A Proposed Model for Improving R&D Project Performance in the Medical Devices Industry

Abstract

Objective - The Research and Development (R&D) projects of medical devices are unique, partly due to the lengthy regulatory process to obtain new product approval depending on the device's risk category and clinical trials required. Despite the establishment of multiple control mechanisms in the medical devices industry, defective medical devices are often known to exist. The main objective of this paper is to propose a framework linking organisational factors (top management support, incentive system, infrastructure, training, and collaboration) as predictors of medical devices in regards to R&D project performance. Efficient R&D project management can reduce project lead time by shortening the critical path of the entire product development, thus increasing the R&D project success rate. Besides identifying critical organisational factors, organisational culture is recognised as a potential moderator between organisational factors and R&D project performance. Methodology/Technique - The literature reviewed shows the innovation-friendly culture (clan culture and adhocracy culture), which prospectively influences the degree of an organisation's creativity. Findings - Four distinct R&D project success criteria (cost performance, schedule performance, quality performance and stakeholder satisfaction) are identified as the key performance measurements in the medical devices industry. A literature review to support the proposed model within the context of the medical devices industry is given in this paper. Novelty - The study contributes to measure performance of medical devices industry. Type of Paper: Review Keywords: Medical Device; Organisational Culture; Organisational Factor; Project Performance; R&D. JEL Classification: I15, I23.