The U.S. Food and Drug Administration’s Minneapolis District Office generated just a single device-related warning letter in 2010 after more than 140 inspections in Minnesota, Wisconsin and the Dakotas.

Cautiously optimistic was the word from one trade group after the FDA released details Wednesday on current and future plans for changes to the 510(k) medical device approval process.”They’re moving in a positive direction,” Dale Wahlstrom, CEO of LifeScience Alley, the Minneapolis-based nonprofit trade association, said in a phone interview. “I was surprised to see 25 things they’re doing right now to make it better, with really tight timelines. That to me says they want to show success quickly, and that’s good as long as they implement with an appropriate amount of detail that doesn’t catch us by surprise.”The detail, of course, is the catch.”The area of concern is the significant number of items that they delayed decision on as they move into dialog with IOM.”

Many medical technologies never realize their full potential because the factors that limit broad adoption are not fully understood and addressed. This is why many technologies realize no more than 15-20% of their true potential, despite massive investments and nearly heroic efforts of the sales, marketing and leadership teams.

One of the biggest issues today in medical technology is not regulatory, or reimbursement, or the burden of clinical evidence; it is the lack of a sufficiently clear understanding of the market and market dynamics.

Dale Wahlstrom is an optimistic guy. But budget-cutting Republicans poised to control the House and Senate, and possibly the governor’s office next year may test the optimism of the BioBusiness Alliance of Minnesota CEO.

Dr. Frank Cerra has hitched his wagon to outgoing University of Minnesota president Robert Bruininks. Cerra, medical school dean and head of the school’s Academic Health Center, is retiring at the end of the year partly because Bruininks is doing the same. It’s just as well. Together, the two men had sought to remake the school into a top research university and an economic engine for Minnesota. But as they prepare to exit, their vision is in doubt.

It seems eons ago when the first cattle rush for Minnesota’s governor’s office appeared on stage at the BIO forum in April. The results of that debate were abysmal for innovation. Eight months later, Tom Horner and Tom Emmer have substantially improved their grades.

In launching Decade of Discovery, a $250 million-to-$350 million diabetes partnership, the University of Minnesota and Mayo Clinic are opting for an approach that requires the help of virtually everyone with a stake in Minnesota’s healthcare economy: hospitals, payers, food manufacturers, device companies, biotech startups.

Diabetes Sentry Products Inc. beat out 400 other startups across the country to win the best pitch competition at the The PerfectBusiness Entrepreneur & Investor Conference in Las Vegas. The company, based in Orono, Minnesota, is trying to raise $1 million to $1.5 million to develop a portable device that alerts diabetic patients when their blood sugar levels fall dangerously low.

Dale Wahlstrom, the CEO of the BioBusiness Alliance of Minnesota, soon will oversee LifeScience Alley under a strategic affiliation the two organizations announced Thursday. Beginning in November, Wahlstrom, a former Medtronic executive, will replace Don Gerhardt, president and chief executive of LifeScience Alley, who will retire at the end of the year. Officials from both groups stressed BioBusiness Alliance and LifeScience Alley are not merging.