As part of the research for this article, the authors interviewed executives from small manufacturers and others involved across the UK to get their accounts of how they repurposed their manufacturing during the first wave of COVID-19. The following case studies provide a further look at some of their experiences.
Rapid prototyping face shields. Image: Midton Acrylics
Midton Acrylics
Lochgilphead, Argyll & Bute, Scotland
Midton Acrylics are specialists in cast acrylic and create products such as lighting components, acrylic sculptural forms, recognition awards and toys — none of which were likely to be in high demand as the pandemic spread. Even before widespread restrictions were introduced in the UK, Midton had changed their shift patterns to limit the exposure of their staff. As the pandemic unfolded, and not being ‘essential’, Craig Cameron and his fellow directors regretfully put their business into lockdown.
The Midton team wanted to find ways to help their local healthcare workers, and realised that they could donate their own personal protective equipment (PPE) to nearby hospitals to help address the shortages. They phoned their local hospital and made the appropriate arrangements, cleaned the PPE, and laid it out for collection. But there was a feeling that a company that prides itself on its creativity and design skills could do more.
They had seen, on social media, open-source designs for visors, and they adopted one from 4C Engineering in Inverness. This design used acetate A4 sheets typically used in printers, and 4C Engineering had also identified the equipment needed to begin manufacture. With minor modifications, this seemed a practical way forward.
Donations from Midton and a parallel crowd-funding appeal enabled them to get the raw materials for the first batches to be manufactured. They described what they were doing on social media and donations flooded in from the local community, enabling Midton’s volunteer staff to make some 10,000 disposable visors in the next three-and-a-half weeks.
Community activity supported Midton’s efforts financially as well as through donations. For example, a local artist in glass, Kirsty Brady, donated a proportion of her sales to Midton’s campaign.
But Midton felt that more could be done, and they shifted their efforts towards reusable visors. Midton had some 3D printers and they invested in more, setting these to work building visors. Again, they picked up open-source designs which they modified to suit their equipment and their manufacturing approach. Midton and five local hobby printers formed a local syndicate and collaborated, all glued together by social media.
By this time, Cameron and his team were getting three or four calls a day from hospitals, care homes and local councils looking for visors. Midton Acrylics, together with the crowdfunding, had paid for and donated the early production. As orders increased, they asked their customers for funds just to cover the materials for the bigger orders and they continued to make visors for another few weeks until slowly, local demand dried up.
In the meantime, Cameron and the Midton team had found another opportunity in the design and supply of Perspex sheeting to shield office and shop workers. Often these needed customising, for example, for the specific needs of hospitals. Flexibility and adaptability were vital, both in design, manufacturing and installation.
By now raw materials were becoming an issue. For example, Perspex were quoting an eight-week lead time for supply. Fortunately, Midton had good relationships with a supplier based in Glasgow who proved able to maintain supply throughout. They also purchased materials from abroad, but when it arrived it proved to be of the wrong quality for this application. ‘It’ll take us five years to use that stock up,’ notes Cameron wryly.
Aware of the sustainability implications of working in plastic, they had already embarked on test batches of recycling to explore the potential. And in mid-2020, it looked as if many of the screens they were making and supplying would become unnecessary when the pandemic abated. So they established a recycling scheme whereby their customers can return the screens when they’re no longer needed. In this way Midton can track the quality of the materials they are recycling — one of the keys to maximising the value of recycled material.
‘Customer response has been great,’ says Cameron. ‘They really like the fact that these screens won’t just end up in landfill.’
They also supplied their screens to hospitals where they found a lot of customisation was required to fit the specific needs of each case and the requirements to complete sign-off protocols for acceptance.
Throughout and following the first wave, social media has been a boon. It has enabled communication and coordination and even opened up new sales channels for Midton.
The local community element has also been important, building a spirit of community solidarity, collaboration and contribution in pursuit of a shared aim.
Further information on Midton’s experience is available on their website.
Display Mode
Corby, Northamptonshire, England
Display Mode’s core business is the design, manufacture and installation of point-of-sale displays for retailers and brand owners, primarily in plastics.
The retail environment had been challenging over the previous few years, but Display Mode’s sales were excellent in the first two months of 2020. However, following the Prime Minister’s speech on 23 March, Display Mode’s sales stopped almost overnight, with cancelled orders and postponed shipments.
Leon Edwards, managing director, and the management team saw three options. The first was to cease trading, which they never seriously considered. The second was to ‘batten down’, to conserve cash and seek to survive until retail recovered. But it was not then clear when this might be, and it was also evident that point-of-sale propositions might forever be changed, as more retail shifted online.
The third was to find something new that built upon Display Mode’s design and manufacturing capabilities in wood, plastic and metal, and on their innovative mindset. Thus they shifted across to visor manufacturing.
There was a massive learning curve to traverse, visor designs to acquire and refine, new manufacturing processes to develop, new supply chains to establish, and new customers to find. And they needed to be quick, to respond to the need, to keep the business going, and to establish a viable position in this new sector.
They operated on the basis that success was going to rest on speed and adaptability, being very focused, using trial and error to learn quickly — using the internal design and prototyping capability, repurposing machinery and building new supply chains. And, with the ambition to make this part of a new business direction, focusing on quality and manufacturability from the beginning.
Their initial expectations were that they would be making about 10,000 visors per week, but production soon ramped up to seven times that figure and they saw single orders for up to 150,000 pieces. They have made some 7–8 million visors to date.
Raw material supply chains were quickly identified as a bottleneck and one that could only get worse as countries and companies competed for the same materials, so the team sought supplies from all over the world. Although some of these new relationships would turn out to be a robust basis for the new business, other suppliers proved problematic. Several proved unable to deliver while others supplied material of inadequate quality that could not be used. In part, this was because some suppliers did not understand the requirements of a healthcare end-use application.
The focus of Display Mode’s designers from the very beginning was on a quality product that would meet their target specification, consistently and reliably. Furthermore, if the business was to be sustainable, then cost-effectiveness would soon become important. So product and process design went hand in hand.
They began by finding that others’ open-source designs — while they weren’t perfectly suited for Display Mode’s purposes — did provide a good starting point. Display Mode then modified the designs to suit their equipment and factory layout.
A central part of their approach was to not fix on a solution too early. They trialled lots of options internally before settling on one. In each case they were explicitly thinking how it might best be scaled, ‘because that would be the key to survival’, says Edwards.
They also focused on creating a ‘minimum viable product’ (MVP) for speed in getting visors to the healthcare front line, but with an explicit intention that this be a stepping-stone to acquiring regulatory sign-off. From the first sample and all the way through prototyping, Edwards insisted on meeting the required specifications, and this idea of a ‘known destination’ underpinned their focus on quality.
Important elements of achieving this certainty of product lay in the management of risk and achieving certification. This included topics such as care in material selection to avoid any potential for skin rashes and allergies among users of the visors.
With design intent established, they started to focus on optimising productivity, working on process development in parallel with refining the product. This led to a cost reduction of around 70 per cent compared to their first attempts.
Although Display Mode considered outsourcing some manufacturing steps, this seemed to add further risk. Some potential subcontractors were too slow, and others sought too much reassurance of continuity of orders, an assurance that couldn’t be given. Others wanted money in advance, and some were unwilling to make changes to their production lines until firm orders were received.
‘When you’re trying to survive, you can’t leave your fate in the hands of people who might be too slow or might not be in the same place,’ says Edwards. So Display Mode decided to keep all manufacturing inside the company.
Some years earlier, the operations manager had bought an old roller press, primarily as a fallback resource. ‘He bought it on the off chance it would be useful one day — and it’s turned out to be invaluable,’ according to Edwards. The machine has proved such a success that the company has bought a new one from Poland and eight more from around the UK from various companies that no longer needed them for their own manufacturing.
A key advantage of moving quickly was to learn swiftly, build credibility early and successfully access the raw material supplies that would become key to success.
Display Mode kept driving down the cost of production and passed these savings on to their customers. ‘We wanted to do the right thing,’ says Edwards. But this also served as a strategy to remain competitive, because, inevitably, as the crisis eased, supply increased and price became an issue.Display Mode kept driving down the cost of production and passed these savings on to their customers. ‘We wanted to do the right thing,’ says Edwards. But this also served as a strategy to remain competitive, because, inevitably, as the crisis eased, supply increased and price became an issue.
Finding reliable information about product requirements and levels of demand proved particularly difficult. Much information seemed conflicting and was later shown to be wrong.
A key challenge was to discern the real requirements, especially when the story was constantly changing. The official government websites and portals were not perceived as a source of useful information on which commercial decisions could be based. Writing to his MP seemed to trigger the contacts that Edwards needed to access orders at high volumes.
In the early days and at the height of the crisis, there seemed also to be a spectrum of responses from hospital in accepting PPE. Some were happy to accept whatever PPE they could usefully employ, while others refused anything that was not CE certified. Some hospitals used only the mainstream NHS procurement channels while others were happy to explore more local arrangements and their own procurement systems.
Edwards thought that the dynamic would change as the crisis subsided. Schools and volunteer groups had many enthusiastic people involved but would start to struggle to access the required materials. Other organisations would return to their core businesses as soon as circumstance allowed. Only those committed to staying in this area and able to manage the required reductions in cost would remain as long-term suppliers.
And as the dynamic changed, so new risks emerged. Suppliers demanded cash with the orders, and accessing reliable sources remained challenging. Matching future orders with long lead-time supplies now required the business to manage cash flows carefully. Because of the specificity of the materials and the difficulty of valuing them, banks were unwilling to lend against material purchases. Having built a capability, very quickly, sustaining it will depend upon the consistency of future demand.
But the dominant message from the crisis was about the intense pressure to learn and adapt as everything changes every day. ‘We were living with a sense of emergency rather than a sense of urgency,’ says Edwards, and it was this that underpinned the repurposing and revival of the business.
LJA Miers
St Neots, Cambridgeshire, England
LJA Miers specialise in the conversion and lamination of rubber, foam, plastic and fabrics. They work across the automotive and other industrial sectors, with a focus on making soundproofing and vibration absorbing materials, among numerous others products. Before the pandemic, they had already decided upon a strategic diversification and were targeting the medical sector but did not yet have relevant contacts. As Tony Barber, their sales director says, ‘Back then we didn’t know what a visor was!’
However, by March, lockdown and the drying up of their core business meant that they’d furloughed their teams and they were ‘staring into the abyss’, says Barber.
One of their machine suppliers put them in touch with Addenbrooke’s Hospital in Cambridge and, having developed the designs and repurposed their manufacturing, they set about making protective face visors for the hospital. They were familiar with the materials, especially the foams and polymers, and they were able to call upon their trusted supply chains and so set up manufacturing cells that could scale production. Having met the initial request for 100,000 visors, they felt that there was much greater potential, if only they could find the orders.
Barber and his colleagues then went out to sell. Like many others, they registered with the UK government websites very early but, despite chasing, heard nothing back. They managed to sell a few thousand visors in Belgium via past contacts and also to distributors who already had links into the NHS, but substantial orders were hard to find. And stock was building up. The team asked themselves whether they should call it a day.
Serendipity, coupled with Barber’s networks, led eventually to a major order from a hospital trust in Wales and NHS England. This was a pivotal turning point for the company and their ambitions. Further links of contacts enabled other orders, and thus expansion. Eventually, they would go on to supply some 1.8 million visors over the following weeks.
Meanwhile, frustrated by the lack of response from UK government procurement channels, Barber wrote to his MP. This coincided with real interest which, via negotiation on price and volumes, turned into an order for hundreds of thousands of visors per week over several months. The crisis averted, the company took on staff to meet demand, first on a temporary basis and then to permanent positions.
LJA Miers also provided valuable innovations in the visor designs for the Addenbrooke’s orders and contributed their design drawing to the technical files that were being developed there [see the Makespace/Addenbrooke’s Hospital case study]. They are continuing their diversification into the medical sector by developing and suppling other products.
Prime Group
Alfreton, Derbyshire, England
For the Prime Group, a personal request set the ball rolling. Jon Tolley, then managing director, heard from his wife, an ICU nurse, about the shortages in PPE. Could the company help, perhaps building upon its experience in plastics and printing?
The team moved very rapidly to do so, receiving a sample to work from by early afternoon. Setting up the machines and working overnight they got a production prototype ready by 6am and back to the hospital for approval. With that approval in place they began manufacture, delivering the first batch by early evening.
One of the clinicians at the hospital tweeted about the delivery and, as Tolley says, ‘it just went crazy’ as they were deluged with requests for visors.
But Tolley realised that this was not sustainable. To manufacture visors in the volumes that would be needed required a shift in mindset — to thinking in terms of high volumes with a supply chain able to cope as they ramped up production. A few phone calls to his network engaged some collaborators with similar equipment able to cut and supply the visor blanks and, importantly, willing and able to step forward immediately. And so began the interim phase of shifting from the core business to manufacturing visors.
But this interim phase also had its headaches. With materials coming in from from Sunderland, London and Sheffield, the logistics were tricky, and Tolley also wanted to increase the volumes yet more. So work continued on rearranging their manufacturing facilities, on finding space to allow their staff to assemble visors while remaining safely socially distanced, and on setting up the supply chains of raw materials. Friends and colleagues in the automotive component supply industries helped with the design and build of new machines, and so enabled an increase in manufacturing capacity.
As Prime scaled-up their activities, they collaborated with Nottingham Trent University to develop their visor designs. These designs were made open-source. Tolley and colleagues created a WhatsApp group to share problems, solutions and insights amongst anyone interested in using these designs. In the end, companies across the world adopted and adapted the design.
News of the endeavour spread by social media and Prime were deluged with requests from nearby hospitals. So, over a period of just a few weeks, Prime pivoted from printing to manufacturing visors at up to 10,000 per week, delivering three or four times per week, free of charge, to local hospitals.
But how? What made this possible? What were the keys to success?
Tolley is well-networked, knowing other like-minded owners and managers of similar businesses who were able and willing to help. He quickly realised the importance of raw material supply. This was a global pandemic, so there would be a global rush for the same raw materials.
And so it proved; within a fortnight the squeeze on raw materials was immense as suppliers struggled to meet a demand that had never been seen before. There were examples of somewhat dubious behaviours as companies and countries fought to secure supply. This was when good relationships, built over years, all the way down the supply chain, came into play.
A crowdfunding programme enabled donations of visors to frontline healthcare workers in the early days. As things progressed, more funding was needed. Understandably, credit was in short supply — who knew which companies would survive the pandemic — and so Prime Group needed to invest ahead of demand; a calculated commercial risk, but motivated by a desire to help the front line as quickly as possible.
But having successfully acquired a significant amount of raw materials and built the capacity, Prime had to find and sign orders for large volumes that would really help address the national need. Contacting the government portals proved ineffectual, telephone calls were inconclusive and, eventually, Tolley turned to the media. This evinced immediate response; the right connections were made and so production ramped up. At peak production, 220 people were working to create the visors and get them out to the hospitals.
Space matters — so being able to quickly access more space to allow manufacturing and assembly under the constraints imposed by social distancing was critical. This was helped by finding a valuable short-term lease that enabled the expansion needed.
Prime Group have opened up a new line of business; they are pursuing the certification for medical devices and continuing to invest. But Tolley remains careful. ‘We only commit to orders we are sure we can fulfil,’ he says, and with raw materials on long lead times of up to three months, this needs visibility of future orders. Herein lies one of the major challenges. Orders cannot simply be turned on and off when materials are expensive and on long lead times, a message mirrored by many of the companies interviewed for this project. And concern remains about finding orders should there be second and subsequent waves of need.
Note: Since these events, the Prime Group merged with the collaborators mentioned here to form the Precision Proco Group.
Sewing scrubs. Image: David Nieper
MarchantCain
Coventry, England
If you are in the business of innovation, and the local enterprise partnership (LEP) knows your skills, then you become an obvious place to turn to in the midst of an unprecedented situation. So MarchantCain were an early port of call for the Coventry and Warwickshire Local Enterprise Partnership seeking companies to help with the development of ventilators in response to the UK government’s Ventilator Challenge.
MarchantCain have grown successfully into a design and development consultancy and a short-run specialist automotive manufacture for high-performance car companies such as Porsche, Aston Martin and McLaren. But partners Rob Marchant and Pam Cain knew enough about the science, engineering and regulatory complexities of ventilators to know that the development learning curves would be steep.
They felt, however, that they could usefully apply their skills to PPE, in parallel with servicing the time-critical and stringent demands of their automotive customers for prototyping and supply.
They quickly heard about the problems that front line staff were encountering with current designs of PPE, such as discomfort and bruising and, Pam Cain says, ‘we were sure we could do better than that — aiming for something that’s comfortable, reusable, maybe a mask-visor combination’.
Their product designers explored function and fitting, leakage and filtering, squeezing this design work into their evenings in parallel with day jobs. They developed mock-ups and iterated on the design, exploring materials selection for comfort and flexibility, and went on to developing jig designs in preparation for manufacture.
But where best to begin supplying the need? This was where social media played its part. They got in touch with teams in the NHS struggling with the issue of how to help the deaf and hard of hearing for whom masks prevent lip reading. Further research, with the help of an expert in respiratory protective equipment, identified the dangers of poor design and the issues of mask fit and discomfort, especially for NHS staff wearing masks for long shifts every day.
Focusing on FFP3 masks, the team at MarchantCain started work, innovating and prototyping. Through their network of past contacts and linking with others through networking services such as Medilink, they found a medical silicon supplier and explored material options for softer and more comfortable masks. They developed early example masks and got feedback, going round the loop to refine the design.
Their efforts never made it to manufacture, as the key raw materials for FFP3 masks dried up, coupled with the need to forward buy on materials that wouldn’t be available for nearly a year. But the designs are there, offering a new possibility to address the needs of thousands of people whose communication is so badly disrupted by the ubiquitous mask.
Berry-BPI
Heanor, Derbyshire, England & Greenock, Inverclyde, Scotland
Berry-BPI is one of the UK’s leading manufacturers of polythene film and currently supply most of the clinical waste sacks used in UK hospitals. This gives them excellent insight and links into the NHS. However, by mid-March, they were seeing a reduction in demand from across the other industries they supply, and Lorcan Mekitarian, sales director, could see that a national healthcare need was going to displace commercial priorities.
The wife of one of the staff, a front-line NHS consultant, told her husband, who worked at Berry-BPI, about the PPE shortages, including the need for single-use aprons. So, with a targeted need, Mekitarian and the Berry-BPI team shifted into making single-use long-sleeved aprons.
Quickly getting a sample apron, the Berry-BPI CAD designers developed the cutting designs, the manufacturing engineers modified their lines and an initial run of 2,000 were made. Knowing the material well, the team were able to work up a short-term solution very quickly. Needing extra help and based in the Midlands, they contacted friends among the automotive suppliers for help with cutting the early gowns. Berry-BPI then completed manufacture and distribution.
Within two weeks they achieved what would usually have taken months of meetings and negotiation of contracts. It was also noticeable that there were many more instances of companies phoning each other and asking for help. People were more obliging, there was less ‘commercial aggression’, and there was much more of a sense of industry collaboration in the face of a shared threat.
To ramp up to the next level of volume production would require automated machinery, but new machines are typically on four- or five-month lead times.
The high-volume low-cost production of single-use aprons has long since moved to China. Facing the same cost and margin pressures as others in the UK, Berry-BPI had also moved their production to China some years ago. As Berry-BPI shifted their focus to higher value-add products, they sold that business to another European company.
Now, with the contacts from years past, Mekitarian turned to that company to source unused machines and then shipped them to the UK. Berry-BPI had an empty factory in Scotland which provided the space. They used their in-house teams to recommission the equipment. They were also very familiar with the characteristics of the raw material, so there was no learning curve, and setup was managed in just a few weeks.
This manufacturing system is not fully optimized for cost-effectiveness because, ideally, one would want material production, material cutting and apron assembly all co-located. Accepting the logistics compromises allowed Berry-BPI to quickly begin manufacturing high volumes of locally sourced aprons.
As a larger company, Berry-BPI were better resourced, with deeper capabilities than many. They have consistently recruited from other industries, so building broader capabilities and networks. Maintaining the manufacturing machinery over periods of time requires the development of in-house capability for agility and adaptability, and Berry-BPI have the resources to do this. Indeed, even some of their retired staff came back to help set up the old machines.
And, as production ramped up in Scotland, so new jobs were created and new skills and networks developed.
The Berry-BPI team moved fast, recognising that they were well-placed to help quickly and determined to do what they could. But they also recognised they could help in the longer term on a commercial basis — so there was clear-eyed investment to build capacity.
Some European countries have identified their likely future needs and are already establishing strategic manufacturing capabilities in PPE. They and the UK will, according to Mekitarian, be able to turn to industry for help as long as purchasing criteria are not on price alone and there are assurances and visibility of the likelihood and size of future orders.
David Nieper
Alfreton, Derbyshire, England
David Nieper makes fashion garments and has sustained its local manufacturing activities while the vast majority of the textile industry has exited the UK in pursuit of lower costs. Christopher Nieper, the son of the founder, ascribes their success to a pursuit of vertical integration and a focus on keeping a rich mix of capabilities in-house.
They do their own design and manufacturing of their garments, design and print of their fabrics, and even the design and print of their catalogue. They have their own café and cabinet makers. They maintain a company strategy focused on short supply chains, local capabilities, agility, and sustainability.
Doing so has insulated them from currency shocks, government policy changes in the UK and abroad, and the risks of disrupted just-in-time supply chains.
Shifting their production from fashion garments to the manufacture of surgical gowns was an obvious step; indeed, gowns are a relatively simple product for them. But adaptation and adjustment were still the order of the day.
By pursuing the idea of reusable gowns, Christopher Nieper focused on increasing the ‘pool’ of gowns rather than on increasing the ‘flow’ of gowns.
They sourced specialist textiles that meet the moisture penetration resistance needs of surgical gowns from Toray, and, importantly, found a material can be washed and reused up to 100 times at 73C.
When supply capacity is constrained — as it was for PPE in the NHS — reuse becomes a key to resilience. Gowns made of the material sourced from Toray can be washed and therefore reused many times. So instead of needing a continuing stream of new single-use gowns, hospitals and other key organisations in the healthcare system have a new option for providing their frontline staff with PPE.
One challenge was coordinating the parties needed to make reusability a practical proposition. The University Hospitals Trust of Derby, representing 15 hospitals, hosted meetings of their procurement team, their current garment suppliers and laundries, and the team from David Nieper. Many hospitals do not own gowns, instead purchasing serviced supplies from specialist laundries. The new approach would therefore require collaboration among all these parties for the change in process.
In addition, the David Nieper designers improved the scrubs by enlarging the pockets, and the gowns by changing fastenings and developing the ‘parachute’ design to minimise contamination risks in disrobing. They also provided ways to track the number of washes the gowns have.
The hospitals explored the testing of the gowns to European standard EN13795, which details a range of technical specifications necessary for surgical gown fabrics, to demonstrate the continued performance of the gowns after multiple washes.
Enabled by internal capability, the manufacturing team at David Nieper reprogrammed their cutters to deal with the characteristics of the new materials, tuned threads and tensions for sewing different garments, and began production.
The company brought back furloughed staff, finding this easiest with the most adaptable and multi-skilled people to help with the early ramp-up of production of the new garments and materials. Within a few months, they had supply agreements with 25 hospitals, locally and nationally. For some hospitals, David Nieper offered colour options — received enthusiastically by customers keen to maintain morale. This local-for-local production of reusable gowns proved very successful.
What of the future? That depends on the ongoing approach to procurement of PPE. The reusable gowns will never be as cheap, in terms of initial cost, as single use gowns sourced from low-cost economies. But once their reusability is considered, when environmental costs are included, and when the intangible benefits of resilience against the unexpected are factored in, then reusable gowns become a more compelling proposition.
Christopher Nieper feels that, with multiple suppliers devoting only a small proportion of their production to PPE, his company could be one of a number that contribute to increased resilience, together with a continuing demand that can underpin UK capabilities throughout the supply chain.
Makespace/Addenbrooke’s Hospital
Cambridge, England
Makespace was established about eight years ago and provides space and equipment such as 3D printers, laser cutters and other workshop facilities for its 400 members, who range from hobbyists to small companies using the facilities for product prototyping. It uses a subscription model to fund its infrastructure but is managed by volunteers, providing training, advice and support for what has become a thriving community. It also stays in touch with an alumni network that numbers over 1,000 members.
So when the threat of coronavirus emerged, it was perfectly natural that Ward Hills, a Makespace director, would contact one of its past members working at nearby Addenbrooke’s Hospital to ask how they might help. What equipment would the hospital value? A series of calls homed in on visors as the greatest need to which Makespace could respond.
The second question was: how could such visors be made in a way that enabled the hospital to adopt and use them safely and effectively? The initial queries were about user need and regulatory acceptability because without answers here, going further was pointless.
Addenbrooke’s Hospital has a clinical engineering group which develops devices for clinical practice. The group is certified to ISO 13485 for design and manufacture and develops in-house designs and small volume manufacture, typically at volumes below the threshold of interest for commercial manufacturers. In other cases, they will develop designs for others to manufacture.
Within this group, Abi Bush, a clinical engineer, was also working on acceptance. How do you move from a world where products are procured against long-established specifications and standards to a world where new products from new suppliers need to be assessed and shown to be safe for use on the front line of a medical emergency? The clinical engineering team is skilled in risk assessment and management, especially in bringing research tools into practice, and this transformed into the task of ensuring that the hospital had a way forward with PPE.
Acceptance is usually based on compliance with externally generated standards and specification. For items being produced by MakeSpace — an organisation very different from the usual PPE suppliers — Bush and her colleagues, clinicians and the procurement team, together with the team from Makespace, now needed to delve into the science and engineering behind the specifications in order to understand and manage the risks of new sources of visors.
Within the Makespace community were people familiar with developing medical devices and with setting up manufacturing facilities for products within a medical context. Working very quickly, the team prototyped their new visors, adapting an open-source design from the University of Wisconsin to the Makespace capabilities. They consulted with the hospital teams to explore issues of comfort, appropriate materials and usability.
In parallel, they set up a ‘manufacturing system’ within Makespace, taping up the workspace to lay out the workstation boundaries to respect the social distancing requirements. They also developed tools and jigs and mapped out how, via jobcards, they would track progress and maintain traceability. By the end of the first week, a volunteer had developed tracking software that was uploaded to GitHub and made widely available with the design.
Most importantly, they developed a technical file which documented the product and the process. It was this documentation which provided a template for others to accelerate their own manufacturing quickly and effectively — together with the quality management system that would support the safe adoption of the visors into the hospital.
Makespace published their visor designs, processes and supporting documents for all to access. Others adopted and adapted the designs for manufacture for Addenbrooke’s while companies across the country adapted them to their local capabilities and needs. Locally, other companies such as packaging designers and manufacturers Charpak and Firstan began to supply, based upon the designs and templates.
Makespace then went on to develop small plastic clips that make visors more comfortable by moving the straps off the wearer’s ears. These designs were also picked up and manufactured by Charpak.
By disseminating these templates and knowledge, willingness and capability elsewhere was translated into rapid and effective responses.
By clarifying and illustrating how the steps of the manufacturing processes fit together, multiple companies were enabled to work together while maintaining the traceability that underpins quality in medical devices.
Meanwhile, other open-source designs were emerging from Cambridge University, such as the ‘Happy Shield’ from the Centre for Natural Material Innovation.
As Makespace ramped up its design and development, as the manufacturing process was laid out and as production began, they set up a group video call every evening to act as a forum to highlight current problems, to brainstorm solutions, and for volunteers to step forward. These calls, which typically attracted some 20–30 participants, gave the team access to broad capability, lots of ideas and rapid outcomes. For example, as supplies of materials began to dry up, one of the Makespace team established that the visor plastic material is the same as that used for the transparent display lids of cake boxes — and a new source of supply was found.
Informed by past experience, the team established ways to test new materials, confirm their suitability and modify the manufacturing to suit. Productivity was maintained. Meanwhile, batch tracing underpinned the quality assurance processes that linked into hospital acceptance of the visors.
Funding was supplied by donors, both from the membership and from the commercial sponsors of Makespace.
Ward Hills believes that the volunteer mindset and the flat organisational structure were keys to the agility and speed of response. Having access to a diverse set of skills from across the network, especially from those with experience in the sector, meant that efforts were well-focused and the team was able to dig into issues such as the implications of changing materials supply most effectively. Having led with the learning, this team of Makespace, Addenbrooke’s and their other collaborators helped other manufacturing groups to step up and deliver to local requirements.
Copyright: Medium
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