Graematter, Inc. – Delivering Regulatory Intelligence Needed to Get Medical Products to Patients
November 11, 2012 • Arch Grant News •
For more than 26 years, I have worked as a regulatory professional in the medical products industry. It is my job to help medical product companies develop, test, and submit data to receive approval from regulatory agencies such as the US Food and Drug Administration. I am passionate about this work because it means that every day I get to be a part of delivering medical advancements to patients who need them.
However, in order to make a case for a product to be approved by the FDA, I have to review the data and reports on similar products, treatments and clinical trials that have previously been submitted to the FDA for review. Since the rapid expansion of the internet, data has become more available, but the growing challenge now is that there is a massive volume of information. It is scattered over hundreds of data sources across multiple government agencies.
The fundamental problem is that there is no easy way to collect and review the information. If critical information is missed, it can easily equate to significant time and money unnecessarily spent. It can even result in the failure to get a product approved with all of this serving as a detriment to prospective patients.
Several years ago I began to address this problem by developing an automated, software-driven process to aggregate important regulatory information and create a comprehensive database that consolidated everything into one resource. The result was a patent application that was accepted and then issued
in 2010. A year later, I left my job and partnered with Skeleton Key, a local application development firm. The addition of experienced executives – Merle Symes as CEO and Peggy Stohr as CFO – followed shortly thereafter, and Graematter, Inc. was off and running! Our primary business model is to establish and maintain a comprehensive database of FDA regulatory data. We make it available on a subscription basis through a web interface to regulatory professionals and other interested parties. Our mission is to speed innovative medical products to the patients who need them by providing superior regulatory intelligence that will improve the quality of medical product development and regulatory submissions.
When Arch Grants chose us as a grantee, their support was immediate and it made a significant difference. Arch Grants gave us great exposure and further established our credibility as an attractive new venture, resulting in support from additional investors. Because we were able to get this immediate support—financial, legal and other resources made available through Arch Grants—we were able to initiate development and meet a critical milestone – presenting the commercial version of the product at the Regulatory Affairs Professionals Society annual conference in October. Without Arch Grants, we would have missed this milestone, which would have significantly delayed and diminished our market introduction. We are grateful for the continued support offered by the Arch Grants supporters and staff.
Graematter, Inc. President, CTO, Founder
“If I could give one tip to fellow entrepreneurs I would say, “Be persistent”. It took over ten years to grow
Graematter from a concept into a business—but it was worth it.”