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Aarno Dietz

Professor (Clinical Research)
Kuopio University Hospital & University of Eastern Finland
Finland

Professor Aarno Dietz is an ENT specialist and otologist with over 25 years of experience in clinical audiology, otologic surgery, and lateral skull base surgery. He holds the title of Professor for Clinical Research and is the Chair of the Center of Excellence for Sense Organ Diseases at Kuopio University Hospital. He leads the Kuopio Cochlear Implant Research Group, the "Towards Better Hearing" project, the Research to Business project TrueHear, and the EU co-funded Hearing Valley project at the University of Eastern Finland, driving advancements in hearing healthcare innovation and research. A recognized expert in the field, Professor Dietz is part of the European Medical Agency (EMA) Expert Panel on medical devices and in vitro diagnostics, serving as Chair of the Subpanel for Hearing. Through his clinical expertise, pioneering research, and leadership in transformative projects, he continues to set benchmarks in audiology and otology, significantly improving patient outcomes, establishing best practices and advancing medical and surgical solutions for hearing loss.

Aiheet

The clinician's perspective for generating clinical evidence

Clinical Evidence Generation
Commercialisation of health technology
7.2.2025 13:15 - 14:00 | Hall 209 - Aurevia

From a clinician's viewpoint, generating clinical evidence is a critical step in medical device development, ensuring both safety and efficacy while meeting the needs of real-world clinical practice. Clinicians emphasize the importance of designing studies that reflect practical use cases, incorporating patient-centered outcomes, and addressing unmet clinical needs. Early involvement of clinicians in the development process helps identify relevant endpoints and optimize usability, ensuring the device aligns with workflow efficiency and improves patient outcomes. Collaborative efforts between clinicians, researchers, and industry partners ensure the generated evidence is robust, reproducible, and directly applicable to enhancing patient care. Regulatory requirements primarily focus on standardized data to demonstrate compliance with predefined safety and performance criteria. In contrast, clinicians prioritize evidence that addresses real-world clinical utility, patient outcomes, and integration into clinical workflows. While there is overlap, regulatory evidence may sometimes fall short of addressing practical, patient-centered concerns that clinicians find critical for adoption in everyday practice. Bridging this gap requires collaboration to align study designs, endpoints, and post-market surveillance with both regulatory standards and clinical relevance.