COVID-19 created exceptional demand for medical device testing in 2020 and this trend will continue throughout 2021. Much of the investigative and R&D work conducted by medical device manufacturers (MDMs) ceased during the first half of 2020, but is starting to return now that the industry has learned how to operate during the pandemic. Due to lost time last year, there is a big rush on testing services and timelines will have to be extended in most cases.
"Many of the postponed projects have picked back up and the industry is trying to accelerate and get back on track," said Maciej Jakucki, medical device testing manager for Element Materials Technology, a Cincinnati, Ohio-based provider of testing services for medical, pharmaceutical, and diagnostic devices. "The last three months in the medical space have been as busy as we have ever seen it."
The impact of COVID-19 has been massive. Laboratory work cannot be done remotely. Even with personal protective equipment (PPE), laboratory staff are handling carcinogens, mutagens, toxins, and sensitizers. Many procedures require lab staff to be in close contact for extended periods of time. "Even when lab coats, gloves, masks, face shields, and goggles are worn, and labs are cycling 100-percent fresh air every four minutes, if someone contracts COVID-19, the entire department can be closed for two to three weeks through contact tracing," said Laurence Lister, director of biocompatibility services for Toxikon Corporation, a Bedford, Mass.-based contract research organization specializing in biocompatibility evaluations of medical devices.
The vast majority of medical equipment being tested is PPE-in part because there is reduced demand for medical devices (fewer scheduled surgeries, a result of the coronavirus).
"PPE is now consistently expedited to get these products out to the front-line healthcare workers," added Lister.
"As a result," said Audrey Turley, senior biocompatibility expert for Nelson Labs, a Salt Lake City, Utah-based contract research organization that provides microbiological, analytical, and biological testing services to medical device manufacturers and pharmaceutical companies, "we have seen validation work in other areas drop off as many companies are focusing on current demand due to the pandemic, rather than working on innovative technology."
PPE testing also involves trying to validate the reuse of this equipment, including single-use masks.
"Until the onset of the pandemic last spring, healthcare facemasks were single use," said Gary Socola, president of HIGHPOWER Validation Testing and Lab Services, a Rochester, N.Y.-based testing facility that validates reusable medical and dental devices. "However, due to the worldwide shortage, many manufacturers are exploring the options to test these masks for multiple uses. These tests include sterilization, adherence to original filtration specifications, and fitment testing."
Advisory services with testing firms are fully booked as MDMs hurry to be ready for the new EU Medical Device Regulation (MDR), which takes effect in May 2021 (originally scheduled for May 2020, the MDR deadline was extended one year due to the global pandemic). "Medical device companies are scrambling to perform the required testing so they can be compliant with the new EU...