NAME Innosasun: Healthcare platform for testing/validation/demonstration of medical devices
Innosasun offers a scientific and technological living lab service to companies, for development, testing and validation of their medical devices and other health related technologies, within the Basque Public Health System (Osakidetza). The program offers strategic advice for product development (contrast of ideas with clinicians, specifications, regulatory issues, etc.) and clinical trials for testing and validation of medical devices.
FIELDS OF APPLICATION
Additive manufacturing
Biomedical consumables
Digital health
Electromedical devices
In-Vitro diagnostics
Laboratory equipment
Medical Image
Orthopedic and rehabilitation Technology
MOST OUTSTANDING EQUIPMENT AND COMPONENTS
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Bioaraba (Health Research Institute)
Runs clinical studies involving health professionals from OSI Araba, OSI Rioja Alavesa and the Mental Health Network of Araba.
Platforms involved: Innovation support platform and Clinical Trials Unit (310 m2 within the General Hospital, with 16 beds for admission and deep freezers for sample preservation) that has personnel with know-how in clinical trials of drugs and medical devices; coordinators, monitors, nursing and data manager. The only phase I Clinical Trials Unit of the Basque Public Health System. -
Biocruces Bizkaia (Health Research Institute)
Executes clinical studies with the participation of healthcare professionals of its area of influence composed of a network of 5 OSIs (integrated healthcare organizations), 2 Hospitals and the Mental Health Network of Biscay.
Platforms involved: Innovation Support Unit; Scientific Coordination and Support Platform for the execution of Clinical Research (SEIC) with personnel with know-how in clinical trials and medical devices: coordinators, monitors, nurses and data managers. They have a Clinical Trials Unit that offers consultation and nursing rooms, with health personnel to carry out clinical trials. -
Biodonostia (Health Research Institute)
It carries out clinical studies with the participation of healthcare professionals of its area of influence composed of a network of 6 OSIs (integrated healthcare organizations) and the Mental Health Network of Gipuzkoa. Platforms involved: Innovation support unit and Clinical Research platform that has personnel with know-how in clinical trials and medical device: coordinators, monitors, nurses and data manager.
SERVICES OFFERED BY THE ASSET
Clinical trials execution
Medical visit for medical devices testing and validation in patients, and data collection in CRF, analysis of results. This service is preferably targeted at companies that develop medical devices or digital health technologies.
General tasks for conducting clinical trials (proofs of concept, usability studies, pre and post-marketing studies)
Selection of health centres and clinical research team, protocol design, CRF and Patient Information Sheet (PIS), regulatory advice and dialogue with official bodies, coordination, data collection, monitoring and follow-up, statistical analysis and reporting. This service is preferably targeted at companies that develop medical devices or digital health technologies.
Strategic Advice
Strategic advice, specially to SMEs, throughout the development process of their medical devices, including technical specifications and regulatory aspects, among others. Additionally, contrast of products with healthcare professionals (potential users of the technology) to know the market, specifications, rival products, use in routine practice, target population, etc. This service is preferably targeted at companies that develop medical devices or digital health technologies.
ENTITY MANAGING THE ASSET
Contact person:
LOREA MENDOZA ARTECHE
lmendoza@bioef.eus