3 sprints from zero to innovative medical device in 16 months: Benefits of combining Human Factors and Agile

Abstract

[EN] This study aims to lay out an Agile product development case study-oriented research with core tenets on the process mapping and the methodologies involved in the solution implementation. The developed prototype is used for measuring the principal vital signs, without contact, only through video images. The measured vital signs are heart rate, respiratory rate, oxygen saturation, temperature, and blood pressure contactless at 2 meters (6.5 ft). The developed solution was presented in the framework of public bidding for the emergency service of the autonomous community of Andalucía (in Spain). The Agile project management approach has been integrated to overcome the limitations of medical devices' commonly accepted Stage-Gate project management approach. During the prototype's concept and detailed design phases, eight designs for Usability (DfU) tools were implemented to generate value. These tools were implemented in the concept phase in parallel with developing the IP strategy, contextual research, risk management strategy, and regulatory strategy development to identify the user's needs in an iterative process. The users in this case study were paramedics, EMT¿s and EMC¿s. Further, during the detailed design phase, the DfU helped detect design flaws and usability issues before the validation phase. A multifunctional team of eight specialists was consolidated to develop the solution, with role distribution according to the scrum team model. This team has been working together for 16 months. In the last sprint, first responders tested the prototype with a TRL 7 in laboratory and field trials simulating real conditions. The results were collected through several requirement acquisition techniques. The prototype was continuously improved by collecting value-generating data along the project and establishing strategic checkpoints. Thus, many design flaws and usability issues were prevented throughout the concept and development phase. Besides, reducing the development time without compromising all the necessary design traceability and quality requirements according to ISO 13485 standards.