Meeting demand in demanding times

In the fight against COVID-19, Europlaz Technologies Ltd., a medical device manufacturer based in Essex, England, immediately stepped forward to work with three customers on three different COVID-19 products, including one that has made a measurable difference to intensive care unit patients' survival odds.

When Testing for All — a not-for-profit initiative developed to provide United Kingdom workers with affordable and accessible coronavirus testing — launched in May 2020, the company had been founded a mere three and a half weeks previously, on April 23.

With government testing efforts focused on essential workers, and the 250 pounds ($327) being charged for a private antibody test, the founders of Testing for All proposed to establish a testing service for health care workers who were most at risk of catching and transmitting SARS-CoV-2.

Thanks to Europlaz, a contract medical device injection molder with 40 years of experience in the manufacture of products ranging from actuators and inhalers to complete operating room kits, quick and decisive action could be taken. Testing for All was especially impressed by the injection molder's fast response to the initial approach, its expertise in medical device manufacturing and track record of engineering highly technical devices.

"As soon as we met the Europlaz team, we knew we would work well together and they would be the best partner for us," said James Monico, the co-founder of Testing for All. "Their understanding of regulatory requirements and their excellent on-site facilities make them an ideal business to work with."

The companies moved rapidly ahead, progressing from an initial enquiry from the organization to a signed contract in the space of just five days. Europlaz also had clear capacity to manufacture the kits within their facilities, having just built two additional Class 7 clean rooms — the industry standard for manufacturing medical devices.

Europlaz set up the assembly of the test kits for Testing for All in its Class 7 clean room, and on May 18, Testing for All successfully processed its first SARS-CoV-2 test.

The coronavirus test kit designed by Testing for All consists of three different types of tests: rapid antibody tests for businesses, home antibody tests and antigen tests. Antibody tests can provide near-immediate results about whether a person potentially has or ever had COVID-19. Based on venous blood draw sampling, the tests could be collected on-site by a nurse or samples returned in the mail and results made available via an online portal within a few days. Early September, the company launched an at-home antibody testing kit using a finger prick sampling kit manufactured by the Swiss pharmaceutical company Roche.

In addition to working with Testing for All, Europlaz has also partnered with genetics research company Edinburgh Genetics on a project to manufacture antibody test kits, also based on a finger prick test. Edinburgh Genetics is a startup specializing in life science research and IVD equipment founded in the second half of 2019. Lacking the technical skills and manufacturing expertise needed to produce and launch the product, the company contacted Europlaz. A visit to the factory site was arranged with the result that Europlaz was awarded with the contract.

"As a young company, we've found Europlaz's technical expertise and its understanding of both supply chain management and the manufacturing process to be invaluable," said Alasdair Young, director of Edinburgh Genetics, who went on to call the partnership "very positive and productive."

Manufacture of the antibody test kits commenced at the beginning of May and have since been distributed around the world.

"We also supported Edinburgh Genetics with the donation of over 500 test kits to Autism Anglia to help autistic people and their families navigate this trying time," said a Europlaz company spokesperson.

Accessibility to coronavirus testing is only one of the challenges posed by the ongoing pandemic. In March, it was estimated that 30 percent of hospitalized COVID-19 patients would require critical care and 250,000 subsequent deaths in the U.K. would arise from a shortage of ventilators, ensuring a sufficient supply of respirators to treat patients in intensive care units became a critical focus for National Health Service hospitals.

At the same time, other concerns soon emerged as well. As patients continued to flood the ICUs, it became evident that up to one-third of hospitalized COVID-19 patients also developed acute kidney injury, which meant they required renal support in the form of dialysis. In fact, dialysis machines were therefore threatening to become the next victim of the shortages arising as a result of the coronavirus outbreak.

Europlaz and its longstanding partner Quanta Dialysis Technologies immediately responded to the rising need for emergency dialysis in the ICUs. Europlaz and Quanta had started collaborating some nine years earlier on the design and in the development phases to bring new dialysis technology to launch, according to the medical molder. "We specialize in manufacturing single-use plastic components for medical devices," the company explained. "It is why Quanta chose to work with us."

Quanta, together with Europlaz and other suppliers, boosted the production of the SC+, Quanta's next-generation hemodialysis system, for which Europlaz produced the high-quality consumables required to connect dialysis machines to patients. As a small, simple-to-use dialysis system, the SC+ was well suited for use in the ICUs, as the length of training required was relatively short.

At Quanta, all involved were "pulling out all the stops to support the NHS and kidney failure patients during this critical time," said Quanta CEO John E. Milad, while at Europlaz, a dedicated night shift was introduced in order to ensure that enough consumables were manufactured in a timely manner and to meet the supply demand of the NHS. Each part takes approximately one hour to make. All machine components are made to ISO 13485, a standard to which the business is certified. At this time, SC+ is not yet FDA cleared and not yet available for sale in the U.S.

"The manufacturing development of proprietary consumables for the SC+ dialysis system has been a true partnership," according to Eddie O'Keeffe, chairman of Europlaz. "Whilst our partner owns the machine, designed it and is responsible for the technology, our role has been to manufacture the high-quality consumables required to connect the dialysis machine to the patient."

The first dialysis machines were distributed to the NHS several weeks ago, and the feedback from the ICU teams is that they are remarkably intuitive and easy to use.

"The SC+ devices were provided in a matter of days," said Emma Vaux, consultant nephrologist at Royal Berkshire NHS Foundation Trust.

"SC+ has been safely installed, and due to its ease of use, training was delivered in under six hours, enabling our ICU nurses to quickly, effectively and efficiently treat those people that need it most. In the long term, we are looking forward to seeing these devices used in our patient's home settings," Vaux said.

Milad said, "I'm proud to see the difference we're able to make with our small, simple and versatile hemodialysis system, SC+, by providing flexible treatment options for patients in urgent need."

All three products are still in production at Europlaz. Asked about further developments in COVID-19 related products, the company said it was in discussions with its current partners, but it declined to comment at the moment.