Combined Clinical and Use Evaluations
One of KYomed INNOV’s particular strengths and an aspect which differentiates us from other companies is our ability to arrange for a use and acceptability component to be undertaken alongside the clinical evaluation of your innovative device, notably at the proof of concept phase.
Why combine a use and acceptability study with your clinical evaluation?
Examining use and acceptability has many benefits. In particular, it highlights the impediments to the device’s adoption, the ways in which it could be improved and the viability of the underlying economic model. Factors such as, ergonomics, ease of installation and use, user-friendliness and intuitiveness can greatly impact on the clinical effectiveness of your device .
This is particularly true for healthcare applications and connected objects, for which France’s Haute autorité de santé recommends that usage studies of devices be carried out in order to optimize suitability and thereby promote their regular and efficient use (cf. Haute autorité de santé benchmark for connected objects and applications).
To save time and to reduce costs, we propose that full-scale studies be carried out at the same time as the proof-of-concept studies; this enables adjustments to be made prior to the larger clinical efficacy and safety evaluations.
Usage data to validate a MD’s fitness for use are, moreover, a mandatory requirement in applications for a CE mark (standard IEC 62366). “Usage errors caused by the medical device’s inadequate usability can be dangerous and therefore justify the non-issuance of the mark’, says our head of Clinical Evaluation of Innovative Devices. ‘This is why usage data are required by the commissions and we advise our customers to begin steps to gather them at an early stage in their project in order to limit as far as possible the risk of a negative outcome.“
Multidisciplinarity at your service
Being a multidisciplinary enterprise, KYomed INNOV is able to offer you the full range of services necessary for you to design with us a methodology that addresses the specific needs of your project. “Our company was created for this purpose and therefore consists of wide-ranging but complementary profiles: designers specialized in user experience (UX design), regulatory affairs specialists, graduates in innovation management, experts in clinical research … Result: your project is considered in all its aspects, through a holistic approach that places the human being and its environment at the center of reflection “, summarizes Daniel Laune, scientific director of KYomed INNOV.
A 360° evaluation
Thus, the connections between the “Usability and Innovation in Connected Health and Autonomous Living ” and “Clinical Evaluation of Innovative Devices” departments make it possible to for us to offer tailor-made studies that evaluate not only the efficacy and safety of an innovative device, but also its usability and acceptability, through a set of both clinical and qualitative data on its usage.