Clinical Evaluation of Digital & Connected Devices
Clinical evaluations and investigations of innovative health devices – be these medical devices, applications or connected devices for the general public – are turning out to be an essential and major step before they are put on the market.
These evaluations and investigations aim to provide scientific validation based on clinical evidence of performance and safety.
How are innovative devices clinically evaluated ?
Although pre-market clinical evaluations are often less restrictive for medical devices (MD) than for new molecules, they are still essential. In addition, they must take into account the uses of the device in real-life conditions.
The clinical evaluation of a MD should follow a defined and methodologically-sound procedure based on a critical assessment of the relevant scientific publications and the results of all available clinical investigations. It must also take into account the alternatives currently available on the market.
These investigations seek to verify that the device performs as claimed, and to identify any possible undesirable side effects and to assess their risks. In other words, clinical investigations are conducted in order to confirm or refute a manufacturer’s claims regarding performance, safety, and the benefit / risk aspects of the device.
The scientific validity of their conclusions is conditional on a sufficient number of observations being carried out.
Why clinically evaluate an innovative device?
To carry out the clinical evaluation of an innovative health device, whether it be a medical device or one intended for the general public, is to demonstrate its effectiveness and its safety.
The regulations and standards governing MDs and their clinical evaluation have evolved over recent years. In Europe, since Decree No. 2010-270 of March 15, 2010, no CE marking is issued for any MD unless a clinical study conforming to the categories and conditions specified in European Regulation (EC) 2017/745 is provided.
The European regulations will be further tightened with the new regulations that come into force in 2020. They will strengthen the clinical evaluation requirements for MDs throughout their life cycle. MD manufacturers will also be subject to an obligation to provide post-market launch clinical data.
US regulations are no less strict: clinical evaluations are also mandatory as part of an FDA (Food and Drug Administration) approval.
Finally, in addition to these regulatory constraints, in France MD manufacturers are required to submit to the Haute autorité de santé clinical and economic evidence obtained through approved methodologies with well-defined criteria if they are to be eligible for patient reimbursement through the state health insurance.
How can KYomed INNOV help you?
“In conducting these evaluations, we help our customers to demonstrate the safety and efficiency of their devices, as well as their compliance with the essential requirements for their category and claim, whether they are applying for a CE mark or for FDA approval“, says our Clinical Evaluation Manager.
Depending on the objectives sought and the extent of progress achieved, we carry out four types of evaluation for innovative devices:
- proof of concept (or proof of feasibility): a study carried out with a small number of subjects in order to verify that the device functions as expected and to establish the effectiveness criteria and facilitate further fine-tuning. One or more of these ‘proof of concept’ studies might be conducted prior to proceeding with further prototype improvements;
- safety and clinical efficacy studies: clinical evaluations and single or multi-center investigations on a larger scale to demonstrate the effectiveness and safety of the device prior to marketing ;
- combined clinical and use evaluations: clinical evaluations that also draw together qualitative data regarding usage, the impact of the device on the quality of life, and the acceptability to potential users;
- clinical studies coupled with a medico-economic study: evaluation of the device’s cost-effectiveness with a view to gaining eligibility for reimbursement through state health insurance.
Why use KYomed INNOV for the clinical evaluation of your innovative device?
When you use KYomed INNOV, your clinical assessment is overseen by an experienced project manager who takes care of the entire evaluation process, drawing on the expertise of a multidisciplinary team which understands the health innovation sector – connected health in particular – and takes a comprehensive, holistic, approach to your project.
We can therefore support you at all stages in the clinical evaluation of your innovative device: the provision of research design assistance and strategic advice, rigorous project management, data collection in real-life conditions, as well as, by integrating all the criteria that might need to be fulfilled in order to gain eligibility for reimbursement via state health insurance (see Medico-economic studies), or in anticipation of possible applications to other regulatory bodies.
Equally, depending on your objectives, we can combine this clinical evaluation with an evaluation of the usability and the acceptability of your device (see Combined Clinical and Use Evaluations), two parameters essential for the elaboration of an efficient system that addresses the reality of the environment into it needs to integrate (see Usability and Innovation in Connected Health and Autonomous Living).