Introducing new technology safely into urological practice
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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.
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.
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.
Urological innovation is a dynamic and challenging process. Increasing efforts are identified within the urological community to render the process more reliable and transparent.
KeywordsSurgical innovation Implementation Training Development Regulation
SVB: protocol development, manuscript writing and editing. BN: manuscript writing and editing. BC: manuscript editing. BE: manuscript editing. IB: manuscript editing.
The study was not funded.
Compliance with ethical standards
Conflict of interest
Dr. Van Bruwaene, Dr. Namdarian and Dr. Billiet declare that they have no conflicts of interest. Dr. Challacombe and Dr. Eddy are proctors for Intuitive Surgical.
Research involving human participants and/or animals
This article does not contain any studies with human participants or animals performed by any of the authors.
- 7.Zargar-Shoshtari K, Lawrentschuk N, Zargar H (2017) Robotic prostatectomy delivers on the promise of minimally invasive surgery: commentary on: robot-assisted laparoscopic prostatectomy versus open radical retropubic prostatectomy: early outcomes from a randomised controlled phase 3 study. Urology 99:3–4CrossRefPubMedGoogle Scholar
- 10.Van Norman GA (2016) Drugs and devices. Comparison of European and US approval processes. JACC: basic to translational. Science 1(5):399–412Google Scholar
- 11.Lois Rogers (2015). Scandal of fruit netting ‘approved as surgical implant’ The Sunday Times. January 11Google Scholar
- 17.Sood A, Hemal A, Assimos D, Peabody J, Menon M, Ghani K (2016) Robotic anatrophic nephrolithotomy utilizing near-infrared fluorescence image-guidance: idea, development, exploration, assessment, and long-term monitoring (IDEAL) stage 0 animal model study. Urology 94:117–122CrossRefPubMedGoogle Scholar
- 18.Lima E, Rodrigues P, Mota P, Carvalho N, Dias E, Correia-Pinto J, Autorino R, Vilaça J (2016) Ureteroscopy-assisted percutaneous kidney access made easy: first clinical experience with a novel navigation system using electromagnetic guidance (IDEAL stage 1). Eur Urol 72(4):610–616CrossRefGoogle Scholar