Project Management for Medical Devices
4.7 (7 ratings)
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Project Management for Medical Devices

Merging solid project management concepts with medical device development
4.7 (7 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.
31 students enrolled
Created by Josh Simon
Last updated 12/2016
English
Price: $200
30-Day Money-Back Guarantee
Includes:
  • 6 hours on-demand video
  • 4 Articles
  • Full lifetime access
  • Access on mobile and TV
  • Certificate of Completion
What Will I Learn?
  • Function as a team member on a medical device development project
  • Understand how to further the student's education on Project Management
  • Relate concepts of Project Management to Medical Device Development
View Curriculum
Requirements
  • A basic knowledge of Medical Device Development and Design Controls
Description

Courses in Project Management (PM) abound both in the classroom and online.  However, nearly all currently available courses focus either on generic PM or specific industries such as construction and software development.  There is a decided lack of PM courses that address medical device development (MDD).  Enter this course.

Through a series of video lectures and slides, this course will tackle the combination of best practices in PM and design controls for MDD.  Students will understand how the contemporary MDD process (design controls) fits into the accepted method for PM taught by the Project Management Institute.  

After a brief definition of PM and medical devices, the course will step through the accepted PM Processes and apply them to the equivalent steps taken in Design Controls as per regulation 21 CFR 820.30, which governs medical devices.   Next, the course will describe key PM Knowledge Areas appropriate for MDD and introduce some new ones, such as Regulatory.

Medical device professionals dealing with development projects either directly or indirectly can benefit from this course, as well as newly hired engineers and project managers that need a basic introduction to the field.

Who is the target audience?
  • Engineers working on medical device projects
  • Product development professionals that work with medical device development
  • Newly hired medical device company professionals that need information on project management
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Curriculum For This Course
31 Lectures
05:57:02
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Introduction and Getting Started - Phase I
7 Lectures 01:07:26

Introduction to Project Management (PM) and some general terms and definitions dealing with projects.

At the end of this lecture students will be able to:

* Determine if this course is the right one to take

Preview 04:11

More details on the course beyond the Intro video.  This lecture sets up the course and looks at:

Definition of "Medical Device"

Definitions of "Project", "Program", "Tactics", "Strategy" and their relationships

Brief introduction to the Project Management Processes

Brief introduction to the Project Management Knowledge Areas

Basic Terms and Detailed Overview
17:20

A basic overview of the Food and Drug Administration (FDA) and explanations of how it can drastically influence and affect Project Management.

At the end of this lecture students will be able to:

* List the three major classes of medical devices in the United States

* List some requirements for each of the three classes of device

* Explain the role of the FDA in medical device development

Considerations for Regulatory in Project Management
10:42

Continued discussion of the FDA's role in Project Management with deeper insights into responsibilities of the FDA and regulatory professionals on the project team.

At the end of this lecture students will be able to:

Explain how regulatory factors make medical device project management different from  other fields.

Considerations for Regulatory in Project Management - Part 2
10:56

At the end of this lecture students will be able to:

Explain relationships between projects, products, medical device product lines, and design controls.

Medical Devices in the context of Project Management
16:06

How functional, projectized, and matrix organizations approach projects differently.  At the end of this lecture students will be able to:

* List three major types of organizations

* Explain how projects are handled differently in those three types

* Explain how organization type influences medical device development

Influence of Organizational Structure and Type on Project Management
08:07

Quick learning check for understanding of material on the introduction to Project Management for Medical Devices

End of Section Quiz 1
5 questions

Discussion forum for introductions in the Project Management for Medical Devices course.

Project Management Discussion Forum - Introductory Forum
00:04
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Project Management Process and Medical Device Development - Phase II
10 Lectures 02:01:11

Project Initiation

At the end of this lecture students will be able to:

Describe Inputs and Outputs of the Initiation process

Tie together Design Control documents and Project Initiation

Project Initiation - The first PM Process
12:18

Project Planning Process

The most important stage of Project Management, this lecture discusses how to integrate planning for medical device development with best PM practices.

At the end of this lecture students will be able to:

* Explain which portions of Design Controls may take place during the Planning Process

* Give inputs and outputs for several Planning Process activities

Project Planning - Integration with Design Controls and MDD
18:08

Methods for planning a project

At the end of this lecture students will be able to:

Explain different types of Work Breakdown Structures (WBS's)

Describe several Planning Tools:  Network Diagrams, Pert charts, Gantt charts

Project Planning Part 2 - Planning Tools
18:24

Discussion of project and task slack and some pitfalls associated with medical device project planning.

At the end of this lecture students will be able to:

Explain concepts of project slack, task slack, and task relationships.

Project Planning Part 2 - Tools and Pitfalls
13:49

Project execution from the project plan

At the end of this lecture students will be able to:

Discuss events occurring during the Execution Process: Team Development, Quality Assurance

Descript pitfalls for medical device projects during the Execution Process

Project Execution
15:23

Discussion on how Design Controls fit into the Executing process of project management.

At the end of this lecture students will be able to:

Give information on Design Verification and Validation

Explain how Design Verification and Validation fit into the Execution Process

Project Execution Part 2
10:56

Overview of the Project Monitoring & Controlling Process with regards to medical device Design Transfer and Change Control.

At the end of this lecture students will be able to:

List activities that take place during Monitoring & Controlling

Project Monitoring & Controlling
15:17

Discussion and examples of metrics:  Earned Value, Planned Value, Schedule Variance

At the end of this lecture students will be able to:

Give the equations for Earned Value, Schedule Variance, and Cost Variance

Explain the significance of these metrics and what they mean

Project Monitoring & Controlling Part 2
10:20

Project Completion - Design Transfer, Contract Closure, Lessons Learned

At the end of this lecture students will be able to:

List the activities necessary to close a project and transfer a medical device to production

Project Closing
06:32

End of Section Quiz 2
5 questions

Discussion forum for Project Management Process topics in the PM for Medical Devices course.

Project Management Discussion Forum - Project Management Processes
00:04
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Project Management Knowledge Areas
10 Lectures 02:16:38

Overview of the PM Knowledge Areas:

Time Management

Cost Management

Scope Management

Quality Management

People (HR) Management

Communication Management

Risk Management

Procurement Management

Stakeholder Management

Integration Management

Special cases as pertaining to Medical Devices and explored further in proceeding lectures.

Project Management Knowledge Areas - Introduction
07:37

At the end of this lecture students will be able to:

List methods for coming up with a Scope Statement

Give inputs and tools for Defining Scope

Give inputs and tools for Controlling Scope

Project Management Knowledge Areas - Scope Management
17:01

Process for engaging in time management for medical device projects

At the end of this lecture students will be able to:

Give inputs and outputs for activities leading up through cost and budget development for a project

Project Management Knowledge Areas - Time Management
16:59

Methods for calculating project costs and pitfalls to avoid

At the end of this lecture students will be able to:

List several techniques for developing project costs: bottom up and top-down

Project Management Knowledge Areas - Cost Management
11:17

Risk Management discussion from the perspective of abstract project management and medical device specifics.

At the end of this lecture students will be able to:

Compare and contrast "project risk" and "device risk" and how to address each of them

Project Management Knowledge Areas - Risk Management
18:55

Discussion on project quality.  By the end of this lecture, students will be able to:

List the three processes for Project Quality Management

Realize the value of Quality Assurance and Quality Control for project milestones and deliverables

Talk about when the use of this knowledge area is appropriate.

Project Management Knowledge Areas - Project Quality Management
16:06

Discussion on management of personnel on the project team.  After this lecture, students will be able to:

List the three processes for project human resource management

Explain how these processes integrate with the Design Development Plan (DDP)

Project Management Knowledge Areas - Human Resources Management
17:10

Basics of Communications Management on a Medical Device Project.  By the end of this lecture, students will be able to:

Discuss what a Communications Plan needs to address

Describe how the Communications Plan relates to Design Controls and Medical Device Project Management

Name several ways by which information is distributed on a project

Project Management Knowledge Areas - Communications Management
12:37

Basic sequence of events governing Procurement Management in a project.  By the end of this lecture, students will be able to:

Describe the sequence of events from planning through acquisition of resources

Talk about the content of the Procurement Management Plan and how it fits into the DDP

Project Management Knowledge Areas - Procurement Management
18:52

End of Section Quiz 3
5 questions

Discussion forum for Project Management Knowledge Area topics in the PM for Medical Devices course.

Project Management Discussion Forum - Project Management Knowledge Areas
00:04
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Project Management Application and Example: Clinical Trial for a Medical Device
4 Lectures 31:51

Overview of the clinical trial example given here for using PM principles, processes, and knowledge areas in medical device development.

Preview 06:40

Discussion of Initiation and Planning processes for a clinical trial

At the end of this lecture students will be able to:

List the roles on the clinical project team

Summarize the Initiation and Planning Processes for a clinical trial

Project Management Application - Part 2
18:03

Discussion on Monitoring & Controlling processes for a clinical trial

At the end of this lecture students will be able to:

Describe the Monitoring & Controlling process for a clinical trial

Project Management Application - Part 3
07:04

End of Section Quiz 4
5 questions

Discussion forum for Clinical Trial application topics in the PM for Medical Devices course.

Project Management Discussion Forum - Clinical Trial Application
00:04
About the Instructor
Josh Simon
4.3 Average rating
169 Reviews
3,490 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.