Medical device manufacturers working towards EU MDR compliance are running out of time. Although the EU MDR deadline will be pushed back to 2021 amid the COVID-19 pandemic, there is still much work to be done for manufacturers hoping to show their devices meet the new compliance standards.
Medical device manufacturers should use the opportunity to get compliant as quickly as possible since the extension means they now have almost no excuse to be unprepared.
Let’s take a look at some of the top literature review challenges facing organizations to comply with EU MDR, and explore some ways they can be solved:
EU MDR literature review challenges
Device manufacturers can’t buy any more time for EU MDR, so it’s essential that they build processes and practices that will create more efficiency in their work. The main challenges involve inefficiency and redundancy in the literature review process. Specifically, the top four challenges we see when talking device manufacturers are:
- The fact that, for many companies, conducting systematic literature reviews is uncharted territory, which means companies must adopt new and unfamiliar processes in a short period of time. Additionally, finding experts to implement these processes can prove difficult.
- As most teams are already maxed out on their resources, it can be challenging to manage the additional workload, especially when new costs and time constraints are added to the mix.
- New, rigorous regulatory requirements means that organizations must show transparency and reproducible results. They must also consistently monitor for adverse events to update their reviews on a regular basis depending on the classification of the device. This is challenging for organizations that are not utilizing the proper tools.
- Content and copyright management including sourcing, storing, and reusing references is a time-consuming and expensive hassle for many organizations.
So, what are the solutions?
Build a repeatable literature review process
Systematic literature reviews are not one-and-done solutions. They are something that will be part of your processes for a long time to come and, therefore, creating a repeatable, prescriptive process for your literature reviews is essential. To do this, we recommend creating templates for every step of the process, such as data extraction, workflows, and reports. Each step of the literature review process is amenable to templating.
By creating templates from the outset, you are setting yourself up for success, since chances are you will do multiple literature reviews throughout the year as new data becomes available. It’s important to keep a dossier for your reviews so you can easily access and reference them when needed.
Standardizing as much as possible will also help make your process more repeatable. Create a lexicon for your processes with codes and unique language so you can remain consistent and true to protocol. If you feel inexperienced or overwhelmed, seek help from the pros.
By creating templates and standardizing your process, you will not only save time on these tasks, but you will also enjoy benefits such as smoother training for new team members and consistency between reports.
Building a repeatable process will help you save time and improve both the efficiency and transparency of your clinical evaluation reports. However, there are other ways to optimize the cost of your literature reviews including:
- Streamlining your full-text procurement processes (more on that later!)
- Building data repositories that let you reuse data.
- Using a tool that promotes real-time collaboration, which enables managers to oversee contributors, run real-time reports and progress check-ins. (Bonus: In addition to cost-saving, this also facilitates project oversight and quality control.)
Automate compliance where possible
New, more stringent regulatory rules mean that device manufacturers must go through more steps to adhere to compliance. When it comes to literature reviews, the best way to mitigate the increased workload is automation.
Comprehensive literature review tools bring further efficiencies in the literature review process by automating mechanistic tasks. For example, tracking data provenance, automatic audit trails, reporting, and easy updates for living reviews are just a few of the ways automation can enhance efficiency within the literature review workflow.
As technology advances, the tasks amenable to automation will continue to grow and support researchers so they can focus on the important part of their work – namely the research and science – rather than the simplistic, mechanistic tasks that comprise many steps of a literature review.
Create efficiencies in your content procurement and management processes
There’s no getting around it. The time and cost it takes to procure full-text references for a literature review is significant. In fact, our friends at Reprints Desk estimate that it typically takes about 24 minutes or more to locate, order, and manage scientific articles if you consider tasks such as:
- Checking if the article was already purchased by yourself of a colleague.
- Registering or logging into individual websites.
- Checking if the articles are available for free or through your existing subscription(s).
- Checking for copyright permissions and reuse.
- Manually purchasing, processing transactions, and saving the files.
If you consider needing to procure hundreds of articles for your literature review, you can see how this becomes a problem!
The solution is to look for reference procurement tools with built-in features to improve efficiency. Some considerations include:
- Adopting enterprise logic in your procurement tools. This means using a tool that enables collaboration, secured ownership of company assets, organization for use in group projects, etc.
- Use of filtering to guide users through the lowest cost options for procurement first. (e.g. rights-managed repositories, subscriptions, open source, renting, etc.) Purchasing a single full-text article should be the last option as it is the most expensive.
- Native copyright management in the application means that you don’t need to worry about copyright compliance issues. It removes one layer of complexity from your work.
- Integration with your review software also reduces friction between applications, saving time and hassle when it comes to procuring, uploading, and storing references.
We can’t create more time, so we need to find more efficiencies
With the EU MDR deadline coming soon (even with the 12 month extension!) it’s more important than ever for organizations to create efficient processes to solve these literature review challenges. Decisions must be made and standards established with efficiency, cost, and compliance in mind.