Covid-19: the med tech bottlenecks

Three months into the Covid-19 outbreak, there are still pronounced global shortages of many essential medical devices and equipment, from personal protective gear to ventilators and test kits. Abi Millar identifies the bottlenecks that have been limiting their availability, from manufacturing challenges to regulatory issues.

On 1 April, just as coronavirus cases were starting to surge, the UK Government made a troubling admission. The previous day, it had announced that thousands of new British-built ventilators would be delivered to the NHS. These would come from a wide range of industrial, engineering and technology businesses, as well as medical devices manufacturers.

However, it now emerged that only 30 would be delivered in the first batch. The devices, which were manufactured by Oxfordshire-based Penlon as part of a consortium, were touted as being the first of ‘hundreds more’.

"That's just one of the consortiums that we've partnered (with) - there are thousands more ventilators in the pipeline from other manufacturers and suppliers who are rapidly working on new devices,” said Downing Street’s official spokesperson.

Given that the UK only had 8,000 ventilators at the time, a far cry from the 38,000 thought necessary to handle the outbreak, the government came under flak for its delayed response. Had it acted sooner to ramp up capacity – rather than waiting till late March to appeal to manufacturers – it is possible some additional lives could have been saved.

The UK Government has faced similar criticism regarding the supply of personal protective equipment (PPE) and diagnostic kits. On 18 April, a British Medical Association survey found that half of doctors working in high-risk areas reported shortages of gowns and goggles, while doctors were advised to reuse their disposable gowns if stocks ran low. And on 19 May, when the NHS expanded the eligibility criteria for a coronavirus test, stocks ran out within hours.

Elsewhere in the world, we have seen similar shortages of essential medical devices and equipment. Italy in particular experienced severe shortages of medical supplies at the peak of the pandemic. The US started out with a shortfall of ventilators, before the likes of General Motors, Ford and Tesla stepped in to help.

Testing rates have lagged behind demand almost everywhere, while the World Health Organization has described the chronic global shortage of PPE as ‘one of the most urgent threats to our collective ability to save lives’.

Why these challenges arose

This said, we shouldn’t underestimate the challenges of producing novel medical devices at speed. Peter Ogrodnik, a professor at Keele University with expertise in medical devices, says there are good reasons why the initial ventilator figures were underwhelming.

“If you go to a brand new company that’s never manufactured a medical device at that level of specification before, there are many hoops and hurdles you’ve got to go through,” he says. “It’s got to be designed properly, it’s got to be tested properly – it’s a very high level of certification. So, when you give it to someone with no background in medical devices and ask them to start from scratch, you’re putting hurdles in place straight away.”

Although some of the usual regulations have been relaxed, ventilators still need to pass hard test protocols. If you’re coming from a different industry (say aerospace or defence) you’ll need to familiarise yourself with a new and complex set of industry standards.

“There are many hoops and hurdles you’ve got to go through.”

“The logical solution would be to go to people who were already the manufacturer of ventilators and find out where the bottlenecks are,” says Ogrodnik. “So, is it the supply of plastic, is it the supply of components, how can we help you to alleviate those supply challenges? With ventilator manufacturers like Smith’s Medical and Penlon, it’s not that they haven’t got one that’s designed, it’s that they can’t accelerate production.”

He points out that, while some manufacturers are turning to 3D printing to scale up production, this isn’t always as straightforward as it sounds when it comes to critical components. Another issue is the supply of raw materials, with unprecedented levels of global demand placing the supply system under strain.

Still another issue is the rise of ‘coronavirus scams’, in which markets are flooded with counterfeit or defective health products. Between 3 ​​​​​and 10 March, the European Union’s law enforcement agency confiscated 34,000 counterfeit surgical masks.

Countries adopt protectionist policies

To speak more broadly, the coronavirus pandemic has had a major knock-on effect on global supply chains. Although organisations like the World Bank have spoken out against medical protectionism, dozens of countries have adopted export restrictions across medical supplies.

As a result, many of the best-prepared countries were the ones with a strong domestic manufacturing base. For instance, South Korea and Germany quickly ramped up their testing capacity, with the former testing 350,000 of its citizens by the end of March.

“When you think for example about how China was able to accelerate production, well that’s because the companies that produce the PPE were already there, and they already had the designs ready to go,” says Ogrodnik. “When they wanted to increase production they looked at the bottlenecks, and they didn’t try to redesign anything, they just tried to increase production.”

“Our supply chains are all too predicated on buying the equipment from somewhere else.”

He thinks that for countries like the UK, which rely heavily on medical imports, coronavirus will prompt a real moment of reckoning.

“Globalisation has worked at one level, but what this has demonstrated is that it can all fall down if your suppliers are from one place only and their production goes down,” he says. “Our supply chains are all too predicated on buying the equipment from somewhere else. It’s very hard to kickstart an industry to replace that when the expertise isn’t there domestically.”

Grassroots initiatives and cottage industries

One of the positive trends to come out of the past few months is an uptick in grassroots initiatives, which aim to get medical supplies to those in need. For instance, since masks and gloves are often used in non-medical settings, we have seen many movements geared around donating PPE to healthcare workers. We have also seen the emergence of a PPE cottage industry, with tailors and costume designers working to produce gowns, scrubs and visors.

A whole host of university teams are designing their own ventilators (including a group from Oxford University and Kings College London who described their prototype as an “IKEA-type ventilator”). And in Afghanistan, a group of teenage girls are designing ventilators from car parts, to the tune of $600 per device.

Ogrodnik himself has launched a charitable organisation, Engineers for the NHS Initiative, which brings engineers and designers together to answer immediate healthcare challenges relating to Covid-19.

“We’ve got engineers, designers and experts sitting at home, trying to think of ways to help.”

“I thought, there must be loads of people like me who were thinking we could be doing something,” he says. “We’ve got engineers, designers and experts sitting at home, trying to think of ways to help, so I thought the best thing to do is to bring them together as a collective. We will be developing solutions to problems that healthcare industries need, and then hopefully be in a position to enable them to get those solutions quickly and locally.”

Another key project will be to test the face masks people have made at home.

“A lot of people have been donating face masks, but how does anybody know they work?” he says. “The UK doesn’t even have the testing facilities to test the PPE in the numbers it needs to be tested, so we’re doing a rapid face protection assessment kit that every hospital can have in the future.”

Of course, supply challenges are likely to persist for some time to come, and the med tech bottlenecks are unlikely to be resolved too easily. However, with many different groups working hard to find solutions, it is likely the world will be far better prepared for a notional second wave.