• 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”

• 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.

• Thomas Fogarty, MD, Fogarty Institute for Innovation: “Value Collaboration between Physicians and Engineers” 
• Robert E. Litan, PhD, 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” 
• William J. Heetderks, PhD, MD, National Institutes of Health: “The Role of Federal Funding Agencies in the Adoption of Value-driven Engineering” 
• DeVon W. Griffin, PhD, NASA Glenn Research Center: “NASA’s Need for Less Complex Medical Devices” 
• Megan Moynahan, U.S. Food and Drug Administration: “Regulatory Innovation Pathway” 
• Marc S. Penn, MD, PhD, FACC, Summa Health System: “Clinical Utility to the Clinician” 
• Stephen P. Welby, U.S. Department of Defense: “DOD’s Value Engineering Initiative”

AKRON, Ohio, February 8, 2012 – A new community-wide collaboration to reduce the impact of chronic disease and empower patients is generating impressive early results, leaders of the Accountable Care Community (ACC) initiative said today.  The Akron-based Austen BioInnovation Institute in Akron (ABIA) is leading the initiative with its founding institutional members and more than 60 public and private community partners.

The groundbreaking effort supported by the Centers for Disease Control and Prevention unites medical, public health and social science professions, nonprofits and faith-based and community organizations for an “all-hands-on-deck” approach to public health. Eventually, communities across the country will be able to apply this new model toward public health, reducing the tremendous negative impact chronic disease has on their economies, said Dr. Janine Janosky, head of ABIA’s Center for Community Health Improvement, who is leading the effort described in a white paper released today.

The news comes just weeks after an Institute of Medicine report called for a new public health approach based on “enhanced collaboration among the public health, health care and community non-healthcare sectors” to address the challenges of chronic disease. The World Health Organization refers to the growing impact of chronic disease as "a global epidemic" reaching crisis levels. The Robert Wood Johnson Foundation estimates that by 2030, half the U.S. population will have at least one chronic condition.

The ABIA, along with national experts and more than 60 Akron organizations, have been collaborating for more than a year on a new, integrated, and measurable strategy to community health that could be replicated in other U.S. communities. The ACC approach detailed in the report “Healthier by Design: Accountable Care Community” utilizes a unique “impact equation” that measures the benefits of a seamless approach to community health, including metrics for a patient empowerment and market value of health, said Dr. Frank L. Douglas, ABIA president and chief executive officer.

"The amount spent on healthcare and health initiatives in the United States should translate into good health for the community and its residents.  Unfortunately, America’s public health continues to lag behind other nations.  Further, we are now in an era of debate about how to reverse the unsustainable cost trends and improve the health outcomes and quality of life for our fellow man," Dr. Douglas said. “The development of this inventive Accountable Care Community model, which not only speaks of the need for collaboration but actually enables all parties to be on the same page with an integrated, measurable strategy, promises to improve the health of millions of patients.”

In Akron, the ACC approach uniquely aligns public, private and philanthropic resources in a coordinated fight to improve community health by identifying and closing gaps in health education, access and delivery. The group’s initial pilot project focused on diabetes self-management. Ultimately, participants changed their behaviors and took increased control over their disease.  Significant results included decreases in blood sugar and bad cholesterol levels, weight loss, decreased body mass, and a decline in emergency room visits. An additional program demonstrated nearly a total of $225,000 of cost savings or cost avoidance for local healthcare institutions through the use of volunteers and community services to monitor and serve low-income, medically underserved patients with diabetes.

The ACC measured the improvements using a unique health and public health-based formula that calculates impact based on changes in patient health, the number of patients affected and the burden of the disease as determined by the cost of care. The Impact Equation outlined in the white paper is a new and crucial way to evaluate community health initiatives, Dr. Janosky said.  “The equation is crucial to a sustainable effort that other communities can implement,” she said.

The vast majority of cases of chronic diseases are caused by a small number of known and preventable risk factors, including unhealthy diet, physical inactivity and tobacco use, Janosky said. “We are convinced a collaborative approach to enhance patient empowerment and improve personal lifestyles will address the community challenges of chronic disease,” Janosky said.

"The Austen BioInnovation Institute in Akron’s Accountable Care Community is taking an important step to improve public health in Summit County by studying the best means of treating and preventing chronic diseases while reducing overall costs. Dr. Frank Douglas, Dr. Janine Janosky, and the sixty partners involved with the ACC are to be commended for their collaborative approach to improve the health and well-being of local residents and communities by uniting public health professionals and the clinical community," said Senator Sherrod Brown of Ohio.

“We believe that our model of an all-inclusive approach to empowering patients and coordinating and improving access can be replicated by any community by first starting the conversation about what priorities matters most to your communities," said Dr. Cynthia Capers, Emeritus Professor and former dean of The University of Akron College of Nursing. "Once you identify your priorities and targets, then performance measurement is an important cornerstone."

In the next phase of the ACC development, organizers will foster community health leadership development, investigate regional health programs, analyze the impact of new health policy such as tobacco-free living, active lifestyles and healthy eating and identify areas of greatest need in Summit County.

"Building a responsible partnership between the clinical care professionals and public health colleagues is a key to success,” said Dr. Hugh Tilson, adjunct professor of Public Health Leadership, Epidemiology and Health Policy, University of North Carolina and adjunct professor of medicine, Duke University, who contributed to the white paper. “Particularly exciting for me as a career public health professional is to witness the strong functional collaboration between the local public health agency and the accountable care organization – a true model for the accountable caring community. I know this is the winning formula for our reformed health care system, with the emphasis on health.”

According to Dr. William Keck, past president of the American Public Health Association and retired City of Akron Director of Health, "Although chronic diseases are among the most common and costly health problems, we know that they are also among the most preventable. It is vital that the increasing importance of chronic disease is anticipated, understood and acted upon urgently. This requires a new approach by both medical and community health professionals, and community leaders, who are in a position to strengthen chronic disease prevention and control efforts."

To learn more about the ACC initiative and download the whitepaper, visit www.abiakron.org/acc.

About the Austen BioInnovation Institute in Akron
The Austen BioInnovation Institute in Akron (ABIA) – an exceptional 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 strategic alignment of public and private support, accompanied with Akron’s rich legacy in materials science, is working to pioneer the next generation of life-enhancing and life-saving innovation that will transform Akron into a model for biomedical discovery and enterprise and move the region toward a secure economic future by accelerating the creation of more than 2,000 jobs during the next decade. For more information about ABIA, please visit www.abiakron.org.

– 30 –
Media Contact: 
Scott Rainone
Office of Communications
Austen BioInnovation Institute in Akron
330-572-7581, srainone@abiakron.org
 

###
 

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, 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 biomaterials solutions for patients with orthopaedic and wound healing problems, nationally distinct in improving health outcomes with a focus on the medically underserved, and recognized for the use of simulation technologies to improve the education of the healthcare team. 

WASHINGTON, D.C., Dec. 15, 2011 – Austen BioInnovation Institute in Akron (ABIA) and the U.S. Food and Drug Administration (FDA) have entered into a ground-breaking collaboration to support and develop regulatory science for the safe and effective use of biomaterials in medical devices.

Effective today, the FDA and ABIA executed a Memorandum of Understanding that will allow the FDA to draw upon ABIA resources—including a library of test methods for crystalline polymers and advanced methods of nanoparticle-based surface defect detections—to develop combinatorial and high throughput methods to support the FDA's safety review of biomaterials used in medical devices. 

Working with the FDA, ABIA will identify and convene a steering committee to guide a process for scientific and intellectual collaborations, outreach, and education initiatives. The steering committee will create a path for joint education and research meetings, and support research collaborations in applied biomaterials, including ways to share unique facilities and equipment specific to the review of biomaterials. The formal Memorandum of Understanding is the first between the FDA and the Akron, Ohio-based ABIA.

“The FDA can better fulfill its commitment to protect and promote public health if it draws upon the intellectual resources, laboratory capacity and research capabilities that reside in academic centers such as ABIA," said Dr. Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health. 

“Our partnership with ABIA will advance regulatory science by augmenting our capacity to examine and better understand engineered tissues, polymers, and coatings and to detect nanoparticle surface defects,” said Shuren.

“We have been impressed with the tremendous professionalism and openness of the Center of Devices and Radiological Health team in working with us to establish this partnership,” said Dr. Frank L. Douglas, ABIA President and CEO. “Given the rapid advances in the technology and development of biomaterials, we anticipate that ABIA will be able to bring sophisticated technologies to the FDA, enhancing the agency's knowledge and expertise in regulatory science as it applies to characterizing and predicting the performance of novel materials in biomedical devices.” 

The FDA and ABIA established this partnership to develop the necessary research protocols and techniques that will standardize ways to evaluate existing or new materials, hybrids, composites and polymer-centric devices, which are anticipated to increase in the regulatory pipeline in the next few years.

The FDA establishes external collaborative partnerships as one way to help achieve their mission of protecting and promoting public health. Through FDA’s Public-Private Partnerships Program, the agency is able to leverage the expertise and resources of both the FDA and qualified parties as an "economically compelling" way to assist in making sound regulatory decisions.

The two groups said they expect to enhance the knowledge of materials development and behaviors, while increasing the capabilities that will aid regulatory agencies that classify, evaluate and monitor the safety and performance of new and existing products. The partnership is expected to generate polymer libraries in physical/structural properties; methods to characterize and predict solubility and degradation of polymers; and characterize the presence of bioactive bindings.  Further, the partnership will look at the short- and long-term durability of flexible implantable devices to determine how coatings impact medical device performance.

ABIA is a unique collaboration of Akron Children’s Hospital, Akron General Health System, Northeast Ohio Medical University, Summa Health System, The University of Akron (UA) and The John S. and James L. Knight Foundation and is focused on innovation and commercialization at the intersection of biomaterials and medicine. In addition to ABIA and its founding members, the assets involved in the agreement include ABIA's Medical Device Development Center, UA and joint ABIA-UA Akron Functional Materials Center. The partnership leverages the home of the world’s largest polymer academic program and greatest concentration of polymer expertise at UA.

About the Austen BioInnovation Institute in Akron
The Austen BioInnovation Institute in Akron (ABIA) – an exceptional collaboration of Akron Children’s Hospital, Akron General Health System, Northeast Ohio Medical University, 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 strategic alignment of public and private support, accompanied with Akron’s rich legacy in materials science, is working to pioneer the next generation of life-enhancing and life-saving innovation that will transform Akron into a model for biomedical discovery and enterprise and move the region toward a secure economic future by accelerating the creation of more than 2,000 jobs during the next decade. For more information about ABIA, please visit www.abiakron.org.
 

WASHINGTON, D.C., November 16, 2011 – Leaders within the U.S. biomedical device industry outlined a new strategy for global competitiveness, innovation and improved health care during a briefing today sponsored by the House Medical Technology Caucus.

Dr. Frank Douglas, president and CEO of the Austen BioInnovation Institute in Akron (ABIA), led a group of leaders from the corporate, academic and biomedical research sectors in describing “Value-driven Engineering” (VdE), an approach designed to enhance the development of devices that offer strong clinical utility, quality and cost efficiency for the entire healthcare system, and reduced complexity for the end user.

“Value-driven Engineering will become a key component of the nation’s drive to bolster its ‘bioinnovation economy,’ maintain global competitiveness within the $350 billion medical device industry and ensure access to device innovation that improves human health,” Dr. Douglas told the audience that consisted of Congressional staff, healthcare representatives and thought leaders.

He was joined by Dr. Carl Schramm, president and CEO of The Ewing Marion Kauffman Foundation; Dr. Uday N. Kumar, founder of iRhythm Technologies Inc. and fellowship director of Global Biodesign at Stanford University; Mike Hess, vice president of Innovation Excellence at Medtronic; and Dr. Martha Gray, professor of Medical and Electrical Engineering, Harvard-Massachusetts Institute of Technology Division of Health Sciences and Technology. Congressional members hosting the briefing included caucus co-chairs Reps. Anna Eshoo, D-Cal., and Erik Paulsen, R-Minn., as well as Rep. Betty Sutton, D-Ohio.

In his remarks, Dr. Douglas referenced a white paper his group issued in June that introduced a unique blueprint to create medical devices that are simple in design and cost effective. The blueprint, “Platform to Advance Value-driven Engineering” (PAVE), was created to guide the nation's funding mechanisms, regulatory incentives, public-private collaboration and educational leadership to incorporate VdE principles into the U.S. biomedical device industry.

“We believe PAVE has the promise to marry American ingenuity and innovation to meet a great challenge of our generation: to create a dynamic new device industry strategy that leads to better, yet less expensive health care,” Dr. Douglas said.
Dr. Schramm urged Congress to support “an extremely important effort to spur national innovation.”

“The need to improve innovation outcomes is more important than ever given the state of the U.S. economy,” he said. “We believe that this will be a tool to stimulate the bioinnovation economy, encouraging start ups and investments that will be fundamental to America’s future economic growth.”

Dr. Douglas and his colleagues initiated the effort around VdE in March, when they convened a national Safe Haven Summit in Washington, D.C. Industry-leading organizations including the Cleveland Clinic, Johns Hopkins University, Massachusetts Institute of Technology, Mayo Clinic, Medtronic, Orthopaedic Research Laboratories, Stanford University and The University of Akron participated.

To determine how best to implement the VdE approach nationwide, biomedical sector leaders will hold an industry summit in Akron, Ohio, in April. Hundreds of executives and researchers in the biomedical device sector are expected to attend to discuss VdE and how to apply it using the PAVE blueprint.
“To remain competitive, biomedical companies in the United States must begin to adopt Value-driven Engineering principles throughout their innovation processes,” Dr. Kumar said during the briefing. “This will be one of the main ways for U.S. healthcare companies to continue to be at the forefront of medical device innovation, to maintain America’s status of being a major net exporter of medical technologies, and to create jobs in various sectors, including engineering and manufacturing, across the United States.”
Medtronic’s Hess also spoke in favor of a new approach to biomedical innovation.
“I have seen the barriers to bringing new medical devices to market and witnessed the life-changing moment when a new therapy, once commercialized, is introduced to a patient in need and changes the way a disease is treated,” Hess said. “PAVE integrates the best of American ingenuity and innovation.”
Dr. Gray supported the role VdE could play in the nation’s biomedical field.
“America is the leader in biotech innovation, and our graduates look forward to productive and lifelong careers in this industry,” she said. “To maintain that leadership and opportunity, American engineers need to become world leaders in Value-driven Engineering.”

(The white paper can be found at http://www.abiakron.org/valuewhitepaper.)

###
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, 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.

The program was launched by the ABIA and University of Akron College of Business Administration in January 2011, and accepted 16 students working on seven innovative technology projects.  The aim of the program is to increase the number of woman entrepreneurs in burgeoning technology fields, and to facilitate commercialization of novel biomedical and alternative energy technologies in Akron, Ohio.

"The Dominion Foundation is proud to be a part of a program that will help to generate innovative new businesses that will enhance the Northeast Ohio region" said Terry Bishop, Philanthropy Manager for The Dominion Foundation.  "These partnerships, ABIA and The University of Akron, as well as other funders, certainly set an example in how we all need to value entrepreneurship and what it means for our future."

The second course is scheduled to take place through The University of Akron College of Business Administration during the 2012 spring semester.  A public informational session will take place on Wednesday, October 26 from 5:00 to 6:00 p.m. in UA’s Taylor Institute (Room 765). 

Projects admitted into the program are those with the potential to be spun into a company, or licensed within 18 to 24 months.  Once accepted, teams are exposed to a comprehensive business curriculum, mentoring by industry leaders and real-world experiences in order to advance their ideas to actual business concepts.

“Both during and after the program, we were surrounded by resources and experienced entrepreneurs who were more than willing to answer our questions and help us in our business endeavors,” said Courtney Gras, a graduate of The University of Akron whose team is targeting the battery industry with a solution to the alternative-energy storage problem.  “The program really helped us to build our network and get integrated into the Northeast Ohio business culture.”

Kelly Mackey, another University of Akron graduate who completed the pilot course, noted how her team’s idea for an artificial connective tissue advanced with the help of the program.  “At the start of the program, our idea was pure concept and over the course of the program we refined it to a product idea that would not only fulfill needs in the marketplace, but displace older methods and provide better recovery for patients,” Mackey said. 

Teams that completed the course in April continue to flourish from the program’s existence.  Gras and her partner recently formed a limited liability company, have been pursuing local business competitions while perfecting their prototypes and were approached by a local company interested in initiating a joint venture.  “This is a very exciting start for us” said Gras. 

Mackey and her partner, Jessica Kemppainen, continue to work on their project in the lab.  While there is still work to be done on their concept before it can be commercialized, she noted that “the benefits of the Women’s Entrepreneurship Program did not end with this idea, but provided an educational foundation for pursuing other ideas in the future.”

Christine Flick, a senior design engineer for the ABIA’s Medical Device Development Center (MDDC) who completed the pilot course with a project that would lead to faster suturing was recently awarded additional funding through the ABIA’s Technology Development Fund (TDF).  The newly awarded funding will be used to create a prototype for her team’s device.