Hardware Podcasts

S1E04 Designing for UAV fighter pilots | Bryant Foster

Being an Engineer · 6 May 2020 · 22m · Episode 4

What this episode covers

Bryant Foster, VP of Human Factors at Research Collective, explains how human factors engineering integrates psychology, design, and engineering to optimize product usability. He details his work with the US Army on UAV fighter pilots, using eye-tracking and biometric data to analyze sensor operator behavior and design realistic training simulations. Foster discusses the specific tools used in this field, such as Tobii glasses and galvanic skin response sensors, and clarifies the distinction between human factors scientists and UX designers. He also highlights the growing importance of human factors testing in FDA 510(k) submissions for medical devices to mitigate misuse risks.

Most relevant to

established companies

Topics

Mentioned

Companies
Research Collective, Google
Tools
Tobii
Also
FDA, Arizona State University

Related episodes from other shows

Other shows on the same ground, closest first.

  • Moore's Lobby · 48m

    Ep. 10 | NASA Astronaut Matthew Dominick on Critical Engineering in Aerospace Technology

    NASA astronaut and former Navy test pilot Matthew Dominick discusses the critical role of electrical engineering in aerospace, from the sensor fusion in F-35 fighter jets to the design of lunar landers. He highlights the importance of human-system integration, explaining how he acts as a 'translator' to ensure engineers remember the physical limitations of the human body inside the cockpit or spacesuit. Dominick also shares insights on the shift towards rapid prototyping in rocket manufacturing and the surprising complexity of designing reliable user interfaces, using toasters as a prime example of user-centric design.

    Industrial & consumer product designEmbedded firmware
    8 chapters

  • Global Medical Device Podcast · 36m

    Setting the Record Straight on Usability & Human Factors

    Mike Drues, a regulatory consultant for Vascular Sciences, joins host Jon Speer to clarify the distinction between usability and human factors in medical device development. They discuss how engineers often fail to test devices on actual end-users, leading to design flaws, and argue that FDA regulations are inconsistent, requiring extensive testing for simple devices while ignoring complex ones. The conversation emphasizes that usability testing should be risk-based, distinguishing between formative testing during development and summative testing after design freeze. Drues highlights the importance of realistic testing scenarios and warns against the 'tick-box' mentality that ignores off-label use risks.

    Medical & health devicesValidation & product-market fit
    8 chapters

  • Let's Combinate · 46m

    049 - "What Does the Data Say?" with Shannon Hoste

    Shannon Hoste, President of Agilis Consulting and former FDA reviewer, explains the regulatory framework for combination products, detailing the distinct roles of CDRH, CDER, and DMEPA in human factors reviews. She clarifies the critical distinction between design validation and human factors validation, emphasizing that the latter focuses specifically on safe and effective use rather than all user needs. Hoste also discusses the methodology for summative evaluations, including the rationale for the N=15 sample size per user group and strategies for recruiting representative participants to identify use errors.

    Medical & health devicesCertification & compliance
    8 chapters

  • Let's Combinate · 36m

    104 -New FDA Guidance, HF vs. Design Validation, Critical Tasks & Pre-IND HF Studies with Sara McNew

    Sara McNew, Chief Scientific Officer at Design Science, discusses the new FDA Guidance on Human Factors for Combination Products, clarifying the distinction between human factors validation and broader design validation. She explains that pre-IND studies must demonstrate that clinical trial participants can use the device correctly to ensure accurate pharmacokinetic data, requiring a hybrid of formative and summative rigor. McNew details how critical task definitions now include administration and dosing errors, not just serious harm, and emphasizes the importance of submitting comprehensive Use Related Risk Assessments (URRA) alongside HF summaries.

    Medical & health devicesCertification & compliance
    9 chapters

  • Let's Combinate · 1h 16m

    012 - "Asking then Seeing" with Sara Waxberg Mcnew

    Sara Waxberg McNew, Chief Scientific Officer at Design Science, explains the human factors process for medical devices, emphasizing the distinction between formative studies and summative validation. She details how to interpret ANSI/AAMI HE75 and IEC 62366-1 standards, manage risk for combination products, and handle regulatory submissions with the FDA. The discussion covers specific challenges like testing rare patient populations, using surrogates, and conducting threshold analyses for generics.

    Medical & health devicesValidation & product-market fit
    12 chapters

The summary, chapters and topics are generated from the episode’s audio by this directory, not written by Being an Engineer. The episode itself belongs to its publisher.