By Tim Pelura
In the present era of affordable and accountable healthcare, how that care is delivered and managed has come under tremendous pressure – and cost containment is the order of the day. Likewise, the role of technology in the care continuum has been confronted with increasing scrutiny. Given this heightened level of risk and uncertainty, how can medical technology innovators improve their prospects for success?
In the past, demonstration of safety and efficacy was often sufficient to get a new product to market. In today’s world, however, innovators must take a broader view. A definitive power shift to payers and providers means that approval of new therapies will increasingly be predicated, to some degree, on outcomes analysis, including an assessment of cost and value. Under the expanded influence of payers, new healthcare delivery models are evolving and the large volume of data these payers have access to is being leveraged to identify patient care pathways that obtain better outcomes with lower costs – garnering a clear advantage to technologies that can deliver verifiable savings. Thus, our new reality of healthcare demands that innovators cultivate a focus on the principals of value and demonstration of outcomes advantage. 
In some regards this new reality has hampered innovation in the industry. Intensified pressures from regulatory and reimbursement fronts have clearly amped-up risk and, as a result, companies are dialing back their R&D initiatives to focus more on incremental improvements to current devices rather than development of truly innovative new products. Moreover, start-ups and small companies, critical engines of medical device innovation, are finding it increasingly difficult to fund the escalating costs associated with bringing new technologies to market. However, given our current predicament of rising healthcare costs and constrained resources, there is a critical need for value-driven innovations that enable greater cost efficiency. This represents a real, albeit challenging, opportunity for scientists and entrepreneurs who have the know-how to embrace the new paradigm. (See the sidebar for essentials of value driven innovation.)