Two new sites seek to mine FDA data to rate devices and drugs –and clarify 'opaque' patient safety situations
SANTA CLARA, CA – Recently, Healthcare IT News put a poll to our readers, asking whether they're likely to "consult medical device ratings sites in making purchasing decisions." More than two thirds (68 percent) of respondents said yes.
Clearly, there's demand for an independent reference site to help trepidatious consumers untangle the vast and often confusing medical device market. At least that's what Nora Iluri is counting on, with her new venture, Clarimed, which launched earlier this fall at Health 2.0
Featuring analytical insights into medical devices, diseases, procedures and manufacturers, the site bills itself as the first independent rating agency for healthcare – and seeks to do for this industry what JD Powers and Morningstar have done for cars and mutual funds, respectively.
Iluri has a PhD in bioengineering from MIT, has worked at McKinsey & Co. and is an entrepreneur who recently sold her last start-up, Zoragen, a molecular diagnostics company for prenatal screening and cancer diagnostics. She also worked for Philips Healthcare for a year, and "saw how difficult quality is to perceive in medical device companies," she says. "It can be a big challenge, not just for patients and physicians but also within those companies."
With the new project, Iluri hopes to harness official government data and other information sources to provide analytics and ratings for consumers and vendors. Too often, she says, physicians, purchasing organizations and payers base their decisions on brand names, rather than quality and performance.
Lack of a transparent ratings entity means manufacturers, meanwhile, might be less likely to risk yet another round of FDA approvals that would be necessary to make needed improvements that might otherwise not be discernible by the general public.
Medical devices represent "one of the most opaque areas of healthcare," says Iluri. "If you look at medical device quality out there, it is not always the greatest – and incentives are not in place to make sure it improves, because of how difficult it is to perceive medical device quality today."
Clarimed mines FDA databases for information on more than 125,000 medical devices, diseases, procedures and manufacturers and rates them on efficacy, safety, usability and more.
Sifting through all that FDA data was not easy. Oftentimes, "it was impossible to make heads or tails of it," she admits. "It was badly reported, there were data quality issues – you have no idea how many different ways Boston Scientific can be spelled."
But all that information is nonetheless hugely important. "You'll never know everything just by running clinical trials," Iluri points out. "Much of the data is being collected post-market on safety issues.”
"Look what happened in the auto industry," she adds. Once JD Power helped "put transparency" on the car’s manufacture, design and safety record, the market was compelled to "drive quality up." With sites like this to reference, "people can make purchasing decisions based on what's working and what's not."
Health 2.0 saw another website launch that makes smart use of FDA filings to educate about patient safety. AdverseEvents, Inc. (AEI) promises real-time information on adverse drug events; providers and patients can research safety issues and side effects by using AEI’s searchable database. AEI’s proprietary data set has applications for both healthcare professionals and patients.
With the FDA's Adverse Event Reporting System (AERS) often inaccessible, filled with errors, incomplete and often out-of-date, patients have been left to rely solely on drug labels. Co-founder Brian Overstreet says his sites insights are all the more crucial – especially with nearly half of Americans taking a prescription drug at a given time, and more than one-fifth taking three or more at once.
"Over 500,000 medication adverse events are reported yearly to the FDA and this is estimated to be only 10 percent of all actual adverse events,” said Overstreet. “With AdverseEvents, patients can take more control of their own care, and healthcare professionals can make better decisions on the development, implementation and use of prescription medications."
