Being a medical device manufacturer involves more than the actual manufacturing of the medical devices.
A manufacturer’s job is not only to come up with a device that will be beneficial to the patient population, and hence will have a place in the target market, but also to ensure that the research regarding the product is thorough along with ensuring all documents needed to eventually launch the product.
There is no need to explain why a literature search is crucial to the clinical evaluation report then. However, the work is typically long and mistakes are made.
As the medical device industry continues to evolve, so does the complexity of clinical data and its role in the overall regulatory process.
A guide or outline with a plan and useful ways to effectively conduct and document literature searches is sorely needed, especially when you have a large team.
To help you out, we have put together some fail-safe tricks and tips for efficient clinical evaluation reports and literature review searches. Your team will create better if you follow these steps.
Managing the team:
This team will be in charge of much of the work regarding the EU MDR certification. You probably have a few clinical evaluation report writers in your team already, however, you will need a little bit more if you are going to achieve more in less time.
Here are the steps you can undertake:
- The team should have a leader who can act as the mediator between individual members and make sure the work is being done according to plan. Start by assigning the teams according to the team members’ expertise and then assign the team head based on their work experience.
- Regular communication and coordination are required between members of the team. For example, the medical device designers will need to collaborate with the CER report writers. The CER provides a comprehensive overview of the medical device design and composition, intended usage and applications, clinical trials analysis and outcomes, relevant literature reviews, protocols, and instructions for use. So, all of these teams will need to have regular communication.
- Assigning an experienced team member to mentor junior staff is an essential requirement when your team is increasing in size.
- A robust approach to risk management must be ensured. All potential risk factors and unwanted results gained from the clinical trial should be assessed and reported according to medical device regulations. The adverse effects should be used to update the developing medical devices when appropriate.
- To ensure that the literature review is a valuable contribution to the overall clinical evaluation report, every member of the team must understand what their specific goals are to maintain focus. So, be very specific. For example, all details of the journals used in the literature review should be double-checked by the head of the literature review team. Responsibilities regarding the cer report should be clearly outlined and agreed upon by each team member before work begins.
- Data regarding substantially equivalent devices, research papers, current clinical research should be included and categorized.
- Encourage both individual responsibility and accountability.
Managing clinical evaluation report:
Have a plan:
The first step is to have a CER management plan. This is a high-level document that will provide an overview of the CER management process and tasks with timelines. This can be used as a skeleton and it can be further elaborated upon by the project manager, once the project starts.
Create an easy-to-access database of all current clinical evaluation reports. That way, you can easily make sure that the information used in current clinical evaluation reports is up to date.
You can also use this database to identify gaps where more literature searches are needed – for example, if the literature search’s journals are outdated, or when a new product is being released and there is no CER literature search on it.
Start by creating a database of all information needed for the clinical evaluation report and literature review, for example, primary studies, clinical evaluation reports of competitor products, scientific papers, or other information sources. Create a centralized location for all your CERs. This could be a shared server drive, an intranet site, or even just a centralized email inbox.
The right group:
Form a working group of your old and new colleagues with different medical backgrounds, who will work together on the clinical evaluation.
Set up a clear organogram within the working group, where each colleague has his/her specific task to take care of. Also, it might be beneficial to have one shared file system for each team, and a list of responsibilities for each person.
Deadlines are pretty useful in making sure that all work is being done in a timely process. The trick is to break each task into several smaller ones and assign deadlines to each. For example, one section of the CER report should not have one deadline rather each section should be broken into several.
Form a project plan with all tasks listed as subtasks in an excel sheet. In this way, you can keep track of all deadlines.
Make sure to stick to the set deadlines for each sub-task and make sure that the working group members are held accountable for their assigned tasks.
Freelance CER writer
Skills needed for CER writers include experience handling regulatory approvals for medical device devices, familiarity with MEDDEV 2.7 Rev.4, understanding of therapeutics, and good analytical skills. It is not possible to always have people in your team that are experts in this. While training the team members is possible it’s not always the best course of action when you have several medical devices or are pressed for time. Hiring an expert on cer literature review will take care of both problems. Hiring a full team of specialists to do the final edits to the document is also a great way to ensure quality.
Emphasizing clinical data
Update your CER with Clinical Data from post Market Surveillance (PMS) and Post Market Clinical Follow-Up (PMCF). Each medical device should reflect on its market performance to stay afloat in this competitive market.
Managing literature reviews:
Identifying search strategies
A typical systematic review protocol includes an exhaustive search strategy, with multiple sets of keywords, and the use of filters and limits. Establishing what these will be before the project begins will save time in the long run.
Define the parameters of your search before starting the literature review process. Also, a common set of inclusion and exclusion criteria should be determined beforehand. This will be used to determine whether or not a study is relevant.
Dedicate a few members to find patterns in the literature on a particular topic, or compare and contrast different theories, methodologies, or findings in a field. You will find the process goes much smoother afterward.
Search in the databases relevant to your device
You can use databases that are rich in papers more suitable for your device. The MDR provides no advice on selecting a Literature Database. The publication is subject to peer-reviewed review. So, there are plenty of publications to choose from.
Use (Boolean) operators
Using Boolean operators lets you narrow down a literature search. Boolean operators define the searches to be more extensive, especially if you don’t want to spend too much time doing everything manually. This operator is used to combine various searches depending on contextual data. Quotation marks and rounded frames help enhance search results. Using these, you can find relevant and targeted searches. Get more details on a particular topic here.
Define roles and responsibilities
Even though everyone on your team will be working on similar tasks (e.g., searching, screening, data extraction), dividing up tasks makes it easier to track progress, prevent duplication of effort, and generally keep the project moving smoothly.
Every paper should be reviewed by two people: one is responsible for reading and another is responsible for writing down quotes and taking notes.
Also, make sure everything has a backup. Avoid losing articles during the download phase. Regularly audit your literature review folder. Update and change things as needed. If you would like, you can hire specialists to do the review for you as well.
Are clinical trials grey literature?
There is no agreed definition of grey literature, although in general it is defined as a document that is not formally published. Since clinical trial reports are generally available online and they go through a vetting process from the UK government, they are not considered to be grey literature.
Why is a clinical evaluation report important?
A Clinical Evaluation is a scientific and clinical evaluation of the safety and performance of a medical device. If a medical device were to be accepted, it would need to meet the essential requirements of the MDR. A clinical evaluation report is part of that.
Does FDA require a clinical evaluation report?
FDA requires a CER but only some CE-marked products have to submit clinical evaluation results.
How long does it take to write a clinical evaluation report?
The expected time for completing the CER can vary depending on the product, the complexity of the procedure, the effectiveness of the team, etc.