Using Your Graematter to Navigate the Regulatory Process

Posted by on Oct 8, 2013 in Featured Stories, Innovation Tuesday | 0 comments

Click here to hear Melissa Walker’s interview on KMOX Innovation Tuesdays segment with Charlie Brennan on 10/8/2013


Melissa Walker admits she has a passion for data, and a flair for managing it.

As a college biology instructor in Texas in the 1980’s, Walker found it a challenge to track all of the data surrounding the daily performance and test results of her 300 students, so she created a computer program to help manage the information.

Later, she built a successful, 27-year career at companies such as Johnson & Johnson, Bausch & Lomb and Stereotaxis, helping bring new medical devices to market by guiding those products through the complex approval process of the Food and Drug Administration.

Now Walker, through her startup company Graematter, is building a product to make navigating through that process a little simpler for medical product companies.

For innovation-minded companies and entrepreneurs looking to bring a medical device or pharmaceutical product to market, the exercise of obtaining the necessary approvals from the FDA – with its different data sets and search tools — can be daunting.   In the pre-Internet era, the problem was an inability to find enough data.  Now the issue has become one of data overload.

“Since the rapid expansion of the Internet,” notes Walker, “data has become more available, but the growing challenge is that there is a massive volume of information.  It’s scattered over hundreds of data sources across multiple government agencies.”   With no easy way to collect and review data, some information can be missed, and that can mean loss of significant time and money for a budding entrepreneur, or even the failure to get a product to market because of a misstep in the approval process.

Enter Graematter, which bills itself as a “regulatory Intelligence” company.   Walker likens Graematter’s work to the popular used-car hunting tool CarFax.  Just as that web-based service aggregates information and produces comprehensive vehicle history reports to consumers seeking used cars, Graematter’s SOFIE software provides a similar service for medical device makers and pharmaceutical companies, streamlining search results and dramatically decreasing the amount of time needed to research all of the necessary information needed.

“I began to address the problem,” says Walker, “by developing an automated, software-driven process to aggregate important regulatory information and create a comprehensive database that consolidates everything into one resource.”  The system examines a wide variety of regulatory items including inspections, sanctions, recalls, and review times.  Walker applied for and received a patent for the software in 2010.

While the company is focusing on medical device makers and pharmaceutical companies right now, other possible clients include law firms, contract research organizations and life science professionals, a fact that has not gone unnoticed within the burgeoning St. Louis life sciences movement.

Funding for Graematter has come from the local Arch Grants program, BioSTL, the BioGenerator seed fund, the Missouri Technology Corporation, St. Louis County’s Helix Fund, the St. Louis Arch Angels, and Washington University.



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