Public Policy

What We Do – The Heart of AIMBE

Among AIMBE’s most important roles is the promotion of public policies that foster continued advancement in medical and biological engineering (MBE).  We educate and influence public officials, regulators, the media and general public about the positive impact MBE has on virtually every sector of society – from human health to a vibrant economy. AIMBE advocates for legislative, monetary and regulatory solutions that assistant our engineering community at each stage of the innovation ecosystem – from the research lab to the bedside of a patient.

 

The Small Business Innovation Research (SBIR) program and the Small Business Technology Transfer (STTR) program are powerful engines for innovation and job growth. Created in the early 1980’s, these programs began to award federal research grants to the country’s best innovators — small businesses.

AIMBE has been a staunch supporter of the SBIR/STTR programs from their inception, and praised both President Obama and Congress’ bipartisan effort to reauthorize the programs last December. As part of the reauthorization, the Small Business Administration (SBA) solicited comments from the public on ways to improve the administration of the both the SBIR and STTR programs, and AIMBE leapt to the opportunity to lend its experience and expertise.

Convening a select committee of AIMBE Fellows, which represent the top two percent of America’s medical and biological engineers, AIMBE submitted a report of common sense, practical solutions to streamline the SBIR/STTR programs. The full report can be found below, but a highlight of their recommendations is to:

• Ensure that enough safeguards are put in place to prohibit grants from going to foreign owned companies by stating the number of foreign investors and the individual amounts of their equity in the business. This will ensure research is predominantly performed in the US, thus spurring local innovation and job growth.
• Dramatically reduce the time for the National Institute of Health (NIH) and the National Science Foundation (NSF) to make grant award decisions, from 12 to 15 months to 90 to 180 days. NSF and NIH are the only agencies who are allowed longer than the 90 to 180 timeline that all other federal agencies abide, which deters small business from applying.
• Prevent fraud, waste and abuse by allowing program administrators more flexibility in reviewing grants as well as implementing stricter procedures. This will prohibit “SBIR Mills” – businesses that receive grants year after year without ever producing products – from being selected.

AIMBE is again highly supportive of the SBIR and STTR programs, and submitted this report to augment their ability to help small businesses across the nation create jobs, springboard ideas and spur economic growth.
 

The Network of Experts Agreement with the Center for Devices and Radiological Health (CDRH) at the Food and Drug Administration (FDA) begin in February, 2012.

The CDRH is responsible for regulating firms who manufacture, repackage, relabel, and/or import medical devices sold in the United States. In order to better meet this responsibility, the CDRH identified a need for additional medical and engineering expertise from the broader scientific and engineering community to enhance the knowledge base of their own staff. Through the Network of Experts Agreement, AIMBE’s College of Fellows—around 1000 innovators and pioneers from the medical and biological engineering community—will be called to provide scientific and engineering knowledge to the CDRH at the FDA’s discretion. This will provide the FDA with access to leading engineers in new and emerging technologies in bioengineering to better fulfill their mission.

By partnering with the CDRH, AIMBE is committing to providing access to the College of Fellows whenever an expert is needed. Through this collaboration, AIMBE continues to demonstrate its role as a major thought-leader in medical and biological engineering.

Jeffrey Shuren, M.D., J.D., director of the Center for Devices and Radiological released this statement: “Rapid access to the expertise of AIMBE’s distinguished College of Fellows will help to broaden CDRH’s scientific viewpoints and assure that we consider the most current information on emerging fields of science and pioneering biomedical technologies related to medical devices.”

Ken Lutchen, Ph.D., AIMBE’s President added, “AIMBE is proud to be providing access to our College of Fellows, comprised of the most cutting-edge and pioneering leaders of biomedical engineering, to the CDRH at the FDA. Our mission includes building strong relationships with government agencies in order to advance the potential for medical and biological engineering to improve our quality of life, and this Network of Experts Agreement contributes greatly to that goal. We consider this a new opportunity for public service leveraging the considerable scientific and medical knowledge of AIMBE Fellows to benefit all Americans.”
 

Convening for the 7th Annual Federal Symposium, AIMBE Fellows across the country traveled to Washington, DC to meet with their Representatives and Senators to advocate the positive impact medical and biological engineering has on society. Each Fellow relayed their personal experience, whether in the lab, classroom or boardroom of how biomedical engineers are not only creating jobs, but a higher quality of life for all Americans.

Bringing with them medical devices and technologies, Fellows illustrated how federal investment in bioengineering research and development translates ideas from the lab bench to the bedside of patients. Even in these fiscally constrained times, Members of Congress and their staff were pressed that there is a direct need for sustained investment in federal R&D, as slashed funding risks forfeiting America’s leadership in the biotechnology industry to Europe or China. In addition, AIMBE Fellows conveyed the reality that erratic and slashed funding impedes the innovation pipeline, as universities and businesses lose the researchers and the brain power vital to the process of product development. At a time when health care costs continue to soar and manufacturing is shipped overseas, biomedical engineers are the entrepreneurs and innovators who are developing the products that lower health costs and are produced right here in the United States.

AIMBE Fellows made a powerful statement, and are continuing to advocate to our policy makers in Washington how medical and biological engineers are fostering healthy lives, a health economy and a healthy world.
 

Another in a series of briefings advocating for the advancement of medical and biological engineering, AIMBE held a Capitol Hill briefing celebrating the 10th anniversary of the National Institute for Biomedical Imaging and Bioengineering (NIBIB). The briefing was kicked off by a rousing address from Congresswoman Rosa DeLauro (D-CT), who was a lead advocate for the legislation that founded the Institute. “Do not let anyone discourage the work you are doing and tell you that it isn’t worth the funding,” Rep. DeLauro Stated. “Health care research is vital to our economy and vital to improving the lives of every American.”

Congresswoman DeLauro was then followed by panelists who testified that over its short ten year lifespan, NIBIB has taken concrete steps to improve health by leading the development and accelerating the application of biomedical technologies. One such technology was showcased by NIBIB grant recipient Dr. Mehmet Toner, an AIMBE Fellow and professor at Harvard. Dr. Toner showcased that through his NIBIB grant, he was close to finalizing his work that would produce a microchip to detect cancer cells. The potential of the chip is tremendous as it will allow physicians to detect cancers early, follow how well cancers are responding to treatments in ‘real time’ and develop drugs that are aimed at suppressing these metastasizing cells. In other words Dr. Toner is on the brink of an innovation that could diagnose certain types of cancer with just a drop of blood, saving millions in health care spending and improving the quality of health care.

The National Institute for Biomedical Imaging and Bioengineering has shown a clear return on investment since it’s founding in 2001, and holds great promise for future innovations in bioengineering. AIMBE will continue to host briefings and reach out to policy makers in Washington to illustrate how medical and biological engineers, and institutes like NIBIB, are revolutionizing the health care industry and improving patient care.
 

The American Institute for Medical and Biological Engineering (AIMBE) began the 112^th Session with an early congressional briefing entitled How Translational Research is Transforming Patient Care and the American Economy. The briefing informed congressional staff about one of the most exciting processes in our innovation ecosystem – how research translates an idea in the laboratory into a product that we see and use in our daily lives.

Speaking from personal experience, the panelists illustrated how federal research dollars allowed them to transform an idea into a device that improves public health.  President and CEO of Actuated Medical, Dr. Maureen Mulvihill, demonstrated how her device that unclogs feeding and decompression tubes met the needs of hospitals and clinicians who were needlessly throwing them due to the inability to effectively remove clogs.  Her product was made possible through a Small Business Innovation Research (SBIR) Grant. Biomedical Engineering Students Neil Shah and Maxim Budyansky explained how the product they are working on to extract bone marrow in a less painful and invasive method was made possible through a federal grant at Johns Hopkins University.  Among the many of things federal research dollars are funding at his laboratory in the University of California Los Angeles, Dr. Warren Grundfest demonstrated how he is working on making more efficient prostheses for wounded soldiers and individuals with disabilities.

Moreover, these panelists not only testified about how federal research helped them develop products benefiting human health, but also created jobs. Dr. Mulvihill and Dr. Grundfest shared their experience about how research impacted the entire cycle of innovation, supporting scientists in engineers in the lab all the way to workers in manufacturing plants and the businesses that make and sell their products.
 

In today’s constrained fiscal environment, every federal dollar must be scrutinized and evaluated. Funding for research and development is no different, and to inform lawmakers why investment in medical and biological engineering (MBE) is worth its weight, AIMBE hosted a briefing on Capitol Hill entitled A Clear Return on Investment: How Bioengineering R&D Fosters Healthy Lives, a Healthy Economy, and a Healthy World.

Four esteemed biomedical engineers showcased their first-hand experience of how investment in MBE leads to discoveries and innovations that improve quality of life and create jobs. Among the many innovations and technologies discussed, panelist Dr. George Pantalos captivated congressional staff with his work on cardiac devices. Holding up the very device that was implanted in Vice President Dick Cheney to maintain his heart beat, a Left Ventricular Assist Device (LVAD), Dr. Pantalos spoke about how just a decade earlier this technology was not available. He stressed that such innovations, which save lives and health care spending, are made possible directly through federal investment in bioengineering research and development.

Focusing on job creation, Dr. Youseph Yazdi illustrated how federal R&D in biomedical engineering allows students at Johns Hopkins’ Center for Bioengineering Innovation and Design to take their innovations from concept to completion. Holding up a pen, Dr. Yazdi marked a piece of paper and spoke about how his students were working on making ink from that pen a diagnostic test for diseases in third world countries. In one very inexpensive and incredibly mobile device, a doctor could carry the pen to a remote area and evaluate how a patient’s urine affects the ink to diagnose disease. This device was made possible by federal research and development grants.

Attendees were then treated to an address by the sponsor of the briefing and former AIMBE Public Policy Award recipient, Rush Holt (D-NJ). “Other countries are doing high-end development work,” Holt said. “But we do not have to lose our edge to them. We will maintain our edge only if we shake off this pessimism out there. The attitude is the US lost it edge and that we can’t do anything about it. That attitude is not what has gotten this country to where it is. And it is not how we are going to grow in the future.”