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Human Factors/Metaphase

User Centered Solutions

(HF/UX)

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User Centered Solutions creates a clear advantage for our clients

A single source partner, leveraging the voice of the user

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Industrial Design & Research

  • Brainstorming and Rapid Visualization
  • Innovation Workshops
  • 2D - 3D Product Design
  • Interface Design
  • IFUs and packaging design
  • Ethnographies and Observational studies
  • Custom Perception and Sensory studies

User Experience & Human Factors

  • Evaluate/Compare overall usability and elicit patient preferences
  • Delivery device selection/refinement
  • IFU development/validation
  • Usability/formative and summative study development/execution
  • Regulatory strategy and submission support

Market Insights & Program Development

  • Primary stakeholder research to uncover needs and validate recommendations
  • Best-in-class training and onboarding tactics that align with stakeholder needs and market expectations

Product Development & Commercial Scale-Up

  • Training Device Development and Production
  • Packaging and Collateral
  • Electromechanical and medical device product development capabilities
  • Certified quality systems and design controls

Launch & Post-Market Optimization

  • Launch workshops
  • Training videos
  • Utilization and global distribution
  • Assessing the performance and impact of training and onboarding on stakeholders

Metaphase Brings Over 30 Years of Expertise and Success in Design and High Touch-Services

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Research

  • VOC
  • Observational Studies
  • Ethnographies
  • User Experience (UX) Research

Industrial Design

  • Brainstorming & Rapid Visualization
  • Innovation Workshops
  • 2D - 3D Product Design
  • Interface Design

Human Factors

  • Expert Analyses
  • Ergonomic & Design Audits
  • Formative & Summative Studies
  • Product Benchmarking

Explore essential insights and guidelines provided by the FDA on Human Factors for Combination Products. 

FDA Guidance: Human Factors for Combination Products

 

Working to Create User Centered Solutions

  • Delivering a comprehensive set of user centered services along the product development pathway
  • Bringing together expertise in product design, user-experience research, human factors, and tailored training & on-boarding solutions
  • Introducing the voice of the patient into the product development journey
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Noble's User Centered Solutions capabilities include:

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Consultation
Assess the device risks and define user groups to formulate a regulatory study and submission plan.

Risk Assessment
Collaborate with the client to analyze user data and generate the requisite risk assessment documents.

Formative Studies
Define the studies needed to collect critical inputs from statistically valid user groups.

HF Validation Studies
Protocol development and execution for the Human Factors Validation Study for regulatory submission

Submission Report
Collaborate with client's regulatory teams to draft the Human Factors Submission Report and support the client with regulatory queries.

In addition to the regulatory requirements of Human Factors research for FDA approval, HF research is critical for improving the patient user experience as well as optimizing the performance of your brand.

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Benefits of Human Factors and ergonomics-based engineering research include...

  • Easy to use devices
  • Easy to read controls and displays
  • Better user understanding of the device's operations
  • Better user understanding of cautions and warnings
  • Safer connections between device components
  • More accurate dosing
  • Reduced user reliance on Instructions for Use (IFU) and Quick Reference Guides (QRG)
  • More effective and efficient training
  • Improved patient compliance and medical outcome
  • Reduced risk of user error and product complaints
  • Reduced risk of adverse events and associated litigation
  • Reduced risk of product recalls
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Human Factors ancillary support

In addition to Noble's core human factors capabilities, Noble combines its expansive knowledge and understanding of the patient's needs and anxieties with its engineering expertise to develop and commercialize patient training devices that mimic the exact feel, force and function of the real drug delivery device—including autoinjectors, prefilled syringes, nasal devices and pulmonary devices. These training devices help to increase patient confidence and adherence when self-administering drug therapies. In addition, Noble assists clients with training utilization, training device Instructions for Use (IFU), and product launch strategies to help individual brands optimize their performance.

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See how Noble's Human Factors services offered started off:

Watch our first Human Factors webinar on regulatory overview:

Learn more about Noble and Metaphase's User Centered Solutions for clients:

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Connect With Our Human Factors + Team