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Industry
- 1. INDUSTRY Industry is made up of a few large companies, and a large Industry is comprised primarily of multinationals number of small and medium-sized companies PRODUCTS Generally based on biomedical engineering, and Based on pharmacology and chemistry. Now developed through mechanical, electrical and/or materials encompassing biotechnology, genetic engineering, etc. engineering to develop a product that permanently or Developed through complex scientific theory before being temporarily replaces tested by clinical trial and then selected on the basis of a function of the body quality, safety and efficacy Comprised of a wide cross-section of technologies, Biologically active: effective when absorbed into the including mechanical, electrical, and materials-based human body engineering, as well as biotechnology and other sciences Continuous innovation and some improvements based Designed and developed in the health-care field with on bio-chemical and genetic science and technology clinicians, to perform certain functions based on quality, safety and effectiveness Generally act by physical means PRODUCT DEVELOPMENT Due to a high rate of innovation, there is a short product Extensive product life cycle and long investment recovery life cycle and investment recovery period (typically 18 period (typically five to seven years development plus months on the market) approximately four years of clinical trial before submission for regulatory approval) The majority of new products bring added functions or clinical value based on incremental improvements, or are Improvements, including revised dosing strategies and invented based on health-care needs off-label indications, cannot be shared by the manufacturer Improvements of medical devices often result from the feedback received from the clinicians and users, and can The active profile of a product is enhanced by studying be shared with the product engineer to improve design the effects in its long-term use with large post-market and best practices patient groups Industry can be responsive to end-users through the Low distribution cost, and, in most cases, no direct development of new technology service or maintenance High cost for distribution, training and education, and Education is primarily focused on the disease or there is often the requirement to provide service and condition and the impact of the product rather than maintenance (for high tech devices) product traits REGULATION IN CANADA
- 2. Risk-based pre-market approval/licensing of individual Prescriptive approach: pre-market approval/licensing of product individual product Licensing requirements vary according to risk Licensing requirements vary according to the nature of classification of product within the Medical Devices the product and the department within the Bureau of Bureau at Health Canada Drugs and Natural Health Products at Health Canada