International Manufacturing Transfer of a Biomaterial Implant Product

Abstract

In 2012 a US based global medical device company, made the decision to transfer the manufacturing of biodegradable implants from its subsidiary in Finland to two facilities in the United States of America. This decision raised some business challenges. How to transfer manufacturing of biomaterial implant products with minimal impact to stakeholders, and how to ensure continuous high quality, safety and production yield of biomaterial implant products when manufacturing is done in the United States. The research goal is to create a best practices process for the transfer, uncover risks and working solutions for the manufacturing steps of a biomaterial implant product. The thesis focuses on transfer of one Biodegradable implant product.