Description
This course will provide a detailed overview of medical device development from a realistic industrial perspective using recorded lectures. The processes used in corporations to conceive and develop devices will be explored from a research, regulatory, marketing, engineering, and legal perspective under the umbrella of project management techniques.
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.
Meet your trainer for this course!
Joshua Simon
With over 18 years of experience in the medical device industry, Joshua Simon has held various roles involved in the development of medical devices, from concept to launch.
His expertise spans through project management, medical device product development, marketing, training, and research planning, allowing him to engage in conversations from multiple perspectives.
While his formal training lies in general business and Biomedical Engineering, with a specific interest in bone tissue engineering and biomaterials, Josh considers himself as a “translator”. He recognizes that the languages of business and science are often not mutually understood, and therefore he plays a pivotal role as the intermediary, facilitating effective communication between the two domains.
Known for his ability to explain complex concepts to diverse audiences, he has successfully presented in device companies, sales training classes, CME programs, and Grand Rounds presentations worldwide. Furthermore, Josh Simon has effectively conveyed crucial business strategies to motivate product development and research professionals in both industry and academia.
Currently, Joshua is the Principal Consultant at Spiral Medical Development and an Adjunct Professor at the New Jersey Institute of Technology.
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
- Use this information in choosing a medical device profession
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
Requirements
- No prior knowledge of medical device development is required
Course Curriculum
- Design Controls Part 1: DHF, Proposal, DDP, Inputs, Outputs, Specifications (16:09)
- Design Controls Part 2: Design Verification (9:25)
- Design Controls Part 2: Design Validation (9:32)
- Design Controls Part 2: Design Transfer, Review, and Change (8:21)
- Design Controls Document Templates - PDF
- Design Controls Document Template - DDP
- Design Controls Document Template - DID
- Design Controls Document Template - DSD
- Quiz 3
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