Medical Device Prototyping Techniques
( 30 Modules )

Module #1
Introduction to Medical Device Prototyping
Overview of the importance of prototyping in medical device development, regulatory considerations, and course objectives

Module #2
Design Thinking for Medical Devices
Applying design thinking principles to medical device development, empathizing with users, and defining design requirements

Module #3
Medical Device Regulations and Standards
Overview of relevant regulations and standards for medical device development, including FDA guidelines and ISO 13485

Module #4
Modeling and Simulation for Prototyping
Using computational models and simulations to inform prototyping decisions, including FEA and CFD

Module #5
Prototyping Methodologies
Overview of iterative and agile prototyping methodologies, including lean startup principles

Module #6
Rapid Prototyping with 3D Printing
Using additive manufacturing for rapid prototyping, including material selection and post-processing techniques

Module #7
CNC Machining and Milling for Prototyping
Using CNC machining and milling for prototyping, including tool selection and CAM programming

Module #8
Vacuum Casting and Silicone Molding
Using vacuum casting and silicone molding for prototyping, including material selection and mold design

Module #9
Lasercutting and Waterjet Cutting for Prototyping
Using lasercutting and waterjet cutting for prototyping, including material selection and design considerations

Module #10
Hand Fabrication and Craftsmanship for Prototyping
Using traditional hand fabrication techniques for prototyping, including woodworking and metalworking

Module #11
Biomaterials for Medical Devices
Overview of biomaterials used in medical devices, including biocompatibility and regulatory considerations

Module #12
Medical Grade Plastics and Elastomers
Using medical grade plastics and elastomers for prototyping, including material selection and processing techniques

Module #13
Metallic Materials for Medical Devices
Using metallic materials for medical devices, including stainless steel, titanium, and nitinol

Module #14
Coatings and Surface Treatments for Medical Devices
Using coatings and surface treatments to improve medical device performance, including parylene and silicone coatings

Module #15
Sterilization and Cleaning Methods for Medical Devices
Overview of sterilization and cleaning methods for medical devices, including EtO, gamma radiation, and autoclaving

Module #16
Electronics Design for Medical Devices
Overview of electronics design principles for medical devices, including PCB design and microcontroller selection

Module #17
Sensor Technologies for Medical Devices
Using sensors in medical devices, including temperature, pressure, and flow sensors

Module #18
Wireless Communication for Medical Devices
Using wireless communication protocols for medical devices, including Bluetooth, Wi-Fi, and cellular

Module #19
Software Development for Medical Devices
Overview of software development principles for medical devices, including agile development and testing

Module #20
Cybersecurity Considerations for Medical Devices
Overview of cybersecurity considerations for medical devices, including risk management and threat modeling

Module #21
Testing and Validation Methods for Medical Devices
Overview of testing and validation methods for medical devices, including verification and validation principles

Module #22
Biomechanical Testing for Medical Devices
Using biomechanical testing to evaluate medical device performance, including fatigue and durability testing

Module #23
Biocompatibility and Toxicology Testing
Using biocompatibility and toxicology testing to evaluate medical device safety, including ISO 10993

Module #24
Human Factors and Usability Testing
Using human factors and usability testing to evaluate medical device usability, including user research and testing methods

Module #25
Clinical Trials and Regulatory Submissions
Overview of clinical trials and regulatory submissions for medical devices, including FDA 510(k) and CE marking

Module #26
Artificial Intelligence and Machine Learning for Medical Devices
Using AI and ML in medical devices, including image processing and predictive analytics

Module #27
Nanotechnology and Microfabrication for Medical Devices
Using nanotechnology and microfabrication for medical devices, including nanostructured surfaces and microfluidics

Module #28
3D Printing for Personalized Medicine
Using 3D printing for personalized medicine, including patient-specific implants and organs-on-a-chip

Module #29
Capstone Project:Design and Development
Students design and develop a medical device prototype, including design requirements, prototyping, and testing

Module #30
Course Wrap-Up & Conclusion
Planning next steps in Medical Device Prototyping Techniques career

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Medical Device Prototyping Techniques ( 30 Modules )

Medical Device Prototyping Techniques
( 30 Modules )