|
Medical Technologies and
Devices |
Pharmaceutical Product |
|
INDUSTRY |
INDUSTRY |
|
Relatively young, very diverse 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 |
PRODUCTS |
|
Generally based on mechanical, electrical and
materials engineering |
Based on pharmacology and chemistry. Now
encompassing biotechnology, genetic engineering, etc. |
|
Designed to perform certain functions based on
quality, safety and performance |
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 |
|
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
service or maintenance |
|
Often integral to clinical procedures, so user
training and education are essential for safe and effective use |
Training required for use much less intensive
than for high tech devices |
|
REGULATION IN EUROPE |
REGULATION IN EUROPE |
|
Regulation founded on the European “New
Approach" |
Prescriptive approach: pre-market
approval/licensing of individual product |
|
Applicable processes depend on risk-category of
devices |
|
|
Notified Bodies are appointed by governments to
certify the conformity assessment procedures |
|
|
Improvements of medical devices often result
from the feedback received from the users |
|
