. For example, a study estimates that over 2,700 manufacturing facilities owned by large firms could be retooled to produce COVID-19 critical items in the US. Communities of small producers, makerspaces and demonstration facilities might also be able to contribute, but their efforts need to be coordinated. Instead of developing new production processes from scratch, manufacturers might be able to more efficiently contribute by becoming temporary turn-key providers to help existing producers increase their output.
• How to produce. Competing product designs may lead to significant delays. Governments including those of the UK and South Africa, have shared specifications of minimally clinically acceptable ventilators and have requested their manufacturers to coalesce around these. Policymakers need to ensure that these specifications are technically sound, sufficiently detailed, and validated by health sector experts and practitioners. Business guidance specifying relevant product safety specifications, standards, type approval, quality assurance procedures, and conformity assessment rules can be valuable single reference points for repurposing firms. Regulatory agencies need to be appropriately resourced to be able to fast-track applications, and test and certify new designs. Out-of-patent designs can also be leveraged and time-limited design licences sought from incumbent firms. Emerging international efforts suggest that opportunities exist for cross-industry and cross-country cooperation to share not only proven product designs and process engineering know-how but also to overcome IP and certifications barriers. For complex items, it is clear that starting from scratch can lead to significant delays.
• Who coordinates. Technical coordination is crucial to rapidly align needs with relevant manufacturing capabilities and efficiently share repurposing know-how. Policymakers leverage the public innovation infrastructure. In some countries, public centres of excellence or technology and innovation centres are emerging as key coordination actors. In the UK, for example, the High Value Manufacturing Catapult, a public research and technology organization, has had a leading role in coordinating firms from the automotive, aerospace and ICT industries to respond to the prime minister’s “ventilator challenge”. Meanwhile, the National Additive Manufacturing Innovation Institute in the US has created an online repository, gathering the needs of healthcare providers, 3D-printing capabilities and digital designs. Policymakers could give such actors in the national system of innovation (including universities and public laboratories) the mandate to coordinate dispersed efforts and ensure an efficient flow of know-how.

When this is all over

It remains to be seen how manufacturers will rise to the challenge of repurposing their production. Clearly, switching production is a costly endeavour and not something that can be achieved over night. Designing support measures requires a detailed understanding of the technical challenges alongside the repurposing journey. Given the urgency of the task, there is a need to leverage on proven designs and methods.

While addressing the global shortage of COVID-19 critical items is the current priority, repurposing is not a long-term strategy and policymakers need to support firms for the eventual transition to “normal” times. There are legitimate concerns from incumbent firms that the call for repurposing will increase competition in an artificially overcrowded market space for a very small selection of products. Similar legitimate concerns exist about overproduction or waste in the future if too many new entrants appear. Policymakers should address such concerns during and beyond the health crisis. Through bulk and coordinated public procurement policies, governments can provide visibility of orders and assurances that any excess items would be part of national stockpiles.

Countries that can call upon their industrial sector to rise to the challenges of repurposing to meet the shortfall in COVID-19 critical items, particularly for the more complex ones, are those with sufficient manufacturing and innovation capabilities and an experienced and agile industrial sector. Repurposing also benefits from established policy making and coordinating capacity. Long-term investments in these capacities pay off.