Bob Schmidt is a medical device entrepreneur who has started several companies, including Cleveland Medical Devices (CleveMed), Orbital Research, Neurowave Systems and Flocel. Schmidt said this about today’s proposed changes to the U.S. Food and Drug Administration’s 510(k) program:

Medical device startup NeuroWave Systems Inc. has received regulatory clearance from the Food and Drug Administration to begin selling a brain-activity monitoring system. The Cleveland Heights, Ohio-based company’s NeuroFAST Monitoring System is intended for use in hospital operating rooms, emergency departments and intensive care units with patients who’ve experienced some sort of brain trauma, such as seizures.

When it comes to keeping smiles on the faces of Ohio’s medical industry leaders, Governor-elect John Kasich’s predecessor did him a big favor. It’s called Ohio Third Frontier.

Bob Schmidt thinks he has an answer for the mega trends of rising healthcare costs, fewer doctors to treat more patients, and provider pay-cuts by the federal government: eHealth. And for Schmidt’s Cleveland Medical Devices (CleveMed), eHealth means dreaming up diagnostic devices for sleep and movement disorders that can cut up to 90 percent of the cost of traditional tests — and even help primary care physicians find new revenue sources.

Ask most people touched by the Ohio Third Frontier project whether it ought to be renewed and you’ll get a resounding “Yes!” A tougher question: How much money should the state borrow to extend the program beyond fiscal 2012, when its term ends? Ohio legislators will grapple with this question as they try to meet a Feb. 3 deadline to get the renewal on the May 4 ballot.

The clearance designations are “a big deal” to the company because they could help it double sales in the next two years, said Chief Executive Bob Schmidt.