Development of a Novel Diabetic Foot Risk Assessment for Low-Resource Healthcare Settings: A Case Study of Lean Design

Abstract

Interest in applying a “lean” philosophy to design has been slowly growing in recent years, but there are still few broadly applicable methodologies and illustrative cases published in the literature to guide lean design processes. Lean approaches promise cost reduction and increased product value, which could be particularly beneficial in product development for low- and middle-income country markets, where value demands are high. We use the clinical need of efficient diabetic foot risk assessment in lowresource healthcare settings to present an example of lean early-stage design of a medical device. The background of existing medical literature and commercial products is intentionally leveraged throughout the design process to streamline development and minimize the need for independent validation of product strategies and design features. Our approach resulted in an efficient design process that generated a novel, purely mechanical plantar pressure evaluation device that can indicate high risk of diabetic foot ulcer in resource-constrained settings. This case provides a practical example of how design processes can be adapted to be leaner where there are large gains from minimizing design cycle time and cost.