BN3101
BIOMEDICAL ENGINEERING DESIGN - 2011 (2011/2012, Semester 1) 

 MODULE OUTLINE Created: 25-Jul-2011, Updated: 05-Aug-2011
 
Module Code BN3101
Module Title BIOMEDICAL ENGINEERING DESIGN - 2011
Semester Semester 1, 2011/2012
Modular Credits 6
Faculty Engineering
Department Biomedical Engineering
Timetable Timetable/Teaching Staff
Module Facilitators
ASSOC PROF Leo Hwa Liang Lecturer
PROF Casey Chan (Bioeng) Lecturer
ASSOC PROF Toh Siew Lok-MPE Lecturer
ASSOC PROF Buist, Martin Lindsay Lecturer
DR Chong Yok Rue, Desmond Lecturer
ASSOC PROF Alberto Corrias Lecturer
PROF Goh Cho Hong, James Lecturer
PROF Casey Chan (Ortho) Lecturer
ASSOC PROF Yu Haoyong 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 Teams


 AIMS & OBJECTIVES Top
Preparation of formal engineering reports (design history file) and fabrication of prototype based on a series of engineering analysis and design solutions illustrating methodology from various branches of engineering, applied mechanics and sciences as applied to bioengineering problems.  Oral presentations are required. Students are exposed to the entire design process: design problem definition, generation of a design specification, documentation, design review process, prototype fabrication, and design verification.


 TEACHING MODES Top
This module consists of a design project to be worked on by a team of 5 or 6 students.  All members of the team 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, design specifications design verification and detail engineering drawings.  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.  Visit to live surgery will be arranged when logistics permit.  At the end of the module each team will submit a design history file and a prototype of their design.


 PREREQUISITES Top
There is no formal requirement.  You will need to be familiar with CAD software (Solidworks) 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 constraints 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 constraints. 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 verification, 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 basic materials such as Stainless steel tubings, needles and nitinol wires.  Also available for prototype fabrications are stock bar of common metal and plastic materials including polypropylene, polycarbonate, acrylic and Delrin.  Plastic anatomical models will be loaned to students for the duration of the project.   The students are expected to use these materials to make a prototype of their proposed design. The necessary tools will be provided by the Bioengineering Design Studio (E3-05-05) and these include rapid prototyping machines, mini lathe, mini milling machines, band saw, sanders and drill press in addition to standard hardware like pliers, cutters, hammers and saws.


 ASSESSMENT Top
Grades for Project – Team          60% (include peer review)

Grades for Project - Individual     20%

Grades for Final quiz                      10%

Grades for Prototype Functionality 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 TEAMS Top

 

Team MATRIC NO. NAME Mentor
1 U093981A PEH KAH YIM Dr. Leo Hwa Liang
1 U095235W AVIK SARKAR  
1 U093952B LIM YONG MONG ANDY  
1 U094004E SEOW JIE YING  
1 U095138H CHAMINDIKA SHEHANI KONARA  
2 U094016Y GAO YANG Dr. Leo Hwa Liang
2 U095229W AKSHAYA SRINIVASAN  
2 U094012A WANG MING  
2 U094024X YANG JINGYI  
2 U093976N LIM WAN CHENG  
2 U093968R TEO SING HUI  
3 U094017L XIAO YUE Dr. Toh Siew Lok
3 U093970W MARSHELLA TANIA  
3 U083441E HO YAN TECK  
3 U095145U NGUYEN THI THANH HA  
3 U095128L OOI JUNMING RONALD  
3 U095086R TAN WEI LIANG DANIEL  
4 U094020B WU KEYU Dr. Toh Siew Lok
4 U090125E WILLIAM LIM  
4 A0078692M LIU BOYUAN  
4 U093997U TAN YUNG LIANG JONATHAN  
4 U093965H TAN BAO ZHU  
5 U093960Y LEE LIEBIN DARYL RENICK Dr. Martin Buist
5 U094008B NG EE XIEN  
5 U095151U NGUYEN YEN NGOC  
5 U093973E PAN SHIYING  
5 U093978M MICHELLE CHEW MEI XIAN  
6 U083465U NG CHAN WAY Dr. Martin Buist
6 U093998E KOK JUN LOONG ALVIN  
6 U093953M THOW XIN YUAN  
6 U093972U LIM JIN YIN  
6 U093980R WAN YEE LING JACQUELYN  
6 U093989W NG JIA YING  
7 U094013N LIM FUI YAU Dr. Desmond Chong
7 U093969A YUDHI INDRA HADISANTOSO  
7 U093951N SIM SIANG LOONG GABRIEL  
7 U094000J LOO YONG EN MATHIAS  
7 U093996H QUEK YU XUAN JANE  
8 U094011R ANDY SIM TIH SIE Dr. Desmond Chong
8 U093974R SUMITRA RAI  
8 U093954Y QU KUI  
8 U093958W YEAP WEI YANG  
8 U093982N WANG AI JIA  
8 U093995W TAN SHI MIN  
9 U093963J STELLA NATHANIA WIBOWO Dr. Alberto Corrias
9 U094001W SHEN JIEXIANG, NATHANIEL  
9 U094007N TEO ZHEN YI  
9 U095066Y NEO BOON WEE EDWIN  
9 U093987X TIAN XINYING  
9 U093966U LEE YING YU  
10 U093992L LIM CHUN MEI MABEL Dr. Alberto Corrias
10 U093985Y PNG SI NING  
10 U093959H LEE JIE WEI  
10 A0073279W ALON RAMOS MENDEZ  
10 U095063N TAN JING HAO JEREMY  
11 U093977B CHAN HUI QIAN SHELIA Dr. Yu Haoyong
11 U090368W CHAN JUN YUAN  
11 U090091J SOO SHENG LI  
11 U094006A PHAN THI NAM MAI  
11 U094010E YAP HONG KAI  
12 U094002H LIM ZI KAI Dr. Yu Haoyong
12 U093983B SARASWATHY D/O GUNASEGAREN  
12 U094015M FOONG YEW JIN  
12 U093964W CHIAM MUN YEE  
12 U093993X FOO YONG JIE CHARLTON  
12 U093984M YEO XIU XIAN REDONNIA  
13 U094021M XUE YANG Dr. James Goh
13 U093979Y ZHANG QIU PING  
13 U095061R CHIA KIAN LIM  
13 U093975A QUEK LI TING  
13 U095149N LEE REY JUN