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Integration of Human Factors into Medical Device Design: FDA and European Commission

By:
Virginia A Lang,
PhD, President & Chief Scientist, HirLan, Inc. and HirLan International SA
David M. Hirning, M.S,
Principal & VP of Product/Business Development at HirLan, Inc.
Coming soon.. Please contact customer care for new schedule

Course Description:

The FDA and the European Commission have both issued several guidances and standards over the past 5 years with respect to the role of Human Factors in Medical Device design, evaluation and approval. These include:

  • ANSI/AAMI HE75: 2009(R) 2013
  • IEC 62366-1:2015
  • Draft Guidance for Industry and Food and Drug Administration Staff - Applying Human Factors and Usability Engineering to Optimize Medical Device Design (June 22, 2011)
  • Design Considerations for Devices Intended for Home Use, Guidance for Industry and Food and Drug Administration Staff (November 24, 2014)
  • Draft Guidance for Human Factors and Combination Products (In progress by the FDA)

Although the two organizations are coming closer and closer together on the role of Human Factors in the Medical Device industry, the implementations can be somewhat different. There are ways to leverage the implementation of Human Factors into the device design, development and validation to accommodate both approving bodies.

At the same time Medical Device companies have come to approach Human Factors as just another ‘hoop’ to go through to gain approval of their devices. In fact, they see it as a ‘barrier’ to getting a device to market quickly and inexpensively. Indeed, the way most Medical Device companies are approaching Human Factors, it does add time and cost a significant amount of money. This course will show that when implemented correctly, in fact, Human Factors can actually save time and money and therefore increase the profitability of a medical device.

Seminar Fee Includes:

Lunch
AM-PM Tea/Coffee
Seminar Material
USB with seminar presentation
Hard copy of presentation
Attendance Certificate
$100 Gift Cert for next seminar

The benefits of this course include the following:

  • Show you how Human Factors can actually decrease development time and overall product development costs.
  • Show how to plan and execute strategic Human Factors testing cycles.
  • Provide a thorough understanding of the requirements of the FDA and the European Commission (CE mark)
  • Provide a thorough understanding of the how Human Factors can present data for lowering use risk by design early in the design cycle.
  • Provide a thorough understanding of the role of user Training and associated documentation (e.g., Information for Use, Labeling, etc.
  • Provide a thorough understanding of the usability design file.


Learning Objectives:

You will:

  • Learn what encompasses Human Factors/Usability
  • Learn which Human Factors Standards and Regulations apply to your products
  • Learn how to create and implement Factors into your product development cycle
  • Learn the relationship between Human Factors and Risk Management
  • Learn how to create a Human Factors Standard Operating Procedure (SOP)
  • Learn what comprises a Human Factors/Usability Design History File
  • Learn how to define a Human Factors Testing Strategy
  • Learn how to define and integrating Users, User Needs and User Requirements into the Product development Life Cycle
  • Learn how to organize Human Factors Testing
  • Learn how to analyze the results of Human Factors Testing and their relationship to Risk Management


Areas Covered:

  • Defining Human Factors, Ergonomics, and Usability
  • ANSI/AAMI HE75: 2009(R) 2013
  • IEC 62366-1:2015
  • Draft Guidance for Industry and Food and Drug Administration Staff - Applying Human Factors and Usability Engineering to Optimize Medical Device Design (June 22, 2011)
  • Design Considerations for Devices Intended for Home Use, Guidance for Industry and Food and Drug Administration Staff (November 24, 2014)
  • Draft Guidance for Human Factors and Combination Products (TBD for release from the FDA)
  • Human Factors Formative Testing
  • Human Factors Summative Testing
  • Information for Use (IFU)/ Labelling
  • User Training
  • Creating and Maintaining a Usability History File
  • Using Human Factors to Design Medical Devices, not just evaluate.


Who will Benefit:

  • Regulatory
  • Compliance
  • Product Managers
  • Project Managers
  • Quality Assurance
  • Device Design Engineers




Course Outline:

DAY ONE (8:30 AM – 4:30 PM) DAY TWO (8:30 AM – 4:30 PM)

Registration Process: 8:30 AM

8:30-8:45 Meet/Greet/Introductions

  • 8.45 am – 10.15 am: Human Factors and Medical Devices: Setting the Stage
    • Definitions of Common Terms
    • How Human Factors Became a Requirement for the Medical Device Industry
    • Overview of the Medical Device Standards and Requirements for the FDA and CE Mark
  • 10.15 am – 10.30 am: Break
  • 10.30 am – 12.00 pm: Human Factors and Risk Management
    • What is an uFMEA?
    • The role of Human Factors and the uFMEA
    • The Human Factors Activities and Documents that contribute to the uFMEA
    • Draft Guidance for Industry and Food and Drug Administration Staff - Applying Human Factors and Usability Engineering to Optimize Medical Device Design (June 22, 2011)
  • 12.00 pm – 1.00 pm: Lunch
  • 1.00 pm – 2.45 pm: Human Factors and Device Design
    • The role of Human Factors in Device Design
    • The Human Factors Activities and Documents that contribute to Device Design
    • ANSI/AAMI HE75: 2009(R) 2013
    • Design Considerations for Devices Intended for Home Use, Guidance for Industry and Food and Drug Administration Staff (November 24, 2014)
  • 2.45 pm – 3.00 pm: Break
  • 3.00 pm - 4.30 pm: Human Factors Standard Operating Procedure (SOP)
    • The Usability Design File?
    • IEC 62366-1:2015
    • Creating and Integrating a Human Factors SOP
    • The key Human Factors documents in the SOP
      • The Application Specification
      • The Task Analysis
      • The Human Factors Plan
      • The Human Factors Testing Strategy
      • The Human Factors Summary Report
  • 8.30 am – 8.45 am: Meet & Greet
  • 8.45 am – 10.15 am: Defining the Key Components for Testing
    • Who Will Conduct the Testing?
    • Define Participant Criteria
    • Collect the Necessary Documents
  • 10.15 am – 10.30 am: Break
  • 10.30 am – 12.00 pm: Human Factors Formative Testing
    • Define the Goals and Methodology
    • Define the User Groups
    • Collect the Necessary Testing Components
    • Analyze the Results
  • 12.00 pm – 1.00 pm: Lunch
  • 1.00 pm – 2.45 pm: Human Factors Summative Testing
    • Define the User Groups
    • Collect the Key Documents:
      • uFMEA,
      • Application Specification
      • Task Analysis
      • Product Description
      • Define Use Scenarios
  • 2.45 pm – 3.00 pm: Break
  • 3.00 pm – 4.30 pm: Human Factors Summative Testing
    • Collect the Data
    • Analyze the Results
    • Create the Human Factors Summary Report




Meet Your Instructor

Virginia A. Lang
PhD, President & Chief Scientist, HirLan, Inc. and HirLan International SA

Virginia started in the medical research field as a Coordinator of Research at the Clinical Research Unit Kennedy Institute of Johns Hopkins Medical Center. She was responsible for the initiation, coordination, and management and/or analysis of research projects in the Clinical Research Unit. These projects were funded by various Federal Government Agencies. Subsequent to Johns Hopkins Medical Center, Virginia entered the field of Human Factors through the doctoral program at SUNY Binghamton. Virginia held a fellowship at the Aeromedical Research Laboratory of the United States Air Force at Wright-Patterson AFB, Dayton, Ohio and a fellowship at NASA. Her research dealt with cognitive factors that differentially affect the characteristics of visual displays. Applications of this research are directly related to various medical devices and software applications providing Medical Device Human Factors by HirLan clients with 30 years of Human Factors experience.

In addition, Virginia has extensive experience in the areas of product design, Customer Centered Participatory Design processes, and product lifecycle management. She is also known in the Human Computer Interaction and Usability Communities for her innovative techniques for collecting and incorporating user/customer feedback throughout the product lifecycle. In July 2014, Virginia founded and established the HirLan Institute of Human Factors with labs in Carlsbad, California and a Consortium arrangement in London, UK. In February 2013, Virginia founded HirLan International SA, a Geneva, Switzerland based company. Both HirLan and HirLan International have been supporting Top Ten pharma/medical device companies, as well as, start-ups with consulting and testing services. These services are in conjunction with their clients’ FDA 510(k) and CE mark applications.

Virginia holds a PhD in Cognitive-Experimental Psychology from SUNY Binghamton, and a Master of Science (ABT) in Applied Technology, Systems Science from SUNY Binghamton.


David M. Hirning, M.S
Principal and VP of Product/Business Development at HirLan, Inc.

David Hirning is a Principal and VP of Product/Business Development at HirLan, Inc. David has over 25 years of experience in Product and Business Development. David has held management and lead consultant positions at University of Southern California, University California Riverside, Guidance Software, HP, RemoteNet, and Symantec. David’s experience provides the clients of HirLan, Inc. the necessary tools to create and enhance products and make business process changes for enhanced business returns.

David has vast international experience in Customer Centered Excellence, in all phases of product development from concept through launch; as well as developing/presenting seminars and training. In addition, David worked and trained consultants and deployment engineers worldwide in his tenure at Hewlett-Packard and experience with HP OpenView Solution Deployment.

He holds a Master of Science in Computer Science degree with multiple emphases in software engineering, data communications, and client server technology.






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