Medical Devices with Embedded Sensor Systems: Design and Development Methodology for Start-Ups

Abstract

Embedded systems have become a key technology for the evolution of medical devices. However, the regulatory requirements that must be met make designing and developing these devices challenging. As a result, many start-ups attempting to develop medical devices fail. Therefore, this article presents a methodology to design and develop embedded medical devices while minimising the economic investment during the technical risk stages and encouraging customer feedback. The proposed methodology is based on the execution of three stages: Development Feasibility, Incremental and Iterative Prototyping, and Medical Product Consolidation. All this is completed in compliance with the applicable regulations. The methodology mentioned above is validated through practical use cases in which the development of a wearable device for monitoring vital signs is the most relevant. The presented use cases sustain the proposed methodology, for the devices were successfully CE marked. Moreover, ISO 13485 certification is obtained by following the proposed procedures.

Considerations in the testing of a minimum viable product in healthcare

“…Generally, medical devices serve one or more of the following five functions: diagnosis, prevention, monitoring, and treatment of diseases or the observation of human body conditions (Therapeutic Goods Administration, 2020). Arandia et al (2023) outline three primary phases in the development of medical devices. The first phase focuses on development feasibility, identifying and validating various ideas and solutions while minimizing risks through prototype development.…”

Integration and Implementation of Scaled Agile Framework and V-Model in the Healthcare Sector Organization

“…In 2009, a method combining SCRUM, Lean, and Kanban-Scrumban-was created. Over time, this method has proven to be suitable for any repetitive process [29].…”

“…In addition, some articles indicate that using an iterative method, such as the agile method in medical device software development, would improve the software development process [65][66][67][68][69][70]. Arandia, Garate, and Mabe present a methodology for designing and developing embedded medical devices while minimizing economic investment during periods of technical risk and supporting customer feedback [29]. In other cited articles, agile methodologies are used to develop software for crisis management during the COVID-19 pandemic [71] and to improve user interfaces in medical software [72].…”

Spiral Development for Non-Software Product and System Engineering

“…Spiral Use and Discussion [64] 2023 Sensors in medical devices This article discussed the design process for medical devices with embedded sensors and proposed a design methodology for start-up companies. The spiral development model was proposed as a way to mitigate and manage risks.…”