“The Road from Academic Research to Clinical Use of 3D Patient Specific Devices: Can we avoid being lost in translation”
The Frank and Grace Yin Distinguished Lectureship in Biomedical Engineering (BME) is part of BME Day 2018.
Abstract: Two technical advances over the past 10-15 years have made the capability to create medical devices from the academic setting a reality. First, it is now straightforward to read patient image data as the basis for designing a patient device and to further simulate the behavior of that device in the patient. Second, there is increasing capability to 3D print that device from a variety of biomaterials including titanium alloy, PolyEtherEtherKetone (PEEK), PolyEtherKetoneKetone (PEKK), and Polycaprolactone (PCL) among others. 3D printing makes it feasible to create patient specific devices for niche patient markets due to the significantly lower manufacturing costs compared to traditional methods. Addressing such niche markets will likely increasingly fall to academic medical centers and biomedical engineering departments. However, such going down this path raises a number of challenges outside the typical academic endeavors. First and foremost is the need to address regulatory and design/quality control concerns from the FDA. Developing research that can be published and compete for extramural funding while being developed within design/quality control guidelines requires a balancing act, as research favors cutting edge complex ideas while clinical use favors established tried and true, simpler measures. This talk will highlight our own experience is addressing these conflicting issues for a patient specific 3D printed airway splint without getting lost in translation.
About Dr. Hollister: Dr. Hollister is the Patsy and Alan Dorris Chaired Professor of Pediatric Technology in the Wallace H. Coulter Dept. of Biomedical Engineering at Georgia Institute of Technology and Emory University. Hollister came to the Coulter Department from the University of Michigan, where he directed the Scaffold Tissue Engineering Group, which develops degradable scaffold material systems to deliver stem cells, genes and proteins to regenerate tissue defects. Dr. Hollister and his collaborators have advanced develoment of multiple strategies for spine fusion and disc repair, craniomaxillofAcial reconstruction, orthopaedic trauma and joint reconstruction, and cardiovascular reconstruction. as part of this effort, Dr. Hollister designed and developed a variety of medical devices utilizing 3D printing, an area of active research and developments since 1997. Dr. Hollister is a fellow of the American Institute of Biological Engineering. His work on a bioresorbable tracheal splint along with Dr. Glenn Green was given a Popular Mechanics 2013 Breakthrough Innovation Award. This implantation of this 3D printed device achieved through a Humanitarian Use Devices (HUD) exemption to save the lives of two children has been featured on the Today Show, USA Today, NPR, Time magazine, Nature, Science, and Popular Mechanics among other media.
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