Technology - Human Factors

Enable Injections has a unique approach to incorporating Human Factors input into our design. We considered the user as the primary and most important variable in our design. We have conducted extensive Human Factors studies beginning at the same time we began our design efforts. Our primary objectives were to develop a safe device that is overwhelmingly preferred by its users. Hundreds of different prototype designs were tested during the product development cycle, with a wide range of user demographics and environments. Many elements of the Enable system are designed to minimize user confusion and errors. We also wanted to develop a discrete, comfortable and friendly product that users were attracted to and wanted to use.

User Driven Design

  • Extensive Human Factor studies conducted:
    Studies began in parallel with engineering design User input incorporated into the design after each study First priority User Safety → Minimize user errors Second priority User Preference → Device should be overwhelmingly preferred

Key User Findings

  • A longer injection time is preferred over a shorter time if:
    The injection is more comfortable
    The device is discreet
    The user is ambulatory and can go about his normal daily activities during injection
    ‘If I can go about my day, then injection time becomes irrelevant’
  • A patient loaded device is preferred to a preloaded device:
    If the ‘warming time’ is eliminated – device can be used immediately after transfer 100% of users preferred user-filled device with automatic warming

Designed to mimimize injection discomfort

  • Enable has over 10 years of research in ‘painless injection’ technology
  • Flowrate adjusts to individual patient tissue pressure for maximum comfort
  • Multiple proprietary features designed to provide a comfortable injection
  • On-Demand ‘Pause’ feature allows patient to pause injection if uncomfortable

The advantages of the Enable Patient-filled system

  • Refrigerated drugs require a ‘warming time’ after removal from refrigerator (typ. 30 min) Refrigeration can increase viscosity by 3x or more Batteries lose power when cold drugs are significantly more painful to inject Device is typically left out on the counter unattended during ‘warming time’ creates disruption in the user process
  • The Enable Injector eliminates the ‘warming time’ for a refrigerated drug
    Automatically warms drug during transfer (typ. 30 sec) Device is ready to use immediately after transfer Eliminates the ‘interruption’ of the drug administration process and possible issues. E.g. Forgetting about device or device is left unattended during warming
  • The Enable Injector only requires the primary drug container to be stored in refrigerator
    Drug container is ‘child resistant’ Requires minimal space in refrigerator for discrete storage

Administration Time = Preparation Time + Injection Time

  • The Enable user does not need to wait for the drug to warm
  • Administration time is significantly reduced

Users

  • Experience
    • Injection naive to expert
    • Patient to HCP
    • Administering to receiving
    • SC, IM, IV, Port
    • Product naive to experienced
  • Demographics
    • Age: 18 → 85 yrs.
    • Gender: M, F
    • Dominant Hand: R, L
  • Education / Training
    • Student, Laborer, Caregiver, Engineer, Retiree, Nurse, Stay-at-Home Mom, Tradesman, Doctor, Athlete, Pharmacist, Driver
    • H.S student → Doctor
  • Cognitive Abilities / Challenges
    • Cognitively disabled → Elite
    • Young → Elderly
  • Emotional Abilities / Challenges
    • Needle fear, phobia
    • Adverse association with illness or condition
  • Life-Style / Use Environment
    • Office, school, frequent air travel, mobile, outdoors, factory, retiree, RV
  • Physical Abilities / Challenges
    • Hand size, abilities
    • Eye disability, bi-focal dependent
    • BMI: Low to High
    • Conditions: RA, MS, Neurological conditions, Oncology, Macular Degeneration, Diabetes, Fibromyalgia, Acute arm and hand injury