This course explores medical device development from a Quality Management System (QMS) perspective, covering concept initiation through design validation and transfer. Students learn about design development and planning, fundamental requirements and standards, testing, clinical investigations, and regulatory requirements, focusing on documenting design inputs/outputs, and QMS elements throughout the development lifecycle.
Athena Title
Medical Device Development
Non-Traditional Format
This course will be taught 95% or more online.
Semester Course Offered
Offered summer semester every year.
Grading System
A - F (Traditional)
Student learning Outcomes
Students will analyze the Medical Device Development Process as they define and sequence the key stages in medical device development from concept to market launch.
Students will apply a Quality Management Systems (QMS).
Students will summarize the phases of a QMS, including Planning, Development, and Design Validation/Design Transfer.
Students will illustrate how QMS principles are applied to ensure compliance with regulatory standards.
Students will ensure regulatory and compliance adherence,
Students will list key regulatory standards applicable to medical devices (e.g., ISO 14971).
Students will develop a checklist to ensure regulatory compliance during development.
Students will develop design and development skills.
Students will generate design inputs and outputs for a hypothetical medical device project.
Students will evaluate material selection and propose solutions for addressing key design considerations (e.g., electrical components, software, or sterilization needs).
Students will outline the documentation required for the design and development phase in compliance with regulatory standards.
Students will evaluate human factors and usability as applicable.
Students will design a basic usability study framework to assess human factors for a medical device.
Students will explain how usability influences design modifications and risk management.
Students will conduct prototype analysis and testing.
Students will outline steps for prototype testing, including design output and validation activities.
Students will identify scenarios where animal studies or biocompatibility evaluations would be required and summarize the testing protocols.
Students will manage manufacturing and clinical investigations.
Students will list the requirements for manufacturing medical devices intended for clinical investigations.
Students will define the elements of a clinical investigation.
Students will draft intended use and indications for use.
Students will explain the difference between an intended use and indications “for use” statement.
Students will discuss how this statement impacts regulatory classification and submission processes.
Students will prepare regulatory filings and plan market launch.
Students will identify key components required for a successful regulatory submission.
Students will develop a timeline and checklist for launching a medical device, including regulatory, manufacturing, and marketing milestones.
Topical Outline
Introduction
Prep-Phase: concept (or improvement) and discovery, not part of formal design and development process
Phases of device development, QMS and compliance to ISO 13485
Formal documentation of design
Phase I: Planning
Device Design
Design Inputs (user requirements)
IMDRF EP, EU MDR/IVDR GSPR
Phase II: Development (includes inputs, outputs, detailed design, and verification)
Human Factors and Usability
Known Problem Analysis KPA (ISO 62366-1:2015, 5.3 Identify known or foreseeable hazardous and hazardous situations)
Prototype Clinical Unit Development & Testing
Design Output, Verification, Validation
Phase III: Design Validation / Design Transfer
Manufacturing
Clinical Investigations
Developed compliant to Declaration of Helsinki and ISO 14155
Identification of countries and PIs, Clinical investigational Protocol, Investigator’s Brochure, Informed Consent, Institutional Review Board
Intended Use/Purpose, Indications for Use Statement
Regulatory filings
Phase IV: Market Launch
Institutional Competencies Learning Outcomes
Analytical Thinking
The ability to reason, interpret, analyze, and solve problems from a wide array of authentic contexts.
