by Kristin Schneeman, Program Director, FasterCures
FasterCures is increasingly interested in the impact that reimbursement decisions, by the federal government and private payers, are having on biomedical innovation upstream.
Developers of new drugs and devices are getting the message that it is no longer sufficient to have a novel product that’s safe and effective and gets through FDA; if the payers won’t pay, your product will flop. For better or for worse, more companies are consulting with payers earlier and earlier in the research process to ensure that they are developing the kind of evidence that will maximize the likelihood that their products will be covered by insurance.
These themes were at the top of the agenda at a recent conference on “value-driven engineering” (VdE), hosted by the Austen BioInnovation Institute in Akron (ABIA) April 23-24. As described by ABIA Founder Dr. Frank Douglas, this is “a way to simultaneously reduce health-care costs while catalyzing innovation in medical devices,” though he considers the concept to have application in the realm of pharmaceuticals as well. The key principles of VdE are “clinical utility driven by patient-centricity in demand, design, use, and function; reduced complexity in product design, and cost savings and efficiency across the health-care system.”
I found one of the most thought-provoking sessions to be the one on “Clinical Utility and Patient Centricity.” Debra Lappin of FaegreBD Consulting delivered an eye-opening view of “the patient as design engineer,” highlighting the experiences of famous patients, such as the painter Pierre-Auguste Renoir, along with her own battle grappling with the debilitating effects of rheumatoid arthritis. She made a forceful case for the importance of putting the patient at the center – in fact and not only in words – of policy discussions about how to create more innovative approval pathways at FDA, and balancing risks and benefits of new therapies.
She was followed by Reade Harpham from Battelle, who provided fascinating insight into their product design process, which consults patients about their needs and preferences at every step along the way – including, for example, research on YouTube that has turned up videos of patients showing others how to disable the safety features of injectors in order to make them more useable. Developers and regulators who do not understand patients’ needs first-hand are working in the dark, no matter how much scientific expertise they may have.
Other speakers during this session discussed how to improve utility to clinicians, another key factor in achieving adoption, the critical step beyond even reimbursement. For instance, improving clinical workflow, or being able to move complex procedures out of hospitals and into doctors’ offices, are important contributors to value for clinicians.
Among the highlights of the event were the graduate students who had competed to present their value-engineered devices – an ultraportable and inexpensive fetal heart rate monitor, a lightweight and easy-to-assemble surgical table (built with parts like car jacks and yoga mats and flat-packed à la Ikea), and a cooling device for newborns suffering from oxygen deprivation made essentially of clay pots and sand. These were designed to be used in low-resource parts of the world but in all cases were nearly as effective, if not more effective, than their state-of-the-art counterparts in the developed world.
The students were astoundingly smart, sophisticated, and inspiring. And their “disruptive innovations” point to a future in which medical progress and the quality of care don’t have to be sacrificed on the altar of cost-cutting, in the U.S. or anywhere else on the globe.