Medical Device Development
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
- No prior knowledge of medical device development is required
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
Currently, I am Principal Consultant at Spiral Medical Development and an Adjunct Professor at the New Jersey Institute of Technology. For over 18 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.