Though the medical device industry supports two million U.S. jobs and prices have increased below the rate of inflation, medical devices and diagnostics take up less than a dime of every dollar spent on healthcare in America, according to a new infographic released at Advamed 2013.
At Advamed 2013, industry leaders met and discussed how startups and innovation can beat the odds without much chance of gaining venture capital at an extremely early stage. Here are realistic options for medical device companies looking to fundraise early rounds without venture. 1. Raise enough for each round. Remember that truism from Mark Twain […]
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.
In her speech at Advamed 2013, FDA Commissioner Dr. Margaret Hamburg said a new challenge will be regulating in some way lab development tests. Now, LDTs are left to CLIA, which, Hamburg said, does not ensure they are properly designed, consistently assembled or clinically valid. She called for a “critical baseline” of these sorts of in […]
Cost effectiveness and outcomes drive value for payers, Cigna‘s Chief Medical Officer Alan Muney said. While some medical device companies assume an FDA approval will mean a definite reimbursement nod from payers, these two forces drive a sometimes wrongheaded “gap of hopefulness” for the industry. (See his discussion of why device companies need to think […]
Venture capital for early-stage medical device companies is drying up. At Advamed 2013, I was able to sit down and talk to Paul Grand, managing director at Research Corporation Technologies Ventures, a life sciences firm focused primarily on medical devices. When I asked him what the three main mistakes startups make when pitching him, he […]
It’s stressful. If you’re a startup, your company depends on it: it’s your FDA panel meeting. And, as Michael C. Morton, the vice president of global regulatory affairs at Medtronic (MDT), said, “It’s kinda culminated with throwing the dice.” In the “How to Avoid Making a Bad Submission to the FDA…” panel at Advamed 2013 […]
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.