Effective Training and Strategy
Planning for HF Submissions and Interactions with FDA.

We provide training and help you plan strategies for HF
undertakings that would be accepted by the FDA

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A Pioneer in Premarket Human Factors
Review Process

From the originator of the FDA premarket human factors review process, HFF is your best source for Human Factors that works for medical devices available.

HFF is Ronald Kaye, President, Chief Scientist, Instructor, Receptionist, and Sole Proprietor. My friends call me “Ron”

Professional Background & Experience

At FDA:

FDA Center for Devices and Radiological Health (CDRH), from June 1996 – July 2015. Center Human Factors Engineering “expert” in CDRH

  • Designed and developed the HF premarket review process for medical devices, was Team Leader of the human factors premarket review team (HFPMET)
  • Reviewed HF content of over 1,000 new device/combination product submissions
  • Lead author of the first (2000) human factors guidance at FDA: Medical Device Use-Safety: Incorporating Human Factors Engineering into Risk Management
  • Lead author of the replacement guidance (2016) FDA/CDRH human factors guidance document as well as the premarket review process described in its content*.
  • Participated as an unpaid lecturer in a dozen (or more) AAMI 3-day human factors courses as the sole FDA representative, authoring and presenting the portion of the course that explained the FDA HF review process, perspective, priority, and identified the data to support it.
  • I have reviewed multiple post-market issues involving possible or actual use-error and UI design problems.
  • Trained (a few, time permitting) FDA inspectors on human factors engineering for medical devices.
  • FDA/CDRH representative on AAMI and ISO/IEC Standards writing committees, contributing to AAMI/ANSI Human Factors in the Design of Medical Devices (HE75:2009) as well as the IEC 62366-1,2: 2015.

*The 2016 guidance was released in final form just after I retired. It should be noted that all references regarding a threshold level of “less than Serious risk level” contained in the Guidance was pushed into it by non-human factors personnel at the Agency who believed this threshold for application of HFE to medical devices would result in less burden on industry.

Unfortunately and predictably, the effect has been increased confusion, time and effort for both industry and human factors review at FDA because "risk level-based" determinations of use-safety and effectiveness are absurd and invalid. When present in a medical device, UI design problems do not simply impact individual users for a single use error; they impact all future uses by user populations with an ongoing potential of user error resulting in compromised medical treatment, injury or death. Risk estimates do not represent scientific data or "best practice." Use-related risk and use-safety can only be accurately derived from HF test data that allows the presence, absence, or control of UI design problems to be described.

Training and Workshops on Human Factors for Medical Devices / Combination Products

  • UPCOMING TRAINING May 10-14, 2021 "Elevated Human Factors" https://www.eventbrite.co.uk/e/elevated-human-factors-tickets-144217377057
  • Europe and USA: Workshops on human factors engineering for medical devices and interactions with the FDA regarding this subject.
  • In-house presentations to client facilities on this topic.
  • Instruction is increasingly focused on use-related risk assessments, essential elements and processes of HF validation testing, and compliance strategies regarding IEC-62366

Recent Public Presentations

International Symposium on Human Factors and Ergonomics in Healthcare

Virtual Conference: May 18-21, 2020

Common Shortcomings in New Device and Combination Product Submissions to FDA.

Human Factors and Ergonomics Society (HFES) and International Ergonomics Association (IEA) Medical Devices: US and UK Perspectives, May 18, 2020. Understanding the secrets of human factors at FDA

What HFF can do for you

I’ll tell you everything I know about human factors for medical devices, testing, reporting, FDA, etc.:

In house training on HF, discussion and Q/A on human factors and medical devices consistent with HF review at the Center for Devices and Radiological Health (CDRH) and the Center for Drug Evaluation Research (CDER).

This will take a solid day or three days with practical exercises, critique, and feedback. Contact my scheduling department.

How to do human factors right the first time:

Planning and strategy for applying HFE evaluation, design, and testing to new, existing, or modified medical devices or combination products.

How to initiate discussion and respond to FDA:

Planning and strategy and development of effective and efficient HF evaluation, testing, and response to FDA HF review “deficiencies” and “requests for additional information” that will be acceptable to the FDA. Prepare HF materials (protocols, questions) for pre-submission, e.g., “Type C” meetings.

“No human factors needed?”:

Analyses to determine when HF validation (Summative) testing is required by the FDA for any situation involving medical devices.

TA-URRA:

State of the art Development and instruction for the most effective and efficient user task analysis-based process for evaluation of use-related risk for HF validation testing “TA-URRA.”

Human Factors Formative and HF Validation (Summative) test services:

HFF does not provide testing, but rather assists with clients’ current test provider to design the most efficient and effective human factors test approaches.

HFF is establishing a network of capable human factors test providers for the recommendation.