Strategi Pengembangan Produk Baru Sel Punca: Studi Kasus di PT Bifarma Adiluhung (Regenic)

Abstract

The development of health technology driving the development of regenerative medicine such as cell therapy faces challenges in terms of lack of knowledge, immature technology, and variability. The Covid-19 pandemic prompted clinical trials of stem cell therapy for patients, but they produced negative data. This research aims to analyze the stem cells’s product development concepts related to Resource-based view and Stage-gate model, including appropriate development to minimize failure, as well as analyzing development challenges. Qualitative data was obtained from literature, in-depth interviews with informants from the industrial, hospital and regulatory sectors in a semi-structured pattern and observation. Transcript analysis using N-Vivo software produced seven themes, including the concept of cell therapy product development, the product development process to minimize the risk of failure, product development strategies and challenges. In addition, it was found that stem cell development has followed QbD principles, but according to stage-gate model there were some aspect regarding un-focus gate resulting in trial failure. Lack in RND organizing and firm capability also contribute in this failure. The proposed strategy for stem cells product is broad differentiation strategy supported by continuous innovate to become pioneer. Focusing on costs also important in business sustainability in addition to having to face challenges involving managing and organizing firm