Who We Collaborate With:

In whichever capacity you need Human Ability Designs, we are committed to helping you achieve your goals of producing regulatory ready, high quality, safe, effective, and accessible designs for your end users that regulators will approve.

Medical Device and Pharmaceutical companies
Large organizations as well as start-ups
Medical device design and development firms
Individuals and teams of Human Factors Engineering professionals

Human Ability Designs Services

Strategic planning and development of human factors engineering processes

Human factors engineering is a process that requires thorough, rigorous, and nimble planning to ensure high quality scientific implementation and regulatory approvals. Strategic planning and rigorous documentation directly impact a program’s overall budget, timeline and human factors regulatory submission success. 

Human Ability Designs has the proven expertise to help you plan, adjust and document a successful human factors engineering process and regulatory submission.

Human Factors Engineering Trainings

Quality, systematic and scientific human factors engineering (HFE) processes and skills are critical to the success of every medical device organization designing and developing medical devices and combination products. The rigor of regulatory human factors expectations for medical devices adds another layer of expertise that is critical for successful submissions.

Human Ability Designs has the extensive experience and expertise to leverage the right training solutions for your organization.

Pre-submission reviews for Human Factors Validation Protocols and HFE/UE Reports

Quality, systematic and scientific human factors formative and summative validation protocols and reports are critical to help you optimize your user interface and present the required evidence to achieve first time regulatory approvals. Many human factors tools and methods exist, but the right approach will directly impact your program and submission success. Documentation also is important for pre-market reviews and post-market audits. 

Human Ability Designs (HAD) serves as a sounding board to help you design, develop, and report your study protocols and reports to ensure you will meet regulatory requirements and requests to help you prove the design of your user interface is safe and effective for end users. HAD provides a pre-regulatory review and advising to help ensure your HFE/UE submission will meet regulatory requirements and reviewer expectations.

Threshold Analyses

FDA requires pre-market human factors evidence of safe and effective use for medical devices with potential for serious harm. Sometimes a threshold analysis is an appropriate alternative to validation data as part of a pre-market submission, which can save time and money. 

Human Ability Designs has successful experience to help you replace validation data with a threshold analysis and documentation of your new drug product with an FDA approved comparator for relevant drug and biologics applications.

Bridging and Leveraging Analyses and Strategies

In order to help streamline the human factors process, FDA is open to the approach of leveraging scientifically relevant information from an earlier phase of the development process or related device to generate part of the pre-market human factors engineering evidence for safe and effective use. 

Human Ability Designs has proven expertise to help you determine if bridging and leveraging is possible as well as to help you develop the required documentation for submission to FDA.

Heuristic and Expert Reviews

Heuristic and expert reviews are time-and cost-effective analyses that can catch user interface design flaws or features that require further mitigations. Expert reviews can be completed early in the design process before participants are involved as well as in parallel of other design activities. 

Human Ability Designs applies knowledge of design principles and guidelines as well as industry expertise to help you assess the design of your device, labeling and training concepts or designs as early as possible in the design process.

Task and Use Related Risk Analyses

Task analysis is a powerful design and assessment tool that is the foundation for developing the risk analysis, user interface, instructions for use, and training. It also serves as an integral part of the regulatory submission to help FDA understand critical tasks, use related risks, use errors and difficulties with the user interface. 

Human Ability Designs applies its extensive understanding of task and use related risk analyses to help you develop, iterate, and review the task and use related risk analyses at any stage in the human factors engineering process.

Preparation for FDA meetings and responses

Corresponding with FDA related to human factors reviews and submissions requires experience and insight to ensure you are correctly interpreting FDA's feedback and expectations. Skillful preparation of your responses will ensure you receive a more efficient FDA review. 

Human Ability Designs helps you prepare  effective submission questions and responses to requests for additional information or complete response letters. We also participate with you in human factors meetings with FDA to ensure your human factors strategy and submission yield a first time approval.

Contact us to discuss how your organization will benefit from over 15 years of successful experience in regulatory Human Factors Engineering.

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Our founder has contributed to HFE submissions for:

  • Home care devices
  • Endoscopes
  • Over-the-counter products
  • Emergency use devices
  • Duodenoscopes
  • Auto-injectors
  • Training
  • Enhancements to legacy devices
  • Ventilators
  • Training
  • Duodenoscopes
  • Wearable devices
  • Infusion pumps
  • Radiology equipment
  • Reprocessing training and procedures
  • Reusable pen injectors
  • Implantable infusion pumps
  • Software as a medical device
  • Robotic surgery systems
  • Wound therapy devices
  • Anesthesiology systems
  • Imaging technologies
  • 483s, CAPAs, and warning letters
  • Examination tables and chairs
  • Respiratory technologies
  • In Vitro Diagnostics (IVDs)
  • Inhalers
  • IFUs, QRGs, and training
  • Implantable device programmers
  • Threshold Analyses
  • Surgical products
  • Telemedicine products
  • Etc.