HirLan is Your Human Factors Partner

HirLan partners with medical device manufacturers of all sizes (i.e., entrepreneurs through top 5 manufacturers/pharma) 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/CE Mark (MDR) 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, creation of QMS usability engineering file and Human Factors evaluation (formative) and validation (summative) testing. Early incorporation of 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 businesprocesses and product lifecycle and thereby satisfy the FDA, CE Mark (MDR) and UKCA Human Factors requirements/regulations.

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/development 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 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, MDR, UKCS and/or FDA 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.

HOW DIFFERENT HUMAN FACTORS REGULATIONS AFFECT MEDICAL DEVICE DEVELOPMENT

Syringes, Catheters, X-Ray Machines, Medical Software (EMR) - All are considered Medical Devices by all of the notified bodies. But depending upon the specific type, the classification can differ between the various notified bodies, e.g. FDA versus MDR. All medical devices are affected by Human Factors Regulations, some more than others. For example, managing Innovation and 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 designs that may result in serious use errors 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 VARIOUS HUMAN FACTORS REQUIREMENTS OF NOTIFIED BODIES THROUGH THE:

• Integration of Human Factors 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 various requirements of different notified bodies, e.g. FDA/MDR, etc.
• Accessibility and Cross Cultural / Cross National Design concerns
• User documentation, packaging and instructions for use

HirLan, Global Human Factors Testing Experts

Both the FDA and MDR (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 requiring 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 requires testing in an EU country. 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 experienced in all methods and requirements associated with global Human Factors Testing.

HirLan specializes in:

• Product Collateral Design and Production (print, electronic and video)
• Creating Information for Use (IFU) Collateral
• Instructional Videos
• User Centered Participatory Design Process Seminars
• FDA Human Factors/Usability Testing: Evaluation and Validation

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, MDR and CE Mark Human Factors Guidance/Regulations. 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 / CE Mark Human Factors/Usability Testing: Evaluation and Validation
• Creation and maintenance of Usability Engineering Filen