The Strategic Adoption of Additive Manufacturing in the orthopedic industry in Sweden

Abstract: Additive Manufacturing (AM) is another name for rapid prototyping and 3D printing (3DP), an advanced manufacturing technology that creates 3D objects. AM's ability to produce complex shapes in industrial production is one of its chief advantages. AM is spreading to different areas in healthcare and is being considered a disruptive innovation that is changing orthopedics.  However, integrating AM into daily orthopedic practice remains a challenging task. This thesis aims to explore clinicians' views on the adoption of AM implants, surgical guides and accessories as well as investigating which way do regulations and policies affect the adoption of 3DP in the orthopedic industry in Sweden. Apart from reviewing existing literature contemplated on factors that affect the adoption of AM in an industry, in this study, a qualitative research approach have been used. A semi-structured interview has been applied to all the seven orthopedic surgeons who participated in the research. Using a thematic analysis approach, the data have been analyzed to address the thesis research questions.    According to the thesis findings, AM adoption in the orthopedic sector is influenced by a number of factors. With the technology, organization, and environment (TOE framework) there are classified into three main contexts. The study used the findings along with the TOE model, which embeds the regulation factor within an environmental context. The findings indicate that the medical device regulation (MDR) affects the adoption of medical devices both positively and negatively in the orthopedic industry in Sweden.  Technologically, the dilemma and challenge of adopting AM is influenced by the lack of resources in the healthcare field which also influence the organization context. It is the viewpoint of the buyer that orthopedists and hospitals have when it comes to adoption of AM. This means that the trading factor expressed in the environment context is another driving factor for AM adoption. By using the Kraljic model, AM technology has been classified as a strategic item. The procurement and purchase efforts should focus on establishing a long-term relationship with a single manufacturing company and both aiming to combine effort and resources to reduce total costs. In conclusion, The implementation of AM in orthopedic practice will be possible as long as all factors are taken into account. In orthopedic practice, AM should be used to create surgical guides, 3D models for surgical planning, and custom implants.