Peter Ogrodnik, Professor of medical devices design at Keele University examines the challenges facing manufacturers entering the medical devices sector for the first time
Manufacturers are stepping up to meet the severe shortage of ventilators prompted by the current coronavirus pandemic – and not just companies in the medical industry. Numerous firms from the aerospace and defence sectors, and even Formula One, have offered their services.

In the UK, domestic appliance maker Dyson, defence contractor Babcock and the Ventilator Challenge UK consortium (including leading firms such as Airbus and Ford) have all received orders to make thousands of new ventilators to meet the government’s target of an extra 30,000. Rather than simply helping scale up production of existing products, these firms are working with designs that have never before been used or tested in real settings.
While all efforts are welcome, there are likely to be some major challenges for manufacturers trying to enter the medical devices sector for the first time. Journalists reported with amazement that the first batch of devices from the Ventilator Challenge UK consortium would include just 30 units. But there are some good reasons why novel ventilators can’t simply be turned out in large amounts with just days’ notice.
Firstly, not just anyone can make a medical device. Manufacturers have to be registered with the relevant regulator. In the UK, that’s the Medicines and Healthcare products Regulatory Agency (MHRA). Higher classifications of devices have more stringent regulations and are also regulated by other specific “notified bodies”. Similar regimes apply in the EU, USA and other established healthcare markets.
Across Europe, ventilators fall into class IIb, the second highest regulatory classification. As such, manufacturing them is not as simple as just making a machine that works in a laboratory. The ongoing production of these devices has to adhere to strict rules. In this time of crisis, some rules have been relaxed. But any new ventilators still have to meet strict specifications and pass hard test protocols.
Medical device companies usually take a long time to get going. They need to build their manufacturing knowledge and supply chains to ensure their products are safe and packaged in a sterile way. They need to understand things like biocompatibility (how materials interact with the body) and materials made from animal byproducts (in order to minimise risk of transmissible diseases such as CJD). These companies also need to develop the necessary skills in specific risk management and quality procedures.
So starting from scratch is not an easy thing to do. The simplest approach to increase ventilator numbers is for a government to contact existing ventilator manufacturers and understand what’s needed to increase production rates. For example, there may be issues with the supply of materials, a need for new machine tools or a lack of funding needed to order thousands more components.
These companies already have the respective approvals and quality procedures in place. Efforts should be made to determine the bottlenecks that inhibit increased production, and then find the solutions. An existing provider, with a working device and functioning procedures, does not need to support a learning curve and is the best first point of call.
But instead of being disappointed that Ventilator Challenge UK only produced 30 machines in its first batch, we should be rather impressed that they have made any so quickly. This is, in no small part, due to medical device companies such as Smiths Group and Penlon donating their ventilator expertise. The first batch is relatively small but it’s most likely to enable trials to demonstrate the machine’s safe operation.
Another example is that of the UCL/Mercedes group, which reverse engineered an existing product design and moved to rapid production. The same sort of post-production trials apply. The simple reason for such trials is that any significant change to the software, design, or production of an existing device requires a new regulatory sign off, for which trials may be demanded. Even in times of crisis we cannot risk anyone’s life just for the sake of speed – someone will be liable in the event of death or injury.
Why not ramp up existing production?
So why modify an existing device to meet production demands instead of ramping up current production? In some cases the two are linked: some of the manufacturers in the Ventilator Challenge are using additive manufacturing (often referred to as “3D printing”) as a solution. This, in itself, is a major design change and has to be formally signed off, not least because additive manufacturing is a highly complicated set of techniques – you can’t just put any design into a 3D printer and press go.
New techniques then are bringing different skills and companies into play which are being married with traditional medical devices know how.
If, however, the manufacturer or any of its supply chain is not within the country there is little a government can do to help. In the UK’s case, successive governments since the 1970s have overseen a relative decline in manufacturing, including in the medical devices sector, its associated supply chain and skills base. As a consequence, the UK is more reliant on overseas subcontractors.
This pandemic has highlighted the failings of this strategy. If a country doesn’t have the capabilities to build its own equipment then it is exposed in a global crisis. Perhaps this outbreak will wake up countries to the notion that certain things have to be essential items in a country’s economic portfolio. The coronavirus has reminded us that food, medicines and medical devices and their respective supply chains are most certainly essential items.
Peter Ogrodnik, Professor of Medical Devices Design, Keele University
This article is republished from The Conversation under a Creative Commons license. Read the original article.
A good summary. The last few paragraphs illustrate the major problem, which as always is the inbuilt or systemic antipathy to manufacturing in this country. As Hitler and before him Rommel, Bonaparte and others have realised, in their case too late and hopefully not ours, if you do not have a secure and working supply chain or sufficient reserve stocks then disaster will always ensue. I hope the financial industry and government are waking up to this fact! I fear that their idea of strategic thinking meaning their next big financial windfall in the near future is too ingrained for them to understand.
I have been in the Machine Tool industry for 42 years. Machine tools are the mother to all of industry. I have witnessed successive governments contribute to the decline of our manufacturing base. The UK’s dependency on other countries for high technology manufactured goods, has been a concern for many years. The current COVID crisis has highlighted this fact. I agree 100% with the comments in this article.
There has been for decades a change in the emphasis placed on purchasing departments to demonstrate their performance by buying at lower and lower costs to enable the profit margin to show a growth. In my experience of over 50 years starting in the aircraft industry in design and manufacturing this has led us from a highly technical understanding of what requires purchasing to a cost only factor. This leads industry in to the realm of knowing the price of everything but the value of very little. If you lack the ability to assess the quality of an item then the lowest price wins and you find you have bought an item from the other side of the world that is not the correct material , is not the correct size and then holds up the production of a vastly more valuable piece of equipment. This lesson is now being learnt and must be applied to UK Ltd as we are I believe still a nation of designers, engineers and manufacturers. When this crisis is over lets see the politicians get UK Ltd back to work again. We just need to have the will to see it through.
Perhaps even more so it shows the folly of leaving the EU and the push for the breaking up of the UK by the Scottish and Welsh Nationalist parties- You can’t survive without a bigger enough scientific, manufacturing and user base, might be ventilators today but it will be something else tomorrow.
Self centred and short sighted nationalism will only cause more harm than good and ironically less independence as smaller nations have to rely on others outside their scope of influence like China, US etc.
Why not release existing designs to new manufacturers. The design would be in certification. Manufacturing entities would not wish to be associated with any corner cutting if they were to be allowed to effectively copy existing technology that is working as required. Is there a bureaucratic log jam in all of this that is effectively holding back mass production of ventilators and other kit? Can Sir Humphrey cope with radical and fast moving situations?
I completely agree with this article; will this issue make the Government wake up to our sorry state of manufacturing? I hope so but I fear not.
As Phil suggests copying existing designs would be the best solution. This worked well during the second world war. The only problem would be access to specialist parts which in many cases still come from China or the Far East! Supply chain again.
I have to add my agreement with the engineers who bemoan the UK de-industrialisation of the last generation. a generation ago the UK had a thriving control and instrumentation sector and a massive textile sector. These would have made the PPE and special instruments. We are now almost entirely dependent upon imported instrumentation. This dependency causes many problems in dealing with prescribed countries (i.e. those prescribed by the CIA).
The Law of Unintended Consequences has certainly applied to the UK de-industrialisation policy since Thatcher.
I think it is very true that the fashionable business/politicans in the UK have derided manufacturing – and, most importantly, manufacturing skills; for without the skills and the associated appreciation one does not realise what is required for manufacturing – and hence one becomes a ignorant customer (rather than a smart customer- who realises the difficulties of manufacture – as well as, most importantly. the opportunities.
I know it was fashionable to believe in outsourcing; indeed it was called a “no-brainer” (possibly suitable, it transpires, for a bear of little-brain).
It now remains to be seen if politicians and management/business consultants/academics can still be true believers; or will this be a time for support for radical (affordable) innovation in manufacturing (as opposed to high cost manufacturing)? It isn’t the money it’s the commitment that will count.
PS I believe that Germany had access to local companies who able to produce lots of testing equipment ; not sure if this was the same elsewhere in Europe…..
Until the 1980s the UK had a thriving manufacturing sector and exported power plants, steel, paper, textiles etc round the world. Now the export business is more financial services than products. This change was the result of Thatcher’s asset stripping policies that were never reversed. We are now trying to live off the assets earned over a generation ago plus a number of high added value industries like aerospace and pharma.
This has led to a large shift in employment to low-grade service sector jobs and almost total dependence upon imports for the many of the products that the UK used to make (steel tube, power projects, incinerators, most paper, textiles to list a few).
The Unintended Consequences of this shift away from manufacturing are that the UK cannot respond to crises unless the rest of the world allows it. It beggars belief that the UK can no longer manufacture simple PPE or instruments: the national security has clearly been totally compromised over one generation by the politicians and Financial Institutions.
What is the solution?
Great article – the most balanced analysis yet on the flaws in the government call for ventilator innovation, and the naive response by design houses and non-ventilator industries. So much effort and talent wasted chasing the wrong ball. We make ventilators here(and nearby in ireland) already, and I know of several organisations who made their own minds up about what could make an impact, and offered their experienced medical device and ventilator- specific resources to help boost production at penlon and medtronic. It’s not headline grabbing and doesn’t support the government-led approach but has made a real difference. Looking forward a modest sustained boost in production to supply a managed stockpile of excess devices will be a much more sensible approach. The cost is minor compared to the nhs budget going into diabetes and obesity management in a single london borough….it is not a question of increasing the overall budget but prioritisation of healthcare spend to deal with reality- that pandemics studied since SARS in 2002 as strange foreign events can hit us here too.
Agree the manufacturing knowledge & at least an in-house capability/minor capacity on such complicated medical devices as respirators is as strategic as design/development under such a global crisis.It does not have to be all made here (100% local) but never only offshore (0% local).In normal times the balance between these extremes will vary – supply/demand/cost,etc.
However it is only engineers that fully understand the profanity of this within the economy be it market based or other. Left to others, especially those in search only of maximising financial benefit, inevitably leads to losing control of ability to produce with a local supply base.
Meantime on the much more simple items like PPE gowns still in similar shortages it is a national disgrace, the Womens Institute could have ramped up production from a basic design (only essentials/ no frills, given usage expectancy) in less time & with very local production across the country would have solved the distribution of PPE that is also still on-going. Sadly relearning old skills from previous events with the death rate still rising is a high price to get the basics back in place.
An excellent article putting some information out there that the engineering community have been telling financial institutions and government for several decades.
We have exceptional engineers in the UK but have in many respects seen the manufacturing infrastructure uprooted and sent overseas.
Short term gains, inexpensive overseas labour have decimated our engineering landscape.
We may have an opportunity, when this current situation dies down, to review the extensive globalisation of our industrial base and pull back to a regional perspective of increased industrial and research cooperation.
While there is a need for complex ventilation there is also a need to increase the use of intermediate PEEP ( positive end expiratory pressure) devices which may reduce the need for more complex ventilation. There are many groups exploring this avenue and provided the manufacturing concepts reasonably meet existing standards they could be manufactured more easily and quickly.
In the meantime please stay safe and well
A good article but I must take issue with the comment about remaining in Europe, I voted leave as over my twenty years in industry I have seen a large part of component manufacture moved to Europe. If we remained I fear this would have accelerated.