Literature Review
A systematic literature review is a vital part of demonstrating the scientific validity of your technology. A thorough review will put your company in a strong position for the rest of your clinical, economic and regulatory journey.
Conducting a thorough and systematic literature review can be intensive but is an essential part of the process. A systematic literature review involves following a pre-specified and reproducible search protocol allowing you to find and critically evaluate published scientific evidence relevant to your device. Being systematic in your approach is essential so that your review can be reproduced and updated regularly as new evidence becomes available.
One of the central questions to ask yourself when approaching the literature review is:
Is there a valid association between the outputs of your technology and the clinical/biological target?
If you are new to systematic literature reviews, some general points to cover include:
Is your technology based on sound scientific principles?
How well does your approach work?
Who are your commercial competitors?
What is the current clinical gold standard in each target jurisdiction?
What are the gaps in the literature? i.e. what studies do you need to do?
During your review you should also look out for best practices in investigation design:
Sample sizing
Control/comparator arms if needed
Validated outcome measures and endpoints (both clinical and statistical)
Gold-standard/current standard of care clinical practice
Best Practices
Align with internationally recognised standards.
You might be thinking, do I really need to do such an in-depth systematic literature review? The short answer is yes. Not only do the regulators require it, but a well-conducted literature review will help you to create the safest and most effective device you can for your intended population. In addition, it could also help you to understand how you may need to modify your product to maximise your chances of commercial success. This is more important than ever in the new and quickly moving software/AI as a medical device space.
Fortunately, there are some guidelines that can help you during this process. The PRISMA guidelines represent the scientific gold standard for systematic reviews. Within this framework, it’s also important to appraise the quality of individual studies (for example, using the GRADE methodology) as well as to ensure you are searching multiple databases to avoid bias. Additionally, the IMDRF appraisal criteria (Appendix F) provides a great framework on how to assess the quality of any literature you find.
Case Study
How Hardian solves the problem.
Hardian worked closely with a novel Radiology AI company to conduct a full systematic literature review. The process helped to uncover the most appropriate performance metrics to validate their AI, and best practices in investigation design. But more than this, it uncovered key commercial competitors and gaps in their offerings. This helped the client to align regulatory, clinical and commercial strategies for a more successful launch plan.
Get in touch
Get in touch to see how Hardian can help you complete your systematic literature review.