Yelp.com has changed how many consumers interact with goods and services. The site relies on reviews by actual customers, editors, and experts to provide groupthink on restaurants, spas, mechanics, and a host of various services. It grows daily and is successful because it is popular, and popular because it is successful.Now, a service set up in a similar model aims to apply ratings and rankings to medical devices. Its service could have a significant influence over users’ knowledge of devices on the market.

September 27, 2011

3 Min Read
A Big Thumbs Up for a Plan to Rate Medical Devices

Yelp.com has changed how many consumers interact with goods and services. The site relies on reviews by actual customers, editors, and experts to provide groupthink on restaurants, spas, mechanics, and a host of various services. It grows daily and is successful because it is popular, and popular because it is successful.

Now, a service set up in a similar model aims to apply ratings and rankings to medical devices. Its service could have a significant influence over users’ knowledge of devices on the market.

Nora Iluri, PhD, has launched a company called Clarimed (www.clarimed.com). The Web-based service contains information on 130,000 medical devices that have been approved by FDA. Iluri plans to eventually expand the service through data feeds and a consulting arm. Information can be sorted by disease states, procedures, and manufacturers. “Our goal is to become a comprehensive healthcare reference over time,” Iluri says.

The Web site is designed as a resource for multiple stakeholders with varying goals for the information. Patients, consumers, physicians, nurses, payers and provider institutions, manufacturers, and even investors can use the database as a resource. Iluri notes that users will be able to rate healthcare products and services but that editorial ratings are limited to subjective topics. Most of the device ratings are based on data primarily derived from FDA, Medicare, and other government sources. “Our goal is to provide the facts and be very transparent on where ratings come from,” Iluri says.

The information is based on public information, so that approvals, changes, recalls, and adverse events will be cross-linked, enriched, and analyzed. Iluri says Clarimed will consider enabling OEMs to submit optional information.

Clarimed contains information on 130,000 medical devices that have been approved by FDA.

To Iluri, the benefits are clear. “Increased transparency around healthcare products and service quality will have a dramatic impact on the quality of these products and services in the industry.” She compares her company to J.D. Power’s car ranking and points out that the service drove improvement in car quality. “We hope to motivate manufacturers and service providers to start competing on the quality and performance of their offerings rather than on reputation and premarket studies that might not fully reflect performance,” Iluri says.

I’m skeptical as to how valuable the information will be. Companies play a bit of a game when it comes to displaying public information about their products, a regulatory approvals expert recently told me. Firms with 510(k)s and premarket approvals are required by FDA to provide key data for products. Confidentially, however, this expert told me that the problem is that firms learned long ago that FDA wasn’t really paying attention and now they share as little as they think they can get away with. When firms see how little their competitors are supplying, they scale back their own data. As a result, publicly available material on medical device products is rather sparse. FDA is taking steps to remedy that scarcity of information, but such an endeavor takes time.

Iluri, however, seems confident that the data her group is putting together will achieve a level of validation and, to take it a step further, drive innovation. “I hope that with increased transparency and the ability to respond quicker, FDA will feel more comfortable letting new, potentially life-saving innovation through the regulatory hurdles,” she says.

For device OEMs, one side benefit that I see is increased exposure to end users who have not been otherwise empowered to care or ask about medical device specifics (brand, make, model, etc). Indirect and qualified brand data could increase that type of consumer knowledge and further drive sales and requests from patients. 

Of course, any program that serves medical devices should be more careful than yelp.com or other user ranking systems. But Clarimed seems to be just as much of a social experiment as yelp.com was at first. Iluri’s innovation could help drive medical device innovation.

Heather Thompson

 

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