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 […]
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 […]
In a webinar on April 16 at 1pm ET, Aneesh Chopra will moderate a discussion with executives from DocuSign, Velatura, and behavioral health providers on eConsent, health information exchange and compliance with the CMS Final Rule on interoperability.
Not very many people have my skin color in Minnesota, especially in the med tech circles which I flow in and out of as part of my job. So, whenever I am meeting someone, I simply have to say, “Look out for a short, long-haired woman” and bam, we are done. But what do you […]
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 […]
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 […]
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 […]
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.
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 media) […]
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 […]
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 […]
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.
Munck Wilson Mandala Partner Greg Howison shared his perspective on some of the legal ramifications around AI, IP, connected devices and the data they generate, in response to emailed questions.
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."
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.