Medical device leaders call for value-driven innovations to improve US global competitiveness

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.”

Offset health care costs

Increasing health care costs and competition from other world leaders in the biomedical device industry threaten to topple America’s lead in the healthcare 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.

Design innovations

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, Inc.

“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.

PAVE

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 leaders.

The ABIA also encourages the use of the VdE principles to ensure the value of innovations.

Funding

The ABIA recommends cooperation of the public-private sectors to fund product innovations.

“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 approach.”

Training

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

Reference:

• 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. www.abiakron.org/vde. Accessed 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.

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 all.

— A. Seth Greenwald, DPhil (Oxon)
Orthopedics Today Editorial Board member
Orthopaedic Research Laboratories
Cleveland
Disclosure: He has no relevant financial disclosures.