MedTech Product Development Framework for Post-Pandemic Era

DS 116: Proceedings of the DESIGN2022 17th International Design Conference

Year: 2022
Editor: Mario Štorga, Stanko Škec, Tomislav Martinec, Dorian Marjanović
Author: Natalia Glazkova (1), Yaroslav Menshenin (1), Dmitry Vasilev (2), Clement Fortin (1)
Series: DESIGN
Institution: 1: Skolkovo Institute of Science and Technology, Russia; 2: Karfidov Lab, Russia
Section: Design for Healthcare
Page(s): 1273-1282
DOI number: https://doi.org/10.1017/pds.2022.129
ISSN: 2732-527X (Online)

Abstract

A case study during pandemic revealed the major drawbacks of the traditional product development process for MedTech industry. Disruption of conventional manufacturing, urgent need for accelerated design and production, faster regulatory approval have challenged the industry. In this paper the conventional medical product development process is explored based on the intramuscular injector case study. The study revealed core areas for improvement of the medical devices development process. The paper proposes the Lean-Agile methodology with the incorporated elements of Concurrent Engineering.

Keywords: agile development, lean product development, organisation of product development