This graduate-level textbook focuses on the validation and applicability of clinically relevant biomedical technologies, the market, regulatory aspects, the economic evaluation and the cost-effective pricing of medical devices. It connects the dots between devices and technologies from R&D and patient.
From the Contents
Validation and applicability of clinically relevant biomedical technologies
Fields of application for biomedical technologies
- Medical devices market
- Diagnostic devices market
- Cosmetic products market
- Medical devices in emerging markets
Regulatory aspects: Protecting the public and the patient
- Protecting your idea with intellectual property
- FDA regulatory processes
- Regulatory processes to obtain CE marking
Bringing biomedical devices and technologies from R&D to the patient
- Fundraising and sound management of the assets
- Manufacturing of tissue engineered products
- Manufacturing and scaling up biological products
- Manufacturing and engineering of medical devices
- Clinical trials
- Entering the market with innovative biomedical technologies
Economic evaluation of innovative medical devices
- Basic principles for economic evaluation
- Cost-effectiveness and pricing of medical devices
Bob Gauvin and Maxime D. Guillemette, Université Laval, Québec, Canada.
