All entries for Thursday 28 March 2013
March 28, 2013
from: Kruger and Kruger - The medical device sector (p. 377 in The Business of Healthcare Innovation, edited by Lawton Burns)
|Hospital supplies commodities||54.8||67.6||80.3||88.7|
Standards can serve different purposes. They can:
1. Provide reference criteria that a product, process or service must meet.
2. Provide information that enhances safety, reliability and performance of products, processes and services.
3. Assure consumers about reliability or other characteristics of goods or services provided in the marketplace.
4. Give consumers more choice by allowing one firm’s products to be substituted for, or combined with, those of another.
Figure: Process for Standard development
In general, good standards have the following attributes:
1. Their development has been overseen by a recognized body, thus ensuring that the process is transparent and not dominated by vested interests.
2. The development process has been open to input from all interested parties and the resulting document based on consensus. Consensus, in a practical sense, means that significant agreement among the stakeholders is reached in the preparation of the standard, including steps taken to resolve all objections. This process implies more than the votes of a majority, but not necessarily unanimity.
3. Good technical standards are based on consolidated results of science, technology and experience, and are aimed at the promotion o optimum community benefits.
4. Standards do not hinder innovations and must be periodically reviewed to remain in tune with technological advances.
From : http://www.who.int/medical_devices/publications/en/MD_Regulations.pdf