title: [Statement: Requirements for the assessment of surgical innovations].
abstract: The term "innovation" refers to new products, but also to the process of developing and distributing new products and procedures. The operative disciplines are often associated with innovations because of their continuous, stepwise adaptation of daily practice to established procedures. Medical devices play a significant role in integrating surgical technology with surgical experience. The success of a surgical innovation and other invasive treatments does not only depend on the surgical procedure, but also on the context of the whole treatment process including the pre- and postoperative phase, the interaction of the surgical team and the setting. High standards have been set for the assessment of surgical innovations in terms of patient safety, efficacy and patient benefit, which will be discussed in the present paper. A stepwise approach to evaluation will be used, split into preclinical development, clinical development (feasibility and safety), evaluation phase (efficacy and patient benefit) and longtime surveillance. Our paper is based on the expert-based consented IDEAL approach as well as the consented recommendations of the European Association of Endoscopic Surgery (EAES). (As supplied by publisher).
authors.affiliation: Institut für Forschung in der Operativen Medizin (IFOM), Fakultät für Gesundheit, Department für Humanmedizin, Universität Witten/Herdecke gGmbH.
authors.forename: Dörthe
authors.initials: D
authors.lastname: Seidel
authors.affiliation: Institut für Forschung in der Operativen Medizin (IFOM), Fakultät für Gesundheit, Department für Humanmedizin, Universität Witten/Herdecke gGmbH.
authors.forename: Dawid
authors.initials: D
authors.lastname: Pieper
authors.affiliation: Institut für Forschung in der Operativen Medizin (IFOM), Fakultät für Gesundheit, Department für Humanmedizin, Universität Witten/Herdecke gGmbH. Electronic address: edmund.neugebauer@uni-wh.de.
authors.forename: Edmund
authors.initials: E
authors.lastname: Neugebauer
mesh_terms: D018795:Device Approval; D004059:Diffusion of Innovation; D004864:Equipment and Supplies; D019317:Evidence-Based Medicine; D005240:Feasibility Studies; D005500:Follow-Up Studies; D005858:Germany; D019983:Guideline Adherence; D006801:Humans; D010535:Laparoscopy; D010043:Outcome and Process Assessment, Health Care; D061214:Patient Safety; D016032:Randomized Controlled Trials as Topic; D012107:Research Design; D018570:Risk Assessment; D013514:Surgical Procedures, Operative
keywords: Chirurgische Innovationen; Evaluationsmethoden; Machbarkeit; Patientennutzen; Patientensicherheit; Surgical innovations; Zugangsvoraussetzungen für Medizinprodukte; evaluation methods; feasibility; medical devices; patient benefit; patient safety