• Semester 6, position 4

Introducing students to the key steps in the process of designing, developing, and manufacturing medical devices. Introducing students to the application of different biomaterials in implant design, in order to understand and study functional behaviour of biomaterials in the human body. Basics of software used in the analysis of stress and strain distributions as well as different ways of load placement on virtual models and analyses of results obtained by simulation.

Upon successful completion of this course, students will be able to: • Modeling a medical device using the SolidWorks software package • Perform deformations and displacements analysis using computer software packages • Master the basic principles of analysis and presentation of reports and analysis of results

Definition of medical equipment and its significance in medical practice. Overview of national and international regulatory bodies that oversee the production of medical equipment. The importance of compliance with regulations and standards in the medical industry. Phases of medical equipment development. Tests for ensuring the safety and reliability of medical equipment. Validation of processes and products to ensure quality and safety. Classification and basic types of implants and biomaterials in medicine. The concept of biocompatibility. Fundamental principles of making implants for the human body. Standards for testing and manufacturing of implants. 3D printing technologies (FDM, SLA, SLS...). Materials used in 3D printing. Applications of 3D printing in biomedical engineering and medicine.

Modeling of a medical device. Introducing students to the Weldment and Sheet Metal modules in SOLIDWORKS software. Testing the durability of the medical device through simulations, analyzing the obtained results, and improving the model. Creating technical documentation, reports, and user manuals. Working with a 3D printer. Examples of biomaterials applications in the design, development and exploitation of structures used in medicine. Implant design used in medicine. Examples and prevention methods of the implants failure (case studies). Basic principles of results analysis and report writing.

Attending requirements are defined by the curriculum of the study program/module.

1. Written course material (handouts). 2. Computers with installed software packages for modeling and analysis: SolidWorks

Total assigned hours: 30

New material: 10
Elaboration and examples (recapitulation): 2

Auditory exercises: 0
Laboratory exercises: 0
Calculation tasks: 0
Seminar paper: 0
Project: 12
Consultations: 0
Discussion/workshop: 0
Research study work: 0

Review and grading of calculation tasks: 0
Review and grading of lab reports: 0
Review and grading of seminar papers: 0
Review and grading of the project: 2
Test: 2
Test: 0
Final exam: 2

Activity during lectures: 5
Test/test: 40
Laboratory practice: 0
Calculation tasks: 0
Seminar paper: 0
Project: 20
Final exam: 35
Requirement for taking the exam (required number of points): 35

Planchard, D.C., Engineering Design with SOLIDWORKS 2022: A Step-by-Step Project Based book Approach Utilizing 3D Solid Modeling, SDC Publications, ISBN-13: ‎ 978-1630574680, 2022; Shanmugam, Prakash Srinivasan Timiri, et al., eds. Medical Device Guidelines and Regulations Handbook. Springer, ISBN-13: ‎978-3030918545, 2022.; Webster, J.G. , Nimunkar, A.J. (Eds), Medical instrumentation: application and design, 5th edition, John Wiley & Sons, ISBN: 978-1-119-45733-6, 2020. ; Chan, Lawrence S., and William C. Tang, eds. Engineering-medicine: Principles and Applications of Engineering in Medicine. CRC Press, ISBN: 9781351012270, 2019.; Simmons, C.H., Maguire D.E. Manual of engineering drawing, Butterworth-Heinemann, ISBN: 9780080966533, 2012