Medical Human Factors

START to End FDA
Human Factors Support

Applying human factors / usability engineering methods during medical device design and development ensures the development of a safe, usable and useful product that users will want to purchase and use. We know the FDA Human Factors guidance and IEC 62366 can seem overwhelming, but we have experience helping a wide variety of medical device teams successfully prepare for their submission.

We are ready to help with the following medical human factor products:

  • Medical Devices
  • Drug/Biologic
  • Combination

From formative research to use error risk analysis to HF validation testing – we’ll be with you every step of the way!

Our Experience:  Surgical Hand Pieces  +  Electrosurgical Generators  +  Infusion Pumps   +  Spinal Implants  +  Patient & Consumer Wearables  +  Patient Monitors  +  Blood Pressure Devices  +  Nurse Call Systems Digital Diagnostic Aids  +  Lab Sample Analyzers  +  Dialysis Clinic Monitors  +  Mobile Healthcare Apps  +  More!

HF Process & Design Assessment
This is the place to start.

Check your progress towards FDA & 62366 Human Factors submission readiness with a HF gap analysis and save money by discovering sooner rather than later if the device design leads to use error.

At the end of this engagement you'll receive the following:

» Gap Analysis Results
» Human Factors Plan (a 62366 requirement)
» Human Factors Activities Road Map to submission
» Heuristic Evaluation Results including potential use errors and recommendations for improved product design usability
Start-to-Finish HF Services
Don't have ample in-house HF support?
No worries!

We'll integrate seamlessly with your product team to infuse improved usability + safety to your product design and establish an effective, fully-compliant HF process. Activities will be customized to fit your product's needs and may include:

» HF Plan & UI Test Plan Preparation
» VOC & Formative Usability Research
» Use Specification Preparation
» Task & PCA Analyses
» User Interface Design
» Use-Related Risk Analysis (e.g., uFMEA)
» HF Validation (Summative) Testing
» HFE Report / UE File Preparation
FDA Submission Readiness Evaluation
Looking ahead to submission?

This is a great option for those who have conducted their HF activities in-house or aren't certain if they are ready to submit.

Let us give you peace of mind and save time by reviewing the HF component of your submission BEFORE you submit. We'll systematically review your HF documents and ensure they clearly tell the story that your product is safe and effective for use. We have talked to and attended in-person trainings and presentations with the same FDA reviewers who will read your submissions. We understand what they need to see and how to organize a HF submission that has the best chance of being approved.
Human Factors
Training
Ready to take it to the next level?

We can give you the boost you need to conduct high-quality Human Factors activities in-house.

Our HF trainings are targeted at specific audiences such as Execs/Managers or non-HF'ers who have found themselves leading HF efforts. Trainings are packed with practical exercises and examples and come with at least one FREE proven document template to get you up and running quickly and ensure important details aren’t missed.
What our Clients Say
netflix
SKYE LEE
Netflix, Inc.
Sr. UX Manager

Shannon is an amazing usability and overall user experience consultant. She is extremely professional, detail oriented, and a great team player. Whether you are interested in qualitative or quantitative data, Shannon can gauge the project and your needs and make sure you obtain all the information you need along with a tactical way to move forward on making your product a success.

ebay
ELISSA DARNELL
ebay, inc.
Director of User Experience

It was a wonderful experience working with Shannon. She took on a challenging project for us with an uncertain outcome. Her research expertise resulted in a final product that far exceeded my expectations. The creativity and customer focus Shannon brought to my project was impressive! I look forward to working with her again.

The Florida Bar Association Logo
FRANCINE WALKER
The Florida Bar
COMMUNICATIONS DIRECTOR

Your comprehensive site review and professional analysis, usability testing, navigation card sort, and design style guide set our redesign efforts on a clear course that helped us improve site usability. The detailed reports are full of examples, explanations and visual aides that continue to be a valuable reference as we continue our efforts to improve The Florida Bar website. We are happy to serve as a reference and to recommend Sage Research & Design as an excellent resource for improving usability.

Tendril logo
TIM ENWALL
Tendril, Inc.
Founder, CEO, President & COO, CIO

I hired Shannon when I was with Access Graphics and again for Tendril Networks. We found Shannon’s input very helpful and appreciated that she found a way to work within our tight budget. You’ll see upon reviewing her credentials that it’d be pretty hard to find a more qualified and experienced user interface expert. I highly recommend Shannon.

userzoom
KIMBERLY OSLOB
Userzoom, Inc.
VP of UX Client Services

When a project comes up that requires UX consultancy work, Shannon is the first person I think of and will call. She is, without a doubt, an asset to any company and will help bring your design to the next level with her stellar research and design skills. I would highly recommend Shannon for any project that requires an excellent User Experience as a result.

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