This course provides an overview of biomedical innovation and its relation to healthcare. It introduces medical technology innovations by identifying clinical needs, inventing new devices and instruments, and implementing devices in patient care. Students will learn the needs finding, inventing, and implementation phases of biodesign. They will validate medical needs, assess markets, define the invention to implementation process, write business plans, and think critically. The course uses readings, projects, presentations and discussions to achieve these goals.

1. BioDesign: Methods for Innovation in
Biomedical
(BYM 513E)
Serkan TÜRKELİ (PhD)
Istanbul Technical University, Biomedical Engineering Graduate Program, Turkey

2. Serkan Türkeli (PhD)
E‐posta: serkanturkeli@yahoo.com/
sturkeli@itu.edu.tr
Internet: serkanturkeli.minmba.com

3. Scope, Purpose and
Description
This course is designed to provide the
student an overview of the biomedical
innovation and how it relates to
healthcare sector. This course introduces
medical technology innovations in the
context of
(A) identifying clinical needs,
(B) the process of inventing new medical
devices and instruments, and
(C) implementation of medical devices in
patient care.
The student learns the process of identify
(needs finding and needs screening),
invent (concept generation and concept
selection), implement (development
strategy& planning and integration)
phases of BioDesign

4. Required Readings Biodesign: The Process of Innovating New Medical
Technologies, Zenios et al 2010,

5. Grading
Criteria
Students will be evaluated using the following criteria:
Active, Meaningful Participation 25%
Midterm Project
Written Deliverable(Case Study) and Presentation 35%
Final Project
Written Deliverable(Case Study) and Presentation 40%
Attendence Policy
70% attendence is
compulsory.
Late submission of
assignments/homework
– Not accepted one week
after the due date.

6. Course Schedule
Week 1: Introduction and Overview
Course Introduction
Student Introduction
Needs Finding: Observation and Problem Identification
Week 2: Needs Finding: Need Statement Development
Week 3: Needs Screening: Validation
Week 4: Needs Analysis and Clinical Q&A
Week 5: Concept Generation: Brainstorming and Prototyping
Basics
Week 6: Intellectual Property Strategy
Week 7: Midterm1

7. Week 8: Concept Selection with focus on Market
Analysis
Week 9: Regulatory Basics
Week 10: Development Strategy and IP Claims
Workshop
Week 11: Fundamentals of Reimbursement
Week 12: Financial Models and Operating Plans
Week 13: Funding and Business Planning
Week 14: Final

8. 8
Objectives and Goal
• At the end of this course, students will be able to
• ‐validate medical needs
• ‐understand market assessment
• ‐define the process and sub processes from invention to implementation
• ‐write business plan
• ‐ read analytically and think critically at a high level
• ‐ understand the general framework of BioDesign

9. 9
Resources 1: Online resources
1. AHRQ National Resource Center for Health IT
http://healthit.ahrq.gov/
2. National Coordinator for Health Information Technology
http://healthit.hhs.gov/
3. Health IT Stimulus News
http://www.ihealthbeat.org/
4. OpenClinical
http://www.openclinical.org/
5. CPOE.org
http://www.cpoe.org/
6. Certification Commission for Health Information Technology (CCHIT)
http://www.cchit.org/

10. 10
Resources 2: Major professional organizations
1. American Medical Informatics Association (AMIA)
http://www.amia.org/
2. Health Information and Management System Society (HIMSS)
http://www.himss.org/
3. International Medical Informatics Association (IMIA)
http://www.imia.org/
4. Certi
cation Commission for Healthcare Information Technology (CCHIT)
http://www.cchit.org/
5. Health Level 7 (HL7)
http://www.hl7.org/

11. 11
Resources 3: Academic journals
1. Journal of the American Medical Informatics Association (JAMIA)
http://www.jamia.org/
2. Journal of Medical Internet Research (JMIR)
http://www.jmir.org/
3. Journal of Biomedical Science (JBS)
http://www.springerlink.com/content/112912/
4. International Journal of Medical Informatics (IJMI)
http://www.intl.elsevierhealth.com/journals/ijmi/
5. Methods of Information in Medicine (MIM)
https://www.schattauer.de/index.php?id=704

12. 12
Q&A?
Thank you for listening
Istanbul Technical University,
Biomedical Engineering Graduate Program,
Turkey
sturkeli@itu.edu.tr