Medical Device Development

Name: Medical Device Development
Rating: 4.3 (94 reviews)

A basic level primer for those starting their careers developing medical devices in a heavily regulated environment.

Created byJosh Simon

Last updated 9/2018

English

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

Course content

12 sections • 49 lectures • 6h 40m total length

Introduction to Medical Device Development13:51
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
Medical Device Development Discussion Forum - Introduction Forum0:02
Discussion forum for Medical Device Development Course - Section 1 Introduction

Project Management 10110:01
What is project management? At the end of this lecture students will be able to:

* Differentiate between Projects and routine tasks
Project LIfecycle and Initiation15:55
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
Project Planning18:32
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
Project Executing, Control, and Closing10:54
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
Medical Device Development Discussion Forum - Project Management Topics0:03
Discussion forum for Project Management topics in the Medical Device Development course.

Pre-Clinical Research Projects17:39
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 Studies18:18
Medical Device Development Discussion Forum - Pre-Clinical Development Topics0:02
Discussion forum for pre-clinical development topics in the Medical Device Development course.

Regulatory Considerations and the FDA14:05
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
Regulation of Medical Devices in the USA21:09
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
Role of The Regulatory Department13:30
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
Medical Device Development Discussion Forum - Regulatory Topics0:02
Discussion forum for Regulatory topics in the Medical Device Development course.

Quality Control and Quality Assurance15:06
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
The Quality System15:33
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
Medical Device Development Discussion Forum - QA/QC Topics0:02
Discussion forum for QA/QC topics in the Medical Device Development course.

Business 1016:41
Introduction to Corporations. After this lecture, students will be able to:

* Tell how corporations formed historically.

* Tell how corporations limit personal risk.
Types of Corporations, Part 115:39
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.
Types of Corporations, Part 215:17
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
Analyzing Companies10:48
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
Medical Device Development Discussion Forum - Business Topics0:02
Discussion forum for Business topics in the Medical Device Development course.

Marketing and Sale of Medical Devices13:40
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
Marketing Strategy and Mix13:04
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
Role of the Marketing Department10:11
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
Product Management7:35
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
The Basics of Sales Forces12:28
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
Medical Device Development Discussion Forum - Marketing and Sales Topics0:02
Discussion forum for Marketing and Sales topics in the Medical Device Development course.

Clinical trials, CRA’s, and CRO’s12:38
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
Roles in Clinical Trials12:27
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
Medical Device Development Discussion Forum - Basic Clinical Research Topics0:02
Discussion forum for topics on basic clinical research in the Medical Device Development course.

Design Controls Part 1: DHF, Proposal, DDP, Inputs, Outputs, Specifications16:09
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
Design Controls Part 2: Design Verification9:25
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
Design Controls Part 2: Design Validation9:20
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
Design Controls Part 2: Design Transfer, Review, and Change8:21
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 - PDF5:00
Design Controls Document Template - DDP9:00
Design Controls Document Template - DID2:00
Design Input Document Template, referenced in the lecture
Design Controls Document Template - DSD10:00
Design Specification Document Template, referenced in the lecture.
Medical Device Development Discussion Forum - Design Controls Topics0:02
Discussion forum on Design Controls topics for the Medical Device Development course.

Risk Analysis: FMECA, Risk analysis document11:57
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
Risk Analysis Document Template - Risk Analysis Instructions26:00
Instructions on Risk Management for an organization, supplemental to lecture
Risk Analysis Document Template - Risk Analysis Template5:00
Template document for conducting a Risk Analysis, referenced in the lecture.
Medical Device Development Discussion Forum - Risk Topics0:02
Discussion forum for Risk topics in the Medical Device Development course.

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

Medical Device Development

What you'll learn

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Course content

Introduction to Medical Device Development - Academia vs. Industry2 lectures • 14min

Project Management for Medical Devices - How Corporations Manage Projects5 lectures • 55min

Pre-clinical Device Development – Research projects3 lectures • 36min

Regulatory Basics for Medical Devices4 lectures • 49min

Quality Control and Quality Assurance3 lectures • 31min

Business 101 – What makes corporations tick and research labs tock5 lectures • 48min

Marketing medical devices, and the basics of sales forces6 lectures • 57min

Clinical Research3 lectures • 25min

Design Controls 1019 lectures • 1hr 9min

Risk Analysis for Medical Devices4 lectures • 43min

Requirements

Description

Who this course is for: