The generalization of telemedicine applications has accelerated the use of health technologies such as the Digital Medical Devices for professional use (DMDs). The diffusion of DMDs should have a substantial impact on health care organization, professional practices, and patients’ treatment pathways. They have also the potential for reducing budget of local health providers and national health insurance (NHI).
The market access for DMDs raised several inter-related regulatory, acceptability and financial questions: personal and clinical data flow modalities, their use and acceptance by patients or healthcare professionals, their integration in current practices and their economic impact. DMDs have to be assessed on all these dimensions to meet the regulatory requirements, allow informed decision-making and enhance your chances of DMDs reimbursement by NHI.
At any stage of your DMDs development, CEMKA will assist you:
- During the acceptability assessment/ approval dossier, post marketing safety monitoring.
- In the organisational impact assessment.
- To produce and elaborate value evidence.
- For budget impact analyses and HEOR modelling.
- In the implementation of studies, model/analyses, or strategic report for market access.
Combined complementary methodologies can be implemented: database analysis, ad hoc surveys and interviews, KOL interviews, literature review, and budget impact models…
- Multidimensional assessment (acceptability, use, patients experience, budget) to produce proof of value.
- Services tailored to your deployment strategy plan, your DMDs’ development stage and available data.
- Analyses/ models or reports built for market access.
- Several possible methods to answer your needs.