No abstract

Blurring the line between the physical and digital environment, augmented reality (AR) is the next frontier for medical device design. It is particularly useful as a means for rapid concept visualization and iterative refinement. By selectively mixing AR and physical prototypes, designers can conduct haptic evaluation alongside visual assessment. The integration of AR and traditional tools during development continues the practice of advancing design methods in parallel with technology. This paper explains the design of a mobile medical device/workstation using an AR aided medical device design process from an industry perspective. This case study demonstrates the viability and benefits of an AR aided design process pairing off-the-shelf AR technology with physical models of increasing fidelity. AR aided medical device design helps design teams accelerate development, lower prototyping costs, assess scaled designs earlier, illustrate contextual constraints, and reduce development risk.

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.