J. langell1,2,3, R. Price2,4, J. Langell1,2,3 1University Of Utah,Center for Medical Innovation,Salt Lake City, uT, USA 2University Of Utah,Department Of Surgery,Salt Lake City, uT, USA 3University Of Utah,Department Of Bioengineering,Salt Lake City, UT, USA 4Intermountain Healthcare,Department Of Surgery,Salt Lake City, UT, USA
Introduction: Over 5-Billion people lack access to safe surgical care. A critical missing piece has been the availability of high-quality, low-cost surgical equipment and the need for costly and unavailable post-surgical hospitalization. Laparoscopic surgery is an advanced minimally invasive surgical approach that results in less morbidity, faster recovery, less pain and near elimination of the need for post-surgical hospitalization. The benefits of laparoscopic surgery are currently unavailable to 82% or the World's populatiopn. The need for expansion of this technology to emerging markets is critical to meeting the needs of the global surgical market.
Methods: We provided the problem of the lack of access to globally available and affordable laparoscopic imaging platforms to an interdisciplinary team of graduate students. Problem validation, needs definition and stakeholder analysis was completed using ethnographic research and the design thinking process. Solution development was conducted through an iterative process that considered environmental constraints, patient safety and usability studies. Device design and prototyping were conducted under regulatory requirements. Device testing and first in man trails were conducted under institutional approval.
Results: We have developed an imaging platform that leverages advances in CMOS image sensor technology and high intensity LED lighting to create a high-definition medical/surgical imaging system. The device provides 780P-HD image quality at a rate of 30+ frames per second. The resultant laparoscope has universal connectivity with almost any image monitor (tablet, laptop, HD-TV, smartphone, etc.). In addition, the technology can run for up to 8-hours on a tablet or laptop. Large animal testing, handle design, ergonomics and first-in-man trials demonstrated positive user feedback. The technology meets FDA and European Union regulatory requirements and is under going formal regulatory review. Estimate cost of production is between $50-90 per scope, depending on quantities produced.
Conclusion: Our team of students and faculty was able to create a low-cost high-definition laparoscopic imaging platform that we believe will facilitate the expansion of laparoscopic surgery worldwide. The pipeline innovation process created at our university has allowed us to accelerate the development of the device under regulatory requirements and has allowed initial testing and user feedback studies. The results of our studies through both surrogate and primary stakeholder analysis have demonstrated technology feasibility and substantial customer interest.