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Differences between MedTech and Pharma
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 Advancing Healthcare Through Innovative Technologies and Devices

Fundamental Differences Between Medical Devices and Research-Based Pharmaceuticals




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

Generally based on biomedical engineering, and developed through mechanical, electrical and/or materials engineering to develop a product that permanently or temporarily replaces a function of the body 

Based on pharmacology and chemistry. Now encompassing biotechnology, genetic engineering, etc.

Comprised of a wide cross-section of technologies,
including mechanical, electrical, and materials-based engineering, as well as biotechnology and other sciences
Developed through complex scientific theory before
being tested by clinical trial and then selected on the basis of quality, safety and efficacy

Designed and developed in the health-care field with clinicians, to perform certain functions based on quality, safety and effectiveness  Biologically active: effective when absorbed into
the human body
Generally act by physical means  Continuous innovation and some improvements based
on bio-chemical and genetic science and technology

Product Development 

Due to a high rate of innovation, there is a short
product life cycle and investment recovery period
(typically 18 months on the market)

Extensive product life cycle and long investment
recovery period (typically five to seven years
development plus 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 invented based on health-care needs
Improvements, including revised dosing strategies and
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 be shared with the product engineer to improve design and best practices  The ‘active profile’ of a product is enhanced by studying
the effects in its long-term use with large post-market patient groups

Industry can be responsive to end-users through the development of new technology  Low distribution cost, and, in most cases, no direct service or maintenance 
High cost for distribution, training and education, and there is often the requirement to provide service and maintenance (for high tech devices)  Education is primarily focused on the disease or condition and the impact of the product rather than product traits

Regulation in Canada

Risk-based pre-market approval/licensing of individual product  Prescriptive approach: pre-market approval/licensing of individual product 
Licensing requirements vary according to risk classification of product within the Medical Devices Bureau at Health Canada  Licensing requirements vary according to the nature of the product and the department within the Bureau of Drugs and Natural Health Products at Health Canada 



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MEDEC is the national association created by and for the Canadian medical technology industry. MEDEC is the primary source for advocacy, information and education on the medical technology industry for members, the greater healthcare community, industry partners and the general public.

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