Medical Device Development

A basic level primer for those starting their careers developing medical devices in a heavily regulated environment.
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71 students enrolled
Instructed by Josh Simon Business / Other
$100
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  • Lectures 37
  • Contents Video: 6.5 hours
    Other: 1 hour
  • Skill Level Beginner Level
  • Languages English
  • Includes Lifetime access
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    Available on iOS and Android
    Certificate of Completion
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About This Course

Published 2/2015 English

Course 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.

What are the requirements?

  • No prior knowledge of medical device development is required

What am I going to get from this course?

  • 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

What 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

What you get with this course?

Not for you? No problem.
30 day money back guarantee.

Forever yours.
Lifetime access.

Learn on the go.
Desktop, iOS and Android.

Get rewarded.
Certificate of completion.

Curriculum

Section 1: Introduction to Medical Device Development - Academia vs. Industry
13:51

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

Section 2: Project Management for Medical Devices - How Corporations Manage Projects
10:01

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

* Differentiate between Projects and routine tasks

15:55

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

18:32

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

10:54

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

Section 3: Pre-clinical Device Development – Research projects
17:39

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

Managing in vivo Studies
18:18
Section 4: Regulatory Basics for Medical Devices
14:05

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

21:09

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

13:30

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

Section 5: Quality Control and Quality Assurance
15:06

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

15:33

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

Section 6: Business 101 – What makes corporations tick and research labs tock
06:41

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

* Tell how corporations formed historically.

* Tell how corporations limit personal risk.

15:39

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.

15:17

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

10:48

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

Section 7: Marketing medical devices, and the basics of sales forces
13:40

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

13:04

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

10:11

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

07:35

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

12:28

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

Section 8: Clinical Research
12:38

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

12:27

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

Section 9: Design Controls 101
16:09

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

09:25

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

09:20

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

08:21

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 Document Templates - PDF
5 pages
Design Controls Document Template - DDP
9 pages
2 pages

Design Input Document Template, referenced in the lecture

10 pages

Design Specification Document Template, referenced in the lecture.

Section 10: Risk Analysis for Medical Devices
11:57

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

26 pages

Instructions on Risk Management for an organization, supplemental to lecture

5 pages

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

Section 11: Organizational Development in Device Companies
10:03

Introduction to Organizational Behavior for medical device projects. After this lecture, students will be able to:

* Describe the different types of oranganizations: Functional, Matrix, Hybrid

* Talk about the advantages and disadvantages each type poses to device projects

05:07

Discussion of Project Management and Design Controls. At the end of this lecture, students will be able to:

* Tell where Project Management techniques and Design Controls overlap

* Talk about some of the differences between the two

Section 12: Consultants and Some Legal Basics
14:30

Basics of contracts and legal guidelines. After this lecture, students will be able to:

* Understand the basic requirements for a legal contract

* Be able to handle situations for Confidentiality agreements and Consulting agreements.

* Understand proper behavior when dealing with Physician consultants.

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Instructor Biography

Josh Simon, Medical Device Development Professional

Currently, I am 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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