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Business Other Business Medical Device Development

Medical Device Development

A basic level primer for those starting their careers developing medical devices in a heavily regulated environment.
Rating: 4.4 out of 54.4 (67 ratings)
171 students
Created by Josh Simon
Last updated 11/2016
English
English [Auto]
30-Day Money-Back Guarantee

What you'll learn

  • 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
  • Describe the regulatory structure for medical devices in the USA
  • Use this information in choosing a medical device profession

Requirements

  • No prior knowledge of medical device development is required

Description


  This course will provide a detailed overview of medical device development from a realistic industrial  perspective using recorded lectures and slides which are all provided.  The processes used in corporations  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.  Material will be presented as an aide to students who wish to decide on careers in either industry or academia. 

    For students or newly minted engineers that find themselves participating on project teams, this course will give them basic knowledge needed to function. 

    For Professors interested in making a change or learning more about their commercial counterparts, this course will bridge the knowledge gap and convey an understanding of what accommodations can be made to do that. 

    Anyone that needs an overview of the major roles found in device companies can benefit from this course. 

Who this course is for:

  • Biomedical Engineering (or other STEM majors) that want to know what medical device development in industry is like
  • 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
  • People fresh out of college that need a basic primer on device development for their job
  • 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
  • This course is NOT for seasoned medical device project professionals

Course content

12 sections • 49 lectures • 7h 37m total length

  • Preview13:51
  • Medical Device Development Discussion Forum - Introduction Forum
    00:02

  • Project Management 101
    10:01
  • Project LIfecycle and Initiation
    15:55
  • Project Planning
    18:32
  • Project Executing, Control, and Closing
    10:54
  • Medical Device Development Discussion Forum - Project Management Topics
    00:03

  • Pre-Clinical Research Projects
    17:39
  • Managing in vivo Studies
    18:18
  • Medical Device Development Discussion Forum - Pre-Clinical Development Topics
    00:02

  • Regulatory Considerations and the FDA
    14:05
  • Regulation of Medical Devices in the USA
    21:09
  • Role of The Regulatory Department
    13:30
  • Medical Device Development Discussion Forum - Regulatory Topics
    00:02

  • Quality Control and Quality Assurance
    15:06
  • The Quality System
    15:33
  • Medical Device Development Discussion Forum - QA/QC Topics
    00:02

  • Business 101
    06:41
  • Types of Corporations, Part 1
    15:39
  • Types of Corporations, Part 2
    15:17
  • Analyzing Companies
    10:48
  • Medical Device Development Discussion Forum - Business Topics
    00:02

  • Marketing and Sale of Medical Devices
    13:40
  • Marketing Strategy and Mix
    13:04
  • Role of the Marketing Department
    10:11
  • Product Management
    07:35
  • The Basics of Sales Forces
    12:28
  • Medical Device Development Discussion Forum - Marketing and Sales Topics
    00:02

  • Clinical trials, CRA’s, and CRO’s
    12:38
  • Roles in Clinical Trials
    12:27
  • Medical Device Development Discussion Forum - Basic Clinical Research Topics
    00:02

  • Design Controls Part 1: DHF, Proposal, DDP, Inputs, Outputs, Specifications
    16:09
  • Design Controls Part 2: Design Verification
    09:25
  • Design Controls Part 2: Design Validation
    09:20
  • Design Controls Part 2: Design Transfer, Review, and Change
    08:21
  • Design Controls Document Templates - PDF
    5 pages
  • Design Controls Document Template - DDP
    9 pages
  • Design Controls Document Template - DID
    2 pages
  • Design Controls Document Template - DSD
    10 pages
  • Medical Device Development Discussion Forum - Design Controls Topics
    00:02

  • Risk Analysis: FMECA, Risk analysis document
    11:57
  • Risk Analysis Document Template - Risk Analysis Instructions
    26 pages
  • Risk Analysis Document Template - Risk Analysis Template
    5 pages
  • Medical Device Development Discussion Forum - Risk Topics
    00:02

Instructor

Josh Simon
Medical Device Development Professional
Josh Simon
  • 4.2 Instructor Rating
  • 540 Reviews
  • 9,817 Students
  • 6 Courses

  Currently, I am Principal Consultant at Spiral Medical Development and an Adjunct Professor at the New Jersey Institute of Technology.  For over 10 years, I have worked in various roles developing medical devices and have touched perhaps hundreds of them in varying capacities from concept to launch. 

  As someone that loves to give back and feels obligated to teach those that are coming after me in the medical device industry, I have always said that it is important to excel in at least two things. Every day I try to be an example to my coworkers and students by using my experience in research and business to bridge the gap between the two. This usually involves conversations from all perspectives covering project management, medical device product development, marketing, training, and research planning.

Being able to explain tough concepts to audiences without background in a subject has been my forte, and I have used it in numerous device companies, sales training classes, CME, and Grand Rounds presentations around the world. Going the other way, I have conveyed crucial business strategies to motivate product development and research professionals both in industry and academia.   

While my formal training is in general business and Biomedical Engineering with specific interest in bone tissue engineering and biomaterials, I see myself as a translator. The languages of business and science are not often mutually understood, and I act as the intermediary. 

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