Medical Devices Analysed from the Human Factors and Ergonomics in Engineering Design Point of View: Case Study

Abstract

Here two real case studies of design and development with different grades of complexity are presented. A medical instrument prototype of a pneumatic retraction and holding system for surgical procedures and an electromedical device for non-invasive glucose measuring developed both from a TRL 4 to reach a TRL 7. The products were designed in the frame time of six months and fifteen months, respectively. The medical instrument was developed using a conventional Lean project and engineering design approach. Meanwhile, the electromedical device was created using Lean project management alongside a human-centred design and person-oriented innovation approaches. Based on the Lean approach, both products were built on a common ground project development path that the IBV follows. Besides, both projects had a common limiting factor, the need to meet a very demanding schedule of deadlines. The paper details the development stages followed in both products to compare how the human-centred design methods are integrated and could have been incorporated in the medical instrument case. Based on the Institute of Biomechanics’ (IBV) background in project management in the design, development and innovation of medical devices, this paper seeks to share applied knowledge on successfully implementing human factors plan and ergonomics in the engineering design process.

Keywords: human-centred design, Lean project management, impact assessment, user-centre design, case study, improvements of outcomes, decision points

DOI: 10.54941/ahfe1001615