Bridging User Needs & Design Requirements

FREE ON-DEMAND WEBINAR

Bridging User Needs & Design Requirements: Answers Are Only As Good As The Questions We Ask!

We did the surgery perfectly, yet the patient died anyway… we designed the medical device perfectly, yet the patient died anyway… we followed the regulation perfectly, yet the patient died anyway.

All are iterations on the same theme, i.e., all have the same root cause: answers are only as good as the questions we ask!

Or put another way: what good is designing the right medical device if we are solving the wrong problem?

Is regulatory and quality simply about making sure your design inputs match your user needs, i.e., ticking the boxes? What if your user needs are wrong? Do we need regulation to require us to make sure we are solving the right problems? asking the right questions?

Regulation is all about the interpretation of words and your ability to defend your interpretation.

Watch the webinar

Using the case study approach, participant will specifically learn:

What is a design input and how do we make sure we have the right ones?
What's the relationship between design inputs and user needs?
How do we turn “user inputs” into a viable product and more importantly the right product!
How do we “translate” user needs to design requirements? Can regs helps?
How to read between the lines of user feedback, i.e., wants vs. needs?
How do we sync design requirements and user needs?
What are the challenges for the future?

In other words, answers are only as good as the questions we ask! i.e., what good is getting the “right” answer if we’re asking the wrong question? In this free 90 minute presentation by Michael Drues, Ph.D., participants will learn best practices to avoid timely and costly mistakes and creative ways to use the regulation to their advantage!

Who Should Attend?

Medical Device Executives
Regulatory Affairs Professionals and Management
Quality Professionals and Management
Clinical Affairs Professionals and Management
R&D Engineers and Management

Hosted by

Presenter: Mike Drues

President, Vascular Sciences

Moderator: Jon Speer

Founder & VP QA/RA, Greenlight Guru

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About Vascular Sciences

Vascular Sciences has been conducting seminars specifically geared toward medical device design, development and testing since 1996. These seminars have been requested by companies ranging in size from start-up to fortune 100 companies, the European Patent Office and the FDA Centers for Devices and Radiological Health (CDRH). Visit their website tolearn more.

About Greenlight Guru

Greenlight Guru is the only Medical Device Success Platform (MDSP) for companies to bring new products to market faster while simplifying regulatory compliance and reducing risk. Being the only industry specific, cloud-based software, Greenlight Guru is easier to implement, easier to use and designed to fit all medical device needs to enable innovative, safe and effective, True Quality medical devices. Visit our homepage to learn more.

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