By Candace Littell.  One of my favorite techniques in movies and television is the “flashback” – a scene that takes the main story back in time in order to recount events leading up to the present.  Often viewed in chronological order, flashbacks form and develop the present story, scene or character.

The concept of flashback came to mind as I recently reviewed a new, innovative medical technology which I refer to here as NewPro. While I could of course understand NewPro as it existed today, I had no background in how it had come into being.  What were the events leading up to its introduction?  Out of the thousands of medical device and diagnostic products that are developed each year, why did NewPro make it to market while others did not? What factors were responsible for its development? 

Experience tells me that the circumstances and events leading to the development of NewPro are likely similar to those surrounding innovation for the vast majority of other medical technologies. 

Like many other medical technology innovations, especially breakthrough or new technologies, NewPro would likely have found its origin in a small or start-up company.  Backed by venture capital and sometimes in partnership with larger companies, these smaller firms often play a unique role in early stage development.  As efforts to bring NewPro to market progressed, the company may have been acquired by a larger firm that could navigate the later stages of the innovation process and introduce the product into medical practice.  A larger firm would also possess the necessary resources for ongoing product refinements and improvements.

NewPro would likely have followed a process of innovation consisting of four elements.  It began with an invention, an idea that medical care could be improved or performed in an entirely different way.  Invention led to development of a model of the product, a so-called prototype. Then development began, where clinicians and company engineers performed testing and evaluation, and refinements were discovered and integrated into product design.  This stage concluded upon regulatory approval for marketing.  Once cleared for marketing, adoption into clinical practice began.  Here, in the process of product diffusion, health care providers and payers determine that NewPro is worth adopting.  Finally, as adoption occurs, innovation begins anew, as the process of feedback yields product refinements and new clinical applications.

Behind this apparent structured process, however, I expect there was much variability in the development of NewPro. Lines between the stages of innovation would blur, and the process would proceed in a non-linear fashion.  Innovation might not proceed smoothly and continuously from concept to product.  It might start and stop.  Product testing would generate new information that redirects the course of product development.  More data, more experience, and more interaction with users could yield information vital to NewPro’s refinement.  And the uncertainty surrounding this process may have resulted in skepticism and resistance, both within the company developing NewPro, as well as among product users, government regulators, payers, and investors.  Close collaboration among many parties was critical – perhaps clinicians, researchers, universities, government agencies, company or industry experts and others – in order to transform what was an idea into a viable medical product.  Through this “dialogue of device innovation” NewPro emerged in form and clinical application. (more…)

President Obama’s 2011 HHS budget builds on the American Recovery and Reinvestment Act (AARA) investment in federally qualified health centers (FQHCs), providing an additional $290 million for further expansions.  With this increase, the administration estimates that health centers will be able to serve more than 20 million individuals in FY 2011.

Combined with other AARA provisions, this is good news for some of our nation’s “safety net” providers, including FQHCs, as well as public and nonprofit hospitals that treat many low income patients.  But there’s also a growing hole in the safety net as free medical clinics struggle to survive the current economic recession.

In a recently released research brief on safety net providers by the Robert Wood Johnson Foundation’s Center for Studying Health System Change^[1], the authors note, “while many FQHCs have benefitted from both the recent ARRA funding and federal expansion grants over the past 10 years, many free clinics without FQHC status were facing more serious financial strains than safety net hospitals and FQHCs.”  The report goes on to quote one FQHC executive as saying, “FQHCs got money, and free clinics are worried about keeping their doors open…There’s a big have and have-nots disparity.”

FQHCs include community health centers, public housing centers and some outpatient programs.  These providers receive federal payments for qualified services and are eligible for stimulus funds and federal expansion grants.  In contrast, free clinics do not receive federal payments and they are not eligible for funding available to FQHCs.  Instead, they depend primarily on private philanthropy and a team of volunteer physicians to provide care to the uninsured.

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