Module Details

Module Code: BIOE9004
Title: Integrated Product & Process
Long Title: Integrated Product & Process Design
NFQ Level: Expert
Valid From: Semester 1 - 2023/24 ( September 2023 )
Duration: 1 Semester
Credits: 10
Field of Study: 5212 - Biomedical Engineering
Module Delivered in: 2 programme(s)
Module Description: The aim of this module is to develop a comprehensive understanding of the methods employed in the design of a medical device, along with the manufacturing technologies required to produce that design. The learner will build knowledge of design software packages in order to produce a 3D model of a design concept. The learner will also learn about the end to end processes that are required throughout the development life cycle, including the multiple interdisciplinary functions that are required to develop a medical device. The learner will develop teamwork and collaboration skills through assignments and workshops which will incorporate ethical considerations as well as technical aspects to the product and process development.
 
Learning Outcomes
On successful completion of this module the learner will be able to:
# Learning Outcome Description
LO1 Define user requirements and clinical application of a medical device
LO2 Develop a product concept using an industry standard software package and methodologies
LO3 Map the process flow for the development cycle of a medical device
LO4 Specify drawing requirements and metrology techniques for product definition
LO5 Evaluate the design against industry manufacturing process technologies to meet product development criteria
LO6 Apply ethical and societal considerations including the UN SDGs for minimal environmental and societal impact for the full life cycle of the design
Dependencies
Module Recommendations

This is prior learning (or a practical skill) that is strongly recommended before enrolment in this module. You may enrol in this module if you have not acquired the recommended learning but you will have considerable difficulty in passing (i.e. achieving the learning outcomes of) the module. While the prior learning is expressed as named MTU module(s) it also allows for learning (in another module or modules) which is equivalent to the learning specified in the named module(s).
Incompatible Modules
These are modules which have learning outcomes that are too similar to the learning outcomes of this module. You may not earn additional credit for the same learning and therefore you may not enrol in this module if you have successfully completed any modules in the incompatible list.
No incompatible modules listed
Co-requisite Modules
No Co-requisite modules listed
Requirements

This is prior learning (or a practical skill) that is mandatory before enrolment in this module is allowed. You may not enrol on this module if you have not acquired the learning specified in this section.
No requirements listed
 
Indicative Content
Digital Prototyping
Development, manipulation and analysis of 3D models using industry relevant modelling software packages
Medical Device Development Life Cycle
Full end to end lifecycle overview from user needs and design concepts to manufacturing and supply chain; including regulatory, clinical assessment, process development, product and process validation, launch management, compliance and cross disciplinary interactions.
Product Specification and Confirmation
Product drawings including tolerancing, material specification and special process definition. Test plans including characterisation, metrology requirements and product functionality testing
Technology Selection
Manufacturing technology assessment and selection, Technology Readiness Level (TRL), technology development, process characterisation and development, scale up planning, cost analysis
Sustainability of product life cycle
Non-technical aspects of product development, such as sustainability, health and safety, user needs for diverse user and ethical considerations
Module Content & Assessment
Assessment Breakdown%
Coursework100.00%

Assessments

Coursework
Assessment Type Other % of Total Mark 25
Timing Week 6 Learning Outcomes 1,3,6
Assessment Description
Team Poster: Process map development
Assessment Type Multiple Choice Questions % of Total Mark 25
Timing Week 7 Learning Outcomes 1,3,6
Assessment Description
Process map individual assessment of previous team activity topics
Assessment Type Written Report % of Total Mark 50
Timing Week 13 Learning Outcomes 2,4,5,6
Assessment Description
Technical Report - development of product concept, drawings and technology selection
No End of Module Formal Examination
Reassessment Requirement
Coursework Only
This module is reassessed solely on the basis of re-submitted coursework. There is no repeat written examination.

The University reserves the right to alter the nature and timings of assessment

 

Module Workload

Workload: Full Time
Workload Type Contact Type Workload Description Frequency Average Weekly Learner Workload Hours
Lecture Contact Lectures Every Week 3.00 3
Lab Contact Workshops Every Second Week 1.00 2
Independent & Directed Learning (Non-contact) Non Contact Self-directed learning Every Week 10.00 10
Total Hours 15.00
Total Weekly Learner Workload 14.00
Total Weekly Contact Hours 4.00
Workload: Part Time
Workload Type Contact Type Workload Description Frequency Average Weekly Learner Workload Hours
Lecture Contact Lectures Every Week 3.00 3
Lab Contact 12 hours of workshops across 3 sessions Every Month 1.00 4
Independent & Directed Learning (Non-contact) Non Contact Self-directed learning Every Week 10.00 10
Total Hours 17.00
Total Weekly Learner Workload 14.00
Total Weekly Contact Hours 4.00
 
Module Resources
Recommended Book Resources
  • Michael Wiklund, Erin Davis, Alexandria Trombley. (2021), User Interface Requirements for Medical Devices, CRC Press, [ISBN: 9780367457938].
Supplementary Book Resources
  • Jose Justiniano,Venky Gopalaswamy. (2004), Six Sigma for Medical Device Design, CRC Press, p.152, [ISBN: 9780849321054].
  • J Paulo Davim. (2012), The Design and Manufacture of Medical Devices, Woodhead Publishing, [ISBN: 9781907568725].
  • Warren D. Seider, Daniel R. Lewin, J. D. Seade, Soemantri Widagdo, Rafiqul Gani and Ka Ming Ng. (2017), Product and process design principles: synthesis, analysis and evaluation, [ISBN: 9781119282631].
Recommended Article/Paper Resources
  • Trust Saidi, Tania S. Douglas,. (2022), Critical elements in the design, development and use of medical devices. A systemic perspective of orthopedic devices landscape in low- and middle-income countries., Health Policy and Technology Journal, Volume 11, Issue 1.
  • Gregor M. Schweitzer, Michael Bitzer, Michael Vielhaber,. (2021), Artificial intelligence in engineering: evolution of virtual product development in the context of medical device industry., Procedia CIRP, Volume 100, p.349-3.
Other Resources
  • International Standard, ISO 13485.
 
Module Delivered in
Programme Code Programme Semester Delivery
CR_EMEDD_9 Master of Science in Medical Device Development 2 Mandatory
CR_EMEDE_9 Postgraduate Diploma in Science in Medical Device Development 2 Mandatory