BioDesign: Methods for Innovation in

Biomedical
(BYM 513E)

Serkan TÜRKELİ (PhD)

Istanbul Technical University, Biomedical Engineering Graduate Program, Turkey

 Serkan Türkeli (PhD)

E‐posta: serkanturkeli@yahoo.com/
sturkeli@itu.edu.tr

Internet: serkanturkeli.minmba.com
Scope, Purpose and This course is designed to provide the
Description 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
Required Readings Biodesign: The Process of Innovating New Medical 
Technologies, Zenios et al 2010,
 Grading Students will be evaluated using the following criteria:
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 Late submission of

70% attendence is  assignments/homework
compulsory. – Not accepted one week 
after the due date.
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
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

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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

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/
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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/
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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
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Q&A?
Istanbul Technical University, 
Biomedical Engineering Graduate Program, 
Turkey

Thank you for listening sturkeli@itu.edu.tr