Lecture 1 Intro 10/07

Question 1

1) Entrepreneur definition - anonymous

2) Entrepreneur definition - webmaster’s

Answer 1

1) someone who will do anything to get out of doing an honest day’s work
2) a person who organises and manages an enterprise, especially a business, usually with a considerable initiative and risk

Question 2

Medical device spending % on pts and globally

Answer 2

Medical devices account for about 30% of spending on pts, or about $400,000,000,000 globally

Question 3

Typical medical device development

Answer 3

Diagram 1

Idea / concept -> Prototypes -> Benchtop / computational testing -> Preclinical safety testing -> Clinical trials -> Regulatory approval -> Profitting and saving lives -> Recover investment, Pay back investors (20x), Next devices

Increasing investments are needed in all steps between idea -> clinical trials

DISTINCTION between devices and pharmaceuticals: always ITERATING the device

Question 4

Brief words on intellectual property

Answer 4

• pathway to the market is not economically feasible if device can be copied after clinical trials
• someone has to take the risk and pay for clinical trials
• public disclosure guarantees it will never benefit patients (a type of hair on the deal)

Question 5

University technology commercialisation

Answer 5

• Mission of public university involves serving the public
• development of advanced technologies is one way
• patents are another form of publication
• ABSOLUTELY necessary for medical devices (regulatory)
• income can benefit university, research and inventors
• not all academicians agree