Innovators that Jumped the Gun
Despite the threats to R&D spending, there's certainly no shortage of innovative ideas out there. Some new entrants to the medtech space managed to benefit from a publicity blitz for creative products that got potential customers talking this year. Unfortunately, marketing and high-profile media coverage also managed to attract some unwanted attention from FDA. Perhaps the most prominent example is that of 23andMe. Thanks to a heavy consumer marketing campaign, 23andMe has enjoyed a rising profile that has garnered such accolades as being named Time's Invention of the Year in 2008 and landing cofounder Anne Wojcicki on MD+DI's list of 10 People Who Changed the MedTech Industry this year. However, the company that brought genetic testing to consumers at an affordable price paid the price of changing the industry without going through the proper channels. At the end of November, 23andMe received a warning letter from FDA that clearly conveyed a sense of frustration at the company's lack of addressing previously mentioned issues as well as at the expanding list of uncleared, publicized indications with its saliva collection kit, and, more notably, with its personal genome service. In response to the strongly worded letter, 23andMe has suspended its health-related genetic tests while it sorts out the compliance kerfuffle, although it continues to market ancestry-related genetic tests and raw genetic data sans interpretation.
The uChek urine analyzer, a mobile app that leverages smartphone cameras to conduct urinalysis for up to 25 medical conditions, is another such product. Biosense Technologies, maker of the uChek, found its technology splashed all over the news earlier this year, thanks to a prominent TED talk and subject matter that lent itself to click-worthy headlines about urinating on iPhones. But this raised profile and media coverage proved to be more of a bother than a boon. In May, FDA fired off an "It has come to our attention" letter to Biosense Webster cofounder Myshkin Ingawale, noting that the uChek seemed to fit the definition of a medical device and, thus, needed to obtain FDA clearance. The company is currently working on raising money to obtain FDA clearance.