Medical device companies have long been accustomed to performing extensive research and development activities as part of their product development processes. Among start-up device companies, R&D is typically the earliest activity that requires significant funding from outside sources. And among mature companies, R&D funding is a key indicator of future performance.

In the past, such company activities focused on establishing a solid demonstration of safety and efficacy sufficient to gain regulatory permission for market entry. Whether in bench testing, simulated environments, animal models, or clinical trials, research into the performance of new medical devices has historically been narrow in scope. With the emergence of healthcare reform imperatives, however, all of that is about to change.

The medical technology industry clearly faces an evidence-based future. Health policy experts, legislators, and regulators have proclaimed loudly and often the need for the United States healthcare system to implement the lessons of medical research, and to move toward a more acceptable ratio between outcomes and costs that is comparable to systems throughout the European Union. There, life expectancy continues to rise, even though the share of gross domestic product (GPD) used for healthcare remains significantly lower than the healthcare share of GDP in the United States. Such glaring differences are driving increased pressure for robust, evidence-based change.

Who will supply this evidence? As it stands today, the Goliath in generating research will be the federal government. Other voices may well be lost among its cudgel-like pronouncements. Will government research have an overt, or hidden, agenda to elevate cost concerns above others? Will its findings be accepted by patients and physicians who learn that their diagnostic alternatives and therapeutic choices are no longer to be paid for?

Our experience at InHealth, which was founded by AdvaMed (the Advanced Medical Technology Association) and is funded by charitable support from the medtech industry, suggests that skepticism may well accompany the government’s findings. InHealth has put in place serious measures to ensure that its university-based grantees independently measure the effects of medical technologies and do not argue to produce a preferred conclusion. Yet despite the stellar reputations of the investigators and universities InHealth funds, questions and eyebrows still are raised.

So, if funding source is a basis for looking askance at research findings, can federally funded studies be objective? That same government has embarked on reforms aimed at cutting costs—in an environment of soaring budgetary deficits and enormous political pressure for spending elsewhere—and even if its science is reliably conducted, its interpretations and conclusions seem destined for political influence. The result is unlikely to encourage the flow of innovative and life-saving technologies, and medtech and diagnostic companies in particular had best be prepared for the consequences.

Reform-era research

New attitudes about the need for a broader approach to healthcare research have been a long time in the making. In the United States, they were given a significant boost with the February 2009 enactment of the American Recovery and Reinvestment Act of 2009 (P.L. 111-5), which provided $1.1 billion for federally directed comparative effectiveness research (CER).

Such thinking was carried over into the Patient Protection and Affordable Care Act (PPACA; P.L. 111-148), the historic U.S. healthcare reform legislation enacted in March 2010. With some of its provisions planned for rollout years into the future, America’s reform legislation remains a work in progress, and may need to survive still further revisions should the Republican Party regain control of either or both Congressional chambers this fall.

Nevertheless, medical product developers should give heed to the trends embodied in this landmark legislation, as they will certainly have an impact on the development of future medical technologies.

Future centerpiece: CER

A key creation of the reform legislation is the Patient-Centered Outcomes Research Institute, a nonprofit corporation that will build on the experience of existing government agencies to make comparative effectiveness research (CER) the centerpiece of health policy. The new institute will be blessed with a broad-based board of healthcare sector representatives, plus a methodology committee devoted to improving the science of comparative effectiveness.

However, CER has a way to go before it will be ready to assess the full value of complex medical technologies. In drug research, for instance, variance in patient effects deemed ‘treatment response heterogeneity’ may result in an otherwise effective drug having harmful effects in some subjects. In medical device research, such patient variance offers an opportunity for incremental innovation, creating products with distinct features. There is a gulf between ‘treatment response heterogeneity’ and ‘beneficial product features’ that CER must yet negotiate.

Continue to next page