Your Partner

HirLan is Your Human Factors Partner

HirLan partners with medical device manufacturers to assist with Human Factors Engineering through product innovation, development, evaluation (formative)/validation(summative) testing, and delivery. We specialize in the custom integration of Human Factors Best Practices into your specific product and business processes environment to meet the FDA 510(k)/CE Mark Human Factors Requirements and comply with IEC 62366-1:2015 and ANSI/AAMI HE75:2009(R)2013 Human Factors Specifications. Our services include on-site business process consulting, on-site training, international seminars/workshops and Human Factors evaluation (formative) and validation (summative) testing. Incorporating Human Factors principles into your product lifecycle will minimize your product development costs and time to market while delivering products with a strong competitive advantage. Our expertise will simplify the process of incorporating Human Factors principles into your business processes and product lifecycle and thereby satisfy the FDA 510(k) / CE Mark Human Factors Guidance.

Our Key Methods include:
  • Usability Testing
  • Iterative Design and Testing Methods
  • Human Factors Design Best Practices
  • Human Factors Training/Education
  • User Centered Participatory Design Methods
  • Innovation Process Methods
  • Business Process Consulting

Personalized Services

HirLan, Experts in Medical Device Innovation

Medical Device Innovation is a process. HirLan's experts can help you introduce Human Factors Methods and Principals seamlessly into your innovation/developement process leading to Safe, Effective, Usable and Profitable products. Dr Virginia A Lang, PhD (President, HirLan, Inc) was part of the BellCore Team that developed the principles of User Centered Participatory Design in the late 1980s. We can help you embrace these methods and principles into your process/product lifecycle leading to a product innovation/developement with minimized product development costs and time to market intervals all while delivering innovative products with a strong competitive advantage.

Need an in-house Human Factors practice? Need short-term Human Factors Consulting? Have a question or two about ANSI/AAMI HE75:2009(R)2013, IEC 62366-1:2015, CE Mark and/or FDA 510(k) Human Factors Requirements? HirLan can help. In whole, or in part - with over 75 combined years of Human Factors experience, HirLan is ready to help you with your Human Factors needs. The sooner you call, the sooner we can help.

Our Key Methods include:
  • User Centered Participatory Design Methods
  • Iterative Design and Testing Methods
  • Human Factors Design Best Practices
  • Innovation Process Methods
  • Business Process Consulting

FDA 510(k) Guidance

How FDA 510(k) Guidance affects Medical Device Development

Syringes, Catheters, X-Ray Machines, Medical Software (EMR) - All are considered Medical Devices by the FDA. All medical devices are affected by the FDA 510(k) Human Factors Regulations, some more than others. Managing Innovation meeting the 510(k) Human Factors Usability Requirements can be a daunting task. Product evaluation, product validation, Human Factors Engineering and User Experience testing are all part of the User Centered Participatory Design process. With R&D expenses escalating, it is beneficial to limit and minimize product risk by identifying product flaws as early in the process as possible.

HirLan specializes in User Centered Design and the evaluation process associated with innovative ideas, product features, and the final integration of innovation and User Centered Design.

HirLan can help you meet the new FDA 510(k) Human Factors requirements through the:
  • Integration of the FDA 510(k) Human Factors Guidance into your product lifecycles
  • Application of the General Principles of Human Factors to your future Product lifecycles through User Centered Design concepts
  • Evaluation and Validation of your products against general Human Factors Principles
  • Manage the Risk Error with respect to basic human skills and abilities
  • Usability Testing and the appropriate methods to meet the FDA 510(k) Human Factors Guidance
  • Accessibility and Cross Cultural / Cross National Design concerns
  • User documentation, packaging and instructions for use

Human Factors Testing

HirLan, Global Human Factors Testing Experts

Both the FDA and CE Mark require Formative and Summative Human Factors Testing for the approval process. Formative Testing is a smaller scoped test performed at various stages throughout the Product Lifecycle to ensure product development is progressing as desired and catch usability issues early in the process. The successful Summative Test is the final Human Factors Test prior to FDA/CE Mark Approval and product release. The ultimate goal of Human Factors Engineering and all testing is to ensure Safe, Effective and Usable products are introduced to the public.

Formative and Summative Testing enlist the help of all intended users of a product. Were a Summative Test requires a minimum of 15 participants from each user group, a Formative Test is much more flexible using up to 8 participants from a target user group. The FDA requires all Summative Tests to be performed in the US whereas the CE Mark is a little more flexible. Generally, all test participants should not be company employees or associated with the company. Care must be taken when using pediatric and/or geriatric participants as there are ethical considerations. HirLan is experience in all methods and requirements associated with global Human Factors Testing.

Product Collateral

Collateral Development That Meets the FDA’s 510(k) and CE Mark Guidance

HirLan helps customers create, produce, evaluate, and validate all types of print, electronic and video product collateral meeting all ANSI/AAMI HE75:2009(R)2013 and IEC 62366-1:2015 Human Factors Requirements. HirLan’s principals actually contributed to the creation of the ANSI/AAMI HE75:2009(R)2013 and FDA 510(k) Human Factors Requirements so you can be assured your materials and collateral will conform to the regulations upon completion. Including:

HirLan specializes in:
  • Product Collateral Design and Production (print, electronic and video)
  • User Centered Participatory Design Process Seminars
  • FDA 510(k) Human Factors/Usability Testing: Evaluation and Validation
Product Packaging
Information for Use (IFU)
Product Inserts (PI)
Instructional Videos

Business Process

Experts in Managing Human Factors Throughout the Product Lifecycle

HirLan helps customers build products that meet user/customer needs and requirements. The processes that are used meet and exceed the ANSI/AAMI HE 75:2009 and IEC 62366-1:2015 standards, as well as the FDA 510(k) and CE Mark Human Factors Guidance. The following business processes when integrated into your product development lifecycle will insure meeting these standards as well as build profitable products:

  • Managing the Innovation Process through effectively collecting and prioritizing Innovative Product Ideas, Requirements and Features
  • Software and Mobile Device Design Process Review
  • User Centered Participatory Design Process Seminars
  • Iterative User Centered Design
  • Stakeholder Participatory Decision Making
  • Usability Testing: Evaluation and Validation
  • Human Factors Principles and Guidelines (ANSI/AAMI HE 75:2009 / IEC 62366-1:2015)
  • FDA 510(k) / CE Mark Human Factors/Usability Testing: Evaluation and Validation
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