The Austen BioInnovation Institute in Akron, Ohio introduced a new
concept called value-driven engineering — aimed at improving U.S. global
competitiveness in biomedical innovation — at a Safe Haven Summit.
Value-driven engineering (VdE) calls for the development of innovative
medical devices that keep value-driven principles in mind. At
the summit, leaders in the biomedical industry discussed how U.S. medical
device entrepreneurs and manufacturers could incorporate VdE principles to
increase competitiveness in an increasingly global market. The leaders
brainstormed ways to weave together the principles at the core of VdE —
assurance of quality, clinical utility, reduced complexity and cost savings
— to accomplish this goal.
“Currently, U.S.-based companies lead the roughly $350 billion
global device industry. It counts for approximately 40% of the world market for
medical devices and instruments,” Frank L. Douglas, MD, PhD, president and
chief executive officer of Austen BioInnovation Institute in Akron (ABIA), said
during a press conference. “Our mission is clear – the United States
must remain competitive in the global biomedical industry for the good of our
nation’s economy and overall health.”
Increasing health care costs and competition from other world leaders in
the biomedical device industry threaten to topple America’s lead in the
health care industry, sacrificing the quality and slowing the invention of new
biomedical devices, according to the speakers at the summit. They noted that
countries such as China, India and Brazil have incorporated principles similar
to VdE into their biomedical device production to offset increasing costs,
while maintaining product quality and encouraging ingenuity.
“We know that companies in China, India, and Brazil are moving to
embrace VdE as a driver for new product development and have for many
years,” Uday N. Kumar, MD said.
Value-driven engineering would allow the United States to benchmark
similar methods used by other countries to encourage the production and
invention of quality biomedical products, according to those at the summit. The
demand for quality would be met by ensuring the clinical utility of biomedical
products and innovations by keeping the economic needs and quality of life of
patients and physicians in mind.
The speakers pointed to companies striving to meet these needs using VdE
principles and some examples of their innovations. iRhythm Technologies
invented a cardiac rhythm monitor to meet the needs of patients and doctors,
while considering cost and quality. The monitor is 8 cm wide, sticks to the
patients’ chests and records their heartbeat for up to 14 days. Patients
then mail the patch back to the physician, who uses high-tech cloud computing
to process the data. The product costs about the same as a blood test,
according to Kumar, founder and chief medical officer of iRhythm Technologies,
“In practice, this is focused on reducing the cost, improving
access, and making diagnosis earlier,” said Kumar. “All of these
things are key elements of VdE. There was no sacrifice of data, if anything,
since we’re collecting everything, and patients don’t have to do
anything with the device, which maintains quality.”
According to the speakers, other companies that developed products
demonstrative of VdE principles include Cortical Concepts and Boss Medical.
Cortical Concepts invented low-cost bone anchors for placement in osteoporotic
spine. Boss Medical developed a minimally invasive method for harvesting
autologous bone for spine fusion that saves cost, time, morbidity and outcomes,
according to the speakers.
To educate others about VdE principles, the ABIA introduced a new
national Platform to Advance VdE (PAVE). The ABIA hopes it will serve as a
roadmap to advance the use of VdE principles for improvement of U.S. standing
in the global biomedical market. The platform strives for demonstrated value,
patient-centricity, public-private funding strategies to support value-driven
device innovations and an educational focus to train future generations of VdE
The ABIA also encourages the use of the VdE principles to ensure the
value of innovations.
The ABIA recommends cooperation of the public-private sectors to fund
“I think it’s very important to focus on the public and
private engagement aspects of this for investment depending on the mechanisms
we have in place that are some of the budget-sensitive and federal funding
levels but tying in across sector human and financial capital models as
well,” Mike Hess, vice president of Innovation Excellence at Medtronic,
Inc, said during the press conference.
According to a white paper by the ABIA, cross-agency initiatives also
must be used. An example is the i6 Challenge in which federal funding of
biomedical innovations was allowed across government agencies, such as the
Department of Commerce, the Economic Development Administration, the National
Science Foundation and the U.S. Patent and Trademark Office.
The platform also seeks regulatory incentives to drive device
innovation, such as commissioning the FDA to give priority review to new
disruptive products with high VdE scores.
“The idea that some of these principles would be applied in some of
the [FDA] review criteria is one way,” Hess said. “They might even go
so far as to have a more experienced, dedicated reviewer team in the FDA be
called upon to look at these products that are disruptive and have a different
The principles of PAVE require training new engineers to continue of the
advancement of biomedical innovations. Johns Hopkins University teaches
students how to overcome health care challenges based on performance and cost
by placing them in the most difficult health care environments, according to
Youseph Yazdi, executive director of the Center for Bioengineering Innovation
& Design at Johns Hopkins.
“PAVE recognizes the need to invest and train a cadre of engineers
to apply the principles of value-driven engineering, namely, clinical utility,
reduced complexity and demonstration of cost savings to an exciting next
generation of U.S. device innovation,” Douglas said during the press
conference. — by Renee Blisard
For more information:
Austen BioInnovation Institute in Akron. White paper. Value-driven
engineering for US global competitiveness: A call for a national platform to
advance value-driven engineering. June 2011.
June 22, 2011
The embodiment of the white paper calls for the development of a
national platform to ensure that creative and innovative steps are taken to
maintain the United States’ lead in developing safe, cost-effective and
clinically beneficial medical devices. In 2009, orthopedic products accounted
for more than $37 billion in global sales, with the United States enjoying 60%
of this market. This is a percentage that is being challenged by evolving
technological bases in Asia, India and Brazil where manufacturing costs are
significantly less than our own and product reliability is increasing. The
quandary facing the United States is how this challenge will be met.
|A. Seth Greenwald|
The current hurdles do not lie just with innovation, but in the
processes of regulation and reimbursement. It is debilitating to corporations
who incur not only product development and manufacturing costs, but the add-ons
imposed by surrogates knowledgeable in product approval pathways, agency
application fees, product excise taxes and liability protection as well as the
time lag between concept and product sale. The white paper is an attempt to
recognize these challenges and encourage the government to begin developing a
long-term strategy that involves the education of future innovators, the
investment of dollar support to promote innovation, the continuous realignment
of government policy that assists global competitiveness, as well as the search
to identify markets and needs.
At the end of the day, value-driven engineering should continue as it is
engrained in the American psyche to be the “firstest with the
mostest” but the stakes are much higher. We must not be a nation of
innovators only to have the endpoint products manufactured elsewhere or not at
— A. Seth Greenwald, DPhil
Orthopaedic Research Laboratories, Cleveland
Greenwald has no relevant financial disclosures.