ETI 2041C - Medical Device Design and Prototyping

Engineering and Building Arts Department

Credit(s): 3
Contact Hours: 62
Effective Term Spring 2020 (570)

Requisites

Pre- or Co-requisite ETD 2371C with a minimum grade of C or
Pre- or Co-requisite ETD 2372C with a minimum grade of C

Course Description

This course will provide an understanding of the processes and procedures for manufacturing a medical devices. Topics include the design process, design tools, prototyping, product development, documentation, post market surveillance, and corrective and preventative actions.

Learning Outcomes and Objectives

  1. The student will discuss and practice design process brainstorming techniques
  2. The student will describe how a design team is organized.
  3. The student will define, describe, and list product specifications as part of the design process.
  4. The student will analyze design requirements of a project.
  5. The student will describe the types of files required, including the design history file (DHF), the device master record (DMR), and the design history record (DHR), to document a project.
  6. The student will define and describe reverse engineering techniques as part of product development.
  7. The student will describe component selection criteria as part of product development
  8. The student will analyze product reliability as part of the product development process.
  9. The student will differentiate between verification and validation as part of the product development process.
  10. The student will list and describe the steps in product development verification and validation processes.
  11. The student will describe and determine how a design requirement is verified
  12. The student will identify methods for producing medical device prototypes
  13. The student will construct a model of a medical device prototype
  14. The student will describe and discuss improvements to the prototype design.
  15. The student will describe pilot production techniques and systems
  16. The student will define the terms associated with production scale-up
  17. The student will describe line balancing in production systems
  18. The student will discuss and analyze inventory management principles
  19. The student will describe and analyze production scheduling principles
  20. The student will determine and list operator training procedures
  21. The student will compare and contrast concepts of quality management like quality improvement, risk analysis, training requirements, device misuse, standard operating procedures, and performance trends
  22. The student will describe how product information is obtained by customer complaints and warranty claims
  23. The student will describe and discuss which types of complaints are reported to the FDA
  24. The student will list the types of issues that trigger a product recall
  25. The student will demonstrate an understanding of corrective and preventative action (CAPA) by:
  26. The student will recognize and discuss the reasons for a corrective action request under CAPA (corrective action and preventative action).
  27. The student will describe how ownership of a corrective action is determined under CAPA.
  28. The student will describe how a problem is defined, isolated, and contained under CAPA.
  29. The student will determine and analyze the root cause of a problem under CAPA.
  30. The student will describe and determine how to chose a corrective action under CAPA.
  31. The student will explain how to implement and validate a corrective action under CAPA.

Criteria Performance Standard

Upon successful completion of the course the student will, with a minimum of 70% accuracy, demonstrate mastery of each of the above stated objectives through classroom measures developed by individual course instructors.

History of Changes

(Submitted as 2060; State approved as 2041.) C&I Approval: 11/13/2007, BOT Approval: 12/17/2007, Effective Term: Spring 2008 (390).
C&I Approval: 09/05/2019, BOT Approval: 09/24/2019, Effective Term: Spring 2020 (570)

Related Programs

  1. Biomedical Engineering Technology (BMET-AS) (640) (Active)
  2. Medical Device Design and Manufacturing (MDDM-CT) (580) (Active)