8G000203 Lecture on Biodesign A2

Hiroshima University Syllabus

Japanese

Academic Year 2025Year School/Graduate School Translational Research Center(University Wide Courses for Graduate Students)

Lecture Code 8G000203 Subject Classification Specialized Education

Subject Name バイオデザイン概論A2

Subject Name
（Katakana）バイオデザインガイロンA2

Subject Name in
English Lecture on Biodesign A2

Instructor HANANOUCHI TAKEHITO

Instructor
(Katakana) ハナノウチ　タケヒト

Campus Kasumi Semester/Term 1st-Year, Second Semester, Second Semester

Days, Periods, and Classrooms (2nd) Fri11-12：MED Rm 2

Lesson Style Lecture Lesson Style
(More Details) Face-to-face, Online (on-demand)

　
Lectures( and Discussions)

Credits 1.0 Class Hours/Week 2 Language of Instruction B : Japanese／English

Course Level 5 : Graduate Basic

Course Area（Area） 27 : Health Sciences

Course Area（Discipline） 01 : Medical Sciences

Eligible Students

Keywords SDG_03, SDG_09, Medical Innovation, Design Thinking, Medical and Healthcare Device Development

Special Subject for Teacher Education 　 Special Subject 　

Class Status
within Educational
Program
(Applicable only to targeted subjects for undergraduate students)
Criterion referenced
Evaluation
(Applicable only to targeted subjects for undergraduate students)

Class Objectives
/Class Outline Biodesign refers to an innovative process for creating innovation in the medical and healthcare fields by integrating medical, engineering, design, and business perspectives.
The content of this class has been renewed since the 2025 academic year, and while it is intended as an overview, additions and modifications have been made to the content to provide an overall flow of medical device development. By inviting outside lecturers, etc., a wide range of content will be provided.

Lecture on Biodesign A1is the first half of the course, and Lecture on Biodesign A2 is the second half,
In other words, it is advisable to take both lecture courses.

As a general rule, classes will be conducted online (on-demand), but if classes are to be conducted in person, etc., depending on the content, etc., this will be communicated separately. When classes are conducted online (simultaneous interactive type) or in person, a recording of the class content will be made available online (on-demand type) at a later date, so that students who are unable to attend will not be disadvantaged.
Homework and assignments will be provided by e-mail or in each lecture.

Class Schedule 1st (through, 9th) October 10 Business Model and Sales Strategy
2nd (through, 10th) October 24 Clinical Research and Clinical Development
3rd (through, 11th) November 14 Regulatory Affairs and QMS
4th (through, 12th) November 28 Regulatory Affairs (SaMD)
5th (through, 13th) December 5 Insurance Reimbursement
6th (through, 14th) December 19 Regulatory Science
7th(through, 15th) January 9 Global Expansion 1
8th (through, 16th) January 23 Global Expansion 2 and Conclusion

A questionnaire to check attendance and understanding will be presented online at the end of some lectures. This will be considered a report to evaluate the final score. An overall evaluation will be made based on the answers submitted by the due date.

Text/Reference
Books,etc. PG Yock, S Zenios et al. "Biodesign: The Process of Innovating Medical Technologies" 2nd ed. (ISBN-13: 978-1107087354; ISBN-10: 110708735X)

PC or AV used in
Class,etc. Handouts, Visual Materials, Zoom, moodle

(More Details) To be announced at lectures

Learning techniques to be incorporated Discussions, Quizzes/ Quiz format, Project Learning, Post-class Report

Suggestions on
Preparation and
Review Specific instructions will be given in each class.

Requirements Depending on the content of individual research, work may be done individually as needed in addition to this time.

Grading Method A questionnaire to check attendance and understanding will be presented online at the end of the lecture. This will be considered an assignment report. The overall evaluation will be based on the answers submitted by the due date.
The overall evaluation will be based on the students' class attendance and the assignment report.

Practical Experience Experienced

Summary of Practical Experience and Class Contents based on it One of main faculty is an orthopaedid physician, has the clinical experiences of over 20 years, and also has the experiences of development
of medical devices.

Message Lectures will be given mainly in Japanese (including English in some cases), but as much English as possible will be included in the slides and handouts so that international students can understand the lectures in English.

Other Sometimes, questionnaires should be done. Them its feedback can be used for the contents of the next year.

Please fill in the class improvement questionnaire which is carried out on all classes.
Instructors will reflect on your feedback and utilize the information for improving their teaching.

Academic Year	2025Year	School/Graduate School	Translational Research Center(University Wide Courses for Graduate Students)
Lecture Code	8G000203	Subject Classification	Specialized Education
Subject Name	バイオデザイン概論A2
Subject Name （Katakana）	バイオデザインガイロンA2
Subject Name in English	Lecture on Biodesign A2
Instructor	HANANOUCHI TAKEHITO
Instructor (Katakana)	ハナノウチ　タケヒト
Campus	Kasumi	Semester/Term	1st-Year, Second Semester, Second Semester
Days, Periods, and Classrooms	(2nd) Fri11-12：MED Rm 2
Lesson Style	Lecture	Lesson Style (More Details)	Face-to-face, Online (on-demand)
Lectures( and Discussions)
Credits	1.0	Class Hours/Week	2	Language of Instruction	B : Japanese／English
Course Level	5 : Graduate Basic
Course Area（Area）	27 : Health Sciences
Course Area（Discipline）	01 : Medical Sciences
Eligible Students
Keywords	SDG_03, SDG_09, Medical Innovation, Design Thinking, Medical and Healthcare Device Development
Special Subject for Teacher Education		Special Subject
Class Status within Educational Program (Applicable only to targeted subjects for undergraduate students)
Criterion referenced Evaluation (Applicable only to targeted subjects for undergraduate students)
Class Objectives /Class Outline	Biodesign refers to an innovative process for creating innovation in the medical and healthcare fields by integrating medical, engineering, design, and business perspectives. The content of this class has been renewed since the 2025 academic year, and while it is intended as an overview, additions and modifications have been made to the content to provide an overall flow of medical device development. By inviting outside lecturers, etc., a wide range of content will be provided. Lecture on Biodesign A1is the first half of the course, and Lecture on Biodesign A2 is the second half, In other words, it is advisable to take both lecture courses. As a general rule, classes will be conducted online (on-demand), but if classes are to be conducted in person, etc., depending on the content, etc., this will be communicated separately. When classes are conducted online (simultaneous interactive type) or in person, a recording of the class content will be made available online (on-demand type) at a later date, so that students who are unable to attend will not be disadvantaged. Homework and assignments will be provided by e-mail or in each lecture.
Class Schedule	1st (through, 9th) October 10 Business Model and Sales Strategy 2nd (through, 10th) October 24 Clinical Research and Clinical Development 3rd (through, 11th) November 14 Regulatory Affairs and QMS 4th (through, 12th) November 28 Regulatory Affairs (SaMD) 5th (through, 13th) December 5 Insurance Reimbursement 6th (through, 14th) December 19 Regulatory Science 7th(through, 15th) January 9 Global Expansion 1 8th (through, 16th) January 23 Global Expansion 2 and Conclusion A questionnaire to check attendance and understanding will be presented online at the end of some lectures. This will be considered a report to evaluate the final score. An overall evaluation will be made based on the answers submitted by the due date.
Text/Reference Books,etc.	PG Yock, S Zenios et al. "Biodesign: The Process of Innovating Medical Technologies" 2nd ed. (ISBN-13: 978-1107087354; ISBN-10: 110708735X)
PC or AV used in Class,etc.	Handouts, Visual Materials, Zoom, moodle
(More Details)	To be announced at lectures
Learning techniques to be incorporated	Discussions, Quizzes/ Quiz format, Project Learning, Post-class Report
Suggestions on Preparation and Review	Specific instructions will be given in each class.
Requirements	Depending on the content of individual research, work may be done individually as needed in addition to this time.
Grading Method	A questionnaire to check attendance and understanding will be presented online at the end of the lecture. This will be considered an assignment report. The overall evaluation will be based on the answers submitted by the due date. The overall evaluation will be based on the students' class attendance and the assignment report.
Practical Experience	Experienced
Summary of Practical Experience and Class Contents based on it	One of main faculty is an orthopaedid physician, has the clinical experiences of over 20 years, and also has the experiences of development of medical devices.
Message	Lectures will be given mainly in Japanese (including English in some cases), but as much English as possible will be included in the slides and handouts so that international students can understand the lectures in English.
Other	Sometimes, questionnaires should be done. Them its feedback can be used for the contents of the next year.
Please fill in the class improvement questionnaire which is carried out on all classes. Instructors will reflect on your feedback and utilize the information for improving their teaching.

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