The medical device industry likes to complain that the Food and Drug Administration's efforts to regulate its products have become too heavy handed. As it turns out, the agency is just getting started.
One big gripe about Minnesota’s medical device community is the lack of college graduates ready to hit the ground running. Speaking at a governor candidates forum last week, Vascular Solutions CEO Howard Root said finding enough workers, including quality engineers and regulatory specialists, is the “number one obstacle” facing his company. He took direct aim […]
At the Abarca Forward conference earlier this year, George Van Antwerp, managing director at Deloitte, discussed how social determinants of health and a personalized member experience can improve medication adherence and health outcomes.
If the Food and Drug Administration has been too cozy with medical device companies in recent years, as some critics charge, Uromedica Inc. must have missed the memo. Since 2000, the Plymouth, Minn.-based company has been haggling with the FDA over its balloon device to treat urinary incontinence. Ten years and several clinical studies later, […]
“We’re not here to bash the FDA,” Mark DuVal, president of Minneapolis law firm DuVal & Associates, told a group of medical device executives and investors late Wednesday afternoon. Too late. The newly formed Minnesota Medical Device Alliance billed the gathering in the downtown Warehouse District as the first step to help save the Food […]
The Minnesota Medical Device Alliance Steering Committee, made up of some of the state's most prominent investors, attorneys and executives, is hosting a meeting in February to discuss ways to push back against critics of the 510(k) program.
The Food and Drug Administration, urged by Congress, has already taken a harder line on 510(k)s. Which makes it only a matter of time before the agency, wary of another Sprint Fidelis debacle, sets its sights on PMA supplements.
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.