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.”[1]
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.
[1]
Douglas, Frank L. “Innovation and value-driven engineering.” Nature Reviews Drug Discovery, vol. 11,
May 2012, p. 335.
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