New revision of ISO 14155 standard addresses the challenges of trial design for medical devices

August 2015

A dedicated norm in line with the rapid evolution of medical technology

New revision of ISO 14155 standard addresses the challenges of trial design for medical devices
Medical Device technology evolves so rapidly that in some cases new models of an innovative device are developed before the end of the studies on the first generation. It is not uncommon that new variants of the product are approved through a process that does not require additional clinical data, depending on the nature of the new features that are introduced during design iterations.

To address these challenges, the working group ISO TC 194 / SW4 has initiated a new revision of the standard UNI EN ISO 14155: 2012 ("Clinical investigation of medical devices for human subjects - Good clinical practice"), a dedicated norm that deals with the proper design, execution and recording of clinical investigations of patients to assess the safety or performance of medical devices.

Among the major innovations in the new revision of ISO 14155, there is the distinction of different types of studies conducted in the pre-market or post-market phase. The most reliable study design to demonstrate the effectiveness of a drug or device is a controlled randomized clinical trial (or RCT), but this type of study has some limitations when applied to the validation of biomedical technologies. In particular, a randomized design is not suitable to evaluate some complex interventions, highly variable and for which the interaction between the operator and the patient has a central role. In addition, a randomized trial is feasible only for comparing curative interventions where they exist, and under strict conditions of ethics. For these reasons a randomized study may not be applicable to highly innovative devices, often destined to patients with no therapeutic alternatives, making it impossible to perform a comparison with a control group.  The ISO 14155 revision will introduce new concepts regarding the study design appropriate for different types and stages of the product lifecycle. 

Thanks to the latest revision of the ISO 14155, the efficacy and safety of the devices will require an evaluation no longer based on a single type of trial. Only the combination of different research designs that complement each other may represent a valid approach to establish the clinical value of new products. Researchers, regulators and industry sponsors will continue to evaluate the the most appropriat methods. Adhering to the standards will aid in the development of technological innovations that will positively impact the health of the population.

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