Join Shannon at the 2017 PFS & Injectables Summit

Shannon will be leading a pre-conference workshop at the next PFS & Injectables Summit in San Diego. On Tuesday, September 26, Shannon will be leading Workshop B on Use-Related Risk Management - Develop a Safe & Usable Medical Device. For more information regarding the PFS & Injectables Summit, visit the event page at and registration is 20% off for being in Shannon's network.

PFS&Injectables Discount

Shannon Clark's latest Article has been published!

Executive Summary: Human Factors is now becoming one of the most critical stages in the design process for medical devices. This is in part due to the FDA’s increased enforcement of Human Factors, as well as the industry’s realization that Human Factors can dramatically affect the success of a product. Introducing Human Factors early in the design process allows for usability testing with iterative prototyping, allowing bad designs to fail sooner, rather than later. Usability testing will also better prepare the product for submission to the FDA, answering any questions the FDA may have regarding safety and efficacy of the device with respect to usability.

For more information on Human Factors, the FDA’s approach to Human Factors, and how Usability testing can increase the success of a medical device, read Shannon Clark’s article in the latest WSGR Life Sciences Report.

Informing the Next Generation of Engineers

Shannon Clark’s recent talk at Santa Clara University informed prospective engineers on the importance of human factors and usability testing. Professor Gerardo Noriega’s classroom included the next generation of Santa Clara University bioengineers, as well as a handful of local startups. The audience was lead through how early implementation of human factors in the design process can reduce potential risk and cost through the product’s lifecycle.

Out-of-the-Box Medical Device Safety

Executive Summary: Out-of-the-box experience is an important consideration in medical device design that not only impacts the user’s impression of the product, but can also have critical safety implications. This article discusses the basic safety questions to contemplate in a use-related risk analysis pertaining to the out-of-the-box experience, and focuses on how the most critical safety risks can be reduced or eliminated by conducting a usability study related to the out-of-the-box experience.

Read the full paper here!

Cognitive Bias in Usability Testing

Executive Summary: Cognitive bias is the tendency to subconsciously change ones actions or thought process based on someone else’s comments or behavior. It is important to consider cognitive bias when performing a usability study because it can significantly alter or impair the validity of the results. While cognitive bias cannot always be entirely eliminated, identifying key cognitive biases to which usability study results are particularly susceptible is the first step to mitigating them. Once experimenters are alert to these subtle traps, they can consider approaches that sidestep the biases and greatly improve the accuracy and overall effectiveness of a usability study.

Read the Full Paper:

Prescient Surgical Announces de Novo clearance for the CleanCision Wound Retraction and Protection System!

UserWise conducted use-risk analysis and usability testing for the CleanCision product, along with authoring their Human Factors submission.

Shockwave Medical Announces FDA Clearance Of The Company's Lithoplasty System, The First And Only Technology To Use Sound Waves To Treat Calcified Peripheral Artery Disease

UserWise assists clients in following the FDA-prescribed Human Factors process in its entirety. Once the product is ready for FDA submission, we compile a Human Factors Submission Package that meets FDA expectations to the letter.  Our goal is always to have zero questions from the FDA about Human Factors, which signifies an expedient review cycle.

Shockwave Medical is a great example of one of our very successful 510(k)s!

Shockwave Medical Announces FDA Clearance Of The Company's Lithoplasty System, The First And Only Technology To Use Sound Waves To Treat Calcified Peripheral Artery Disease

Training Decay - Is an Hour Long Enough?

Training Decay Selection for Usability Validation

Executive Summary

When conducting usability validation testing, representative users must use the device in the expected conditions of use in the field. There is usually a period of time—days or weeks—between the point in time a user is trained, and the moment they use the device for the first time. For this reason, the FDA acknowledges the need for “training decay” as part of usability validation testing, but manufacturers face challenges simulating real-time decays. In response to challenges associated with lags of days or weeks between training and usability validation testing, medical device manufacturers typically simulate shortened training decay periods. This paper discusses the theory behind the shapes of various training decay curves and the variables that drive differences between training decay curves.  The author proposes to use a task-based approach for defining training decay curves in usability validation studies and sets out generalized training decay curves at a high level. Future research could reveal detailed and generalizable training decay curves. Identifying generalizable training decay curves could standardize the usability testing required for medical devices, and ultimately improve use error identification while avoiding an undue toll on manufacturer resources.

Full Published Paper:

Human Factors Talk at MedTech Frontiers

MedTech Frontiers had their largest turnout yet when Shannon Clark spoke about Human Factors. See the full presentation at the following link!


February 3, 2016 was an important date in the history of medical device usability. On this day, the FDA issued the guidance, “Applying Human Factors and Usability Engineering to Medical Devices,” which emphasized the importance of designing usable medical devices. The guidance outlines the FDA’s recommended process for developing usable medical devices.

Shannon Clark’s talk will describe what “Human Factors” means to the FDA, why Human Factors has become such a popular topic in the field of medical device development, and what usability engineering process needs to be followed when developing new medical devices. Shannon will share her experience conducting usability testing for medical devices, and she will discuss how to identify and assess use-related risks for medical devices

Bringing Legacy Medical Devices into Usability Compliance

Bringing Legacy Medical Devices into Usability Compliance

Need to know the process of bringing a device into usability compliance even if it is currently on the market and did not originally follow the usability engineering process? Then take a look at this presentation.


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