Kauffman Foundation sponsors National Conference on Value-driven Engineering

Researchers, health care engineers and medical device experts gathered this week for the inaugural National Conference on Value-driven Engineering to Improve Medical Innovation for U.S. Global Competitiveness assembled by the Austen BioInnovation Institute in Akron (ABIA) and sponsored by the Ewing Marion Kauffman Foundation. Experts from some of the nation's leading biomedical device engineering companies and research institutions advised the U.S. healthcare device industry to accelerate innovation by changing their approach to research and development.

For nearly a year, members of a national steering committee, led by ABIA, have promoted Value-driven Engineering as a strategy for medical device development that embraces simplicity while advancing quality and improved, patient-centered care as a way to promote innovation, value and efficiency across the healthcare system. The process marries American creativity and innovation that aims to advance U.S. medical device development past the trends of other countries like China, India and Brazil who are focused on frugal and reverse engineering.

Different from frugal engineering, which focuses on reduced manufacturing costs, Value-driven Engineering focuses on improved clinical utility and reduced complexity to the end user, as well as value and cost efficiency across the entire healthcare continuum. The Value-driven Engineering approach is critical to the U.S. medical device sector's ability to remain a global leader, said Dr. Frank L. Douglas, president and CEO of ABIA, a unique collaboration of leading Akron institutions.

"We must, as an industry, adopt new approaches to understand 'value' and how it should be measured to accelerate innovation and improve patient care," Dr. Douglas, who chairs the Value-driven Engineering national initiative, said. "This conference attracted top medical researchers and engineering talent. It is another valuable step down the path of widespread acceptance of Value-driven Engineering principles in the biomedical device industry."

During the two day conference, attendees heard from:

• Dr. Thomas Fogarty, Fogarty Institute for Innovation: "Value Collaboration between Physicians and Engineers"
• Dr. Robert E. Litan, Ewing Marion Kauffman Foundation: "The Importance of Harnessing Bid Data with Respect to Defining the Value Equation"
• Mike Hess, Medtronic Inc.: "What Value-driven Engineering Means to the Medical Device Industry"
• Dr. William J. Heetderks, National Institutes of Health: "The Role of Federal Funding Agencies in the Adoption of Value-driven Engineering"
• Dr. DeVon W. Griffin, NASA Glenn Research Center: "NASA's Need for Less Complex Medical Devices"
• Megan Moynahan, U.S. Food and Drug Administration: "Regulatory Innovation Pathway"
• Dr. Marc S. Penn, FACC, Summa Health System: "Clinical Utility to the Clinician"
• Stephen P. Welby, U.S. Department of Defense: "DOD's Value Engineering Initiative"

One of the conference's highlights was presentation by students of real-world Value-driven Engineering project, including:

• A team of students from Johns Hopkins University Center for Bioengineering Innovation and Design, who won the conference grand prize for case studies, created an ultraportable, easy-to-use fetal heart rate monitor. Every year, approximately 1 million stillbirths occur and nearly 99% of these newborn deaths are in developing countries. One major cause is the lack of monitoring of the baby's status during labor. The student team's battery-powered device uses a portable microphone with a modified attachment and a smartphone to display fetal rates prior to delivery. Though Doppler monitoring devices have been proven to be more effective, they are not widely available due to their prohibitively high cost.
• A team studying at Virginia Commonwealth University, who helped develop an easy to assemble operating room table. The affordable, easy-to-use table will improve healthcare in surgical rooms around the globe.
• A lower-cost, high-value and quality medical device developed in collaboration with Johns Hopkins School of Medicine that can save the lives of babies with an ailment called Hypoxic-Ischemic Encephalopathy (HIE), an asphyxial event which occurs in three of 1,000 live births and causes death to 10% to 60% of affected infants. The device essentially is a "pot-to-pot" method, where a larger clay pot lined with nearly 5 cm of sand contains a smaller pot, in which a patient will be placed for therapeutic cooling. The experimental results indicate that the "Cooling Cure" is more efficient at cooling than the existing technology. In addition, the clay pot device costs $100 to build, which is less than 1% of the cost of the state-of-the-art device.