Medical Product Development
Fee: $1,195
Instructor: Jason Williams
Who Should Attend:
This seminar provides attendees with a two-day overview of the plastic medical device design process. It is primarily focused an integrated new product development process beginning with product ideation and continuing through to production handoff. It is appropriate for product managers, engineers, marketing professionals, and management.
Course Description:
This seminar has been developed to provide participants with a basic understanding of the plastic medical device development process. It will teach students how products proceed from basic idea through production in the context of a regulated industry. Attendees will leave with an understanding of the regulatory environment and the overall integrated new product development process. This will be taught with a combination of lectures and group activities.
Seminar Outline:
- Introduction of Medical Plastics
- Overview of industry and products
- Overview of regulatory environment
- Review of regulations and standards
- FDA
- ISO
- Device levels and overview of submission processes (510k, PMA)
- Product development processes and Organizations
- Introducing the product development process
- Review of product development organizations
- Project and product selection
- Identifying customer needs
- Developing requirements documents and specifications
- Marketing Requirement Documents (MRD)
- Product Requirement Documents (PRD)
- Concepts
- Concept generation
- Industrial design
- Concept selection and testing
- Prototyping
- Product architecture
- Planning product structure
- Modular vs. Integrated
- Materials for medical plastic products
- Overview of medical plastic materials
- Requirements and material selection
- Detail Design
- Part and assembly considerations
- Design for manufacture
- Design history files
- Environmental considerations in plastic medical devices