Youtube Channel about Medical Device Regulation in the world.

The Emergo Group made a very good introduction of medical device regulation in Youtube.

Innovation- beyond Technology and Product Innovation

The medical device industry is a hotbed of innovation. In today's intense competitive and fast-changing markets, innovative products or services have paramount importance for organizations to obtain sustainable competitive advantage either in lower costs or differentiation or both.

R&D staff or manager with technology background is easy to think the technology is the first consideration in innovation. Science and technology is No 1 factor, which may work in the university but often fails in the industry.

According Peter F. Drucker's article "The Discipline of Innovation", innovation starts with a conscious, purposeful search and analysis of new opportunities. The sources of innovation opportunities can be from without a company or industry:

• unexpected occurrences
• incongruities between expectations and results
• process needs
• industry and market changes

Three additional sources are from outside of a company:

• demographic changes
• changes in perception
• new knowledge

Product, process, market, organization, management, service, logistics, business mode, technology innovations can result from these opportunities. These sources will have different importance at different times, areas and firms such as the established and the start-up. New knowledge-whether science, technology or society - is just one in seven sources of innovation. Drucker emphasizes that knowledge-based innovations are superstars of entrepreneurship, demand many kinds of knowledge and long lead times, and is more market dependent than any other kind of innovation.

Product innovation can get idea from above opportunities. For example, aging (demographic changes) is a serious problem for society but it is an opportunity for medical device industry. I believe that the successful product innovation should be customer-oriented, i.e. meet current customers requirement (incremental and sustaining innovation) or create new customers and markets (great breakthrough or disruptive innovation). For medical device industry, customers may include patients, doctors and nurses.

Check before using any Chemicals

When we design any formulation of medical device or cosmetics, had better check the information of chemicals used including general property, safety data, toxicology, cancer et. al. The searchable databases are:

• TOXNET, Databases on toxicology, hazardous chemicals, environmental health, and toxic releases. Highly recommended, can search many databases by the US EPA, CDC et. al. in one site.
• NIST Chemistry Webook, chemical and physical property data for chemicals.
• Information on Chemicals in European Chemicals Agency, higly recommended, integrated site for chemical information in European.
• Integrated Risk Information System, by US Environmental Protection Agency (EPA)
• eChemPortal, in OECD Chemical Safety and Biosafety
• International Chemical Safety Cards(ICSC), by CDC and ILO.

Of course, searching th chemical in FDA site with "chemical name site:fda.gov" in google is the first thing to do.

Aerosol Online Resource

Magazines
Spray Technology&Marketing
Aerosol Europe
Aerosol Revista

Regulations
Aerosol Dispensers Directive 75/324/EEC and revision in 1994, 2008, and 2013

United States Environmental Protection Agency
California Air Resources Board