About the session

How Rapid Prototypes Can Influence Feedback and Development Risk in Regulated Products

1) Requirements validation can be accomplished with rapid prototyping as design evolves; 2) The interaction user-prototype needs to be anticipated and well planned in order to obtain the most useful feedback; 3) The compliance records that impact both budget and schedule when requirements changes are discovered late in regulated products.

Early requirements validation is one of the most effective ways to prevent cascading compliance impact in regulated product development. Thus, avoiding the late changes ripple effect through verification, validation, documentation, and submission activities. Rapid prototyping is an excellent vehicle to validate requirements. However, the way prototypes are presented can unintentionally lead users to behave in a way that limit the quality of the feedback teams receive. In this presentation, I will share examples where rapid prototyping within focus groups produced unexpected user behaviors and the lessons I learned for guiding early requirements validation to reduce development risk.

What you will take away

• Use rapid prototypes to validate requirements while the design is still evolving.
• Plan the user-prototype interaction carefully so the prototype does not distort the feedback you receive.
• Understand how late requirement changes cascade into verification, validation, documentation, budget, and schedule.

About the speaker

About Marina

Marina Prasek, PMP, is Senior Director, Project & Portfolio Management at MaxCyte. She previously held product lifecycle management (PLM) leadership roles at Thermo Fisher Scientific, Mettler-Toledo AutoChem, and Smiths Detection. Marina holds a Laurea of Doctor in Chemistry and is an active member of the PMI community.