Examining the Role of 3D Printing in Improving Custom Prosthetic Device Manufacturing in the Indian Pharmaceutical and Medical Device Sector

Abstract

This dissertation explored the role of 3D printing in the enhancement of the manufacturing of custom prosthetic devices in the Indian pharmaceutical and medical device sector. Conventional manufacturing of prosthetics in India is much centralised, labour-intensive, and expensive, and does not cater to the needs of patients, especially in the low-income areas and the rural population. It is on this backdrop that the concept of 3D printing or additive manufacturing is emerging as a disruptive technology with the potential to provide decentralised, patient-specific, and efficient solutions. This study was aimed at exploring the level of adoption, perceived benefits, challenges and enablers of 3D printing in the Indian prosthetic industry. The study used a survey-based and quantitative research design, which included professionals in pharmaceutical/medical device organisations. Analysis was carried out with a descriptive and inferential approach, like ANOVA, one-way ANOVA, correlation, regression, etc. and focused on the adoption trends, benefits perceived, such as accuracy and faster turnaround and barriers, such as regulatory ambiguity, the control of the supply chain and high capital costs. The results indicated that the level of awareness of 3D printing is high, yet at the organisational level, full-scale adoption is low, with the majority of organisations experimenting or partially adopting the technology. Respondents stated that the main advantages were decentralised delivery and speedier production, although they were less sure about cost-effectiveness and scalability. Key barriers were regulatory uncertainty and insufficient supply of materials that are validated and biocompatible, and the key enablers were viewed to be cooperation between industry and universities and training of the workforce and regulatory transparency. The present dissertation can be of help to the current body of literature as it puts the global trends of 3D printing in perspective to the environment in India, which depends upon the local challenges that are not reflected in the developed economies. The work presents policy recommendations to policymakers and the industry, such as enhancing regulatory structures and conducting supply chain resilience investments and developing workforce potential. Finally, the study shows that 3D printing has the potential to be transformational, but implementation in India is possible only with the coordinated effort of policies, organisational strategy, and technological preparedness.