Project Management for Medical Devices

Name: Project Management for Medical Devices
Rating: 4.2 (39 reviews)

Merging solid project management concepts with medical device development

Created byJosh Simon

Last updated 12/2016

English

What you'll 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

Course content

4 sections • 31 lectures • 5h 57m total length

Introduction to Project Management for Medical Devices4:11
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
Basic Terms and Detailed Overview17:20
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
Considerations for Regulatory in Project Management10:42
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 - Part 210:56
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.
Medical Devices in the context of Project Management16:06
At the end of this lecture students will be able to:
Explain relationships between projects, products, medical device product lines, and design controls.
Influence of Organizational Structure and Type on Project Management8:07
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
End of Section Quiz 1
Project Management Discussion Forum - Introductory Forum0:03
Discussion forum for introductions in the Project Management for Medical Devices course.

Project Initiation - The first PM Process12:18
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 Planning - Integration with Design Controls and MDD18:08
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 Part 2 - Planning Tools18:24
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 - Tools and Pitfalls13:49
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 Execution15:23
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 Part 210:56
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 Monitoring & Controlling15:17
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 Part 210:20
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 Closing6:32
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
End of Section Quiz 2
Project Management Discussion Forum - Project Management Processes0:03
Discussion forum for Project Management Process topics in the PM for Medical Devices course.

Project Management Knowledge Areas - Introduction7:37
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 - Scope Management17:01
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 - Time Management16:59
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 - Cost Management11:17
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 - Risk Management18:55
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 - Project Quality Management16:06
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 - Human Resources Management17:10
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 - Communications Management12:37
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 - Procurement Management18:52
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
End of Section Quiz 3
Project Management Discussion Forum - Project Management Knowledge Areas0:03
Discussion forum for Project Management Knowledge Area topics in the PM for Medical Devices course.

Project Management Application - Intro to Clinical Trials6:40
Overview of the clinical trial example given here for using PM principles, processes, and knowledge areas in medical device development.
Project Management Application - Part 218:03
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 37:04
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
End of Section Quiz 4
Project Management Discussion Forum - Clinical Trial Application0:03
Discussion forum for Clinical Trial application topics in the PM for Medical Devices course.

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 this course is for:

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

Project Management for Medical Devices

What you'll learn

Explore related topics

Course content

Introduction and Getting Started - Phase I7 lectures • 1hr 7min

Project Management Process and Medical Device Development - Phase II10 lectures • 2hr 1min

Project Management Knowledge Areas10 lectures • 2hr 17min

Project Management Application and Example: Clinical Trial for a Medical Device4 lectures • 32min

Requirements

Description

Who this course is for: