How safe is your imaging equipment? A new website could have the answer
September 29, 2011
by
Brendon Nafziger, DOTmed News Associate Editor
When buying a car, nearly everyone reads through the user reviews or checks safety ratings first. But for purchasing managers at hospitals, or doctors looking to buy diagnostic imaging equipment or other medical devices, there's little easily accessible, objective information. Now, a new website hopes to change that.
Named Clarimed, and launched this week at the Health 2.0 conference in San Francisco, the website compiles adverse event reports, recalls and – eventually – physician user reviews for tens of thousands of medical devices. Already, it has info on more than 125,000 devices, according to the company's founders.
The website can be seen as something of a mini-trend, as AdverseEvents, which hopes to make drug interactions and side effects reporting more accessible to patients, also launched at the same conference.
Though Clarimed will also provide ratings or reviews for everything from diets to hospitals, medical devices are expected to be the big driver, according to Nora Iluri, the Santa Clara, Calif.-based company's founder and CEO.
A former consultant who spent six years at McKinsey & Company, Iluri said she was moved to launch the site because she saw there was a need for more transparency, and better access to safety information, in the device sector.
"It was just shocking to me how little it's known how devices perform once they enter the marketplace," she told DOTmed News.
Right now, many features on the site, whose beta officially went live only on Tuesday, aren't up yet. But the aim is to offer safety information on recalls and adverse events pulled from Food and Drug Administration databases -- information that is often hard to come by on the government's own, sometimes not very user-friendly websites.
Iluri said the plan is not just to share raw data, but rather provide ratings for devices based on a normalized adverse event or recall rate -- basically, how safe a product is compared to similar devices already on the market. Eventually, this could expand to include ratings tailored for new devices, which haven't been on the market very long, so providers would be able to take that into account when gauging their riskiness.
But the ambitions are larger than that: by helping to make post-approval device data more accessible to the public, the site could help doctors better understand the state of the industry.
"If you had better transparency once (the devices) reach the market, you could respond much quicker to potential problems and therefore (answer) the age-old question: is the FDA too strict or too lenient, (is it) holding back innovation or hurting people?"
For now, safety is the first of the three areas the company had hoped to address, the others being efficacy and usability. For usability, the aim is to include, when more features roll out at some point over the next six to 12 months, physician reviews of products. But because of the known problems with user reviews -- people generally only comment if they really hate or really love something, and the difficulty in guaranteeing only physicians, and only physicians who have actually used the device, will comment -- Iluri said this feature will not be the primary draw of the site.
Efficacy, the third pillar, is also something the site hopes to address over the next year, possibly by using clinical trial aggregations or partnering with electronic medical record vendors, using information drawn from EMRs. If the EMR partnerships don't pan out over the next year, however, the company said it would look into getting commentary from thought leaders in the field.
But the company still has some growing to do. Iluri, who said she was the only full-time employee, now relies on about 20 contractors, but she plans to bring them in full-time once the next round of financing is complete.
As for revenue, she said they hope to make money off advertising and by generating partly customizable reports for providers or manufacturers, based on their data.
Iluri thinks her company has a shot, as she feels health care is where the car industry was before J.D. Power and Associates launched in the late 1960s.
"Automobiles were very unsafe, quality was pretty bad, until somebody shined a light and said, 'Hey, this car is better than that car, you might want to make your purchasing decisions about this.' And suddenly within a decade car safety and quality improved dramatically," she said.