HUMAN FACTORS REFINEMENT OF A MULTIMODAL LAPAROSCOPIC HAND TOOL M. Robert Garfield 1 Abbott St. Paul, Minnesota, USA Mary Beth Privitera Department of Biomedical Engineering University of Cincinnati Cincinnati, Ohio, USA ABSTRACT Laparoscopic surgery offers multiple clinical advantages over open surgical procedures. The rise in adoption of laparoscopic surgery brings with it unique human factors challenges for surgeons and device developers. The design of laparoscopic surgical tools requires specialized human factors analysis and ergonomic considerations to overcome these challenges. Often, this necessary ergonomic design refinement is a secondary effort after proof-of-concept engineering prototypes demonstrate technological feasibility. In this paper, the evaluation and redesign of an engineering proof-of-concept multimodal hand tool, is presented. The baseline design, a three-in-one laparoscopic hand tool for liver resection, merged three distinct devices into one integrated solution for dissection, vessel sealing, and tissue cautery. The work described herein evolves the initial prototype using a multifaceted human factors analysis and design process. This included the use of operating room and laboratory contextual inquiry, simulated use studies, anthropometric underlays, an iterative design process, and expert reviews. The revised design reduced ulnar deviation based on directed hand position via design, provided dual grip options, added over-molded interaction points, incorporated end-effector rotation, and implemented a new handle and controls layout based on anthropometric underlays. The outcome reinforces the notion that human factors and industrial design principles are required elements of a successful user centered design process. Keywords: Human Factors, Contextual Inquiry, Hand Tools, Industrial Design, Laparoscopic Liver Resection. 1 Contact author: mrobert.garfield@abbott.com, One St. Jude Medical Drive, St. Paul, MN 55117 USA. INTRODUCTION Laparoscopic surgery provides multiple clinical advantages over open surgical procedures. These include reduced blood loss, reduced intravenous narcotics use, lower morbidity rates, shorter hospital stays, and fewer complications [1]. Nevertheless, the rise in adoption of laparoscopic surgery brings with it increased mental stress, fatigue, and potential for injury to the surgeon [2,3]. Inadequate human factors and ergonomic considerations during the design of laparoscopic surgical instruments has harmful effects on device and surgeon performance [3]. Compounding these problems, textbook design principles used to develop traditional hand tools do not address the challenges of laparoscopic surgery [4,5]. The unique human factors and ergonomic constraints that arise during laparoscopic procedures include range of motion limitations, mirrored end-effector movement, reduced visibility, and increased levels of fatigue from poor ergonomics [6-12]. The design of laparoscopic surgical tools requires specialized human factors and ergonomic considerations to overcome these challenges. Often, this necessary human factors and industrial design refinement is a secondary effort after proof-of-concept engineering prototypes demonstrate technological feasibility. The objective of this project was to evaluate and redesign the handle and controls of a proof-of-concept multimodal hand tool to maximize device usability for laparoscopic surgery. To achieve this goal, the team used a user centered waterfall process [13]. Haridas, Privitera, and Rudich [14] outline the development of the initial engineering prototype that was the starting point for this effort (Figure 1). That baseline concept for a three-in-one laparoscopic liver resection device was based on the Kelly crush clamp technique [15]. The device ergonomically mimicked the Kelly clamp and added mono- and bi-polar cautery in a unified design [14]. The prototype merged three distinct devices into one integrated solution for dissection, vessel sealing, and tissue cautery. Its design featured a Y-grip handle Proceedings of the 2019 Design of Medical Devices Conference DMD2019 April 15, 16-18, 2019, Minneapolis, MN, USA DMD2019-3204 1 Copyright © 2019 ASME Downloaded from https://asmedigitalcollection.asme.org/BIOMED/proceedings-pdf/DMD2019/41037/V001T08A001/5171223/v001t08a001-dmd2019-3204.pdf by guest on 01 July 2020