Fundamental Differences Between Medical Devices and Research-Based Pharmaceuticals

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

Comprised of a wide cross-section of technologies, including mechanical, electrical, and materials-based engineering, as well as biotechnology and other sciences

Designed and developed in the health-care field with clinicians, to perform certain functions based on quality, safety and effectiveness

Generally act by physical means

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

Developed through complex scientific theory before being tested by clinical trial and then selected on the basis of quality, safety and efficacy

Biologically active: effective when absorbed into the human body

Continuous innovation and some improvements based on bio-chemical and genetic science and technology

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

The majority of new products bring added functions or clinical value based on incremental improvements, or are invented based on health-care needs

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

Industry can be responsive to end-users through the development of new technology
High cost for distribution, training and education, and there is often the requirement to provide service and maintenance (for high tech devices)

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)

Improvements, including revised dosing strategies and off-label indications, cannot be shared by the manufacturer

The ‘active profile’ of a product is enhanced by studying the effects in its long-term use with large post-market patient groups

Low distribution cost, and, in most cases, no direct service or maintenance

Education is primarily focused on the disease or condition and the impact of the product rather than product traits

Risk-based pre-market approval/licensing of individual product

Licensing requirements vary according to risk classification of product within the Medical Devices Bureau at Health Canada

Prescriptive approach: pre-market approval/licensing of individual product

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