Regulatory challenges for advanced wound closure and securement products

Development timescales for advanced closure and securement products are lengthy, and regularly compare with the time taken to develop a pharmacological product incorporating new chemical entity (NCE). Long development timescales, significant risks and the high level of investment required to bring these products to market means that significant sales reward must be potentially available to drive investment in this growing category of medical therapy.

Timescales for Development of Closure and Sealant Products

     

Source: MedMarket Diligence, LLC; Report #S180, "Worldwide Surgical Sealants, Glues, Wound Closure and Anti-Adhesion Markets, 2008-2015."

A wide range of regulatory categories apply to closure and securement products. For example, sutures are classed as Class I devices, whereas hemostats, sealants and glue products are often classed as Class III devices by regulatory authorities around the world. These Class III products require clinical efficacy data that often involves substantial proof of clinical benefit in comparison to other procedures and products. In addition to the requirement for clinical data to prove efficacy and attain regulatory approvals, companies also use such clinical competitive advantage to promote products through product claims and educational materials.

However, the process of clinically developing surgical closure and securement products is generally an uncertain, time-consuming, complex and expensive business. A number of criteria must be considered for clinical evaluation of the efficacy of closure and securement products. For example, to evaluate the efficacy of a new hemostat or an adhesion prevention product for restenotomy in cardiac patients, a multicenter clinical trial would need to be set up comprising in excess of 10 surgical centers in order to evaluate between 300 and 400 patients in a randomized controlled trial in a reasonable period of time; this trial might take two years to complete and would represent the culmination of years of pre-clinical and clinical evaluation. The cost per patient would be tens of thousands of dollars due to the expense of the surgical setting, staffing and materials etc. Follow-up for the hemostatic effect of a product used in this procedure could be relatively short, since the trial would be predominantly focused on proving efficacy and speed of hemostasis and prevention of post-surgical bleeding. However, an adhesion prevention claim would probably require considerable follow-up, and possibly even some sort of biopsy or minimally invasive diagnostic therapy to prove the reduction in adhesion formation as a result of treatment.

(This coverage continued in Report #S180.)

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