Description

This is a basic online course about Medical Device Development for new professionals or those just  entering the field.  The material supplies a detailed overview of medical device development from a realistic industrial perspective using recorded lectures and slides. The processes used in companies to conceive and develop devices will be explored from a research, regulatory, clinical, QA/QC, marketing, engineering, and legal perspective under the umbrella of project management techniques. The course is 100% online and modeled after the “Medical Device Development”  class taught at the New Jersey Institute of Technology since 2009.  Students in this course will gain a broad  overview of all aspects for the early phases of device design.  This course assumes no prior knowledge of  medical devices or their development.  New students should be able to understand the entire content with  no prior background.

Medical Device Development Course Objectives:

• Function as a member of a medical device project team
• Understand the various disciplines involved with medical device development
• Know the roles that different departments and professions play in medical device development

Who should take this course?

• Biomedical Engineering (or other STEM majors)
• Academics that need to understand the difference between Industry and Academia
• Physicians that have a medical device idea and wish to know the basics of how to get started
• Graduate and Undergraduate students whose schools do not offer courses like this one
• Medical Device Engineers with 0 to 2 years of experience that need a basic education about the various roles in device development

Medical Device Development Course Outline:

• Introduction – Medical Device Development: Academia vs. Industry
• Project Management 101 – How corporations manage projects
• Pre-clinical Device Development – Research projects
• Regulatory considerations for medical device development
• Manufacturing, Quality Control, and Quality Assurance
• Business 101 – What makes corporations tick and research labs tock
• Marketing medical devices, and the basics of sales forces
• Clinical trials, CRA’s, and CRO’s
• Design Controls 101: DHF, Proposal, DDP, Inputs, Outputs, Specifications
• Design Controls 101: Verification, Validation, Transfer
• Risk Analysis: FMECA, Risk analysis document
• Organization types, putting together project teams, Project Management: The Sequel
• Consultants – Role in medical device development, Advamed, Anti-kickback statute, Confidentiality

What you get:

• Unlimited time access to 30 recorded online lectures (~ 7 hrs of content)
• Basic template documents for common device development processes
• Access to a forum for discussing/asking questions to the instructor
• Free updates to course material