Schedule

Medical devices research and development (required)
Lectures/Training plan agenda
1	The Overview of medical device development approval and process
2	The charactor of Product development and technology accumulation in Japanese industry
3	The discovering medical unmet needs (1)
4	The discovering medical unmet needs (2)
5	Solution creating for needs(1)
6	Solution creating for needs(2)
7	Prototyping, Clinical Trial, Productization(1)
8	Prototyping, Clinical Trial, Productization(2)
9	The overview of the approval examination process on the medical device(1)
10	The overview of the approval examination process on the medical device(2)
11	The communication among Medical staff. Medical Technician, Medical Researcher(1)
12	The communication among Medical staff. Medical Technician, Medical Researcher(2)
13	The future of medical device development process(1)
14	The future of medical device development process(2)
15	The Conclusion

The clinical trial by doctor exercise (required)
Syllabus
1	The Overview of medical device development approval and process
2	The Overview of clinical trial led by medical doctors
3	The Document management system in clinical test(1)
4	The Document management system in clinical test(2)
5	The clinical test protocol and it’s design(1)
6	The clinical test protocol and it’s design(2)
7	(CRC,SMO,clinical trial adjustment bureau etc）
8	PMDA and advising
9	The examples of clinical trial led by medical doctors(1)
10	The examples of clinical trial led by medical doctors(2)
11	Protocol/Clinical trial document exercise(1)
12	Protocol/Clinical trial document exercise(2)
13	Problem in real world and solutions for them(1)
14	Problem in real world and solutions for them(2)
15	Conclusion

The globalisation training
Syllabus
1	The Overview of the context in the global medical device development
2	The Character and medical device development team in Minnesota University US(1)
3	The Character and medical device development team in Minnesota University US(2)
4	The Conclusion and discussion(1)
5	The Conclusion and discussion(2)
6	The Character and medical device development team in Silicon valley US(1)
7	The Character and medical device development team in Silicon valley US(2)
8	The conclusion and discussion(1)
9	The conclusion and discussion(2)
10	The Character and medical device development team in Boston area around Harvard University(1)
11	The Character and medical device development team in Boston area around Harvard University(2)
12	The conclusion and discussion(1)
13	The conclusion and discussion(2)
14	Global comparison and Status of Japan
15	The Conclusion