BIO07021 2019 MEDICAL DEVICE TECHNOLOGIES

General Details

Full Title
MEDICAL DEVICE TECHNOLOGIES
Transcript Title
MEDICAL DEVICE TECHNOLOGIES
Code
BIO07021
Attendance
N/A %
Subject Area
BIO - Bio Tech/Eng/Chem
Department
LIFE - Life Sciences
Level
07 - NFQ Level 7
Credit
05 - 05 Credits
Duration
Semester
Fee
Start Term
2019 - Full Academic Year 2019-20
End Term
9999 - The End of Time
Author(s)
Ailish Breen
Programme Membership
SG_SBIOM_B07 201900 Bachelor of Science in Biomedical Science SG_SMEDI_H08 201900 Bachelor of Science (Honours) in Science in Medical Biotechnology
Description

This course aims to provide the student with a broad understanding of the various medical devices available for the treatment and prevention of diseases, their control and regulation and their modes and methods of manufacturing and finishing. It also aims to provide an overview of the medical device industry both globally as well as nationally, ethical issues and the role the industry plays in society. 

Learning Outcomes

On completion of this module the learner will/should be able to;

1.

Demonstrate a knowledge and understanding of the medical device industry, the principal companies involved and the main product types being manufactured, evaluate ethical questions and societal impact of the industry.   

2.

Explain the various principles and practices involved in the control and regulation of the medical device industry both in Europe and the USA.   

3.

Evaluate current and future manufacturing processes for polymer based, metallic, ceramic and composite based medical devices.

4.

Describe the support activities involved in medical device manufacturing, such as sterilization, labelling and packaging.      

5.

Communicate and critique scientific data relating to medical device manufacturing and evaluate current trends and future research areas.

Teaching and Learning Strategies

This module will be delivered using a blended learning approach; students will access online bespoke content prior to attending live lectures / workshops and some practical demos. Live classes will primarily be delivered in a workshop format using methods of flipped learning, group based and evidence based learning.   

 

Module Assessment Strategies

Continuous assessment will take the form of team based assignments, reports, essays and regular short quizzes.  Formative assessment will include problem solving, data analysis and critical assessment of the literature, debates on ethical and societal issues pertaining to this sector.   This module has an end of semester exam.

Repeat Assessments

Repeat assessments will be given as necessary

Module Dependencies

Prerequisites
None
Co-requisites
None
Incompatibles
None

Indicative Syllabus

1.What is a medical device? An outlook of the main companies and products being manufactured in Ireland and investigation of current global and national trends and challenges, ethical and societal issues.  A brief look at anatomy, common diseases and need for medical devices

 

2. What regulations govern medical device certification in the EU and USA?  Steps involved in device classification and certification. How do these regulations impact how companies do their business?  What challenges companies face implementing new regulations.

 

3. Reasons for choosing polymer, metal or ceramic materials and coatings, their advantages and disadvantages and suitability for different devices.  What polymers are used in medical devices.  Steps involved in current polymer processing techniques such as additive manufacturing, extrusion, injection moulding etc.  What metals are used in medical devices.  Steps involved in current metal processing techniques such as additive manufacturing, metal injection moulding, laser cutting etc.  What ceramics and other composites are used and steps involved in sintering etc. 

 

4. Sterilisation methods such as ethylene oxide, gamma ray, e-beam, labelling requirements and packaging options available.

Coursework & Assessment Breakdown

Coursework & Continuous Assessment
40 %
End of Semester / Year Formal Exam
60 %

Coursework Assessment

Title Type Form Percent Week Learning Outcomes Assessed
1 Ongoing quizzes Continuous Assessment Assessment 20 % OnGoing 2,3,4
2 Assignment Case study and Presentation Continuous Assessment Assignment 20 % Week 6 1,2,5
             

End of Semester / Year Assessment

Title Type Form Percent Week Learning Outcomes Assessed
1 Final Exam End of term exam Final Exam UNKNOWN 60 % Week 14 1,2,3,4,5
             
             

Full Time Mode Workload


Type Location Description Hours Frequency Avg Workload
Lecture Flat Classroom Lecture 2 Weekly 2.00
Directed Learning Flat Classroom Blended learning 1 Weekly 1.00
Independent Learning UNKNOWN Self Study 3 Weekly 3.00
Total Full Time Average Weekly Learner Contact Time 3.00 Hours

Required & Recommended Book List

Required Reading
2011-09-28 Medical Device Technologies Academic Press
ISBN 9780080961125 ISBN-13 0080961126

Medical Device Technologies introduces undergraduate engineering students to commonly manufactured medical devices. It is the first textbook that discusses both electrical and mechanical medical devices. The first 20 chapters are medical device technology chapters; the remaining eight chapters focus on medical device laboratory experiments. Each medical device chapter begins with an exposition of appropriate physiology, mathematical modeling or biocompatibility issues, and clinical need. A device system description and system diagram provide details on technology function and administration of diagnosis and/or therapy. The systems approach lets students quickly identify the relationships between devices. Device key features are based on five applicable consensus standard requirements from organizations such as ISO and the Association for the Advancement of Medical Instrumentation (AAMI). The medical devices discussed are Nobel Prize or Lasker Clinical Prize winners, vital signs devices, and devices in high industry growth areas Three significant Food and Drug Administration (FDA) recall case studies which have impacted FDA medical device regulation are included in appropriate device chapters Exercises at the end of each chapter include traditional homework problems, analysis exercises, and four questions from assigned primary literature Eight laboratory experiments are detailed that provide hands-on reinforcement of device concepts

Required Reading
2015-04-10 The Biomedical Engineering Handbook, Fourth Edition CRC Press
ISBN 1439825335 ISBN-13 9781439825334

The definitive "bible" for the field of biomedical engineering, this collection of volumes is a major reference for all practicing biomedical engineers and students. Now in its fourth edition, this work presents a substantial revision, with all sections updated to offer the latest research findings. New sections address drugs and devices, personalized medicine, and stem cell engineering. Also included is a historical overview as well as a special section on medical ethics. This set provides complete coverage of biomedical engineering fundamentals, medical devices and systems, computer applications in medicine, and molecular engineering.

Required Reading
2013 Biomaterials Science Academic Press
ISBN 0123746264 ISBN-13 9780123746269

With over 29,000 copies sold, this is the most comprehensive coverage of principles and applications of all classes of biomaterials Edited by four of the best-known figures in the biomaterials field today and fully endorsed and supported by the Society for Biomaterials Fully revised and expanded, key new topics include: tissue engineering, drug delivery systems, new materials, and new clinical applications New teaching and learning material includes: end of chapter exercises, case studies, downloadable image bank This new edition is printed in full-color with high-quality artwork The third edition of this renowned and best-selling title is the most comprehensive and up-to-date single text on all aspects of biomaterials science. It provides a balanced, insightful approach to both the learning of the science and technology of biomaterials, and acts as a key reference for practitioners who have involvement in the applications of materials in medicine. This resource is ideal for undergraduate and graduate students, practitioners in biomedical engineering, life and biological sciences, materials, mechanical and engineering sciences, and medicine. Over 29,000 copies sold, this is the most comprehensive coverage of principles and applications of all classes of biomaterials: 'the only such text that currently covers this area comprehensively' - Materials Today Edited by four of the best-known figures in the biomaterials field today; fully endorsed and supported by the Society for Biomaterials Fully revised and expanded, key new topics include of tissue engineering, drug delivery systems, and new clinical applications, with new teaching and learning material throughout, end of chapter exercises, assignments and case studies; and a downloadable image bank. The new edition is printed in full color throughout, with new high-quality artwork

Module Resources

Non ISBN Literary Resources

Listed

Journal Resources

Biomaterials (Springer)

Expert Review of Medical Devices (Taylor and Francis online)

BMJ Innovations (BMJ Journals)

URL Resources

www.cochranelibrary.com

https://www.fda.gov/MedicalDevices/default.htm

https://www.hpra.ie/homepage/medical-devices

 

 

Other Resources

Medical Device Regulations - REGULATION (EU) 2017/745 (Official Journal of the European Union)

Additional Information

None