LifeScience Alley

Devices & Diagnostics

Med tech groups in Minnesota and Israel team up to boost business partnerships

The BioBusiness Alliance of Minnesota and LifeScience Alley announced late last week that it is teaming up with an Israeli consulting company to promote business partnerships in medical technology between the two regions. Specifically, the alliance with MedVance Ltd. seeks to make establishing these partnerships easier, more efficient and effective. While BBAM plans to use […]

Devices & Diagnostics

Former Medtronic CEO to chair initiative to advance regulatory science

LifeScience Alley, which represents the medical device industry in Minnesota, announced Wednesday that former Medtronic CEO Bill Hawkins will be the inaugural chairman of a new public-private partnership to advance regulatory science. Regulatory science is a set of tools and methods for evaluating the safety, effectiveness, quality and performance of medical devices. The three entities […]

MedCity Influencers

How to stay current and connected in the medical device industry

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 […]

News

LifeScience Alley names two new board directors

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 are Joe Galatowitsch, founder and CEO of Dymedex Consulting LLC, and Robert Kieval, founder and chief technology officer of CVRx Inc. Galatowitsch has more than 25 years of experience in medical […]

Policy

Minnesota Congressman looks to Web for medical device tax repeal

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 […]

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A Deep-dive Into Specialty Pharma

A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.

Devices & Diagnostics

FDA 510(k) reaction: The trade group (Minnesota)

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."