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Developing a Human Factors Validation Plan with Consideration for the Digital Health Marketplace
June 5, 2019
Developing a Human Factors Validation Plan with Consideration for the Digital Health Marketplace

This workshop will provide an overview of human factors validation strategies that companies should consider as the pre-filled syringe market increasingly takes on digital health components. A case study of a pre-filled syringe with connection to a mobile app will be utilized throughout the course to demonstrate the concepts under discussion and help participants work through a study plan. The workshop aims to generate discussion around challenges, lessons learned, and future directions for human factors considerations regarding similar products

Workshop LEADER

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Natalie Abts

Head of Human Factors Engineering, Genentech

Natalie Abts is the Head of Human Factors Engineering at Genentech, where she manages the team that conducts all human factors activities for Genentech’s drug delivery devices. Prior to joining Genentech, Natalie worked in medical device consulting for seven years with the National Center for Human Factors in Healthcare. Natalie has specialized experience in planning and executing both formative stage usability evaluations and validation studies for medical devices and combination products on the FDA approval pathway. Natalie holds a master’s degree in industrial engineering with a focus on human factors and ergonomics from the University of Wisconsin, where she was mentored by Dr. Ben-Tzion Karsh.

Workshop agenda

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13:00

Registration & Coffee

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13:30

Opening Remarks and Introductions

Rita Lin, Human Factors, Biomedical Engineer, FDA Center for Devices and Radiological Health

Natalie Abts, Head of Human Factors Engineering, Genentech

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13:40

Overview of Human Factors Guidance Documents

  • Review FDA human factors guidance Applying Human Factors and Usability Engineering to Medical Devices
  • Review Xcertia mHealth App Guidelines and discuss relevance to pre-filled syringe industry
  • Discuss current directions and challenges with pre-filled syringes from regulatory and industry perspectives
     
  • Rita Lin, Human Factors, Biomedical Engineer, FDA Center for Devices and Radiological Health

  • Review FDA human factors guidance Applying Human Factors and Usability Engineering to Medical Devices
  • Review Xcertia mHealth App Guidelines and discuss relevance to pre-filled syringe industry
  • Discuss current directions and challenges with pre-filled syringes from regulatory and industry perspectives
     
  • Natalie Abts, Head of Human Factors Engineering, Genentech

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    14:20

    Case Study Introduction

  • Case study product overview – testing a pre-filled syringe utilizing Bluetooth to communicate with an accompanying app
  • Discussion of risk analysis and risk considerations for this type of product
  • Preliminary discussion and review of product documentation
     
  • Rita Lin, Human Factors, Biomedical Engineer, FDA Center for Devices and Radiological Health

    Natalie Abts, Head of Human Factors Engineering, Genentech

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    15:00

    Afternoon Tea

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    15:30

    Validation Study Planning

  • Discuss key components of a good validation study design
  • FDA perspective on common problems with validation plans
  • Industry perspective on problem-solving for difficult-to-test products
  • Rita Lin, Human Factors, Biomedical Engineer, FDA Center for Devices and Radiological Health

  • Discuss key components of a good validation study design
  • FDA perspective on common problems with validation plans
  • Industry perspective on problem-solving for difficult-to-test products
  • Natalie Abts, Head of Human Factors Engineering, Genentech

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    16:10

    Creating a Study Plan

  • Work time to create a validation study plan for the device introduced during Session 2
  • Team report out of study plans
  • Discussion of lessons learned from the exercise
  • Rita Lin, Human Factors, Biomedical Engineer, FDA Center for Devices and Radiological Health

    Natalie Abts, Head of Human Factors Engineering, Genentech

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    16:50

    Closing Remarks from Workshop Leaders and End of Workshop

    Rita Lin, Human Factors, Biomedical Engineer, FDA Center for Devices and Radiological Health

    Natalie Abts, Head of Human Factors Engineering, Genentech

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