Module: Design for Medical Innovation

Latest Module Specifications

Current Academic Year 2025 - 2026

Module Title	Design for Medical Innovation
Module Code	MEC1081 (ITS: MEC1048, MM500)
Faculty	Engineering & Computing	School	Mechanical & Manufacturing Eng
NFQ level	9	Credit Rating	7.5

Description

To provide the students with clinical exposure and the ability to engage with clinicians successfully to solve design problems. To expose students to real world problems associated with the use of a range of current clinical scenarios. The focus is on clinical needs identification, needs synthesis, concept generation, and early concept screening that incorporates not only technical and clinical feasibility but also intellectual property assessments (patentability and freedom to operate), regulatory pathways, reimbursement considerations, and business model insights; recognising that these are essential criteria during Biodesign concept screening. The module facilitates students to develop the necessary skills to communicate effectively with medical practitioners and to solve design problems in relation to clinical needs in conjunction with clinicians. To engender in the students an awareness of the constraints within the environment of medical practitioners and the ethical implications of their work. By integrating perspectives from healthcare systems, regulatory science, reimbursement landscapes, and early value modelling, students will learn to frame problems and select concepts that are not only technically sound but also viable within real world clinical and commercial contexts. The module introduces students to ethical dilemmas facing medical innovators, including global inequalities (UN SDG 10) and issues pertaining to Good Health and Well-being (UN SDG 3).

Learning Outcomes

1. Critically evaluate and contextualise the Stanford Biodesign Process, with particular emphasis on the Identify and Invent phases, including how regulatory pathways, reimbursement environments and business-model considerations inform early concept screening (EI-PO1, EI-PO8).
2. Analyse complex, ill-defined healthcare problems by synthesising clinical observations, stakeholder perspectives and system constraints to identify and prioritise unmet clinical needs (EI-PO2, EI-PO4).
3. Formulate clear, solution-agnostic clinical need statements that define engineering problems while accounting for professional, ethical, societal and sustainability considerations (EI-PO2, EI-PO5).
4. Generate and develop multiple concept solutions in response to identified clinical needs using structured ideation and design methodologies (EI-PO3, EI-PO4).
5. Apply and justify systematic early-stage concept screening decisions, incorporating technical feasibility, regulatory classification, reimbursement context and preliminary business considerations (EI-PO3, EI-PO8).
6. Investigate relevant prior art, standards, clinical practice and emerging technologies to support needs filtering and concept selection (EI-PO4, EI-PO1).
7. Demonstrate professional and ethical judgement in early-stage medical technology innovation, including consideration of patient safety, equity, sustainability and societal impact (EI-PO5, EI-PO8).
8. Work effectively as a member of multidisciplinary teams and reflect on individual learning needs in the context of medical technology innovation (EI-PO6).
9. Communicate clinical needs, design concepts and concept-screening rationale effectively to technical and non-technical stakeholders using appropriate written, visual and oral formats (EI-PO7, EI-PO3).

*Type*	*Hours*	*Description*
Workload	Full time hours per semester
Lecture	12	No Description
Directed learning	24	Workshops to help students progress
Seminars	9	Attendance at clinical seminars and interviews
Group work	100	No Description
Independent Study	42.5	No Description
Total Workload: 187.5

Section Breakdown
CRN	12164	Part of Term	Semester 1 & 2
Coursework	100%	Examination Weight	0%
Grade Scale	40PASS	Pass Both Elements	N
Resit Category	RC2	Best Mark	N
Module Co-ordinator	Owen Clarkin	Module Teacher

Type	Description	% of total	Assessment Date
Assessment Breakdown
Participation	Quizzes, needs submissions, engagement	20%	n/a
Report(s)	Need Specification Report	15%	n/a
Poster presentation	Students will be asked to individually present the needs identified in their Needs Report to the class in a poster and oral presentation.	15%	n/a
Group project	Produce a written report which includes a detailed description of the clinical problem you are trying to solve, a review of the broader market space, a complete description and rendering (on paper or via prototypes/models) of your top 4 concepts, and an explanation of the market, IP challenges and development considerations (technical work packages) you have for each of the concepts proposed, along with an assessment of each concept’s likelihood to address the need criteria, and achieve regulatory approval and reimbursement.	30%	n/a
Group presentation	Presentation of final report in the form of an 'Interim Concept Development Overview'	20%	n/a

Reassessment Requirement Type
Resit arrangements are explained by the following categories; RC1: A resit is available for both^* components of the module. RC2: No resit is available for a 100% coursework module. RC3: No resit is available for the coursework component where there is a coursework and summative examination element. ^* ‘Both’ is used in the context of the module having a coursework/summative examination split; where the module is 100% coursework, there will also be a resit of the assessment

Pre-requisite	None
Co-requisite	None
Compatibles	None
Incompatibles	None

All module information is indicative and subject to change. For further information,students are advised to refer to the University's Marks and Standards and Programme Specific Regulations at: http://www.dcu.ie/registry/examinations/index.shtml

Indicative Content and Learning Activities

Indicative Description
Whilst the Stanford Biodesign Course comprises two successive modules, the focus of this module is in the early stage of the innovation process, namely needs finding through to concept creation with some additional focus on concept selection. In particular, the module will also explore how engineering technologies may be used to explore the feasibility of each concept proposed whereby technical work packages will be proposed which will enable the best concept to be identified with a view to commercialisation in the longer-term. The module is completely continuously assessed.

Indicative Reading List

Books:

Paul G. Yock: 2015, Biodesign, Cambridge University Press, 855, 9781107087354
Joseph Tranquillo,Jay Goldberg,Robert Allen: 2022, Biomedical Engineering Design, Academic Press, 0, 978-0128164440
The European Union: 2017, Regulation (EU) 2017/745 of the European Parliament and of the Council on medical devices (EU MDR),
0: The Code of Federal Regulations (CFR) Title 21 CFR Parts 800–1299, https://www.ecfr.gov/current/title-21, 1726599
2019: Medical Device Design: Innovation from Concept to Market, Academic Press, 0, 9780128149621, 1726600
0: ISO 13485:2016. Medical devices — Quality management systems — Requirements for regulatory purposes, 1726601
2020: Medical Instrumentation, John Wiley & Sons, 928, 978-1-119-45733-6, 1726602
2021: Biomedical Engineering Fundamentals, Third Edition, McGraw-Hill Education, 736, 1260136264, 1726603
2010: Business Model Generation, John Wiley & Sons, 295, 978-0-470-87641-1,

Articles:
None

Other Resources

None