Regulatory & Compliance

Resolving Medical Regulatory Challenges with Gap Analysis

Sterilization of medical devices and equipment

Bridging the gap between a venture capital firm and medical device company to support regulatory submission of a new product

What do you do when you need an objective, independent review of regulatory submission documents? When a venture capital firm needed to be certain that its investment in a startup's new surgical sterilization wrapper was ready to bring to market, they called on Exponent to gain a thorough understanding of the data validation testing and regulatory submission content.

The Challenge

A medical device company was preparing its application to the Food and Drug Administration for regulatory clearance of a new sterilization wrap, and its investment firm wanted to ensure there were no gaps in the required data. Without deep technical knowledge in the regulatory requirements, the investment firm turned to Exponent for a detailed, third-party assessment.  

EXPONENT's Multidisciplinary Solution

Exponent's Biomedical Engineering & Sciences team set out to review existing test reports and product description information provided by the medical device company. Our team conducted a gap analysis of the data available on the sterilization wrap compared to FDA regulatory requirements and then reviewed the manufacturer's 510(k) regulatory submission to assess its completeness.

Exponent's Impact

Exponent provided recommendations to the investment firm that were implemented by the manufacturer's team, leading to the sterilization wrap being cleared within the 90-day goal set by FDA's Medical Device User Fee Amendments (MDUFA). Exponent's ability to objectively analyze and summarize the technical findings for the venture capital firm helped bridge the gap between the investor and the manufacturer for their mutual benefit.