The Program
Program structure at a glance
DUAL MASTER’S DEGREE PROGRAM
SUMMER TERM OF THE 1ST YEAR (1ST SEMESTER)
BMEN 646: Algorithm Engineering and Machine Learning for Biomedical Engineers
BMEN 633: Risk Based Development and Testing of Medical Devices
Total Credit Hours/ECTS for Semester
6 CH / 15 ECTS
6 CH / 15 ECTS
FALL SEMESTER OF THE 1ST YEAR (2ND SEMESTER)
BMEN 643: Risk Based Development and Testing of Medical Devices
BMEN 676: Professional Development for Biomedical Engineering
BMEN 680: Biomedical Engineering of Tissues
BMEN 645: Advanced Medical Device Manufacturing
BMEN 681: Seminar
Total Credit Hours/ECTS for Semester
12 CH / 30 ECTS
12 CH / 30 ECTS
SPRING SEMESTER OF THE 2ND YEAR (3RD SEMESTER)
Design for Sustainability
Sustainable Manufacturing
Life Cycle Analysis and Circular Economy
Sustainable Materials
EU Regulatory and Ethical Framework on Medical Devices/In Vitro Diagnostics
Smart Materials and Nanotechnologies for Medical Devices
Seminar Series on Sustainable Medical Devices
Total Credit Hours/ECTS for Semester
30 ECTS / 12 CH
30 ECTS / 12 CH
FALL SEMESTER OF THE 2ND YEAR (4TH SEMESTER)
Master’s Thesis
Total
30 CH for TAMU MEng
90 ECTS for AUTh MSc
90 ECTS for AUTh MSc
Course list per semester
Summary of Courses
MEng Biomedical Engineering, Texas A&M University & MSc, Design & Manufacturing of Sustainable Medical Devices, Aristotle University of Thessaloniki
1st Semester @TAMU (June - August) 6 Credit hours - 15 ECTS
1. BMEN 646: Algorithm Engineering and Machine Learning for Biomedical Engineers
Investigation and practices of applications of data analytics, machine learning, and deep learning in health sciences and biomedical data; includes exploratory data analysis (EDA), algorithms and methods of deriving insights from patient biometrics, patient history data, sensor data, electronic health records, microscopy images, and medical images.
2. BMEN 633: Biodesign I: Translation of Medical Technologies
Project-based course focus on front-end innovation-needs identification through customer discovery, peer-reviewed outcomes data, post-market and Real-World Evidence (RWE) analysis, market and gap analysis, development of clinical need statements, needs scoping and criteria definition, structured ideation, intellectual property (IP) landscape analysis; conceptual solution development for unmet clinical needs.
2nd Semester @TAMU (August - December) 12 CH - 30 ECTS
1. BMEN 643: Risk Based Development and Testing of Medical Devices
Focus on the detailed design and development phases of the design innovation process for healthcare applications; includes medical device development projects in which teams will work on innovative medical devices that progressed through the concept phase of the development life cycle; includes detailed design and development, risk based design process, including the conduct of hazards analysis, design FMEA, application FMEA, process FMEA, device manufacturing, device testing and FDA design verification and validation.
2. BMEN 676: Professional Development for Biomedical Engineering
Advanced concepts in professional interactions including oral and written communications, skills related to interviewing and obtaining job offers and understanding employment compensation and benefits, professional ethics.
3. BMEN 680: Biomedical Engineering of Tissues
Introduction to engineering strategies used to repair tissue; literature-grounded overview of current strategies using stem cells, 3D scaffolds and drug/gene delivery including ethical considerations of these therapies.
4. BMEN 645: Advanced Medical Device Manufacturing
Explores manufacturing and assembly of medical devices, process development and relevant regulations. Topics include manufacturing methods utilized in advanced medical devices, fabrication of devices for minimally invasive surgery; catheter-based interventions, implants for tissue repair. Engineering theory and manufacturing process physics, polymer processing; metallic devices & metallurgy, shape memory metals; manufacturing process capability studies and FDA regulations.
5. BMEN 681 Seminar
Designed to permit student to broaden capability, performance and perspective in biomedical engineering via his or her own formal presentation and by presentations from other professionals.
3rd Semester @AUTh (February - May) 30 ECTS - 12 CH
1. Design for Sustainability
Principles of eco-design and design methodologies for easy disassembly that minimize the environmental impact of medical devices. Design and analysis methods using the Finite Element Method (FEM) and strategies for developing sustainable medical and pharmaceutical products.
2. Sustainable Manufacturing
Technologies for the fabrication of sustainable medical devices, with an emphasis on additive manufacturing (3D printing) and production methods that minimize resource and energy consumption. Advanced mechanical, physicochemical manufacturing technologies and their application to the development of sustainable healthcare products.
3. Life Cycle Analysis and Circular Economy
Methodologies for assessing the environmental impact of medical devices throughout their life cycle. Measurement techniques and strategies for improving sustainability. Application of circular economy principles in the design and manufacturing of medical devices. Development of sustainable processes and strategies for material recycling and reuse.
4. Sustainable Materials
Study of materials used in the manufacture of medical devices, with an emphasis on environmentally friendly, biodegradable, and recyclable materials. Analysis of their properties and applications. Corrosion and protection of biomaterials under biological environments.
5. EU Regulatory and Ethical Framework on Medical Devices/In Vitro Diagnostics
The regulatory framework for medical devices and in vitro diagnostics in the European Union. The general safety and performance requirements for medical devices and in vitro diagnostics. The classification of medical devices and in vitro diagnostics. Technical documentation. The risk management system (standard EN ISO 14971). Clinical evaluation and performance evaluation. The post-market surveillance system and vigilance. The quality management system (standard EN ISO 13485). The conformity assessment procedures and the role of conformity assessment bodies. The registration requirements and the European database for medical devices and in vitro diagnostics (EUDAMED). The ethical framework for research and development in the field of medical devices and in vitro diagnostics.
6. Smart Materials and Nanotechnologies for Medical Devices
Properties and applications of smart materials and nanotechnology in the design and fabrication of medical devices. Discussion of modern technologies enabling the development of devices with adaptive functions, improved biocompatibility, and enhanced performance in disease diagnosis and treatment.
7. Seminar Series on Sustainable Medical Devices
Series of seminars given by invited lecturers on timely topics of design and manufacturing of medical devices and sustainability. Designed to broaden the perspective of students in the field and boost their ability to comprehend new topics. Students are required to deliver a specific report in a topic relevant to the topics of the seminar.
4th Semester @AUTh (September- December) 30 ECTS - 12 CH
Required Thesis for all Dual Degree Candidates
Master’s Thesis
The Master’s thesis shall be prepared during the fourth semester of study under the supervision of a professor/instructor of the DMDP. The candidate shall submit to the JCC an application for the preparation of the Master’s thesis, in which the title of the thesis, a summary of its subject matter, and the supervisor(s) are proposed. The JCC shall appoint the supervisor(s) and the three-member Master’s Thesis Examination Committee for its evaluation, in which the supervisor(s) shall also participate. In exceptional cases, where there is an objective inability or a serious reason (including, indicatively, the resignation of the supervisor(s)), the replacement of the supervisor(s) or of a member of the Master’s Thesis Examination Committee may be approved by decision of the JCC.
The total duration of the examination of the Master’s thesis may not be less than thirty (30) minutes nor more than forty-five (45) minutes. The time allotted for questions by the examiners may not be less than ten (10) minutes.
In the evaluation, consideration shall be given to the scientific quality of the thesis, the completeness and structure of the written text, the oral presentation, as well as the student’s knowledge of the subject area, as demonstrated by the answers given to the examiners’ questions.
Following its approval by the Master’s Thesis Examination Committee and the incorporation by the student of any required corrections or modifications, the final version of the Master’s thesis shall be mandatorily uploaded to the website of the Central Library of AUTH and recorded in the Program’s thesis archive.
The language of writing and examination of the Master’s thesis shall be English. The title and abstract must also be translated into Greek. As a general rule, the Master’s thesis should not exceed one hundred (100) pages and shall normally include: a cover page containing the thesis details, title and abstract, table of contents, chapters constituting the main body of the thesis, bibliographical references, and appendices.