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?

While the US has traditionally been seen as the medical device market with the largest potential, regulatory and reimbursement risk factors are volatile.   The last year has seen a shakeup in leadership at CDRH and questioning of 510K practices, notably in the RenGen case.  As entrepreneurs and investors know all too well, having unknown and inconsistent sources of risk can be deal breakers for a venture.  Without knowing the impact that healthcare reform will have on top of the current tumult, there are many unknowns in the large US market.  Alternatively Europe has a smaller overall market but with more definition, and the emerging BRIC markets have large growth rates but their own inherent risks.

So what can be done?  According to an interview with Newsweek’s Howard Fineman, the government is actively engaging stakeholders in the healthcare system.  This includes industry groups (including AdvaMed), physician groups, hospital groups, insurance groups, etc.  Understanding the positions being drafted are important, as is getting involved in the discussions, at any level.   Furthermore, entrepreneurs and investors are going to have to stay creative in the strategic choices made and directions taken.

As innovators, thought leaders, and practitioners in the healthcare industry, issues such as this are relevant to the current and future status of individual endeavors.  As stakeholders on a personal and professional level, it is important to be aware of the debate.  The choices being made will have a tremendous impact on innovation, economic development, level of patient care, and the system in which physicians work.  Thoughts and comments are welcome, as this post is meant to stimulate debate.


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