According to Time magazine, the COVID-19 outbreak means that working from home is “no longer a privilege, it’s a necessity"
As medical device manufacturers start working remotely for the first time, Ramya Sriram, Digital Content Manager at Kolabtree, the freelance platform for scientists, explores how freelance experts can help these companies adapt.
Oval Medical Technologies, a company that specialises in drug delivery, is just one example of a medical business moving to remote working. The company announced it would minimise the number of staff in laboratories and keep all employees working from home wherever possible.
In light of the pandemic, medical device companies may find it more difficult to access the specialist skills needed to obtain CE marks for current products, or bring new products to market. One way to access specialist skills during the pandemic is consulting an experienced freelancer, who can work remotely on regulatory, clinical trial or statistical projects.
The COVID-19 pandemic has sparked a shortage in facemasks and gowns and many institutions are having to reuse equipment. Businesses are springing into action to help, for example technical textiles manufacturer Milliken & Company is now producing critical barrier protection fabrics for gowns and headcovers.
Before hospital staff can use the equipment, these new designs need to be verified and the materials checked for safety and efficacy.
Manufacturers that do not already have a CE mark for their products under the medical device regulations (MDR) must obtain one so that they can sell the device in the EU once the transition from the current medical device directive (MDD) ends in 2021.
Similarly, those bringing new products to market to address the pandemic will need quick access to regulatory specialists to get products approved.
A freelancer can help complete documentation in the technical file, such as clinical evaluation reports (CER), for which the MDR now requires much more detail.
Medical device companies can look for a freelancer experienced in clinical project management, technical writing and with a broad knowledge of the regulatory landscape, to help with this task.
To gain a CE mark under the MDR, manufacturers of existing products may have to conduct additional clinical trials. Manufacturers of new products that have been designed to contribute to the COVID-19 effort, may also be under pressure to get trials completed quickly.
Conducting statistical analysis of clinical trial data away from the laboratory can be a challenge because manufacturers can lack the computing power and necessary software when working from home.
One way around this challenge is to recruit a remote biostatistician or similar specialist skilled in managing data to perform tasks like compiling datasheets or writing algorithms for your clinical study. As a result, you can stay on top of your data and monitor the effects of your devices.
Another vital part of a product’s technical documentation is the literature search. The literature search involves gathering and appraising clinical data from a range of sources, including information from research papers or a medical database, such as MEDLINE.
It can also include information from competitors, for example if the manufacturer is trying to claim equivalence.
A freelance literature search consultant is able to perform all stages. By using a standardised protocol, they can also repeat these searches across subsequent CER updates. As CERs will no longer be a static document under the MDR, and will have to be periodically updated, this is a forward-looking approach.
Although working from home is now “a necessity” for many medical device manufacturers, it doesn’t have to be a barrier.