Medical Devices

The literature review process is not without its challenges. Stringent MDR and IVDR regulatory requirements put more pressure on medical device manufacturers to show transparent, systematic, and reproducible review processes in their CERs or PERs. Benefits of an automated CER/PER literature review process include:

1. Doing More Faster and Smarter. With automation in place, research and literature review teams can complete more accurate literature reviews in less time and more cost-effectively.
2. Taking Control of the Submission Process. A configurable literature review workflow is structured and repeatable. Literature review software can support continuous reviews for ongoing CER and PER submissions, as well as support post-market surveillance.
3. Managing a Single Source of Trusted Evidence. Literature review software, like DistillerSR, allows research teams to track all review activity. This allows for greater transparency and auditability of literature reviews across a product portfolio or business unit.

It’s estimated that 90% of spreadsheets contain formula errors and approximately 50% have material defects. These errors, coupled with the time and resources necessary to fix them, adversely impact the management of the literature review and clinical evaluation process and could lead to delays, omitted references, mistakes – or, worse, rejected clinical evaluation report or performance evaluation report submissions.

DistillerSR software was specifically designed to address the challenges faced by literature review practitioners: namely, the need to efficiently screen and extract reference date, eliminate review bottlenecks and better manage regulatory requirements through auditable submissions to notifying bodies Efficiency, consistency, better collaboration with global review teams, and quality control are just a few of the benefits you’ll get when you choose DistillerSR’s literature review workflow over a manual spreadsheet.

MEDDEV 2.7/1 Revision 4, Annex 5, Section 3 of the European Union’s Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) outlines methods for setting up the literature review screening guideline. This part of the EU MDR protocol is critical in demonstrating to auditors that medical device manufacturers are following a robust and repeatable process and can justify the inclusion or exclusion of specific data.

Duplicate literature references, transcription errors, and data entry errors can skew, or even invalidate, your results. DistillerSR provides built-in automation and validation tools that dramatically reduce the potential for errors in your clinical review process.

DistillerSR tracks all review activity and makes it easy to view the provenance of every cell of data. When your Notified Body comes to ask about your clinical evaluation report or performance evaluation report , DistillerSR can help you with capabilities such as a detailed audit log, data version control, and quick searching and lookup capabilities. Simply put, it effectively tracks all activity from your literature review protocol and process so that you don’t need to do it manually.

From conducting searches to removing reference duplicates and irrelevant articles, screening, extracting data, and preparing reports, literature reviews are a time-intensive process. DistillerSR reduces literature review times by 35%-50% on average by automating every stage of the process and by reusing already collected data. From automatically importing new references, to AI powered form-base screening, to robust reference deduplication, and standard reporting like PRISMA flow diagrams, DistillerSR automates many of the traditional review tasks. Some customers have experienced even greater time reductions in their literature reviews, check out the Philips case study on how they reduced literature screening by 70% for their CER submissions.

Distributed teams can collaborate more effectively and improve performance. Using DistillerSR, medical writers have  standard processes in place and reduce overall management overhead. Reviewers are automatically assigned and notified of new work, regardless of the number of projects they are working on. Project managers can view real-time user and project metrics to gain insight into the team’s workload, participation, quality, and performance to more efficiently complete a clinical evaluation report or performance evaluation report.

Scheduled reports can be configured and sent to you (and your stakeholders) automatically via email as needed. Reports can be configured based on rolling date ranges and distributed at specific time intervals.