BN3101
BIOMEDICAL ENGINEERING DESIGN - 2013 (2013/2014, Semester 1) 

 MODULE OUTLINE Created: 21-Jul-2010, Updated: 08-Aug-2013
 
Module Code BN3101
Module Title BIOMEDICAL ENGINEERING DESIGN - 2013
Semester Semester 1, 2013/2014
Modular Credits 6
Faculty Engineering
Department Biomedical Engineering
Timetable Timetable/Teaching Staff
Module Facilitators
ASSOC PROF Leo Hwa Liang Lecturer
PROF Casey Chan (Ortho) Lecturer
DR James Kah Lecturer
DR Michael Girard Lecturer
DR Ren Hongliang Lecturer
MR Muhammed Abdurrahiem Bin Abdul Coordinator
MDM Lee Yee Wei Coordinator
MR Aneel Kumar Maheshwari Coordinator
MR Soon Hock Wei Coordinator
Weblinks
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Aims & Objectives | Teaching Modes | Prerequisites | Preclusions | Synopsis | 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 demonstration 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.



 ASSESSMENT Top
Grades for Project (Team Effort)           55%
  • Presentation               15%
  • Design                        15%
  • Documentation           15%
  • Functional Prototype   15%

Grades for Project - Individual      45%

  • Individual Report          15%
  • Peer Review                10%
  • Mentor Assessment    10%
  • 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/2008/02/17/impending-changes-on-the-promotion-of-off-label-use/

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

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

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

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

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

7) Mother Lode of Health Care Information - http://biomed.blog.com/1312929/mother-lode-of-health-care-information/

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

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



 WORKLOAD Top
2-0.5-0-3-4.5


 FINAL GROUPS Top
Group Matric No. Name Mentor 
1 A0097504B CHAN XIANG QUAN Casey Chan
1 A0074276Y GOH SUZANNE
1 U093988J DEBRA SANGEETHA NAIR
1 A0087330J CHUA JEFRI
1 A0087473U HO SONGYE
1 A0083528Y ZHANG XINYU
2 A0086079R SHELDON HO
2 A0085541E SEOW HUI TING
2 A0084819R CHEW ZI AI
2 A0080950H JASON DERRY ONGGO
2 A0083220W MICHELLE CHEE SHU JIUN
2 A0088408W M.H. PINKY
3 A0082966N HADI WIPUTRA
3 A0070650N XIE YI
3 A0087186R ZHANG ZIRUI
3 A0087670W SOH WEN YU
3 A0085375W NG YUET LING JOANNA
4 A0092172J LIN MU Ren Hongliang
4 A0081085H WANG JUNXIANG
4 A0087970N TAN SWEE YANG JUSTIN
4 A0084955N VANESSA MAK WEI-LIN
4 A0085545X DHASHNI D/O MANOGARAN
5 A0081167E NG KWOK YANG PAUL
5 A0080973X KHOR JING AN
5 A0083671B NEERAJHA RAM
5 A0084067B ONG JUN SHU
5 A0085320N ANSELINA GOH SOK MIAN
6 A0084328B HEE YI LIN RINA
6 A0083867M SAW JHEN JIN
6 A0086485N GOH SI WEI
6 A0084616B LI SHUTING
6 A0094349U KIM JAEJUNG
6 A0085640E DENISE ANN YEOH JIAXIN
7 A0088419R VEENA SALIM James Kar
7 A0092168Y XIE YINGYAO
7 A0067227A LIEW XUAN KAI JUSTIN
7 A0087279L JARYL NG CHEN KOON
7 A0087996Y KO ZHEN YU, GORDON
7 A0077172A HONG HENG LENG SHERYL
8 A0087027A NG JUN-JIE COLIN
8 A0083783U JACLYN CHONG SHU YEEN
8 A0083468U GAO ZHENGYANG
8 A0087319W TAN ZHI XIANG
8 A0085543B NASIMA BEGUM BTE ABDUL AZIZ
8 A0083501R KAMRUN NAHAR
9 A0092162L THORIQ SALAFI
9 A0092187X JIANG WENXUAN
9 A0084203R YANG HUA
9 A0081152R RUSSELL KOH WEIREN
9 A0087265W TAN HONG HAN
9 A0083076A DOROTHY NEO SHUZHEN
10 A0087902Y LIM BING YI Michael Girard
10 A0083497N CHUA CAI LIN
10 A0086548N KHOR BOON KEAT JAMES
10 A0091020B ROSLYN FOONG PEI LI
10 A0083393Y JOYCELIN GOH SOCK HWEE
10 A0086049X TENG YAO ZHONG, EDWARD
11 A0087195R TEO ZHAN TENG
11 A0084871W SHARON LEE WEI LING
11 A0086830B TAN KIAN YU ROYSTON
11 A0078255X ANKSHITA PRASAD
11 A0090584Y BERYL YEE WEN-YEN
11 A0086781R LIN ZHINING ISAAC
12 A0092232N ZHAO JIEFEI
12 A0080994R GUAN YANGYUE
12 A0083852Y DING XIN YI
12 A0087197M NG RUI JIE
12 A0081177A MOHAMMED NOOR HAFIZUDDIN BIN HASLIR
12 A0092185B SHEN SHEN
13 A0083815B FOO ZI HUI Leo Hwa Liang
13 A0084424H CHIU HSIN YAO
13 A0080919X GOH EE THEAN
13 A0086381Y KARTHIC ANBALAKAN
13 A0085597J KENGADEVI D/O JEYARAMAN
13 A0087493N YEOW Y-YBEE
14 A0002889X LIM ZHI CHIAW
14 A0092177Y LIU JIANYING
14 A0086499E ADIB RIDZUAN B MOHAMAD ROSLAN
14 A0078021N HU ZHULIN
14 A0084173E ISABEL LOOK PIK YING
14 A0081091M MUHAMMAD NAQIB B ISMAIL
15 A0085519W RACHAEL YEE BEI
15 A0088239R ONG JUN YONG
15 A0085546W LIM JIE YING
15 A0085457U CHIN ZHI YUN
15 A0088124E CALLY OWH
15 U095158Y MOHAMMED AMANUR RAHMAN
16 A0087939E SEAH JIA HONG
16 A0083526A ROZEN HASANATH
16 A0084720J LIM PAN YIN
16 A0081332R ONG XIAN DA LUCAS
16 A0080902M SOON HONG YEE
16 A0083411R LEOW WEN NING