As any regulatory professional can attest, finding information on the US Food and Drug Administration's (FDA) website is difficult-really, really difficult, even.
So difficult, in fact, that it has inspired the creation of a new regulatory intelligence company, Graematter, that's already attracting attention and significant amounts of funding from members of the medical device and pharmaceutical industries.
The company, founded by Melissa Walker, formerly senior vice president of regulatory affairs for Stereotaxis, grew out of Walker's attempts to manage the crush of information coming out of FDA through its various and growing databases.
"There's an information overload coming out of FDA right now," Walker said in an interview. "The problem now is, how do you manage to find the information you need in these separate databases? It's extremely frustrating to do without the right tools." By the count of Walker and Graematter CEO Merle Symes, a former VP at Bausch + Lomb, there are more than 100 different databases maintained by FDA, including ones for adverse events, Warning Letters, drug approvals and 510(k) clearances.
Which presents a distinct challenge if you're a regulatory professional trying to hunt down everything related to a specific device, Walker said. "You need a complete picture of everything that's come before your product," she added. For a 510(k) submission, that includes knowing which devices have been cleared, which claims might have resulted in Warning Letters, which guidance documents reference a device, and what regulators expect of clinical trials protocols.
"For regulatory professionals operating in the device space, the frequent question we hear is, 'Is there a better predicate?'" Walker says. "It's easy to miss something, even during a week-long search."
Bridging the Gap
That's where Graematter is looking to make a difference, Walker and Merle said. Their new software system, the SOFIE Regulatory Intelligence system, is meant to link together FDA's various systems, bringing all of that data into one central location where it can be parsed using more specific search terms than what FDA's databases current allow.
Walker cited the example of a device professional looking for information on all catheters cleared by FDA. Under FDA's current system, the professional might need to parse through hundreds, if not thousands of clearance documents to find the one particular type of catheter applicable to the company's current project. Such a search comes with considerable cost, both in time and opportunity.
"Most of the professionals we're surveyed said they block out around a week of time to search through a database to find-or try to find-everything they're looking for," Merle explained. "There's a huge potential not only to save costs through spending less time searching," he added, noting that many companies have a difficult time finding enough regulatory talent as is.
Assisting the Submission Process
But the real value for companies may come when it comes time for submissions, Walker and Merle said. "FDA already has access to this data in most cases," Merle added. The question, then, becomes whether a company with a submission before the agency is operating from the same document framework as FDA. For example, if a company is operating off an old guidance document, it may not have generated the data FDA is looking for to complete a study on a drug. On the other hand, a company may have conducted a trial unnecessarily if they're not aware of an approved predicate, costing the company money and harming patients by delaying access. SOPHIE, they said, allows companies to obtain the most up-to-date and relevant documents in a fraction of the time.
Another benefit to the SOPHIE system lies in its separation from FDA's databases, Walker and Merle explained. Some of FDA's databases now periodically delete information older than a certain date, or previous iterations of a document. For example, try finding the draft version of a now-complete guidance document on FDA's website, and you will almost certainly find yourself out of luck. The SOPHIE system solves this by downloading documents and cataloging them natively, allowing companies to research past records that in some cases even FDA review staff might not have access to.
$850,000 in Venture Support
Despite Graematter's software still undergoing beta testing, the company is already getting some major support from investors. In May 2013, the company announced that it has received $835,000 in funding through an investment seed round, reflecting what the company said was a recognition of the value it could bring to the industry.
"What we've heard from our investors is that they recognize that the time to approval for most FDA-regulated products is increasing," Merle said. "FDA is now changing and updating its major document much more frequently than it did even a few years ago, and it's more difficult for companies to keep up. What regulatory professionals and companies are looking for now is more granularity and ways to drill into FDA's data to support their development programs."
The benefit, they said, will be if companies can find a crucial document that most closely matches what they're looking for, and do so in a fraction of the time. The company claims what used to take regulators a week to research can, using their SOPHIE system, take as little as two hours with an experienced researcher.
'Something Completely Unique'
"We think we have something completely unique here," added Merle. "We've designed this entire system to make this otherwise complex process as simple as possible.
As to the cost of the product, Merle said the company is still figuring out a variety of pricing options, but hopes to have a range for companies large and small to choose from. "Right now we're developing 'modules' for the product," he said. "For example, a small device company could purchase a package that includes only basic device information, while a large corporation might purchase an advanced module that allows for greater search capabilities across all product lines."
Walker and Merle said they expect to launch SOPHIE to the public in either July or August, depending on the progress of their beta testing.
Online at graematter.com
Full disclosure: Walker was formerly chairman of the Regulatory Affairs Professionals Society's (RAPS) Board of Directors, the parent organization of Regulatory Focus. Your editor only learned this after deciding to write about the company.