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The Secrets to Uncovering and Addressing Design Flaws BEFORE Usability Testing
June 5, 2019
The Secrets to Uncovering and Addressing Design Flaws BEFORE Usability Testing

 

Overview of the workshop:
Workshop attendees will learn
1. Principles of design that are key for developing medical products or selecting drug delivery devices for new drugs, and
2. Best practices for how to conduct an expert review to uncover design flaws even before entering into usability testing.
 

A review will be presented on numerous examples of Good vs. Bad Design and delegates will be trained on how to best select the drug delivery platform for a specific product as well as use principles of informal use error analysis, IEC 62366 PCA task analysis, and use-related risk analysis to uncover use errors that could negatively impact usability testing results and ultimate product success.
 

About the workshop leader
Shannon E. Clark is founder and CEO of UserWise, a consultancy that helps medical device manufacturers and start-ups to design safe and easy-to-use medical devices. The consultants at UserWise conduct usability testing for a variety of medical devices ranging from surgical robots to home-use injection platforms. UserWise consultants also perform safety assessments to comply with U.S. and international regulations related to Human Factors. Before founding UserWise in 2015, Shannon was a Human Factors Engineer at Intuitive Surgical and Abbott Laboratories. Shannon graduated from UCLA with a B.S. in Mechanical Engineering and a technical breadth in Technology Management. Shannon is additionally a Certified Processional Industrial Engineer, holds two patents, and has written and published three books.

Workshop LEADER

keynote-img

Shannon E. Clark

Principal, UserWise, Inc.

Shannon E. Clark is founder and CEO of UserWise, a consultancy that helps medical device manufacturers and start-ups to design safe and easy-to-use medical devices. The consultants at UserWise conduct usability testing for a variety of medical devices ranging from surgical robots to home-use injection platforms. UserWise consultants also perform safety assessments to comply with U.S. and international regulations related to Human Factors.

Before founding UserWise in 2015, Shannon was a Human Factors Engineer at Intuitive Surgical and Abbott Laboratories.

Shannon graduated from UCLA with a B.S. in Mechanical Engineering and a technical breadth in Technology Management. Shannon is additionally a Certified Processional Industrial Engineer, holds two patents, and has written and published three books.
 

UserWise, Inc.

UserWise is a team of Human Factors Engineers dedicated to designing best-in-class medical products, packaging, and labelling. With experience ranging from home-use injectables and diagnostics to robotic surgery platforms, our consultants successfully navigate medical device and combination product regulations via usability testing, use-related risk analysis, and compliance documentation.

Workshop agenda

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8:30

Registration & Coffee

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9:00

Opening Remarks and Introductions

Shannon E. Clark, Principal, UserWise, Inc.

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9:10

Principles of Design

Shannon E. Clark, Principal, UserWise, Inc.

  • What are the guiding principles of designing a new medical product or selecting a drug delivery device for your new drug?
  • How do I conduct an expert review to uncover design flaws even before entering into usability testing?

     

  •  

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    9:50

    Good vs. Bad Design

    Shannon E. Clark, Principal, UserWise, Inc.

  • Study numerous examples of Good vs. Bad Design and start training delegates to see the patterns of good vs. bad design
  • Review the principles of comparative expert reviews - How do I select the best drug delivery platform for my product?
  • Review the principles of informal use error analysis, IEC 62366 PCA task analysis, and use-related risk analysis to uncover use errors
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    10:30

    Morning Coffee

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    11:00

    Interactive Expert Reviews

    Shannon E. Clark, Principal, UserWise, Inc.

  • Delegates will be presented with different real-life medical product prototypes and concepts, and they'll be tasked with conducting an expert review
  • Discuss the principles of identifying whether the product is "optimized" and ready for testing

     

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    11:40

    Closing Remarks from Workshop Leader and End of Workshop

    Shannon E. Clark, Principal, UserWise, Inc.

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    WHAT IS CPD?

    CPD stands for Continuing Professional Development’. It is essentially a philosophy, which maintains that in order to be effective, learning should be organised and structured. The most common definition is:

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