BN3101
BIOMEDICAL ENGINEERING DESIGN - 2009 (2009/2010, Semester 1) 

 MODULE OUTLINE Created: 10-Jul-2009, Updated: 28-Jul-2009
 
Module Code BN3101
Module Title BIOMEDICAL ENGINEERING DESIGN - 2009
Semester Semester 1, 2009/2010
Modular Credits 6
Faculty Engineering
Department Biomedical Engineering
Timetable Timetable/Teaching Staff
Module Facilitators
ASSOC PROF Toh Siew Lok-MPE Lecturer
PROF Goh Cho Hong,James Lecturer
PROF Lim Chwee Teck Lecturer
ASSOC PROF Buist, Martin Lindsay Lecturer
DR Lee Taeyong Lecturer
ASSOC PROF Kim Sangho Lecturer
ASSOC PROF Trau, Dieter Wilhelm Lecturer
ASSOC PROF Leo Hwa Liang Lecturer
PROF Casey Chan (Ortho) Lecturer
PROF Casey Chan (Bioeng) Co-Lecturer
MR Soon Hock Wei Coordinator
Weblinks
http://biomed.blog.com/2008/02/17/impending-changes-on-the-promotion-of-off-label-use/
Impending Changes on the Promotion of Off-Label Use
Blog Website
http://biomed.blog.com/2571994/stay-hungry-stay-foolish/
Stay Hungry. Stay Foolish
Blog Website
http://biomed.blog.com/2453184/time-magazines-best-inventions-of-the-year/
Time Magazine's Best Inventions of the Year
Blog Website
http://biomed.blog.com/2034193/willful-infringement/
Willful Infringement
Blog Website
http://biomed.blog.com/1791515/a-new-class-of-3-d-printers-is-going-to-change-the-design-process-for-medical-devices/
A new class of 3-D printers is going to change the design process for medical devices
Blog Website
http://biomed.blog.com/1732639/websites-you-need-to-know/
Websites You Need to Know
Blog Website
http://biomed.blog.com/1312929/mother-lode-of-health-care-information/
Mother Lode of Health Care Information
Blog Website
http://biomed.blog.com/1242745/learning-from-your-competitors-mistakes/
Learning from your competitors' mistakes
Blog Website
http://biomed.blog.com/1042401/looking-for-medtech-info/
Looking for medtech info?
Blog Website
Tags --


Aims & Objectives | Teaching Modes | Prerequisites | Preclusions | Synopsis | Practical Work | Assessment | Texts & Readings | Workload | Final Groups


 AIMS & OBJECTIVES Top
Preparation of formal engineering reports on a series of engineering analysis and design problems illustrating methodology from various branches of applied mechanics as applied to bioengineering problems. Statistical analysis. A term project and oral presentation are required. Students are exposed to the entire design process: design problem definition, generation of a design specification, documentation, design review process, prototype fabrication, testing and calibration.


 TEACHING MODES Top
This module consists of a small design project to be worked on by a group of 5 or 6 students.  All members of the group are expected to contribute to the overall design however each member of the team is responsible for a specific task such as regulatory affairs, patent review, etc.  There are a series of lectures and tutorials to address specific issues in the design process.  There will also be demostration laboratory and consultation with surgeons on various clinical issues.


 PREREQUISITES Top
There is no formal requirement.  You will need to be familiar with CAD software to complete the Design Project.


 PRECLUSIONS Top
Nil


 SYNOPSIS Top

Introduction

The majority of graduating engineers will pursue an industrial position upon completion of their bachelor degree. The fresh graduate may immediately be confronted with practical issues such as project management, design review, user specifications, regulatory compliance, design documentation, design verification amongst other myriad of responsibility piled upon them. Having spent four years studying various academic subjects the recent graduate may be frustrated by the apparent disconnect between university education and the real world. The intent of this module is to create real world experience by introducing real world medical problems requiring design solutions. Using project-focused environment, the students will learn design methodologies drawing upon knowledge already acquired in other courses. Emphasis will be placed on providing bioengineering design solutions within the constrains of regulatory requirements, economics and bioethical issues while at the same time appreciating the clinical environment and clinical needs in which the design solution will have to operate in.

 

Brief Module Description

This module is designed as a core module for the third year bioengineering undergraduates. It introduces concepts, processes and frameworks for analyzing user needs, creating and documenting design solutions and defining and identifying constrains. Topics are presented in a problem-focused modular format to enable the student to acquire new skills to solve a real world bioengineering problem drawing upon relevant knowledge acquired from other courses. Topics covered include, design methodology (including ergonomics and human factors), quality systems, intellectual property protection, design validation, regulatory requirements, bioethics and CAD modeling. Emphasis is on teamwork, project-based learning and entrepreneurial thinking. The team based term projects will require design process documentations and oral presentations.



 PRACTICAL WORK Top
Students are provided with Stainless steel tubings and bone models. Together with the fabricated designs, the students are expected to use these materials to make a prototype of knotless suture anchor system. The necessary tools will be provided by the Bioengineering Design Studio (E3-05-05).


 ASSESSMENT Top
Grades for Project - Group           60%

Grades for Project - Individual      20%

Grades for Mid term quiz             10%

Grades for Final quiz                   10%



 TEXTS & READINGS Top

References for Regulatory Affairs

 

1)  Title: FDA Regulatory Affairs
     Editor: DJ Pisano and D Mantus
     Call No. : RM301.25 Fda 2004 (RBR)
     * * * *

2)   Title: Reliable Design of Medical Device

      Author: Richard C. Fries

      Call No.: R 856.6 Fri (RBR)

      * * * *

References for Design

 

1)   Title: Product Design and Development
     
Author: Karl T. Ulrich; Steven D. Eppinger

      Call No.: HDD 31 Ulr 2004 (RBR)
   * * * *

2)   Title: The medical device R & D handbook

      Author: Theodore R. Kucklick.
 * * * *          

3)       Title: Design of Biomedical Devices and Systems

      Author: Paul H. King; Richard C. Fries

      Call No.: R 857 Bio.Ki 2003 (RBR)
* * * *

4)       Title: Introduction to Ergonomics, 2nd edition

      Author: R.S. Bridger

      Call No.: TA 166 Bri 2003 (RBR)

* * * *

5)       Title: Clinical Evaluation of Medical Devices; Principles and Case Studies

      Editor: Karen Becker Witkin

      Call No.: R 856 Cli (RBR)

      * * * *

 

References for Patent

 

1)       Title: Bringing New Technology to Market

      Author: Kathleen R. Allen

      Call No.: HF 5415 All 2003 (HSSML Books)

      * * * *
References for Bioethics

 

1)   Belmont Report (US) 1979 (Must Read).

 

2)   Declaration of Helskinki (Must Read)

 

3)   Bioethics Advisory Committee Report (Singapore) (Must Read Section VI

      Researcher and Section VII Institutions).

 

4)   JAMA, May 24/31, 2000, Vol 283, No 20 for International Ethical Guidelines.

 

5)       Beecher : Ethics and clinical Research, NEJM 1966, 274: 1354-60.

 

6)       What makes clinical research ethical? – 7 ethical requiremenets for clinical research, Emmanuel EJ, Wendler D, Grady C, JAMA 2000 Vol 283 No 20: 2710-2711.

7)       Monitoring clinical research: report of one hopsital’s experience by Jane McCusker, Zita Kruszewski, Belaine Lacey, Benjamin Schiff, CMAJ, May 1, 2001; 164(9).

8)       Quality of informed consent in cancer clinical trials: a cross sectional survey by Steven Joffe, E Francis Cook, Paul D Clearly, Jeffrey W Clark, Jane C Weeks, The Lancet, Vol 358, November 24, 2001.

9)       Interpretation of the Bolam Test in the standard of medical care: Impact of the Gunapathy case and beyond by Catherine Tay Swee Kian, Tolley’s Profesisonal Negligence, Vol 19, No 2, 2003, pages 384-394.

10)   Is there a scientific rationale for placebos? NEJM 11 August 1994, vol 331, no 6, 394.

Recommended Reading at www.biomed.blog.com

Issues discussed in these blogs are related to topics discussed in class.

1) Impending Changes on the Promotion of Off-Label Use - http://biomed.blog.com/2722750/

2) Stay Hungry. Stay Foolish - http://biomed.blog.com/2571994/

3) Time Magazine's Best Inventions of the Year - http://biomed.blog.com/2453184/

4) Willful Infringement - http://biomed.blog.com/2034193/

5) A new class of 3-D printers is going to change the design process for medical devices - http://biomed.blog.com/1791515/

6) Websites You Need to Know - http://biomed.blog.com/1732639/

7) Mother Lode of Health Care Information - http://biomed.blog.com/1312929/

8) Learning from your competitors' mistakes - http://biomed.blog.com/1242745/

9) Looking for medtech info? - http://biomed.blog.com/1042401/



 WORKLOAD Top
2-0.5-0-3-4.5


 FINAL GROUPS Top

STD_NM STD_MATRIC_N Group Topic Mentor
CHEN ZHOU DE  U083446M 1 Knotless suture anchor for Bankart repair Prof. Toh
MOHAMMAD SAMI TAHIR   U076332H 1
KOH CHEE GAKE U075182X 1
HE SONG   U075229Y 1
GOKULA KRISHNA BANUMURTHY U075227B 1
KHOO YONG CHEAN U075216U 1
TAN SZE YEE  U083471U 2 Knotless suture anchor for Bankart repair Prof. Goh
ZHOU YI   U075232N 2
MUHAMMAD SAFWAN NAQI U076816B 2
ER ZI JIAN KENNETH  U083445B 2
YING KE SIN   U075218R 2
CHIA YUXUAN BERNICE  U083473R 3 Knotless suture anchor for Bankart repair Prof. Lim
TANG YING U075230R 3
HU MINGYI   U075251W 3
LI XIANG  U065634H 3
LIM YU MING U075193E 3
CHENG ZI YI NICHOLAS U075178W 3
TANG WENLUE U075239W 4 Knotless suture anchor for Bankart repair Prof. Buist
LEO HZE MING AMY U065582R 4
JEEVA LAVANYA LAKSHMI U076248Y 4
CHEN PO-YU U075171N 4
TAN ZEHAO  U075245W 4
NG XI YUN  U083472E 5 Knotless suture anchor for Bankart repair Prof. Lee
TAN WEN QI   U075203M 5
WANG KUN U075237X 5
THAM SHEE LENG U075198M 5
LEOW MING YI U075209H 5
SUDIPTO BARI U065643R 6 Knotless suture anchor for Bankart repair
ZHENG JIYUN U075238J 6
D ANITHA U075194R 6
DING YANXING U048721L 6
HUANG CHAOLI U075241Y 6
GAO JIE U075236L 6
MA KYI PHYU SHWE U075211L 7 Knotless suture anchor for Rotator Cuff repair Prof. Leo
HAN WEICHENG U075247U 7
RAVICHANDRAN SHWETA U075195A 7
NEW SHI YOU U075173M 7
LEY MINGHUI JONATHAN U070287H 7
CHANG PUI HAAN U075215H 7
SARASWATHY DEVI D/O B U075190W 8 Knotless suture anchor for Rotator Cuff repair
TAN HONG YI CLEMENT U075175L 8
OU SHAOTING U078862Y 8
WU TIE CHENG U075256A 8
CHIN SHU MIN U075187E 8
NIRODHA ARIYARATNE U075242L 8
LU ZHENG PING U070098U 9 Knotless suture anchor for Rotator Cuff repair Prof. Kim
WANG WENDUO U067203A 9
QING SONG U075233B 9
LI YUE  U075250J 9
KOH LENG DUEI U075185H 9
LI ZHENHONG DARYL U075174Y 9
NURHUDA BTE MOHAMED ISHAK U076245N 10 Knotless suture anchor for Rotator Cuff repair
HU DONG U075240M 10
ZHU CHI U075253U 10
LI LU U075249R 10
Zhuang Yuhang U075177J 10
JIN JING  U072503Y 10
PRUSOTHMAN A/L M.SINA RAJA U075213J 11 Knotless suture anchor for Rotator Cuff repair Prof. Trau
TAN HSIAO WEI U075188R 11
ZHANG XUEJIE U076307B 11
CHAITANYA PRASHANT URSEKAR  U075246H 11
MUNIRAH BTE ISMAIL   U076243R 11
TEO CHYE KEONG U075179H 12 Knotless suture anchor for Rotator Cuff repair
SWATI JAIN U075254E 12
MUHAMMAD HASANUL ARIFIN B Z U070142R 12
YANG XUE  U075252H 12
TEO YUN LIN, PENNY U075184W 12