by William Mann on March 5, 2013

If you haven’t done so, take a minute to read Part 1 first, as this post builds directly on that.

The first level of scientific and clinical development for a new product is simply a basic review of the published literature in your target field. For companies that want to take an exhaustive deep-dive, a full systematic review is usually the next step. The systematic review is essentially the scientific version of a market assessment. This means that you will comb as much published scientific literature that you can, looking for any devices or applications that fall into your space, and create a document that gives a “lay of the land” for your particular target area. Seems simple, right? Unless you have experience performing systematic reviews, this will not be an easy task. For example, if this was done professionally (ie. sponsored by a big pharma company) it would cost $20,000+ and take a minimum of 6-8 months from start-to-finish. We recommend that you bring someone onto the team that has a background in masters-level or higher academic publications, or has worked in medical communications for a pharma or med device company. The reason for this is because there is a massive amount of protocol to follow to ensure that your work is scientifically credible, especially if it is your goal to publish this review. It also gives the review an “arms length” editor to mitigate any potential bias.

There are many different options, formats, and tactics to consider when creating a review, each of which brings their own pros and cons:

  • First and foremost: will you want to publish this review to add to the scientific landscape?
  • Which is more appropriate: a narrative review, a systematic review, or a meta-analysis?
  • What resources do you have to pull onto the project that can increase the transparency, accuracy, and credibility of the publication?
  • Will the literature search be performed by a medical librarian or information specialist?
  • Do you have a key opinion leader from the space who can oversee and act as the senior author?
  • If a meta-analysis is chosen, will you have a statistician to ensure the statistics are correct?
  • Finally, once published, what resources will you use to ensure that this publication is seen by as many people in the space as possible?
  • Which journals do you target for publication?
  • Will you have evidence rankings, and how will these rankings be made as transparent as possible?

Regardless of whether you chose to publish this information or not, this review should be used as a precursor for product development (or at least run in parallel). Key learnings that are made in the process of creating this review should be used to iterate the product and ensure that you are creating a value proposition not just from a market standpoint, but from a scientific standpoint as well.

This review also helps you be as thorough as possible when searching for competing products. There are several products that may have been created and patented in academia, that were never actually commercialized. This review not only helps to ensure that you are not retreading what has already been created, but to avoid legal headaches around intellectual property. If you do discover that your idea for a product has already been created, it may open up avenues for your company to either license the product or collaborate clinically with an academic party who has no interest in commercialization. Finally, it serves as a vehicle to access key opinion leaders in your target field and seek their input and advice regarding product design. This way, the product is designed around what best addresses unmet patient needs, directly from leaders in the field.