From Healthcare Policy

Med Device Tax: Punch in the Gut for Medtech Entrepreneurship

Medical devicesThe medical device tax—a 2.3% excise tax on all medtech company revenues—is a controversial element of the Affordable Care Act and has been making news recently as part of the recent budget talks on Capitol Hill. It also was recently supported in a surprisingly hostile yet uninformed New York Times Op-Ed piece, despite being one of the only issues in Washington these days with bipartisan support. See the medtech industry’s response here. In the last couple of months, the passing of a bipartisan budget with “non-binding language” supporting repeal is a good first step. Read more

Moving Forward Together: MDMA and FDA

Though he admits to feeling like a “grim reaper” at times, Mark Leahey, CEO of the Medical Device Manufacturers Association (MDMA), is “actually an optimist” about the future of the industry. One of the reasons for his optimism is the recent FDA effort of enhanced transparency and accountability led by Christy Foreman, Director of the Office of Device Evaluation (ODE) at the FDA. Last month, Biodesign Alumni sat down with both Leahey and Foreman to discuss their work, challenges, and opportunities for help. Read more

Top 5 Reasons To Audit Your Patent Portfolio In 2013

Anyone who knows what “IP” stands for almost certainly also knows the three-letter acronym “AIA.” (America Invents Act, in case you’re not one of those people.) Many companies rushed to file big boluses of patent applications before March 16, 2013, when the final provisions of AIA went into effect and the United States converted to a first-inventor- to-file patent system. But simply filing patent applications quickly is only a small part of building a strategic, valuable patent portfolio. In fact, just filing applications quickly but haphazardly when a company’s inventors toss invention disclosures over the wall is very unlikely to produce meaningful patents that yield significant return on investment. Read more

Death of a (Medtech) Salesman?

Medtech sales is being turned on its head by policy changes and the growth of Big Medicine.   Sales reps and device innovators can pivot their strategy and still be successful if they properly identify stakeholders and adapt their value proposition.

Only a few years ago, a medical device sales representative (“rep”) could establish a relationship with a clinician, convince this provider of a new product’s clinical benefit, and close a sale.  These days, throughout the medtech industry, we often hear horror stories of hospital systems taking purchasing decisions away from clinicians, large group purchasing organizations (GPOs) stifling innovation, and physician-owned distributors trying to replace sales reps. What in the heck is going on with medtech sales?

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How does the FDA affect you? Here’s why you should be concerned…

Recently, Josh Makower MD, Aabed Meer, an MD-MBA Candidate at Stanford, and Lyn Denend, a Research Associate also at Stanford published results of a survey that sought out to (1) investigate problems with medical device company interactions with the FDA and compare these interactions with those necessary for clearance in Europe, (2) assess perception of FDA versus European regulatory pathways from these companies, and (3) provide a quantitative measure of the time and cost to navigate the current FDA system.

The survey gathered data from 203 companies with 213 unique product submissions.  The participating companies represent approximately 20% of medical device companies in the US. Read more

Thoughts on the Healthcare Reform Debate

riskThis morning, the US House of Representatives is debating the current version of the healthcare bill.  As it stands US healthcare seems to be unsustainable, with increasing costs and decreasing access.  According to the 2007 census 45.7 million Americans were without health insurance during that year, with an even more categorized as under insured.  In the June issue of the New Yorker, Dr. Atul Gawande described a mismatch between dollars spent on healthcare and the level of care received in his article The Cost Conundrum: What a Texas town can teach us about health care.  Furthermore it seems that Americans are already paying a form of public option, in the form of “ER healthcare”.  BUT these are not the issues being addressed in this posting; rather the question to be raised is the impact reform is currently having on medical device innovation in the US?

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