Medical device manufacturers worldwide are working remotely for the first time. While many R&D functions cannot be done virtually, here are some areas medical device remote jobs that companies can look at outsourcing to consultants or freelancers.
Bringing a medical device to market is a complex processes involving several steps including product development and validation, clinical trials and regulatory approvals. Due to the COVID-19 pandemic, medical device companies may find it more difficult to access the specialist skills needed to obtain FDA approval or CE marks for current products, or bring new products to market. One way to access specialist skills during the pandemic is to collaborate with a medical device consultant, who can work remotely on regulatory, clinical trial or statistical projects.
Manufacturers that do not already have a CE mark for their products under the medical device regulations (MDR) must get one before they can sell their device in the EU. 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. In the US, medical devices need to get FDA approvals for their device before it can be made available. A FDA 510(k) consultant can help prepare the submission documents and ensure they meet all requirements.
Clinical evaluation is huge part of the revamp to the Medical Device Regulations in the EU. Clinical evaluation consultants can help with developing the clinical evaluation report (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.
Statistical verification for clinical trials
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. As more and more specialists move to remote working, manufacturers now have a larger pool of freelance experts they can tap into.