The ICAN IHU has forged close links with a number of medical device companies and has a SNITEM representative on its Board of Directors.
The ICAN IHU aims to promote translational research in the field of cardiometabolic diseases and nutrition, and has participated in the development of several innovative medical devices.
IHU ICAN strives to support manufacturers of innovative medical devices to meet the new preclinical and clinical requirements introduced by European regulations 2017/745 for medical devices and 2017/746 for in vitro diagnostic medical devices.
ICAN has a number of resources at its disposal to provide services for medical device manufacturers:
- Targeted advice and expertise on preclinical and clinical strategy in the field of cardiometabolic and nutritional pathologies (NASH, heart failure, diabetes and chronic wounds, rare diseases, etc.).
- Identification of patient needs and participation in assessments of suitability for use in clinical settings.
- Advice on identifying patient needs, defining expected performance and the target population for the medical device.
- Design, implementation and analysis of in vitro and ex vivo preclinical studies (iPS cells, human liver tissue, metabolomic and lipidomic analysis).
- Scientific and medical support for the design of the clinical evaluation or performance assessment plan.
- Scientific and medical support in drafting clinical study protocols.
As part of the implementation of a clinical evaluation plan, the ICAN IHU has a clinical investigation platform specialising in the recruitment of patients suffering from cardiometabolic and nutritional pathologies, based on :
- Highly specialised analysis platforms(lipidomics, metabolomics).
- A location at the heart of the Pitié-Salpêtrière hospital
- A Biological Resources Centre in the immediate vicinity (identification, technicage, conservation) – certified ISO 9001 and NF S 96-900
- A dedicated team (clinical research physician, IDEs, expert TECs)
