A very important facet of engineering research and practice is often the design, development and marketing of a useful product. This is, perhaps, why a knack for engineering and problem solving often goes hand-in-hand with entrepreneurial desire. Translational research is defined by the study, design, and fabrication of viable new products and treatments targeted toward patients. With that in mind, translational research is known to be an exceptionally expensive and complex challenge, which involves numerous disciplines, regulatory bodies, and policies. Consequently, experts from different fields often experience difficulty in making the first few steps to advance basic biomedical research down the pipeline. Here at the Wallace H. Coulter Department of Biomedical Engineering at Georgia Tech and Emory Univeristy (BME), the Translational Research Institute for Biomedical Engineering & Science (TRIBES) assists in bridging that gap.
“The concept was to bring together more clinicians and [BME] faculty to work on very specific projects that relate to pediatric healthcare and the Department of Defense” said L. Franklin Bost, MBA, IDSA, Executive Director of the Master of Biomedical Innovation & Development program (BioID), and the Director of Education at TRIBES and the Atlanta Pediatric Device Consortium (APDC). He explains that TRIBES works to pool talent from a variety of professional backgrounds to help facilitate the administrative hurdles involved with developing ideas into functioning prototypes and, subsequently, marketable devices and treatments. TRIBES would offer a host of services, such as advice on robust product development, licensing, prototyping, and clinical studies. During the past two years, TRIBES has also partnered with the Georgia Tech Research Institute (GTRI).
According to Bost, it is often the case that BME faculty and students have great ideas, conduct pertinent research, and even complete work with small animals. They may then seek assistance in developing prototypes and marketing applications for their discoveries. Bost says, “TRIBES is positioned to be an early stage bridge between academics, clinicians, and students and to assist in moving an idea toward commercialization.”
Bost continues to explain how TRIBES operates by highlighting achievements and partnerships with other academic research and clinical bodies such as APDC, Children’s Healthcare of Atlanta, and Emory University. APDC was initially funded in 2010 via a grant from the U.S. Food and Drug Administration (FDA). “The development of devices for pediatric applications is a recognized under-served area; the pediatric market in itself is fairly small and you just can’t downsize a product to make it for pediatric use,” Bost remarks (http://www.pediatricdevicesatlanta.org). “Commercial companies look at ‘Where can I put my resources? How long is it going to take to get a return? How big is the market?’ Also, many times, a device, treatment or product idea would simply be too premature in development for an industry company to take on.” Bost continues, “For that reason…the FDA awarded grants to pediatric consortiums to develop new products specifically for pediatric healthcare.” APDC has three primary products in development: The Remotoscope®, Kids CARRT®, and a product for craniosynostosis. APDC has also awarded $318,000 in seed grants for 25 projects presented by students, clinicians, faculty, and outside entrepreneurs.
In 2012, TRIBES co-sponsored a meeting at FDA headquarters on “Minimal Important Clinical Differences.” This workshop brought FDA internal experts together with academic and industry stakeholders to discuss challenges and approaches in defining the minimum clinically important difference (MCID) for patient-reported outcome instruments used in orthopaedic device-related procedures. The goal was to streamline evidence-based scientific rationales for regulatory guidance of clinical trials and device study design for gender, age and BMI factors. Approximately 150 attendees represented views of the biomedical industry, clinical stakeholders, and the FDA on MCID study design.
Talking more about the translational pipeline for biomedical research, Bost recalls interactions with many physicians who say, “I have a great idea to address an unmet need in my practice!” but then struggle with developing it further. Integrating these ideas with the BME Capstone Courses provides our students with clinically relevant projects and interactions with medical personnel to experience problem definition, alternative generation, solution direction, and prototyping experience. A key skill for engineers is explaining their work in oral presentations and written documents. The BME engineering design courses provide students with multiple opportunities to develop this skill.
On Feb. 21 and 22, 2013, TRIBES is hosting its third workshop at the GT Global Learning Center. This BioID 2013 Conference will bring together experts for industry, legal, regulatory, and product development to speak with faculty, clinicians, and entrepreneurs about the very early stages of device concept-development and documentation, updates on the FDA regulatory process, and the new America Invents Act on the patent process. The day-and-a-half workshop is based on teachings from the BMED 2300, 4602, and 4603 courses, “Problems in Biomedical Engineering II” and “Capstone Design”, respectively, at the Coulter Department.
Presentations & Proceedings: http://www.tribes.gatech.edu/mcid-conf-2012.
2013 BioID Conference: http://www.tribes.gatech.edu/bioidconf2013