In this Design Input training will define design input, review robust requirements development, assess the impact of User needs Vs Patient needs and discuss options for timing your design reviews.
Did you know that a well-planned design input phase can save you time and money in your product development process? Or that engaging your customer-facing personnel (Marketing, Sales, Customer Service) in these early stages of planning can contribute to a more successful product in the marketplace?
In this beginner/intermediate seminar, we will define design input, review robust requirements development, assess the impact of User needs vs Patient needs and discuss options for timing your design reviews.
This seminar presumes a basic understanding of the Development Planning process.
Areas Covered in the seminar:
- The FDA guidelines for design input requirements
- Identifying User requirements vs Patient needs
- Why requirements are critical to defining the device you plan to develop and sell
- What constitutes a complete requirement
- How to refine ambiguous or conflicting requirements
- Gaining buy-in from customer-focused functions (marketing, sales, customer service)
- Compliant as well as functional documentation and review
- When to refine requirements during development and when not to
Who will benefit:
- Quality Assurance managers and personnel
- R&D managers & engineers
- Regulatory Affairs personnel
- Quality system auditors
- Marketing product managers
Instructor Profile
Michelle Sullivan, is a consultant with AlvaMed, LLC, an innovative medical technology consulting firm. She is a key contributor to AlvaMed’s Business Development and Product Development & Project Management practice, having over 14 years of experience in the medical device industry.
Michelle has developed and launched a variety of products and has managed multi-million dollar product lines to deliver exceptional product line growth year-to-year. She has experience in both product management and R&D, leveraging both disciplines to translate customer needs into actionable engineering requirements.
Her diverse career has provided her with experience in all phases of a design (from concept through commercialization) from engineering, project management and marketing viewpoints in the areas of vascular implants, catheter-based delivery systems, cosmetic surgery and in-vitro diagnostics.
