Additive Manufacturing in Orthopedics and Craniomaxillofacial Surgery for the Development of High-risk Custom-made Implants : A Qualitative Study of Implementation Factors from a Multi-stakeholder Perspective

Sammanfattning:   Additive manufacturing (AM) has enabled the possibility for the hospitals to become their own implant producers developing implants that are tailored to patient’s anatomy. Despite the enormous potential of custom-made implants there are challenges that complicate the implementation of them into clinical practice. The aim of this research is to (1) identify the main driving forces and barriers for the delivery of custom-made implants; (2) explore staff stakeholder views and practices related to the implementation of AM in surgery for the development of custom-made implants; (3) formulate recommendations on how to cope with the implementation challenges. The research method was an explorative qualitative study consisted of a literature review on the challenges of custom-made implants in clinical applications coupled with the collection and inductive analysis of empirical data. The empirical study was based on ten semi-structured interviews conducted among both domestic and international hospital managers medical doctors and research engineers. The consolidated framework for implementation research (CFIR) was utilized for data collection. Using the five domains of CFIR, the following results were obtained: (1) Characteristics of individuals: Most research participants indicated a positive attitude towards the innovation expressing self-efficacy to its use; (2) Intervention characteristics: Custom-made implants were perceived to have a relative advantage in surgical practice due to their high degree of observability and geometrical adaptability providing increased surgical quality, perfect patient fit and better understanding of pathologies. However, high implementation costs, low degree of trialability and high degree of complexity in the development process were regarded as drawbacks of the innovation; (3) Outer setting: the regulatory uncertainty and lack of reimbursement limit the accessibility of custom-made implants to low income populations; (4) Inner setting: scarcity of resources, staff resistance to change, insufficient management support, communication difficulties, limited access to educational materials and training opportunities as well as lack of time and innovative capacity were regarded by the majority of participants as implementation barriers; (5) Process: central for the success of implementation is the need for a coherent implementation plan and evaluation process as well as the engagement of key stakeholders such as hospital managers, payers, regulatory and implementation advisors. This dissertation proffers a deeper understanding of the implementation issues related to custom-made implants and offers preliminary recommendations on how to cope with implementation impediments through the use of Rogers diffusion of innovation coupled with concepts from the field of organizational change and innovation management including Clayton’s disruptive innovation.