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HFE and Cybersecurity Experts Lunch and Learn- Concord, MA


Description

Meet our UL HFE and Cybersecurity experts over a lunch and learn program happening at our local HFE facility in Concord, MA. You can choose to attend either of the topics or both.

The session on HFE will be from 10:30 AM to 12 Noon followed by lunch. The Cybersecurity session will be from 12:45 PM to 2:15 PM. Lunch will be provided.

 

HFE: 

UL’s Michael Wiklund (General Manager – Human Factors Engineering) will share his team’s latest insights about meeting regulators’ expectations regarding the application of human factors engineering during medical product development efforts. His presentation will be relevant to companies developing medical devices, combination products, and in vitro diagnostic devices. Mr. Wiklund will initially address the following topics that can cause considerable debate, if not consternation, among developers:

  • How to apply HFE retrospectively to products that have evolved over years or even decades (i.e., building an HFE design history file for a largely pre-existing device).
  • Selecting a summative usability test participant sample when a product’s users vary widely in terms of age, occupation, where they will operate the device (e.g., clinical versus non-clinical settings), whether or not they are formally trained to use the device, whether or not they have prior experience using similar devices, and whether they have specific impairments, to name just a few user population variables.
  • Deciding a product is ready for submission even though a summative usability test revealed continuing interaction problems (e.g., use errors, close calls, difficulties).
  • Determining the appropriate intensity with which HFE should be applied to devices fitting categories that appear – versus do not appear – on FDA’s list of high priority devices that will garner more intense HFE review.
  • Dealing with what can be called the “generic device conundrum,” whereby a developer might plan to produce a device identical to the predicate going off-patent, but also see opportunity to improve the generic device’s user interface to enhance safe and effective use.

Following the presentation, Mr. Wiklund will conduct a Q&A session during which attendees can seek general guidance or specific advice pertaining to applying HFE to medical products. Discussion topics could be related to conducting user research, performing a comprehensive use-related risk analysis, developing user interface specifications, designing user interfaces that promise excellent user experiences, conducting formative and summative usability tests, and producing complete HFE documents including the HFE Report that FDA expects to be included in submissions associated with high-risk products.

Cybersecurity:

In our presentation, we discuss various aspects of medical device cybersecurity. This is particularly important for manufacturers preparing to submit new network-connected devices and software via the FDA 510(k) submission process. We will also provide an overview of security design considerations recommended by the FDA Guidance as well as key processes assuring security risks are managed for products currently in the market.

 

Objectives

What you will learn:

  • Learn various aspects of medical device cybersecurity
  • Understand security design considerations recommended by the FDA Guidance
  • Discover key processes assuring security risks are managed for products currently in the market
  • Understand testing strategies that support your product security claims
  • See how the standards correspond to FDA guidance

Target Audience

    • Medical software developers
    • Medical device product developers
    • Compliance and Regulatory professionals
    • Technical marketing professionals
    • Human Factors Engineers
    • Quality Managers

Speakers

Michael Wiklund

Michael Wiklund serves as General Manager of the human factors engineering (HFE) practice at UL (Underwriters Laboratories). Previously, he founded Wiklund Research & Design, a human factors consulting firm that UL acquired in 2012. He has 30+ years of experience in human factors engineering, much of which has focused on medical technology development—optimizing hardware and software user interfaces as well as user documentation. He is a Certified Human Factors Specialist and Licensed Professional Engineer. He is author, co-author, or editor of several books on human factors, including Usability Testing of Medical Devices, Handbook of Human Factors in Medical Device Design, and Medical Device Use Error – Root Cause Analysis. He is one of the primary authors of today's most pertinent standards and guidelines on human factors engineering of medical devices: AAMI HE75 and IEC 62366. In addition to leading UL's human factors engineering practice that now includes over 50 HFE and user interface design specialists, he is a Professor of the Practice at Tufts University where he teaches graduate courses on HFE, including applying HFE in medical technology development.

Justin Heyl, Cybersecurity Director Business Development, Innovations & Strategic Partnerships UL LLC 

Justin is responsible for the management of UL LLC’s suite of services to support global regulatory approvals for medical device companies. He is a cybersecurity panelist with the FDA, a participant with the VA/UL CRADA for cybersecurity and developing requirements and solutions for several major hospitals and procurement groups in US, EU and APAC. He is a member of the MDS2 committee, AAMI, AdvaMed, FDA Pre-cert workshop and public comment. He joined UL as the Global Account Director responsible for Boston Scientific, Medtronic, St. Jude and supporting the global accounts team with medical related compliance services. Prior to joining UL, he was the program manager for Intertek’ s consulting services, worked as an orthopedic sales representative for Primary Surgical and a mechanical engineer for Crane Engineering and Forensic Services. He has partnered with medical device companies throughout the product development cycle and certification to expedite market access on a global scale. He has successfully managed projects and international submissions with start-ups, VC backed companies as well as many of the top 10 medical companies in the world.  Justin holds a Bachelor of Science degree in Mechanical Engineering from the University of Minnesota and has over twenty-two years of industry experience focusing on medical regulatory solutions and business development with medical companies.


 

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Media

Time Requirement

Cost

Instructor-Led

The session on HFE will be from 10:30 AM to 12 Noon followed by lunch and the Cybersecurity session will be from 12:45 PM to 2:15 PM.

$35 for one session, $50 for both sessions

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