Root Cause Insights
your global Human Factors and Usability partner
At Root Cause Insights, we understand the importance of collaboration and communication in delivering successful outcomes for our clients. We work closely with our clients to understand their specific needs and requirements, and we strive to deliver tailored solutions that meet their unique challenges.
Committed to providing a quality service
We are committed to staying up-to-date with the latest global regulatory guidance to ensure that our clients receive the highest quality service possible.
Early-Stage User Research
IFU Design
Formative/Validation Human Factors Testing
Human Factors Documentation
IRB/Ethics Review
Regulatory Consulting (FDA, IEC, MHRA & Other Regulatory Agencies)
About Root Cause Insights
A research consultancy dedicated to the safety, effectiveness, and usability of products for the intended user.
At RCI, we understand the critical importance of designing products that meet the needs of the user. Our global team includes researchers, human factors engineers, usability experts, regulatory specialists, and graphic designers who work collaboratively to ensure that our clients’ products are intuitive, safe, and effective. Our team is passionate about improving user experience and is dedicated to helping our clients create products that positively impact people’s lives.
We are committed to staying up-to-date with the latest global research methods and industry best practices to ensure that our clients receive the highest quality service possible. Our services include early-stage user research, task analysis creation, IFU design, human factors training, formative/validation (summative usability) testing, IRB/ethics review, regulatory consulting, and all documentation required for regulatory submission. Our team also has proven experience in the design, development, and evaluation of medicinal products, medical devices, and combination products.
We work with clients at all stages of product development, from concept ideation to post-market evaluation, to ensure that their products are optimized for use safety and efficacy.
Our Services
Early-Stage User Research
Human Factors Engineering (HFE) is best applied early in a project, ideally during concept generation. Early-stage user research can help identify user needs and reduce use-related and commercial risk. Applying HFE early can lower overall development costs and reduce the project timeline by helping to design the right thing and design the thing right! RCI can support products and ideas from the first steps of the development journey.
Task Analysis
A task analysis is a key starting point in the human factors process. It builds an understanding of how users interact with the device by breaking down high-level tasks into discrete steps that can be analyzed using the Perception, Cognition, Action (PCA) model. A task analysis sets the foundation for a Use Related Risk Assessment (URRA), your study protocols, and even the design of your Instructions for Use (IFU). RCI is skilled in creating task analyses that are straightforward enough to be shared across multi-disciplinary teams, helping foster a deeper understanding of the product across your business.
IFU Design
Instructional material, such as Instructions for Use (IFU), Quick Reference Guides (QRG) and packaging labeling, can either help or hinder the usability of your device. While mitigating risk by design is the first step of device safety, instructional materials are another way to support the safe and effective use of your device. RCI has a range of experience in applying human factors in conjuncture with graphic design to create instructional material that is engaging, simple to understand, and easy to follow. Since regulatory agencies require instructions to be included in validation studies, RCI recommends starting the design of your instructional materials early in product development and iteratively testing them to ensure successful validation testing.
Formative Human Factors Testing
RCI conducts formative testing with the aim of providing you meaningful and practical data around your product in development. This testing process includes the identification of potential use errors and their corresponding root causes, as well as recommendations for design improvement and updates to your risk management file. Unlike with validation studies, which must follow a more rigid structure, there is a large level of freedom in formative studies: think-aloud, expert reviews, user ideation, concept testing are all possible. The primary objective is to learn!
Validation Human Factors Testing
Human factors validation testing (sometimes referred to as summative usability testing) is required by regulatory agencies to prove that your device is safe and effective to use by its intended users in its intended use environment. The RCI team is experienced in delivering human factors validation testing across a range of products and can offer support on several levels, from advising on validation strategy to executing studies in their entirety.
Human Factors Documentation
Successful human factors (HF) documentation should tell the story of your product’s development, presented clearly enough for reviewing authorities to quickly grasp the rationale behind design choices. RCI can produce documentation for your Usability Engineering Files, from Intended Use Specifications to Human Factors Summary Reports, to meet requirements of the FDA, IEC, MHRA and other regulatory agencies.
Human Factors Training
Designing products with usability considered throughout begins with educating your team in the principles of human factors. RCI is experienced in providing human factors training to a wide range of audiences, from whole organizations to small product teams, to distinct internal departments of larger organizations. From regulatory, quality assurance, and remediation teams, to research and design, to marketing, RCI brings a practical understanding of distinct departmental needs when it comes to understanding and applying human factors.
Training benefits no one when it can’t keep its audience awake, and RCI knows this! Our clients have appreciated the engaging, lively way we train teams. RCI aims to keep the material straightforward and relevant, while providing practical hands-on examples. The length of training depends on your requirements, so please contact us to find out more.
IRB/Ethics Review
The group review process, carried out by an Institutional Review Board (IRB), serves an important role in the protection of the rights and welfare of human research subjects. RCI’s IRB is registered with the U.S. Department of Health and Human Services (HHS) to review and monitor plans for biomedical research involving human subjects. RCI’s IRB has the authority to approve, require modifications in (to secure approval), or disapprove research, in accordance with FDA regulations. RCI is also experienced in managing ethics reviews across Europe, including working with the UK’s Health Research Authority (HRA).
In addition to comprehensive IRB services, RCI can review your recruitment screener in advance of reviewing full study protocol. Having first-hand experience in planning and executing complex usability studies, our team understands the practical need to get recruitment underway while protocol is still being finalized, and can work with you and your project requirements. Thanks to our focus on simulated-use studies, our efficient, non-bureaucratic review process, and our personal dedication to ethics in research, RCI’s in-house IRB streamlines the review and approval process of study materials and documentation, offering you faster IRB review at a lower cost.
Regulatory Consulting (FDA, IEC, MHRA and Other Regulatory Agencies)
The process of regulatory submission brings a product from development to market ready. While RCI does not submit on behalf of our clients, we can help prepare you for the process. In addition to offering comprehensive services in creating your HFE/UE report, from planning to drafting to review, RCI can provide any required gap analysis of the human factors process. Furthermore, RCI can offer strategic guidance on regulatory submission. We provide expert advice, a course of action, and a proposed schedule tailored to your unique situation. We are happy to consult on the following guidance documents:
• FDA Guidance – Applying Human Factors and Usability Engineering to Medical Devices
• ANSI/AAMI HE75
• Usability Engineering File for IEC 62366-1,-2
• ISO 14971
• ISO 13485
Leadership
Chris Kim, MD
Co-Founder, CEO
Chris holds a Medical Degree from the Perelman School of Medicine at the University of Pennsylvania, and he has been working in the area of medical and regulatory affairs for over 16 years.
Chris specializes in the strategic implementation of human factors and usability testing for both medical devices and consumer products. His clinical background helps give him medical insight into the safety and efficacy of a product while understanding the risks that may prevent a smooth regulatory process. Under his guidance, over 400 medical devices have successfully met their safety and regulatory requirements.
Chris teaches at the University of Pennsylvania and Jefferson School of Medicine about the medical device development process and is considered an expert in the area of human factors application to design.
Reece Knight
Co-Founder, Global Technical Director
Reece holds a first-class degree from Loughborough University in Ergonomics (Human Factors Design) BSc.
Reece has applied his training in human factors to many industries including automotive, defence and medical device sectors. For much of his career, he has worked for manufacturers and thus has a very practical understanding of applying human factors.
Reece found a passion for working on medical devices and combination products and now has 8 years of experience in this area. During this time, he worked on a huge variety of devices and assisted hundreds of devices through FDA submissions and regulatory audits against international standards.
Contact Us
Contact our professional and friendly team with any questions you may have about what we offer, or if you would just like a chat to start your project with us.
Email: [email protected]
US Phone: +1 267-494-9335
UK Phone: +44 7412 118587
US Office:
Root Cause Insights
Offsite at Fitler Club
2400 Market Street, No. 200
Suite 204G-H
Philadelphia, PA 19103
UK Office:
1 Main Street
Swanland
North Ferriby
HU14 3QP
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