Medical Device Development
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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.
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|Section 1: Introduction to Medical Device Development - Academia vs. Industry|
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|
What is project management? At the end of this lecture students will be able to:
* Differentiate between Projects and routine tasks
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
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
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|
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
|Section 4: Regulatory Basics for Medical Devices|
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
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
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|
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
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|
Introduction to Corporations. After this lecture, students will be able to:
* Tell how corporations formed historically.
* Tell how corporations limit personal risk.
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.
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
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|
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
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
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
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
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|
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
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|
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
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
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
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
Design Controls Document Template - DDP
|Lecture 30||2 pages|
Design Input Document Template, referenced in the lecture
|Lecture 31||10 pages|
Design Specification Document Template, referenced in the lecture.
|Section 10: Risk Analysis for Medical Devices|
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
|Lecture 33||26 pages|
Instructions on Risk Management for an organization, supplemental to lecture
|Lecture 34||5 pages|
Template document for conducting a Risk Analysis, referenced in the lecture.
|Section 11: Organizational Development in Device Companies|
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
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|
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.
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.