Changing Times Raise Barriers to Device Innovation
While legal considerations play a role in determining if or how soon use of a medical device is adopted, other factors are now just as important and in some cases more important in influencing a provider’s product selection process.
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In many US hospitals, materials, purchasing, and supply chain executives often have the clout to influence thumbs-up or thumbs-down decisions on most new products that enter the building. That is one major reason why medical device manufacturers are waking up to the fact that so-called "me-too" items and minor upgrades to existing products aren’t as acceptable to hospitals as they once were. But in the evolving market in materials office supplies, smart manufacturers with a clear path to working alongside materials executives offer products that keep costs down, add to patient safety, and enhance patient care.
At the recent Stanford Center for Cardiovascular Technology Annual Symposium 2010, hosted by Stanford University's Peter Fitzgerald, MD, PhD, and Alan C. Yeung, MD, one of the newest buzzwords in medical device development was "negative innovation". Increasingly, executives, particularly at big companies, are coming around to the notion that in the future, a product development model that posits that incremental device innovation will continue to be rewarded with premium pricing and wide adoption won't hold anymore. Instead, they argue, in a world in which health care costs are scrutinized ever more closely and initiatives like comparative effectiveness bring cost and quality into the same discussion, the US health care system will begin to favor a new kind of value proposition: devices that reduce costs, while delivering equivalent, and perhaps in some cases even slightly worse, outcomes.
Ideally, the studies would be underway at the time of approval, as the US FDA’s new authority allows, but Office of Therapeutic Products Director Nicole Verdun sys there will be exceptions.