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SBIR Pulse Interview #9
SBIR Awareness Day on the Hill: A Q&A with Actuated Medical’s co-founder Maureen Mulvihill.
This issue of SBIR Pulse interviews Maureen Mulvihill, the co-founder and majority owner of Actuated Medical, a Pennsylvania-based company that presented at SBIR Awareness Day on Capitol Hill on December 8, 2015. Actuated Medical has received SBIR awards from several SBIR programs, including at the Department of Health and Human Services, National Scientific Foundation, and Department of Agriculture.
Left: Maureen Mulvihill of Actuated Medical
SBIR Pulse: What inspired you to develop your technology and products at the first place?
MM: In 2006, while sitting in a doctor's office talking about micro-actuators, the doctor said, "I have a clinical need. I have 6 hours to get to the blood clot or my patient will have irreparable brain damage. I need a solution." That was it ... There was a market need for an agile small business with expertise within medical devices.
Shortly after, Actuated Medical, Inc. (AMI) was founded with a mission to integrate motion into medical devices to improve patient outcomes. Our Innovative Motion® devices move in such a way to give devices new or better functionality, improve patient outcomes, and reduce healthcare costs.
SBIR Pulse: For small businesses, inventing medical devices can be challenging. What have been some of the main challenges and how have you addressed these challenges?
MM: At the concept stage of a medical device, an inventor must look at clinical need, market size, regulatory approaches, intellectual property, and reimbursement strategies. We develop our medical devices using a 7-stage process which is under our FDA compliant quality management system. The process includes verification and validation of the product and manufacturing processes to show that manufacturing is reproducible and that the devices meet the product specifications repeatedly.
SBIR Pulse: How did the SBIR program build capacity for the R&D work that you do?
MM: SBIR is an incredible mechanism to move innovation from concept to commercialization. Many angel and VC investors are not willing to fund early high risk medical device development. The TubeClear System (NSF SBIR) has improved the outcomes for many patients, the first of which was a 27-year old soldier at Walter Reed National Military Medical Center.
SBIR Pulse: There are people waiting for your innovations. What do you want to tell them today?
MM: We have a lot of evidence that the TubeClear System minimizes healthcare costs since it works at bedside; therefore, minimizing transportation or hospital readmission costs (see www.tubeclear.com/roi).
SBIR Pulse: Congratulations on winning a 2014 SBIR Tibbetts Award! What did it mean for your company?
MM: We were very excited to be recognized by the SBA and receive the Tibbetts Award. We work hard with the funds received from the SBIR program to move devices out to market. Winning the Tibbetts Award reaffirmed for us that the SBA recognizes our dedication and commercialization successes.
--This interview was produced by Kento Kitano of the Small Business Administration and Edward Metz of the Department of Education --
SBIR Awareness Day on the Hill was held on December 8, 2015, in the Rayburn Building on Capitol Hill in Washington, D.C. The morning event showcased small businesses who have demonstrated significant commercial success and societal impact as a result from their SBIR awards. The event brought together government leaders, technology developers, stakeholders, and SBIR program representatives that operate SBIR programs across 11 different Federal agencies. For a previous SBIR Pulse interview of Shannon Rhoten of SBA, the organizer of the event, see here.
About SBIR Pulse
SBIR Pulse provides interviews with individuals from the different corners of the high-tech, start-up ecosystem. The intent is to share various perspectives on how SBIR impacts small businesses, drives innovation, and leads to technological solutions. For more editions of SBIR Pulse, see here.
About SBIR & STTR
The Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs are collectively the largest single source of early-stage capital for innovative small companies in the United States. The federal government invests over 2 billion dollars in early stage and high growth American entrepreneurial firms to develop and commercialize technologies that strengthen our nation's defense, improve the health of our citizens, and enhance education. For more information, please visit www.SBIR.gov, and follow us on Twitter (@SBIRgov)!