Comments on FDA Public Workshop, Identifying Unmet Public Health Needs and
Facilitating Innovation in Medical Device Development
July 23, 2010
The Juvenile Diabetes Research Foundation (JDRF) places great importance on medical
device innovation. Through its work on the Artificial Pancreas Project to advance the
development and availability of automated systems to deliver insulin based on real-time
changes in blood sugar levels, JDRF has engaged with numerous federal agencies and
nongovernmental institutions to advance research, regulatory approval, and health
insurance coverage which are critical to innovation in device development. We applaud
the Food and Drug Administration (FDA) for convening the Council on Medical Device
Innovation and for holding the public workshop last month, Identifying Unmet Public
Health Needs and Facilitating Innovation in Medical Device Development, to identify the
most important unmet public health needs and the barriers to the development of medical
devices that can cure, significantly improve, or prevent these illnesses and injuries.
Below we offer a few specific suggestions based on our experiences. We are also happy
to work more broadly with the Council to identify other ways the Federal Government
can impact device innovation.
There is a great unmet public need for improved devices for the treatment of diabetes.
Over 24 million Americans have diabetes, which costs our nation over $174 billion a year
in health care costs and lost productivity. It is a leading cause of heart attacks, blindness,
amputations, seizures, comas and death – all public health problems that could be
prevented with innovation in diabetes devices.
The Federal Government can encourage device innovation in a number of ways,
including:

Research – Proof of concept trials are an essential stage in the development of
innovative new devices, but many barriers slow the funding and launch of these
efforts. We encourage federal agencies to fund this type of early-stage research.
Some success stories in diabetes are funding by the National Institutes of Health
(NIH) of artificial pancreas research and funding by the Department of Defense
(DOD) of glucose monitoring research.

Regulatory – For proof of concept trials to be timely and successful the
regulatory system needs to encourage them. Regulatory flexibility should be
provided to advance innovation while protecting the safety of patients instead of
holding them to the same standard as trials to support marketing authorization.
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Additionally, the convergence of wireless communication and healthcare
technology is an important focus of innovation for diabetes devices. A welldefined regulatory framework between the Federal Communication Commission
(FCC) and FDA to clarify regulatory requirements and the approval process for
these devices is needed to foster that innovation and make the devices available
to patients.

Reimbursement – For better devices to improve the public health, patients need
to have access to them. Reimbursement is essential for access, and billing codes
are essential for reimbursement. Billing codes or “HCPCS” codes, which are set
by a Centers for Medicare and Medicaid Services (CMS) panel, are only done so
once a year, a schedule which can significantly slow the adoption of innovative
new devices. For example, continuous glucose monitors which have been shown
to dramatically improve diabetes outcomes were first approved by FDA in the
summer of 2005, but codes were not in place until January 2008. We encourage
more frequent review of codes to promote adoption of device innovation.
JDRF is the worldwide leader for research to cure type 1 diabetes. It sets the global
agenda for diabetes research, and is the largest charitable funder and advocate of diabetes
science worldwide. The mission of JDRF is to find a cure for diabetes and its
complications through the support of research. Since its founding in 1970 by parents of
children with type 1 diabetes, JDRF has awarded more than $1.4 billion to diabetes
research, including $101 million last year.
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