Sharing best practices. Bridging knowledge. Identifying resources. Providing access to expertise. Is all of this possible within the medical device space? Answer: it can be! In this interview with Frank Jaskulke and Ryan Baird, we learn how LifeScience Alley is helping its members build and sustain their medical device careers and respective organizations.INTERVIEW HIGHLIGHTS WITH [...]

Last week, three editors at influential medical journals largely dismissed two studies that the medical device industry has been parading around as evidence of failures at the U.S. Food and Drug Administration.Those studies are part of a campaign to show how the industry has been chafing under uncertainty with the agency’s device review process and [...]

LifeScience Alley, a Minnesota-based medical device industry lobbying group, wants to be more proactive about how it addresses regulatory challenges for its membership.The ongoing debate over the 510(k) review process at the U.S. Food and Drug Administration and the imposition of the device tax as part of healthcare reform legislation initially saw the Minnesota trade [...]

Facebook recently confirmed that it has 750 million users. One new user who has taken on the daunting task of creating a B2B Facebook page is LifeScience Alley, the Minnesota trade association.As a result, the group now has a presence on each of the Holy Trinity of healthcare social media (indeed any social [...]

Minnesota’s LifeScience Alley, a medical device and life sciences industry trade group and lobbying organization, named two new officers to its board of directors Wednesday.They areJoe Galatowitsch, founder and CEO of Dymedex Consulting LLC, and Robert Kieval, founder and chief technology officer of CVRx Inc.Galatowitschhas more than 25 years of experience in medical and medical [...]

U.S. Rep. Erik Paulsen, one of the top boosters for the medical device industry in Congress, doesn’t see a major repeal of health reform taking place. Still, the Minnesota Republican is hopeful some aspects of the law will change, including an upcoming tax on medical devices that Paulsen believes will stifle innovation.The nearly 50-member House [...]

The present fee-for-service payment model that dominates healthcare doesn’t begin to meet what needs to be done to properly treat people with open wounds and diabetes. That was the primary complaint heard at an experts panel that the life sciences trade group LifeScience Alley held in downtown Minneapolis on Wednesday.

LifeScience Alley, a Minnesota trade association representing medical technology companies, has circulated an inaccurate document about licensing and commercialization at the Minnesota Partnership for Bioscience and Medical Genomics.

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.”