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# Sage Research + Design | Human Factors Engineering - Boulder, CO: Sage Research & Design provides human factors engineering, UX research, usability testing, risk analysis, and FDA-focused consulting for medical device companies seeking safer products and successful regulatory submissions.

## Sitemaps
[XML Sitemap](https://sage-research.com/sitemap_index.xml): Includes all crawlable and indexable pages.

## Posts
- [YOUR DEVICE IS SAFE. BUT IS IT SECURE?  THE IMPORTANCE OF SAFETY AND SECURITY RISK MANAGEMENT.](https://sage-research.com/your-device-is-safe-but-is-it-secure/): Great news! Your medical device product development team followed your safety risk management process to a tee - but did they ensure security risk management was considered in the proper context?
- [Making Sense of the Gaps: Bridging FDA Guidance and Real-World Complexity in OTC SaMD Self-Selection Testing](https://sage-research.com/making-sense-of-gaps-hfes2026/): An oral presentation given at the 2026 HFES International Symposium on Human Factors and Ergonomics in Health Care on Wednesday, March 25, 2026.
- [Crowd-Sourced Helpful Online Tools for the UX and Medical HF Spaces](https://sage-research.com/crowd-sourced-helpful-online-tools-for-the-ux-and-medical-hf-spaces/): It’s important to be equipped with the right tools for the job! Online tools are essential for different aspects of our work as User Experience and Human Factors practitioners.  We recently got together with members of our professional community and allowed everyone to share helpful online tools that they use for their jobs. Here’s a summary of the tools that people shared:
- [Proven Tips for the Human Factors Component of Your 510(k) or De Novo Submission](https://sage-research.com/proven-tips-for-the-human-factors-component-of-your-510k-or-de-novo-submission-2/): Submitting your medical device for approval from the FDA is an exhausting and emotional experience.  You’ve spent years caring for and nurturing your device to get it to this defining moment. As you wait for your response, the last thing you need or want is to be left wondering – did we do everything we needed to do?
- [Why the FDA Cares about Human Factors and So Should You](https://sage-research.com/why-the-fda-cares-about-human-factors-and-so-should-you/): Human Factors is an integral part of our everyday! Every time a product, process or system is engineered with the goal of being more efficient for the humans that use it, that’s Human Factors at work. Ultimately, the purpose of Human Factors (HF) is to apply what we know about the strengths and weaknesses of being human to improve the quality of interaction between people and products. Increased quality in this case means reduced human error, increased productivity and increased safety and comfort.
- [The Importance of Human Factors:  A Clinician’s Perspective –   Part 3 of 3](https://sage-research.com/the-importance-of-human-factors-a-clinicians-perspective-part-3-of-3-the-second-victims-of-medical-errors-clinicians/): In this three-part blog series, Sr. UX/HF Consultant, Agatha Kalinchenko, MD will discuss the importance of Human Factors from a clinician's perspective:
- [The Importance of Human Factors:  A Clinician’s Perspective –   Part 2 of 3](https://sage-research.com/the-importance-of-human-factors-a-clinicians-perspective-part-2-of-3/): In this three-part blog series, Sr. UX/HF Consultant, Agatha Kalinchenko, MD will discuss the importance of Human Factors from a clinician's perspective:
- [THE IMPORTANCE OF HUMAN FACTORS:  A CLINICIAN’S PERSPECTIVE –   PART 1 OF 3](https://sage-research.com/importance-of-human-factors-for-clinicians/): In this three-part blog series, Sr. UX/HF Consultant, Agatha Kalinchenko, MD will discuss the importance of Human Factors from a clinician's perspective:
- [Human-Centered Design at BCH Foothills Hospital](https://sage-research.com/human-centered-design-at-bch-foothills-hospital/): It’s no wonder my chosen profession is as a user experience consultant specializing in healthcare.   In order to help our clients create products and processes used in hospitals, it’s imperative we have a rich understanding of the hospital environment and user groups.  It may be surprising to some, but the user groups (the people who interact with the products or processes we touch) in a hospital environment are widespread and can include clinical staff, other healthcare workers, patients and even family members and caregivers.  As such, we’re always eager to talk to healthcare users and learn everything we can about the unique demands of the hospital use environment.  So, when we were recently offered a tour of the Boulder Community Health Foothills Hospital, our team jumped at the chance.
- [Heuristic Evaluation of Healthcare Technology](https://sage-research.com/heuristic-evaluation-of-healthcare-technology-3/): In this first PEP (Practical Exercises for UX/HF Practitioners) talk, our Sage President and Sr. UX/HF Consultant, Shannon Halgren, PhD taught our Medical Technology UX/HF Meetup group how to conduct a Heuristic Evaluation of Medical Technology.   See our PEP Talk Introduction post which describes the PEP Talk format and our Medical Technology UX/HF meetup.   We hope you can come join us at our next meeting!
- [PEP Talk Series Introduction](https://sage-research.com/pep-talk-series-introduction/): In 2014, we started the Medical Technology UX/HF Meetup to connect with other UX|HF professionals in the Boulder/Denver area working in healthcare.  As anyone who works in this field knows, there is no shortage of interesting and juicy challenges for UX / HF practitioners.  The goal of our meetup was to form a group of experts who could share resources, experiences and mentor the next generation into this vital profession.    A mere 5 years later, we've met over 35 times and have grown to over 350 members, and made countless new friends!
- [Combining Qual and Quant UX Research Methods](https://sage-research.com/combining-qual-and-quant-ux-research-methods/): It’s easy to find helpful blogs, tutorials, and books on UX research methods.  If you want to learn how to conduct a solid usability study or card sort study, there are some great references out there.

## Pages
- [Homepage- 2026 Preview Copy](https://sage-research.com/homepage-2026-preview-copy/): Maintain compliance and improve device safety and effectiveness by identifying and mitigating risks before they reach the field.
- [Homepage- June 2026](https://sage-research.com/): Let us be your experienced guide.
- [Medical Device Risk Management](https://sage-research.com/medical-device-risk-management/): Don't wait for risk management to become a documentation exercise at the end of your project; our team is ready to improve your design process by identifying risks early and letting our risk management process inform your designs to create safer, more effective products.
- [Pam Arroway, PhD](https://sage-research.com/team/pam-arroway/): Pam has been on several dinosaur digs in Utah and New Mexico.
- [Ryan Madden, BFA](https://sage-research.com/team/ryan-madden/): Ryan’s first commercial job after graduating art school was helping to illustrate a biology textbook. If you thought drawing hands was hard try sketching the coronary artery or a polysaccharide chain! 
- [Elizabeth Mueller, MS](https://sage-research.com/team/elizabeth-mueller-ms/): I enjoy running, hiking and backpacking (especially with my dog), and snowboarding. And I can say the alphabet backwards!.
- [Devon Hammerland, MS](https://sage-research.com/team/devon-hammerland/): Devon’s favorite creative outlet is baking, and she laments the fact that she has never been a resident of the UK, and therefore can never be on The Great British Bake Off. In consolation, she does own 1 square foot of Scottish land, gifted by her sister-in-law, making her Lady Devon Hammerland.
- [Carter Gerard, BS](https://sage-research.com/team/carter-gerard-bs/): Carter is among the 2 percent of the adult population that has previously broken her heel bone (Calcaneus bone). After 2 months on crutches, she has made a full recovery and now enjoys hiking, skiing and rock climbing on the regular!
- [Jennifer Fukagawa-Mahan, MS](https://sage-research.com/team/jennifer-fukagawa/): Jennifer was born and raised on Maui. She enjoys scuba diving, loves stand-up paddleboarding, and knows her colors and numbers in Hawaiian.
- [HFES 2024 – IRB Poster References](https://sage-research.com/hfes-2024-irb-poster-references/): 1 Commissioner, O. of the. (2023). Informed consent guidance for IRBs, clinical investigators, and sponsors. U.S. Food and Drug Administration. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/informed-consent
- [Webinar Registration](https://sage-research.com/webinar_registration/): Please join us for our virtual webinar “Why the FDA Cares About Human Factors and So Should You.”  
- [User Research Privacy Policy](https://sage-research.com/research-privacy-policy/): We process your personal information for a variety of reasons, depending on how you interact with our Services, including:
- [Website Privacy Policy](https://sage-research.com/website-privacy-policy/): <br>
- [Natalie Stepien-Bernabe, PhD](https://sage-research.com/team/natalie-bernabe/): Natalie was 1 lb 14 oz when born, but grew (a little) since then and love sports and physical activity! She was a fast-pitch softball pitcher for nearly a decade, played competitive badminton, and now spends her free time hiking, running, and weight training.
- [Kay Newman, MS](https://sage-research.com/team/kay-newman-ms/): Kay enjoys sharing her design knowledge by volunteering in the Denver/Boulder Startup community through organizations such as TEDx Denver, Rockies Venture Club, 10.10.10, and Denver Startup Week.
- [Sangeeth Jeevan](https://sage-research.com/team/sango-jeevan/): Sango is an avid board game fan and especially enjoys playing Pandemic and Terraforming Mars with his wife and friends on the weekends.
- [Kimberly O’Brien, PhD](https://sage-research.com/team/kim-obrien/): Kim relaxes by doing puzzles. A recent tidying up of her cars and purses and house revealed dozens of crossword, Sudoku, Binairo, KenKen and Numbrix puzzles in various states of doneness.
- [Colleen Pellissier](https://sage-research.com/team/colleen-pellissier/): Colleen created, hosted and produced a year-long daily podcast for Cards Against Humanity all about good news.
- [John Milanski, MDes](https://sage-research.com/team/john-milanski/): John was a volunteer firefighter and EMT for over 15 years, and is now an elected director for his local fire department.
- [Connect](https://sage-research.com/connect-2/): JTVCZmMlMjBpZCUzRCUyNzIlMjclNUQlNUIlMkZmYyU1RA==
- [Benjamin Basseches](https://sage-research.com/team/benjamin-basseches/): Benjamin went on a 4-month, 20,000+ mile road trip around North America last winter, including 60+ days snowboarding, 23 US states, 3 Canadian provinces, and 9 natural hot springs. He considers it a life-changing experience and the best choice he’s ever made!
- [Services](https://sage-research.com/services/): 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.
- [Jody Solem, MS](https://sage-research.com/team/jody-solem-ms/): Jody loves to volunteer in the community including teaching English to non-English speaking immigrants, Elementary School PTA/O President and Firefighter/EMT (retired). Her family often wonders what will be next!
- [Agatha Kalinchenko, MD](https://sage-research.com/team/agatha-kalinchenko-md/): Agatha loves to learn languages and knows four languages fluently: Danish, Swedish, Norwegian, Polish and English Conversational in Italian, French, and Russian. Also enjoys competing in Ironman competitions and other endurance sports!
- [Kevin O’Brien, PhD](https://sage-research.com/team/kevin-obrien-phd/): Kevin is an enthusiastic mentor for a high school FIRST Robotics team. He enjoys bringing his lifetime of experience restoring cars to help students design and build mechanical systems.
- [Bill Pawlak, MS](https://sage-research.com/team/bill-pawlak-ms/): Bill was once bamboozled into standing on home plate and singing the National Anthem with his (then) girlfriend’s theater group before a nationally-televised Chicago White Sox home game. He got himself a Jumbotron close-up and everything!
- [Shannon Halgren, PhD](https://sage-research.com/team/shannon-halgren-phd/): Shannon’s favorite form of family vacation is to tour by bike. She’s taken over 10 vacations by bike and plans on taking many more!
- [Team](https://sage-research.com/team/): We have a wide network of talented colleagues with expertise in user experience and related fields such as web and software development, project strategy, and IT that can be brought in to lend their expertise to any project as needed. Clients will have an opportunity to approve of all team members brought in to work on their project.
- [Our Work](https://sage-research.com/our-work/): Google
- [Healthcare Patient + Clinician Experience](https://sage-research.com/healthcare-facility-patient-clinician-experience/): Zooming in on the patient and clinician experience through Human-Centered Design processes is the solution to numerous problems faced by patients, clinicians, and additional healthcare professionals in healthcare facilities.
- [Usability + User Experience](https://sage-research.com/usability-user-experience/): Technology users demand products that are intuitive, efficient, and are a delight to use. Each year this demand grows stronger and products that go the extra mile to create products with a stellar user experience win in the marketplace. A User-Centered Design process that incorporates the voice of your users into the design is critical when developing products that meet and exceed users needs and expectations.
- [Medical Human Factors](https://sage-research.com/medical-human-factors/): 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. It's also essential for a smooth FDA or MDR submission. 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.
- [Privacy Policies](https://sage-research.com/privacy-policy/): <br>
- [Page 404](https://sage-research.com/page-404/): JTNDc3ZnJTIwdmlld0JveCUzRCUyMjAlMjAwJTIwNjAwJTIwMTcwJTIyJTNFJTBBJTBBJTIwJTIwJTNDJTIxLS0lMjBHcmFkaWVudCUyMC0tJTNFJTBBJTIwJTIwJTNDbGluZWFyR3JhZGllbnQlMjBpZCUzRCUyMmdyLXNpbXBsZSUyMiUyMHgxJTNEJTIyMCUyMiUyMHkxJTNEJTIyMCUyMiUyMHgyJTNEJTIyMTAwJTI1JTIyJTIweTIlM0QlMjIxMDAlMjUlMjIlM0UlMEElMjAlMjAlMjAlMjAlM0NzdG9wJTIwc3RvcC1jb2xvciUzRCUyMiUyMzJEQjA3MCUyMiUyMG9mZnNldCUzRCUyMjAlMjUlMjIlMkYlM0UlMEElMjAlMjAlMjAlMjAlM0NzdG9wJTIwc3RvcC1jb2xvciUzRCUyMiUyMzJEQjA3MCUyMiUyMG9mZnNldCUzRCUyMjEwMCUyNSUyMiUyRiUzRSUwQSUyMCUyMCUzQyUyRmxpbmVhckdyYWRpZW50JTNFJTBBJTBBJTIwJTIwJTNDJTIxLS0lMjBUZXh0JTIwLS0lM0UlMEElMjAlMjAlM0N0ZXh0JTIwdGV4dC1hbmNob3IlM0QlMjJtaWRkbGUlMjIlMEElMjAlMjAlMjAlMjAlMjAlMjAlMjAlMjB4JTNEJTIyNTAlMjUlMjIlMEElMjAlMjAlMjAlMjAlMjAlMjAlMjAlMjB5JTNEJTIyNTAlMjUlMjIlMEElMjAlMjAlMjAlMjAlMjAlMjAlMjAlMjBkeSUzRCUyMi4zNWVtJTIyJTBBJTIwJTIwJTIwJTIwJTIwJTIwJTIwJTIwY2xhc3MlM0QlMjJ0ZXh0JTIwdGl0bGUtaDElMjBsaWdodCUyMiUwQSUyMCUyMCUyMCUyMCUyMCUyMCUyMCUyMHN0eWxlJTNEJTIyZmlsbCUzQSUyMHVybCUyOCUyM2dyLXNpbXBsZSUyOSUzQiUyMGZvbnQtc2l6ZSUzQSUyMDIzMHB4JTNCJTIwbGluZS1oZWlnaHQlM0ElMjAxJTNCJTIyJTBBJTIwJTIwJTIwJTIwJTIwJTIwJTIwJTIwJTNFJTBBJTIwJTIwJTIwJTIwNDA0JTBBJTIwJTIwJTNDJTJGdGV4dCUzRSUwQSUzQyUyRnN2ZyUzRQ== PAGE NOT FOUND We’re sorry, the page you have looked for does not exist in our database! Maybe go to our   home page   or try to use a search?
- [Insights](https://sage-research.com/insights/): YOUR DEVICE IS SAFE. BUT IS IT SECURE? THE OVERLAPPING IMPORTANCE OF BOTH SAFETY AND SECURITY RISK MANAGEMENT…
- [Connect](https://sage-research.com/connect/): JTVCZmMlMjBpZCUzRCUyNzQlMjclNUQlNUIlMkZmYyU1RA==

## Case Studies
- [Mobile App Diagnostic Aid](https://sage-research.com/pf/mobile-app-diagnostic-aid/): ResApp Diagnostics
- [Patient Wearable Monitor](https://sage-research.com/pf/patient-wearable-monitor/): Confidential
- [Consumer Wearable Medical Device](https://sage-research.com/pf/consumer-wearable-medical-device/): Confidential
- [IT Management Tools](https://sage-research.com/pf/it-management-tools/): SolarWinds
- [Surgical Devices](https://sage-research.com/pf/surgical-devices/): Bolder Surgical
- [Hospital Emergency Response](https://sage-research.com/pf/hospital-emergency-response-tool/): LiveProcess
- [HCD in Healthcare](https://sage-research.com/pf/online-job-board-ux-research-2/): HFES Healthcare Symposium Poster
- [Job Board / HR UX](https://sage-research.com/pf/online-job-board-ux-research/): Indeed
- [Productivity + Entertainment UX](https://sage-research.com/pf/dell-product-usability-testing/): Dell
- [Surgical Specimen Removal](https://sage-research.com/pf/surgical-handpieces/): Eximis Surgical
- [Nurse Call System](https://sage-research.com/pf/nurse-station-call-system/): Ascom
- [Dialysis Clinic Monitor](https://sage-research.com/pf/dialysis-clinic-water-quality-monitor/): Hach
- [Science Classroom App](https://sage-research.com/pf/science_classroom_app/): Google
- [Innovation Sessions](https://sage-research.com/pf/innovation_sessions/): Netflix
- [VR UX Research](https://sage-research.com/pf/virtual-reality-ux-research/): Oculus

## Sage Templates
- [Main Footer](https://sage-research.com/?post_type=thegem_templates&p=890): Have questions about our services, work or us? Let's talk today!