Lecture 10 Flashcards
what does it mean by “high cost low volume”?
you make small amounts of something, (low volume) (e.g. dental implants) but you charge large amounts of money (high cost)
what does FDA stand for and what does it approve?
Food and Drug Administration, approves food and drugs lol
what is Health Canada Licensing?
the Canadian equivalent of the FDA–it is very strict
what does CE stand for?
Conformité Européene, also very strict
what are the different types of ISO labels?
ISO13485:yyyy –> 13485 = hardest label to get, for dentistry, very prestiguous
ISO14000:yyyy–> environmental
ISO9000:yyyy–>least strict, for industrial
yyyy–>the year the ISO approval was achieved
important to remember ISO approval for overseas companies may not mean anything as there is corruption
ye
what make dental materials tough field from a manufacturing point of view?
- added costs of research and dev
- additional certification requirements
- profit
- liability
where might costs come from in economics?
- characteriztion of materials
- biocompatibility studies
- selling/distribution
- customer technical service
- manufacturing
- liability
- regulatory
- interest costs
what are the stages of cash flow?
- conception – materials optimization
- design –> in-vitro/in-vivo
- clin. trials
- commercialization
- market acceptance
- product maturity
- obselescence–>technology takeover
