[How to assess new medical devices].

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Currently, regulatory agencies have serious difficulty in obtaining high-quality scientific proof that demonstrates the clinical efficacy of new medical devices. These difficulties are specific to medical devices and to the medical environment that uses them. Schematically the clinical development of a new medical device has two stages: feasibility studies and studies to demonstrate clinical benefits. Feasibility studies are proposed immediately after the preclinical phase. The type of study that is methodologically appropriate is a noncomparative trial that responds to questions about patient selection, the development of implantation techniques, clinical efficacy, and complications. The demonstration of clinical benefits depends on the performance of a randomized control trial, although the feasibility studies are taken into account. The construction of the trial should be based on the formulation of a clear, specific, and pertinent principal objective. Eligible patients should correspond to those for whom the new device is intended in daily practice. The choice of a control group depends on the reference strategy or treatment, determined from the literature. A single principal endpoint should be proposed, consistent with the principal objective, which should be clinical (whenever possible), pertinent, and validated. The measure used to determine the endpoint must be as objective as possible. Multicenter trials are preferable to facilitate patient recruitment and minimize the inclusion period. Moreover, the results of multicenter studies can be extrapolated more readily. Nonetheless, the teams likely to participate in a multicenter trial must have stabilized their learning curve. To meet the methodological requirements of clinical trials for new medical devices, clinical research must improve its structure, especially by promoting the links between industry, clinicians, and academics.

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... This possibility should be assessed critically though as it might lead to a bias in regard to missing an effectiveness. The demonstration of clinical benefits is be based on the prior feasibility studies (148) and provides best evidence of the new product when conducted as a randomized controlled study. Before conducting the trial a clear, specific and pertinent principle objective should be framed as a unique goal (146). ...
... A catalogue of duties ensures a standardisation of the implantation techniques, the experience of the medical personnel, the level of technical expertise and a quality control of the medical data. The planning of the trials should take into account an eligible number of patients, the number and the location (national vs. international) of centres participating and possible biases such as uncontrollable drop-outs (19,146,148,149). ...
... To meet the methodological requirements of clinical trials for new medical devices, clinical research must improve its structure, especially by promoting the links between industry, clinicians, and academics. Figure 27: Key stages of the clinical development suggested by HAS (19,146,148,149). ...
Background: The CE mark is a mandatory European conformity marking for medical devices (MD) sold within European Economic Area. After meeting the requirements of the CE mark MD are subject to further national appraisals leading to differences in methodologies in France and Germany. HTA (Health Technology Assessment) reports aim to inform governmental players about medical, social, and economic implications of development, diffusion, and use of health technology. HTA intends to provide a bridge between the world of research and the world of decision-making. There is little information on the differences between France and Germany regarding the assessment on MD. What differences apply to the participating HTA and national bodies? Which methodology to assess innovative MD do the countries apply? This comparative health analysis clarifies the impact of HTA on reimbursement on MD and illustrates hurdles both for manufacturers and governmental players. Results: The participating HTA bodies in France are HAS and CEPS; IQWiG and g-BA in Germany. Their iterative work leads to an assessment and finally to reimbursement. Although the scope of work regarding HTA of HAS is broader, HAS and IQWiG are both independent, transparent bodies conducting appraisals on MD. CEPS and g-BA are rounding off the appraisals and make decisions (predominantly in camera). Hurdles for new MD are high in both countries regarding information needed on evidence and benefit. For very innovative MD France has introduced economical evaluations and measurements such as QALY and ICERs. In Germany on the other hand, an early benefit appraisal will be launched (2015) to address MD of risk level 2b and 3 in mainly inpatient care softening the boundaries between out- and inpatient care. Discussion: Including information such as QALYs and ICERs into decision-making is a new concept in ‘old Europe’. The impact of this new French methodology on decision-making of the CEPS is yet unclear. The role and need are questionable if they do not have a direct impact on decision-making but rather ‘inform’ as it is the case in France. By contrast, Germany aims to include broader appraisals on MD in inpatient care focusing on another field of interest: The two yet separate ‘markets’ of out- and inpatient care. Conclusion: In the last years both countries show tendencies to improve evidence-based decision-making by taking efficiency measurements and safety considerations into account. A combination of both systems regarding economic analyses and the early-benefit assessments would be preferable.
Innovative medical devices offer solutions to medical problems and greatly improve patients' outcomes. Like National Health Technology Assessment (HTA) agencies, hospitals face numerous requests for innovative and costly medical devices. To help local decision-makers, different approaches of hospital-based HTA (HB-HTA) have been adopted worldwide. The objective of the present paper is to explore HB-HTA models for adopting innovative medical devices in France and elsewhere. Four different models have been conceptualized: "ambassador" model, "mini-HTA" model, "HTA unit" model and "internal committee". Apparently, "HTA unit" and "internal committee" (or a mixture of both models) are the prevailing HB-HTA models in France. Nevertheless, some weaknesses of these models have been pointed out in previous works. Only few examples involving hospital pharmacists have been found abroad, except in France and in Italy. Finally, the harmonization of the assessment of innovative medical devices in France needs a better understanding of HB-HTA practices.
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