SCIENCE, PRACTICE AND EDUCATION DOI : 10.35279/jowm202107.02 How to integrate new technologies into daily practice: The clinician perspective Luc Téot, MD, PhD, Montpellier University Hospital, Cicat Occitanie Hôpital La Colombière CHU de Montpellier 38 rue Charles Flahaut 34295 Montpellier cedex 5 Sylvie Meaume, MD, APHP Paris, Rothschild Hospital, Jean Charles Kerihuel , MD. Vertical Paris Correspondence: l-teot@chu-montpellier.fr · Conflicts of Interest: None Keywords: Keywords: Technology, wound healing, regulations, clinical trials ABSTRACT Background The integration of new technologies can call for obeying different rules and should be considered a long-term evolutionary process that is realised step by step. Before a medical device appears in the mar- ket, a long regulatory process has been completed, including safety, experimental and preclinical stud- ies leading to an authorisation for distribution in a national market. Depending on the target countries and their respective regulations, the need for robust clinical studies, including randomised clinical trials, is often mandatory for distribution. Post-clinical trials may be used to confirm the results obtained from a medical device. The efficacy of the introduction of new technology in daily practice is then depend- ent on clinicians’ perceptions of the improvement in wound-healing. Complications may occur even after a long period of time, with severe consequences for patients’ quality of life. Since the PIP (Poly Im- plant Prothèse) scandal, more restrictions have been imposed to prevent such failures and increase the safety for the population. artificial intelligence-based medicine, in addition to new therapeutic applications of gene-editing tech- nologies. These technological introductions require changes in our knowledge acquisition processes and in patient–health professional relationships, to suc- cessfully address potentially dramatic challenges. Introducing any new technology into daily practice requires careful thinking and precise planning. Sev- eral steps must be followed; this process may help to inform learning by using the most efficient means available. Prerequisites before introducing a new technology The authorisations to use medical devices given by national authorities are not subject to the same level of scrutiny that drugs are, in terms of critical levels of evidence-based medicine (EBM), but many regu- latory departments and/or reimbursement agencies believe that companies proposing new medical de- vices (MD) should bring a high level of EBM when asking for reimbursement. INTRODUCTION Changing practices is a difficult process in wound healing, as new technologies regularly emerge, forc- ing experts to create a new space for integrating these devices into their practical armamentarium. This process has accelerated dramatically in the past 50 years. Indeed, we are currently facing new concep- tual revolutions with the emergence in daily practice of machine learning devices and the development of One of the first questions to be asked in this pro- cess concerns the class of the new medical device, as defined by the European Community Medicine Evaluation committee (MEDEV). With the above in mind, designing the right proto- col has become an art that calls for following spe- cific guidance, as comparing two groups presenting identical wound-healing pathologies and outcomes remains extremely difficult. Developing randomised JOURNAL OF WOUND MANAGEMENT OFFICIAL JOURNAL OF THE EUROPEAN WOUND MANAGEMENT ASSOCIATION 7
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