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Lemaitre’s Bold Acquisition Has Been a Long Time Coming

Artegraft processes and sells biologic vascular grafts that are derived from bovine carotid arteries and are implanted primarily in hemodialysis access patients. The products are sold only in the United States. Artegraft generated trade sales of $15.6 million and estimated hospital-level sales of $18.6 million during the twelve-month period ended May 31, 2020. Artegraft’s unit sales grew 10% in 2019.

Canaccord Genuity analyst Cecilia Furlong noted in an investment report that the deal is a relatively rich price for LeMaitre to pay. That said, the analyst views the deal as a core strategic move by LeMaitre.

“Artegraft represents a differentiated biologic vascular graft that [LeMaitre] can build around and leverage as a cornerstone offering to drive pull-through sales of the firm’s current hemodialysis-focused product offerings,” Furlong said. “Furthermore, Artegraft strengthens [LeMaitre’s] core focus on the vascular surgeon while continuing to expand the firm’s biologics focus. We think the deal, and the firm’s willingness to add debt to the balance sheet to execute the acquisition, speak both to management’s confidence in its current business (notwithstanding the current COVID impact) as well as the needle-moving potential inherent in this portfolio addition. We’d note this acquisition was a long-time coming, with ample due diligence performed.”

SVB Leerink acted as exclusive financial advisor and Lowenstein Sandler served as legal counsel to Artegraft. Cooley served as legal counsel to LeMaitre Vascular. LeMaitre expects the acquisition to be accretive to profits in the first 12 months following the closing.

“While we lean positive on today’s announced acquisition, we remain on the sidelines for now, and would wait to see the Artegraft integration, and the firm’s transition out of COVID play out, before becoming more aggressive,” Furlong said.

 

Source: https://www.mddionline.com/cardiovascular/lemaitres-bold-acquisition-has-been-long-time-coming?ADTRK=InformaMarkets&elq_mid=13574&elq_cid=4538143

Preparing for the EU Medical Device Regulation

Despite a delay to the EU MDR, there are many changes for medical device manufacturers to put in motion now. Can freelance scientists help?

The EU Parliament has adopted the EU Commission’s proposal to postpone enforcement of the EU Medical Devices Regulation (MDR) by one year until May 2021. The decision to delay was made in response to the COVID-19 outbreak’s impact on manufacturers, notified bodies, suppliers, research institutions, and other parties, with patient health and safety as a guiding principle. Though this delay would give businesses an extra year, it will be challenging for some businesses to prepare in the context of the pandemic. (The proposal does need to be approved by EU member states and published in the Official Journal before it will enter into force, but this is expected by May 26, the EU Parliament reports.)

The shift from the previous regulations, the Medical Devices Directive (MDD), to the MDR (officially titled Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices), will bring significant changes and a more stringent requirement to obtain the much-needed CE mark. The impact will be felt by every medical device manufacturer in the EU―and those that sell into the EU―because it will apply to existing products, not just new entries to the market.

Kolabtree has had many enquiries from medical device manufacturers who need help from a freelance scientist, whether it’s with adjusting to changes to traceability, device classification, or post-market surveillance. Commonly though, we find businesses are looking for a medical writer to help with their technical documentation, which we’ll come on to later. Some common enquiries relating to the changing regulations are explained below.

Classification Changes

Under both the MDR and the MDD, medical devices are categorized into four classes: I, IIa, IIb, and III, with the classification relating to the degree of risk associated with a device. The new regulations mean that some products will fall into a different group than they did before.

“The fact that certain products will be moved into a different class is likely to cause difficulties, particularly if a product will be moved to a higher class,” explains Kolabtree freelancer Dr. Sergio Perez. “The change of class will affect other areas of the regulation and, if the device is moved into a higher class, will come with more stringent requirements.

“For example, the manufacturer may need to provide additional data on an existing medical device if a device moves from Class IIa to III, where a clinical investigation is needed to justify certain clinical claims,” he adds.

Another cause for concern may be for companies whose products were not previously classified as medical devices at all. Liposuction equipment and contact lens solution, for example, will be covered under the MDR, so manufacturers of such products will need to catch up quickly with MDR requirements.

Equivalence

Under the MDR, you can meet the safety and performance requirements using either clinical data from your own device or an equivalent device. The purpose of claiming equivalence is to avoid having to conduct redundant studies. One reason this may be challenging is that the MDD did not define equivalence, while the MDR has a clear statement on what it is.

Under the MDR, it will be more difficult than it used to be to claim equivalence. According to the definition, you must prove that a product is biologically, technically, and clinically equivalent to the reference product, and it may be difficult to come across this degree of information on a competitor’s product.

If a company is no longer able to claim equivalence with a product that they previously could under the MDD, they may be required to perform further research or remove a claim from their product.

Many manufacturers of devices that have been on the market for years will have to determine whether they have enough clinical data to comply with the MDR. This will prompt them to take steps such as conducting their own post-market clinical follow up studies and other post-market surveillance activities.

Clinical Evaluation Reports (CERs)

A clinical evaluation report (CER) is part of the technical file that provides information on the device design, features, intended use, risks, data sources, and more. Producing CERs involves multiple stages: defining the scope of the device, collecting and validating clinical data, analyzing and interpreting the data, competitor and equivalence analysis, and identifying risks and uncertainties during post-market surveillance. This is an ongoing process, which should be updated throughout a device’s lifecycle.

The MDR will increase the emphasis on CERs, requiring an increased level of knowledge, understanding, and expertise. This stepped-up level of understanding combined with the significant amount of changes from the previous regulations will make CERs into a stumbling block for companies transitioning to the new regulations.

“Identifying and gathering all the data that goes into the CER and preparing the document according to the guidelines can take several weeks or months,” explained Kolabtree freelancer Dr. Sophie Laurenson. “Post-market surveillance (PMS) forms a big part of the process even after CE Mark certification, and PMS has to be a core part of the manufacturer’s quality management system (QMS). Some cases also require post-market clinical follow up (PMCF) which involves proactive collection of clinical data and evaluation to meet safety and performance requirements.

“The CER is not a static document. It is recommended that medical device manufacturers develop a robust process and strategy incorporating good practices to help them retain market access in the EU, avoid any product recalls and streamline their time and resources used to maintain the document,” she added.

Because of such challenges, numerous companies are hiring a freelance clinical evaluation report writer. When looking for a CER writer, it is important to look for a qualified expert with experience in clinical research methodology across a range of therapeutic areas. They should also be experienced in regulatory affairs and well versed in scientific literature, added Kolabtree freelancer Mahasweta Pal.

Adapting to all the changes in the MDR can seem overwhelming for many medical device manufacturers. While the original deadline has been extended by a year, manufacturers still need to prepare themselves so that they can obtain that much-needed CE mark in time for May 2021.

 

Source: https://www.mddionline.com/preparing-eu-medical-device-regulation?ADTRK=InformaMarkets&elq_mid=13174&elq_cid=4538143

Six million more to benefit as NHS locks in the benefits of stronger partnerships

The NHS and its partners will be able to ‘lock in’ improvements to their work by putting whole-system planning at the heart of coronavirus recovery plans, the NHS’s Chief Operating Officer said today.

The comments came as NHS England and NHS Improvement confirmed four new ‘integrated care systems’, together serving more than six million residents.

As part of the effort to respond to the COVID-19 health emergency, NHS and local government staff have been fast-tracking new technology, new partnerships and new ways of working, to make services easier and more convenient for residents.

Integrated care systems (ICSs) and, in other areas, sustainability and transformation partnerships have been central to the coordination and delivery of this response, bringing together hospitals, care homes, GPs and others to plan for immediate and future needs. This has included important initiatives between NHS and local government, such as mutual aid agreements.

A further four ICSs were confirmed today, joining 14 previously announced plus two devolved health systems in Greater Manchester and Surrey. Taken together, around half of England’s population is now served by such a system.

This includes the whole of Yorkshire (with the confirmation of an ICS covering Humber, Coast and Vale) and all of London south of the river Thames (with South West London joining its neighbour in South East London).

The two other partnerships confirmed today are one covering Sussex, and another in Hertfordshire and West Essex.

Highlights of recent partnership work in these areas include:

  • Hospitals in Hertfordshire and West Essex are working together to build a vascular services network built around a specialist centre with vascular hub sites elsewhere. This will improve diagnosis, care quality, experience and outcomes for patients such as those who require major arterial surgery.
  • Humber, Coast and Vale has developed new roles in its health and care workforce to support existing doctors, nurses and therapists and meet local need. This has included helping to train and recruit more than 300 advanced clinical practitioners, nursing associates and physician associates, who are already enabling more people to access faster care and support.
  • The NHS in South West London has joined forces with 140 schools and 6 further education colleges to improve mental health support for around 80,000 pupils. The programme offers group and one-to-one work with pupils, online resources, staff training and parent workshops.
  • The system covering Sussex improved performance against the national A&E four-hour target by 1.2 per cent during 2018-19 (compared to a small dip elsewhere) while improving its financial position more (at 2.4 per cent) than any other part of country.

Amanda Pritchard, Chief Operating Officer at NHS England, said: “The response to COVID-19 has touched every part of our health and care systems. We have seen our hospitals transformed, accelerated use of technology in GP surgeries, mental health services and hospital clinics, innovation in community-based services and been reminded of our interdependence with social care, and the critical role of public health. The response to the COVID-19 health emergency has been whole-system working and so must be the recovery.

“As well as locking in the improvements we want to keep, we must maintain the agility that has served the NHS so well. Changes that have been debated for years, delivered overnight with strong partnership working. We have acted our way to transformation and better care, and we must continue to do so.”

To become an ICS, each system has shown that its partners have a shared vision to improve services for its whole population now and in future, backed up by robust planning and strong collective leadership and accountability.

In areas not yet designated as integrated care systems, whole-system efforts have been overseen by sustainability and transformation partnerships, which perform a similar local leadership role while they prepare to make the transition to full ICS status by 2021, as set out in the NHS Long Term Plan.

ICSs bring together local organisations in a pragmatic and practical way to deliver the ‘triple integration’ of primary and specialist care, physical and mental health services, and health with social care. They will have a key role in working with local authorities at ‘place’ level, and through ICSs, commissioners will make shared decisions with providers on population health, service redesign and NHS Long Term Plan implementation.

 

Source: https://www.england.nhs.uk/2020/05/six-million-more-to-benefit-as-nhs-locks-in-the-benefits-of-stronger-partnerships/

Continuous glucose monitoring market surge during Covid-19 pandemic

The continuous glucose monitoring (CGM) devices market is set to grow robustly regardless of the major upheaval caused by the Covid-19 pandemic. According to GlobalData’s analysis, the global CGM market was valued at $3.3bn in 2019 prior to the pandemic. GlobalData expects CGM market growth to reach mid-double digits in 2020.

The major three players in the industry, Dexcom, Abbott and Medtronic, reported promising Q1 data for their CGM products. Dexcom’s revenue in Q1 grew 44% versus the same quarter of 2019 to $405.1m, while Abbott reported more than $600m for FreeStyle Libre with an increase of 62.5% versus Q1 2019. Medtronic said supplies and consumables in its Diabetes Group are in high demand, while the vast majority of Medtronic’s businesses have experienced declines.

Additionally, Dexcom’s G6 received regulatory approvals in Australia, Japan and South Korea. Abbott’s FreeStyle Libre expanded its reimbursement coverage in Japan to include people with type 2 diabetes who inject insulin multiple times daily. Therefore, the glucose monitoring market in Asia-Pacific is likely to expand exponentially in 2020.

During the Covid-19 pandemic, there has been an emphasis on the use of virtual clinics and telemedicine for diabetic management. For example, the UK’s National Health Service (NHS) updated its clinical guide to encourage remote contacts via telephone, email and video conferencing. This has resulted in an increased demand for diabetic care devices that can share data remotely.

There are significantly more data available by using CGM devices, which can help patients and healthcare providers improve glycemic control and potentially increase patient self-management. Covid-19 has opened new opportunities for the CGM systems to gain more popularity in the diabetic care market.

The surging demand for CGM is primarily driven by a growing awareness of the devices but also partly due to companies’ quick responses to the Covid-19 pandemic. Both Dexcom and Abbott have received clearance by the US Food and Drug Administration (FDA) to make their CGM systems available for use in hospital settings and other healthcare facilities. Health Canada recently announced that the Dexcom G6 CGM system has been temporarily authorised for expanded use in Canadian hospitals.

Remote monitoring with CGM devices for patients with diabetes can help reduce exposure for healthcare providers and preserve personal protective equipment. Additionally, similar to insulin giants Novo Nordisk and Eli Lilly, CGM companies have initialised new patient assistance programmes to support current CGM customers who have lost insurance due to the Covid-19 pandemic in the US. Dexcom reduced its CGM cost to $45 per 90-day supply for its existing, qualified patients.

However, the CGM startup company Senseonics has been severely hit by Covid-19. Unlike other CGM devices, the sensors used in its Eversense CGMs require in-clinic procedures that have decreased greatly due to the outbreak. The company suspended its sales and marketing efforts to acquire new users of CGM to reduce commercial costs. As a result, the current top players in the CGM market are expected to strengthen their leadership in 2020.

 

 

Source: https://www.medicaldevice-network.com/comment/continuous-glucose-monitoring-market-surge-covid-19/

FDA Authorizes First COVID-19 Test Using Saliva Collected at Home

FDA has given the green light to Rutgers Clinical Genomics Laboratory for its COVID-19 laboratory developed test (LDT), which now offers the option of using home-collected saliva samples. The test remains prescription only.

To be clear, this isn’t the first test the agency has authorised with a home-collection option, but it is the first saliva-based COVID-19 test with a home-collection option. Rutgers’ test previously had been added to FDA’s high-complexity molecular-based LDT “umbrella” emergency use authorisation to permit testing of samples self-collected by patients at home using the Spectrum Solutions SDNA-1000 saliva collection device.

Last month FDA authorised the first diagnostic test with a home-collection option, but that test uses a sample collected from the patient’s nose with a nasal swab and saline. That authorization is for LabCorp’s COVID-19 RT-PCR test using samples patients collect themselves with LabCorp’s Pixel home collection kit.

Master Bond EP30Med is a two part, room temperature curing epoxy featuring high bond strength, superior durability and outstanding chemical resistance. It meets USP Class VI requirements and is widely used in the manufacturing of medical devices.

“Authorizing additional diagnostic tests with the option of at-home sample collection will continue to increase patient access to testing for COVID-19. This provides an additional option for the easy, safe and convenient collection of samples required for testing without traveling to a doctor’s office, hospital or testing site,” said FDA Commissioner Stephen Hahn, MD. “We will continue to work around the clock to support the development of accurate and reliable tests, as we have done throughout this pandemic. The FDA has authorized more than 80 COVID-19 tests and adding more options for at-home sample collection is an important advancement in diagnostic testing during this public health emergency.”

 

Source: https://www.mddionline.com/fda-authorizes-first-covid-19-test-using-saliva-collected-home

Pulmonx raises $66m to commercialize minimally-invasive emphysema treatment

Pulmonx announced today that it raised $66 million in a financing round led by global life science investor Ally Bridge Group.

The Redwood City, Calif.-based company also received contributions from new investors Adage Capital Management, HealthQuest Capital, Partner Fund Management and Rock Springs Capital, along with existing investors. Pulmonx secured an additional $17 million in growth capital through CIBC Innovation Banking for refinancing an existing debt facility.

Pulmonx said in a news release that the proceeds from the funding are earmarked for the global commercial expansion efforts for the Zephyr Valve system for severe emphysema, a form of chronic obstructive pulmonary disease (COPD).

The Zephyr Valve system is an FDA-approved minimally invasive treatment option. Its treatment is performed through a bronchoscopy with no incision or tissue resection.

“We are pleased to be able to accelerate our efforts to bring our landmark technology to severe emphysema patients who need it,” Pulmonx CEO Glen French said in the release. “The recently secured financing will ensure we are able to continue to scale our commercialization efforts to meet the global demand for our Zephyr Valve system, as well as continue R&D efforts on new minimally-invasive pulmonary treatments.”

 

Source: https://www.massdevice.com/pulmonx-raises-66m-to-commercialize-minimally-invasive-emphysema-treatment/

FDA approves Q-tip-like swabs to allow patient self-testing for COVID-19

The FDA announced today that spun synthetic swabs — with a design similar to Q-tips — could be used to collect samples from patients suspected of having COVID-19. Patients could even take the samples themselves from the front of the nose, the agency said.

The solution could help solve multiple problems:

  • The nationwide shortage of  long nasal swabs typically by healthcare workers used for COVID-19 sample collection.
  • Danger to healthcare workers from exposure to COVID-19 patients.
  • Calls from several governors, business leaders and members of Congress to vastly increase testing before businesses can reopen and social distancing can be reduced.
  • The level of discomfort that patients who have been tested using those traditional swabs have reported, including President Donald Trump. “Not something I’d want to do every day,” Trump said after being tested March 13 for the first time. (He was tested again April 2.) “Nothing pleasant about it.”

The FDA said it collaborated with UnitedHealth Group, the Gates Foundation and diagnostics company Quantigen on a clinical investigation to determine whether spun synthetic swabs could be used for COVID-19 testing.

U.S. Cotton (Gastonia, N.C.) developed a polyester-based, Q-tip-type swab that is fully synthetic for compatibility with COVID-19 testing, according to the agency. Harnessing its large-scale, U.S.-based manufacturing capabilities, U.S. Cotton plans to produce these new polyester swabs in large quantities to help meet the needs for coronavirus diagnostic testing, the agency said.

“This action today demonstrates the ingenuity that results from the FDA working in partnership with the private sector,” said FDA commissioner Stephen Hahn in a news release. “We appreciate the work of these collaborators to consider how these test supplies could be broadly distributed to meet not only the testing needs of the United States but also global needs around the pandemic. All of these actions by these American organizations will help continue to expand our testing capability.”

 

Source: https://www.massdevice.com/fda-approves-q-tip-like-swabs-to-allow-patient-self-testing-for-covid-19/

Covid-19 pandemic: a wake-up call for domestic production of medical devices

According to GlobalData analysis, approximately 75,000 more ventilators and 5.6 billion N95 respirator masks are in demand due to the Covid-19 outbreak in the US. The crucial reality is that demand is much higher than domestic manufacturers’ ability to deliver. Supply chains have moved abroad for many years and are highly dependent on imports.

To secure medical supplies, many countries have ceased export of the essential medical devices to other countries. On 2 April, the US invoked the Defense Production Act to resolve supply chain issues related to the manufacturing of ventilators and to ensure the production of additional N95 face masks, requesting 3M to cease exporting respirators that are manufactured in the US to the Canadian and Latin American markets. In late March, the European Union announced it was restricting the export of personal protection equipment to all third-party countries. The Indian government has banned the export of ventilators and sanitizers since 24 March. As the pandemic continues to worsen, more countries are likely to introduce new export curbs.

Domestic manufacturing of essential medical devices can not only overcome trade barriers but also ensure product quality and market stability. During the pandemic, counterfeiting and price gouging of imported goods happen frequently with surging demand. The Netherlands has recalled nearly half of the shipment of 1.3 million masks imported from China, which do not meet quality standards. The price of masks made in Indonesia increased four times after the outbreak. Some ventilator distributors tripled the pricing for the same model and still sold out immediately, leading to inflation in the ventilators market.

China lies at the heart of many medical supply chains. According to the International Trade Centre, China exported approximately $73M of medical or surgical related instruments in 2019 with an increase of 8% since 2016. This does not include the raw materials that are required for medical devices manufacture, such as the rubber bands that hang masks on ears. China is the largest manufacturer and exporter of masks, with 50% of the global supplies. Many multinational medical suppliers, such as 3M and Kimberly-Clark, have increased production capacity in China for many years, resulting in 95% of the masks in the US being imported. Most manufacturers would be devastated if China followed other countries’ restrictions and stopped exporting essentials.

China has yet to issue any ban on the export of personal protection equipment, ventilators, and their raw materials for production since the Covid-19 outbreak. In fact, 3M received approval from China to export 10 million China-manufactured N95 respirator masks to the US this week in response to Covid-19. According to Chinese customs data, exports of essential hospital supplies only declined 15% in the first two months of 2020, despite of the surging domestic needs due to coronavirus and the trade war with the US. The Chinese government has offered to export protective equipment to Italy and other countries after the global outbreak.

However, despite the hope from China, ramping up domestic production capacity of medical supplies is the major focus for many countries as Covid-19 spreads. From a risk analysis perspective, relying on imports of essential medical devices is a serious threat to public health security. GlobalData expects a noticeable trend towards moving from a dispersed supply chain back in favour of domestic production for key medical devices.

 

Source: https://www.medicaldevice-network.com/comment/respirator-masks-covid-19/

Tesla Shows Off Prototype Ventilator For COVID-19 Patients Made Out Of Electric Car Parts

The coronavirus crisis has led Elon Musk to jump into the medical device industry, with SpaceX fabricating components for Medtronic MDT ventilators, corporate donations of BiPAP breathing machines that can be modified for use as non-invasive ventilators and promising to use a Tesla TSLA factory to produce ventilators. Now Tesla engineers have designed a prototype ventilator that uses parts adapted from electric vehicles.

The carmaker posted a video Sunday featuring a group of engineers, all wearing surgical masks and gloves, showing off their creation built with inhouse automotive parts, rather than with the compressors, pumps and other highly specialized components desperately needed by medical device manufacturers to ramp up ventilator production.

“We want to use parts that we know really well, that we know the reliability of, and we can go really fast and they are available in volume,” said Joseph Mardall, Tesla’s engineering directory.  “We’ve used a lot of those.”

The device shown in the video includes a touchscreen display panel, the same used in Model 3 electric sedans, that track intake of oxygen and output of carbon dioxide, a Model 3 infotainment computer system, lithium-ion battery, as well as pumps, compressors, tubes and an oxygen mixing chamber. Given that it’s just a prototype, it’s not clear when or if Tesla will be able to produce the devices in high volume–assuming they are tested and approved for use for COVID-19 patients by the U.S. Food and Drug Administration

Musk said via Twitter on April 3 that SpaceX is making “proportional solenoid valves for Medtronic.”

Musk’s moves come as General Motors GM and Ford also team up with medical device makers to help them accelerate production, though neither of those automakers has touted their own designs. Instead GM and Ford, like SpaceX, plan to make components at auto parts plants, which companies including Medtronic, Ventec, GE Healthcare and ResMed RMD say is most critical.

“It’s not a final ventilating manufacturing problem. It’s a parts problem,” ventilator maker Mick Farrell said in an April 1 interview on CNBC. “When we get genuine offers from automotive companies, aerospace companies and defense companies, and we’ve had hundreds of offers, we say fantastic! Don’t make a ventilator and buy these parts. Make these 10 parts for us and let us scale, which we can, between us and our competitors, to meet the demands of COVID-19.”

The FDA accelerated the approval process for coronavirus-related treatments on March 31 to help with the health crisis. Nevertheless, ventilators made for patients with the most severe breathing problems are extremely complex and certification will take time, according to Gail Baura, an engineering professor at Chicago’s Loyola University who specializes in medical device technology and is author of a textbook on the subject that’s widely used at medical schools.

“There are all these engineering standards that are used to design these medical devices, and the FDA looks to make sure that you have tested and proved conformity to these standards before you can get FDA clearance and legally sell these devices,” she tells Forbes. A lot of time will be required to validate ventilators coming from these new manufacturing partnerships, “even with the emergency use authorization that the FDA is providing.”

 

Source: https://www.forbes.com/sites/alanohnsman/2020/04/06/tesla-touts-a-prototype-ventilator-for-covid-19-patients-made-out-of-electric-car-parts/#4ac1fa2f235b

How the UK plans to source 30,000 ventilators for the NHS

The government is pursuing a three-pronged strategy to source 30,000 ventilators for the NHS to treat Covid-19 patients, ordering newly designed models, scaling up production of existing ones and importing machines from overseas.

The defence firm Babcock joined the engineering company Dyson on Thursday in revealing plans for an entirely new medical ventilator working to specifications set by the government.

A consortium called Ventilator Challenge UK, involving companies including Airbus, Rolls-Royce and Ford, is separately providing the manufacturing muscle to scale up production of proven models already made by the specialist UK firms Smiths and Penlon.

A small firm called Inspiration Healthcare has received a £4m order from the NHS for which it will import hundreds of the devices – used to keep patients with respiratory problems breathing – from the US and Israel.

Late on Thursday, the government said it would also join an EU scheme to procure ventilators, having initially said it would not take part because it had missed an invitation to do so owing to a “communication problem”.

A Westminster source said it made sense for the government to pursue multiple strategies in parallel to mitigate the risk of any one option failing.

The firms involved are waiting for the government to go public with its plans but the delay in announcing them is not thought to be holding up the production effort.

Dyson has revealed the most detail about its progress, including pictures of its CoVent prototype. It hopes to begin producing within weeks, pending approval from the Medical and Healthcare products Regulatory Agency (MHRA), which has been talking to Dyson during the design phase.

However, the government has placed firm orders for 10,000 of the Dyson machines, which will be made at the company’s lab in Hullavington, Wiltshire, a former wartime RAF base, and supplied at cost price.

The company’s founder, Sir James Dyson, has said he will pay for the provision of a further 5,000 machines out of his own pocket, with 1,000 reserved for the NHS and the remainder available to underpin international healthcare efforts.

Babcock is working on a new model in partnership with a leading medical equipment manufacturer that has asked not to be identified but that has experience making hospital ventilators.

The supply chain will come from factories in Scotland and south-west England.

Dyson and Babcock both expect it to take a couple of weeks before they reach production, meaning the government faces a race against time to produce enough machines to deal with an anticipated surge in patients.

But Ventilator Challenge UK, bristling with the UK’s best-known industrial names, is thought to be ready to move faster because it is working from existing models.

The group is headed by Dick Elsy, of the High Value Manufacturing Catapult research group, coordinating efforts from Airbus, Meggitt, GKN, McLaren, BAE Systems, Ford, Inspiration Healthcare, Renishaw, Rolls-Royce, Siemens, Thales and Ultra Electronics.

These firms will help massively scale up production lines for Smiths, which already produces a lightweight portable “paraPac” ventilator, and Penlon, which makes a more heavy-duty machine suited for hospital use.

Ventilator experts said smaller models typically cost about £5,000 to make, while the larger devices could sell for £25,000.

All of the companies involved are expected to waive any profits, given the national crisis, and the supply chain will come entirely from the UK, in case of any disruption to cross-border trade.

In the meantime, the government has also ordered ventilators from overseas to ensure that it can bridge the gap until the other working groups can get up and running.

Inspiration Healthcare, based in Crawley, West Sussex, said it had taken a £4m order from the NHS and was importing ventilators from suppliers in the US and Israel.

It typically ships medical equipment to the UK but its chief executive, Neil Campbell, said the devices would come in by air because “time is of the essence”.

Breas UK, a Stratford-upon-Avon company that specialises in ventilators, is also working with the NHS to supply ventilators in the more immediate term.

The company has tripled its capacity since December, adding employees and production lines, and moving to seven-day working at factories in the UK, Sweden and the US. It is also offering remote training on how to use the ventilators for medical staff unfamiliar with them.

 

Source: https://www.theguardian.com/world/2020/mar/26/how-the-uk-plans-to-source-30000-ventilators-for-nhs-coronavirus?CMP=share_btn_link

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