GCMI’s foremost goal as an affiliate of the Georgia Institute of Technology is to partner with Georgia Tech faculty and engineers in the innovation process of new medical products. One successful example of this partnership has been our work with Dr. Scott Hollister. With GCMI’s help, Children’s Healthcare of Atlanta surgeons used Dr. Hollister’s process and expertise in performing Georgia’s first-ever procedure to place 3D-printed tracheal splints in a pediatric patient.
Currently working with GCMI multiple steps earlier in the medical product innovation process is Dr. Omer Inan. Dr. Inan is Associate Professor of Electrical and Computer Engineering and Adjunct Associate Professor of Biomedical Engineering at Georgia Tech. The Inan Research Lab at Georgia Tech focuses its work on physiological monitoring and modulation in the interest of designing technologies for human health and performance.
In its own words, the Inan Research Lab addresses five main applications: unobtrusive cardiovascular monitoring, musculoskeletal sound analysis, pediatric bioengineering, non-intrusive neuromodulation of stress and wearable biomechanics, “all involving a tight integration of sensing systems, analog electronics, embedded systems concepts, and physiology-driven data analytics.”
Dr. Inan is one of a growing cadre of Georgia Tech faculty members utilizing GCMI’s facilities and capabilities to advance their scientific research. He graciously shared with us more about his scientific research and his work with GCMI.
How did you get introduced to GCMI?
“I was writing a grant for DARPA in 2013,” Dr. Inan told us. “A colleague happened to work in the same building with GCMI. He mentioned GCMI as a potentially interesting resource with whom our team and the university could collaborate. This was particularly appealing because there aren’t any other organizations or facilities in the vicinity that have the same capabilities.”
Which GCMI facilities or capabilities do you use?
“We use their “Phase 0” early stage product investigation services, and preclinical testing services and facilities [known still by some as T3 Labs] for in vivo studies,” he continued. “One of our projects used both sides of the GCMI house, early stage in vivo studies and market analysis. In vivo studies for our sensing systems would not have been possible without GCMI being ‘in our backyard.’”
“GCMI collaborated with our team to create an appropriate and efficient animal model, and performed studies that generated results strong enough for publication in the IEEE Journal of Translational Engineering in Health and Medicine,” Dr. Inan said. “The performance results and comparisons are an important step towards clinical translation of sensing technologies for detecting IV infiltration.”
What are the most important capabilities GCMI brings to your work?
“Experienced staff is one of the most important things,” he said. “They listen and collaborate. ‘Easy to work with’ is a great strength the GCMI staff possesses.”
[Related: GCMI takes great pride in our staff’s scientific acumen. Read more from the archives: “A partner that understands your science and your product development needs.”]
How does your research translate to patient care?
“We are involved in early-stage, basic research,” Dr. Inan explained. “Overall our projects serve our most likely scenario, monitoring capabilities for patients at home so care can be personalized and meet changing needs of patients rather than remain static at hospital settings. Our work seeks to empower patients and lower cost.”
“IV-infiltration, for example, is a risk to patient safety. It can cause swelling, ballooning, tissue death and permanently disfigured skin. We are working on a wearable sensor for peripheral limb detection of IV infiltration funded through the Pediatric Technology Center, and our preclinical studies were funded through the Coulter Translational Research Program.”
A practical examination of process: research > project > product > patient impact
“Taking a concept from research and benchtop studies into a clinical investigation requires significant work beyond the research phase, and some of this work is not obvious to researchers,” according to GCMI Director of Product Development Mike Fisher. “In Omer’s case, his clinical partner wanted to know how his device would be cleaned between uses. His graduate student came to GCMI and discussed the design and the need for cleaning.”
GCMI developed a device coating process and created a cleaning protocol that could be followed to improve safety in clinical use. Eventually, this technology will require formal design procedures and documentation to meet regulatory requirements. These documents assemble into a “design history file” that will describe the product in exquisite details, examine all the risks of how the device is used, designed and manufactured, apply a quality system to cover both the design and manufacturing aspects of the product and generate a system for supporting post-market launch issues with the devices.
“Generation of these formal design documents is critical for both FDA and potential commercialization partners,” Mike added. “Often, the difference between a viable product and a really ‘cool idea’ are these documents and the thought that went into their creation. This is where GCMI excels in partnering with entrepreneurs and investigators who are subject matter experts, but may not know all the rules to achieve compliance in the highly regulated medical device industry. We take great pleasure in helping investigators bring innovations into commercial use. Each stakeholder in a successful medical research project wants to affect patient care. This may be the most rewarding part of our job – to know that we have helped an innovation positively affect health care!”
For other faculty and principal investigators, what’s most important to know about GCMI?
“Have an actual idea and be prepared,” Dr. Inan said. “Still, don’t be afraid to engage the GCMI team early in the thought process and leverage their experience. They can really be helpful in putting the product development and commercialization structure around a broad range of medical technologies.”
GCMI helps verify, validate and accelerate commercialization of new medical technologies that save lives and improve patient care. You know the “what,” we know the “how” for medtech innovation. We speak both biomedical engineering and regulatory pathway fluently. From our Northyards and 14th Street facilities in midtown Atlanta, we have the resources, including equipment and qualified staff, to commercialize your technology in a capital efficient way. We help find the finish line for medtech innovations at any point on the pathway from bench to bedside.
Email firstname.lastname@example.org to learn more about how we can help, from the back of the napkin through regulatory submission, with your innovative medical product idea.