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Corona

UK government has set up a portal for organizations who can offer support in the supply of ventilators and ventilator components, as part of the government’s response to COVID-19.

The initiative follows the government reaching out to manufacturers in heavy engineering in general to see how they can support the effort for urgently needed ventilators. (Also see "Regulatory Experts React As UK Gov Asks Heavy Engineering Firms To Produce Ventilators" - Medtech Insight, 16 Mar, 2020.)

The UK has just 5,000 ventilators compared to Germany’s 25,000, and is pushing to have 20,000 additional machines produced and available as soon as possible. The UK government has stated that it is determined to do whatever it takes to have them produced.

There is clearly not time to produce these ventilators in the next four to eight weeks  ̶  rather than the years it would usually take. And there is certainly not enough time for new ventilators to demonstrate conformity with the current EU Medical Devices Directive, or the EU’s Medical Devices Regulation, which fully applies from 26 May 2020

The EU is already looking at waiving certain requirements out of necessity (more to follow on this in an upcoming story).

Medtech Industry’s Response

“As well as a focus on new producers, existing manufacturers would welcome government support to expand their own, existing capacity” says the Association of British HealthTech Industries (ABHI).

It adds that its member companies currently manufacturing these products support the new government initiative to have more companies involved in the manufacture of ventilators. The ABHI’s companies can partner with new entrants when this is appropriate and can expedite increased production, it says.

The ABHI calls for a clear and transparent process for the procurement of additional products.

It recognizes that responses to manage the COVID-19 crisis will not be limited to ventilators, and says that industry is already working to support the rapid dissemination of technologies in other areas, such as diagnostic tests and personal protective equipment (PPE).

The Portal

The portal has three main sections to aim to identify the suitability and readiness of organization to be involved in the initiatives. These ask for basic details and contact, supply chain experience and business capabilities.

But at the time of publication, this portal no longer seemed available. A link will be provided soon.

Smaller Niche Companies May Be The Answer?

There has been some considerable skepticism (Also see "Regulatory Experts React As UK Gov Asks Heavy Engineering Firms To Produce Ventilators" - Medtech Insight, 16 Mar, 2020.) voiced about manufacturers in other sectors, such as JCB and Rolls Royce being able to gear up to manage to quickly produce these highly regulated – Class IIb products. A recent report by the BBC News suggests that lesser known companies could take the lead. These include Renishaw, which makes small precision measurement parts used in other types of medical equipment and aircraft, and TT Electronics, which makes specialty coils and ultra-fine wound wire for radiation therapy equipment and surgical navigation devices.

UK Ventilator Business

According to ABHI, the UK anesthetic and respiratory sector employs 3,499 people across 82 sites, with an annual turnover of £750m ($900m). A variety of UK companies manufacture ventilators, and there is a complex supply chain supporting them.  

The NHS procures these technologies through the NHS Supply Chain, with pricing set through competitive tendering.

Coping Strategies Around Europe

The UK is not the first country to have reached out for emergency help. Italy had told its only ventilator manufacturer, Siare Engineering, to quadruple its monthly production from 125 to 500 a month, even deploying members of the armed forces to help, according to theFinancial Times. Germany, meanwhile, ordered an additional 10,000 ventilators from Draeger Medical AG, but has imposed export controls, something that has drawn criticism from Spain as its regular suppliers do not have products in stock.

Germany has some 28 critical care beds per 100,000 people. Of its 28,000 intensive care beds, 25,000 are equipped with ventilators.

Italy has 12.5 critical care beds per 100,000 people, and the UK is near the bottom of the Europe league, with just 6.6 per 100.000. France has 5,065 intensive care beds equipped with ventilators, and another 7,364 intensive care beds that lack ventilators

 

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