FUNDAMENTAL DIFFERENCES BETWEEN MEDICAL DEVICES AND RESEARCH-BASED PHARMACEUTICALS

THE NEED FOR A DIFFERENTIATED REGULATORY APPROACH WITH MEDICAL DEVICES: Comparison of Medical Devices and Pharmaceuticals and Review of Key Differences

MEDICAL DEVICES	PHARMACEUTICALS
INDUSTRY Relatively young, very diverse industry	INDUSTRY Industry with long historical background
Industry is made up of a few large companies and a large number of small and medium-sized companies.	Industry is comprised primarily of multinationals
PRODUCTS Generally based on mechanical, electrical and materials engineering Comprised of a wide cross-section of technologies, including mechanical, electrical, and materials based engineering, as well as biotechnology and other sciences.	PRODUCTS Based on pharmacology and chemistry. Now encompassing biotechnology, genetic engineering, etc.
Designed to perform certain functions based on quality, safety and effectiveness	Product development by trial and selection on basis of quality, safety and efficacy
Generally act by physical means	Biologically active: effective when absorbed into the human body
Continuous innovation and iterative improvements based on new science, technology and available materials	Continuous innovation and some improvements based on new science and technology
Short product life cycle and investment recovery period (typically 18 months on the market)	Extensive product life cycle and long investment recovery period (typically 5-7 years development plus approx. 4 year clinical trial before submission for regulatory approval)
The majority of new products typically bring added functions and clinical value based on incremental improvements	Long investment recovery period
High distribution and training education costs and requirement to provide service and maintenance (for high tech devices)	Low distribution cost, and, in most cases, no direct service or maintenance
Often integral to clinical procedures, and must work closely with a diverse group of healthcare providers, to provide information including appropriate procedures.	Education is primarily focused on the condition and impact of the product rather then product traits.
REGULATION IN CANADA Pre-market approval/licensing of individual product	REGULATION IN CANADA Prescriptive approach: pre-market approval/licensing of individual product
Licensing requirements vary according to risk classification of product	Licensing requirements vary according to the nature of the product and the department within the TPD
Improvements of medical devices often result from the feedback received from the users and can be shared to improve best practices Industry can be more responsive to end-users	Improvements including revised dosing strategies, and off-label indications cannot be shared by the manufacturer Less input by end users into the development process and limited opportunity to change product