Leaders in industry and academia outline a national platform to apply American innovation and patient-centered research to accelerate medical device development
AKRON, OHIO –Leaders within the U.S. biomedical device industry unveiled today a national strategy to apply “Value-driven Engineering” (VdE) to enhance the development of devices with great clinical utility, quality and cost efficiency and reduced complexity. VdE will become a key component of the nation’s drive to bolster its “bioinnovation economy,” maintain global competitiveness, and assure access to device innovation that improves human health, the leaders said.
Recognizing the U.S. leadership within the $350 billion global medical device industry, the group’s white paper, “Value-driven Engineering and U.S. Global Competitiveness” introduces a unique blueprint to marry American ingenuity and innovation with a renewed commitment to create medical devices that are simple in design and cost effective, yet support premium health care. This “Platform to Advance Value-driven Engineering” (PAVE) guides the nation’s funding mechanisms, regulatory incentives, public-private collaboration and educational leadership to incorporate VdE principles into the U.S. biomedical device industry.
“Value-driven Engineering is key to the U.S. biomedical device industry increasing its leadership position in the global health care community while continuing the innovation that improves the care of patients worldwide,” said Dr. Frank L. Douglas, President and CEO of the Austen BioInnovation Institute in Akron (ABIA). ABIA convened leaders from industry, academia and the public and private sectors during a summit in Washington, D.C. to examine VdE as a key impetus to fuel future medical device innovation in the United States. “PAVE, as we have detailed, provides an avenue for disruptive innovators to apply VdE principles to their important work.”
“The principles of VdE need to become part of our product development culture, particularly if we want to stay at the forefront of global medical device innovation,” said Dr. Uday N. Kumar, Founder and Chief Medical Officer of iRhythm Technologies, Inc. and Fellowship Director of Global Biodesign at Stanford University. “We need to preserve and protect quality, but reduce unnecessary complexity of design and focus on what is required for clinical utility and patient-centric use and function. These principles will lead to cost savings and efficiencies across health care systems, while maintaining or improving outcomes and promoting increased access to innovative new devices and services.”
At the ABIA Safe Haven Summit on Value-driven Engineering and U.S. Global Competitiveness, former House Majority Leader Dick Gephardt, now President and CEO of Gephardt Government Affairs, and Chair, Council for American Medical Innovation, responded to the call for public-private collaboration outlines in the VdE initiative. Reflecting on the model presented by SEMATECH (SEmiconductor MAnufacturing TECHnology), created in the late 1980s, Gephardt said, “SEMATECH strengthened the U.S. semiconductor industry by leveraging resources and sharing risks to solve common manufacturing problems. I am pleased to see that a similar call for investments from the government and the private sector is being made to support device innovation through Value-driven Engineering. Recommendations proposed in this white paper have the potential to help drive our nation’s vitality by generating jobs and building upon our global leadership in the biomedical device sector.”
U.S. Senator Sherrod Brown noted the leadership role the Austen BioInnovation Institute in Akron is taking in developing and implementing a new strategy for biomedical device development.
“Akron is home to world-class researchers and educators, business leaders and entrepreneurs and has earned its designation as a Hub of Biomaterials Innovation and a Center of Excellence for Biomedicine and Health Care. ABIA embodies the keys to our nation’s economic competitiveness: innovation and manufacturing,” he said. “The national strategy released today will lead to the creation of jobs in Ohio and across the country while ensuring that the United States maintains an edge in the growing biomedical industry. Thanks to the remarkable work of Dr. Frank Douglas and the many stakeholders involved, the ABIA is leading the nation in advancing the American biomedical industry. Akron is once again on the map as a world leader in innovation, collaboration, and commercialization. I look forward to hearing of the Institute’s continued progress and success.”
“Part of our success in industry relies on our ability to meet patient needs while providing a useful product that is safe, efficient and cost-effective enough for purchasers to invest in,” said Mike Hess, Vice President of Innovation Excellence at Medtronic. “We believe the adoption of these principles from all involved – whether they be in industry, academia, venture philanthropy or the public sector – will help to spur innovation in the biomedical sector.”
“A common theme throughout this effort is ensuring innovators are supported through all stages of their development – from classroom to the commercialization of innovations,” said Dr. Youseph Yazdi, Executive Director, Center for Bioengineering Innovation and Design, Johns Hopkins University. “In order to produce value-driven engineers, we must create educational environments in which our students practice Value-driven Engineering in a practical sense. In the white paper, we introduce a series of recommendations for increasing education around Value-driven Engineering focused on the development of critical partners, leveraging federal funding strategies and promoting workforce development.”
The national Safe Haven Summit that ABIA convened in Washington, D.C., in March, included participation by a number of industry leading organizations such as the Cleveland Clinic, Johns Hopkins University, Massachusetts Institute of Technology, Mayo Clinic, Medtronic, Orthopaedic Research Laboratories, Stanford University and The University of Akron.
The white paper can be found at www.abiakron.org/Data/Sites/1/pdf/abiawhitepaper6-14-11.pdf.
About the Austen BioInnovation Institute in Akron
Based in Akron, Ohio, the Austen BioInnovation Institute in Akron ‐ a unique collaboration of Akron Children’s Hospital, Akron General Health System, Northeast Ohio Medical University (formerly Northeastern Ohio Universities Colleges of Medicine and Pharmacy), Summa Health System, The University of Akron and The John S. and James L. Knight Foundation ‐ is focused on patient‐centered innovation and commercialization at the intersection of biomaterials and medicine. The institute is focused on being a global leader in discovering, developing and commercializing biomaterial solutions for patients with orthopaedic and wound healing problems, nationally distinct in improving health outcomes of the medically underserved, and recognized for the use of simulation technologies to improve the education of the healthcare team. To learn more about the Austen BioInnovation Institute in Akron, please visit www.abiakron.org.
ABIA Director of Communications