Introducing new technology safely into urological practice

Abstract

Purpose: Surgical innovation is necessary to ensure continued improvement in patient care. However, several challenges unique to the surgical craft are encountered during the development and validation of such new technology. This article highlights some of these challenges and gives an overview of existing solutions.

Methods: A Pubmed review was performed about the "introduction of new technology" to identify challenges. Cross-referencing was used to explore the possible solutions per challenge.

Results: Several characteristics of the surgical craft itself limit our ability to establish randomised controlled trials and hence provide clear categorical evidence. Existing certification bodies for new technology often use unstructured regulations and allow fast-track bypassing systems. Consequently the IDEAL framework (innovation, development, exploration, assessment, long-term follow-up) proposes an objective scientific approach whilst defining stakeholder responsibilities. The selection of which new modality to implement is heavily influenced by third parties unrelated to the best patient outcomes and thus professional organisations can aid in this decision-making. Appropriate training of surgeons and their teams until proficiency is achieved is essential prior to credentialling. Finally long-term surveillance of outcomes in the form of registries is an increasing responsibility of the urological community to maintain our role in directing the adoption or rejection of these innovations.

Conclusion: Urological innovation is a dynamic and challenging process. Increasing efforts are identified within the urological community to render the process more reliable and transparent.

Keywords: Development; Implementation; Regulation; Surgical innovation; Training.