Medical Device Development
4.3 (22 ratings)
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Medical Device Development

A basic level primer for those starting their careers developing medical devices in a heavily regulated environment.
4.3 (22 ratings)
Instead of using a simple lifetime average, Udemy calculates a course's star rating by considering a number of different factors such as the number of ratings, the age of ratings, and the likelihood of fraudulent ratings.
88 students enrolled
Created by Dr. Josh Simon
Last updated 11/2016
English
Price: $200
30-Day Money-Back Guarantee
Includes:
  • 6.5 hours on-demand video
  • 12 Articles
  • 6 Supplemental Resources
  • Full lifetime access
  • Access on mobile and TV
  • Certificate of Completion
What Will I 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
View Curriculum
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 is the target audience?
  • 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
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Curriculum For This Course
Expand All 49 Lectures Collapse All 49 Lectures 07:37:25
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Introduction to Medical Device Development - Academia vs. Industry
2 Lectures 13:54

First introduction and overview of the course. At the end, students will be able to:

* Differentiate between how things work in Industry vs. Academia

* Know who should and should not take this course

* Gain an introduction to the course instructor

* Know what this course will cover

Preview 13:51

Discussion forum for Medical Device Development Course - Section 1 Introduction

Medical Device Development Discussion Forum - Introduction Forum
00:03
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Project Management for Medical Devices - How Corporations Manage Projects
5 Lectures 55:25

What is project management? At the end of this lecture students will be able to:

* Differentiate between Projects and routine tasks

Project Management 101
10:01

Overview of the Project Lifecycle and Initiation Phase. At the end of this lecture, students will be able to:

* Understand the Project Life Cycle

* Be able to list the different phases of a Project

* Understand the strategic hierarchy from Program through Task

Project LIfecycle and Initiation
15:55

Overview of the Planning phase of Project Management. After this lecture, students will be able to:

* Name some events that take place during the Planning phase

* Understand some tools used for planning: Network Diagram, Gantt Chart, Pert Chart

* Get an idea of the concepts of slack and critical path

Project Planning
18:32

Overview of the Executing, Monitoring & Controlling, and Closing phases of a project. At the end of this lecture, students will be able to:

* Describe what events take place in each phase

* Understand the concepts of Earned Value, Scheduling Variance, and Cost Variance

Project Executing, Control, and Closing
10:54

Discussion forum for Project Management topics in the Medical Device Development course.

Medical Device Development Discussion Forum - Project Management Topics
00:03
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Pre-clinical Device Development – Research projects
3 Lectures 36:00

Distinctions between Academic and Industrial (Commercial) Research. At the end of this lecture, students will be able to:

* Differentiate between the different research enviornments

* Understand the different drivers for each kind of research

Pre-Clinical Research Projects
17:39

Managing in vivo Studies
18:18

Discussion forum for pre-clinical development topics in the Medical Device Development course.

Medical Device Development Discussion Forum - Pre-Clinical Development Topics
00:03
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Regulatory Basics for Medical Devices
4 Lectures 48:47

Brief history of FDA and some important Acts. At the end of this lecture, students will be able to:

* Tell a little about the early days of the FDA

* List two important Acts that influence how the FDA works today

Regulatory Considerations and the FDA
14:05

Detailed description of medical device classifications by the FDA as well as drug and biologic regulatory pathways. At the end of this lecture, students will be able to:

* Describe the different regulatory pathways for drugs, devices, and biologics.

* Tell which sub-agencies at the FDA govern drugs, devices, and biologics

* Understand how to deal with combination products

Regulation of Medical Devices in the USA
21:09

Description of the role that the Regulatory Affairs department plays in a medical device company. At the end of this lecture, students will be able to:

* List the common tasks for Regulatory Affairs during product development and post-marketing

* Understand the relationship between Regulatory Affairs and the FDA

* Know the various job titles often encountered in the Regulatory Affairs department

Role of The Regulatory Department
13:30

Discussion forum for Regulatory topics in the Medical Device Development course.

Medical Device Development Discussion Forum - Regulatory Topics
00:03
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Quality Control and Quality Assurance
3 Lectures 30:42

Brief introduction to Quality. At the end of this lecture, students will be able to:

* State the difference between Quality Assurance and Quality Control

* Name some important factors for a functional Quality System

Quality Control and Quality Assurance
15:06

Overview of the Quality System and its component parts. After this lecture, students will be able to:

* Define what a Quality System and list its parts

* List the parts of the Quality Unit

* Describe the role of the Quality System in the organization

The Quality System
15:33

Discussion forum for QA/QC topics in the Medical Device Development course.

Medical Device Development Discussion Forum - QA/QC Topics
00:03
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Business 101 – What makes corporations tick and research labs tock
5 Lectures 48:28

Introduction to Corporations. After this lecture, students will be able to:

* Tell how corporations formed historically.

* Tell how corporations limit personal risk.

Business 101
06:41

Overview of different types of corporations. At the end of this lecture, students will be able to:

* State the differences between a sole proprietorship, LLP, LLC.

* Describe how each type of corporation is owned, managed, and taxed.

Types of Corporations, Part 1
15:39

Continued overview of different types of corporations. At the end of this lecture, students will be able to:

* State the differences between C-corp's and S-corp's

* Discuss flow-through taxation and double taxation

Types of Corporations, Part 2
15:17

Basic overview of financials and financial ratios. At the end of this lecture, students will be able to:

* Discuss the different financials for a company

* Express which ratios are good for analyzing certain aspects of a corporation

Analyzing Companies
10:48

Discussion forum for Business topics in the Medical Device Development course.

Medical Device Development Discussion Forum - Business Topics
00:03
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Marketing medical devices, and the basics of sales forces
6 Lectures 57:02

Introduction to Marketing. After this lecture, students will be able to:

* Understand the definition of a Market

* Become familiar with the terms "market size" and "market share"

* Learn about SWOT analyses

Marketing and Sale of Medical Devices
13:40

Overview of Marketing strategy. After this lecture, students will be able to:

* Be able to discuss Vision and Mission Statements

* Define the "4 P's" of Marketing

* Understand some modern best practices for Marketing

Marketing Strategy and Mix
13:04

Overview of the role of the Marketing Department. After this lecture, students will be able to:

* Describe different facets of the Marketing Department

* Describe how Marketing fits in with all other departments in the company

* Describe the role that Marketing plays in medical device development

Role of the Marketing Department
10:11

Introduction to Product Management and how it fits into medical device development. After this lecture, students will be able to:

* Describe the role of the Product Manager before and after market release of a device

* Describe the phases of a Product Life Cycle

Product Management
07:35

Introduction to sales forces and how they work. After this lecture, students will be able to:

* List several examples of sales channels

* Describe how sales reps contribute to product development

* Describe the relationship between Marketing and Sales

The Basics of Sales Forces
12:28

Discussion forum for Marketing and Sales topics in the Medical Device Development course.

Medical Device Development Discussion Forum - Marketing and Sales Topics
00:04
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Clinical Research
3 Lectures 25:09

Overview of Clinical Research. After this lecture, students will be able to:

* Tell the difference between pre-clinical and clinical research

* List some of the regulations and standards used in clinical research

Clinical trials, CRA’s, and CRO’s
12:38

Description of the various roles that different people play in clinical trials. At the end of this lecture, students will be able to:

* Describe what each role does: Sponsor, Investigator, CRA, CRO, IRB

* Describe some of the forms and steps in conducting a clinical trial

Roles in Clinical Trials
12:27

Discussion forum for topics on basic clinical research in the Medical Device Development course.

Medical Device Development Discussion Forum - Basic Clinical Research Topics
00:04
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Design Controls 101
9 Lectures 43:19

Introduction to Design Controls. At the end of this lecture, students will be able to:

* List the major steps for Design Controls mandated by 21 CFR 820.30

* Talk about some of the documents that go with the initial steps

Design Controls Part 1: DHF, Proposal, DDP, Inputs, Outputs, Specifications
16:09

Steps for Design Verification. After this lecture, students will be able to:

* Describe the need for Design Verification

* List the steps and documents associated with Design Verification

Design Controls Part 2: Design Verification
09:25

Steps for Design Validation. After this lecture, students will be able to:

* Describe when Design Validation is appropriate

* List the steps and documents associated with Design Validation

* Explain how Clinical Research is relevant to Design Validation

Design Controls Part 2: Design Validation
09:20

Overview of the final stage of Design Controls and how to Review and Change Designs. At the end of this lecture, students will be able to:

* List and explain activities that take place during Design Transfer

* Discuss the importance of Design Review

* Explain the steps for changing documents in the Design Controls process

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 Input Document Template, referenced in the lecture

Design Controls Document Template - DID
2 pages

Design Specification Document Template, referenced in the lecture.

Design Controls Document Template - DSD
10 pages

Discussion forum on Design Controls topics for the Medical Device Development course.

Medical Device Development Discussion Forum - Design Controls Topics
00:04
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Risk Analysis for Medical Devices
4 Lectures 12:00

Introduction to Risk Management. After this lecture, students will be able to:

* Describe the process of Risk Management

* Tell how the process dovetails with Design Controls

Risk Analysis: FMECA, Risk analysis document
11:57

Instructions on Risk Management for an organization, supplemental to lecture

Risk Analysis Document Template - Risk Analysis Instructions
26 pages

Template document for conducting a Risk Analysis, referenced in the lecture.

Risk Analysis Document Template - Risk Analysis Template
5 pages

Discussion forum for Risk topics in the Medical Device Development course.

Medical Device Development Discussion Forum - Risk Topics
00:03
2 More Sections
About the Instructor
Dr. Josh Simon
4.6 Average rating
143 Reviews
3,192 Students
6 Courses
Medical Device Development Professional

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.