Sprint Fidelis after the wires began to fall apart. It’s a design flaw that affects hundreds of thousands of patients and may have contributed to at least dozen of deaths, the company said.
“I do know that the agency is faced with extreme scrutiny by the government and that any ‘event’ that is published because a device (or drug) has caused a problem puts what I consider an unfair amount of blame on the agency,” says Tom Clement, chairman and co-founder of Pathway Medical Technologies in Kirkland, WA. “So much of what we do in the world of bringing new products to market is to help very sick people and unfortunately in that environment, some outcomes are not good—even when most are.”
Though the FDA approved Sprint Fidelis from its stricter pre-market approval (PMA) program, which requires extensive clinical trials to prove the safety and effectiveness of truly novel new devices, industry critics soon shifted to the FDA’s 510(k) regulatory program. Critics, some from within the FDA itself, accused of the agency of green lighting 510(k) applications without proper safety reviews. “From investors’ and entrepreneurs’ perspective, it certainly seems like the process is getting harder,” Clement says. “There is more scrutiny on the 510(k) devices, and more of them are being required to have clinical data.”
In some ways, it’s now easier to win FDA approval for drugs than devices, said one venture capitalist based in Silicon Valley near San Francisco.
Ironic, since medical device companies like to complain the FDA regulates the industry as if they made pharmaceuticals. If only.
Companies face a much more predictable FDA regulatory path towards drugs; the same cannot be said for devices, the venture capitalist said.
TOO FEW DRUGS, TOO MANY DEVICES—Despite spending billions of dollars on developing drugs to treat cancer, Alzheimer’s and Parkinson’s diseases, Big Pharma so far has little to show for its efforts.
The economics also don’t favor Big Pharma: it takes about $1.3 billion and seven years to bring a product to market, according to Tufts University’s Center for the Study of Drug Development.
The drug industry’s research productivity has been
