Ramya Sriram, Digital Content Manager, Kolabtree03.15.21
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 enlist these skills during the pandemic is to consult an experienced medical device freelancer who can work remotely on regulatory, clinical trial, or statistical projects. How can medical device consultants help remotely?
1. Regulatory Writing
Manufacturers that do not already have a CE mark for their products under the medical device regulations (MDR) must obtain one so 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 affairs consultants 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.
2. Verification of Materials for New PPE or Equipment
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.
3. 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.
4. Literature Searches
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 standardized 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.
Ramya Sriram is a digital content manager at Kolabtree, the freelance platform for scientists.
1. Regulatory Writing
Manufacturers that do not already have a CE mark for their products under the medical device regulations (MDR) must obtain one so 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 affairs consultants 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.
2. Verification of Materials for New PPE or Equipment
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.
3. 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.
4. Literature Searches
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 standardized 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.
Ramya Sriram is a digital content manager at Kolabtree, the freelance platform for scientists.
