MHealth Fairview Masonic Children’s Hospital

Overview of Study: Assist MHealth Fairview Masonic Children’s Hospital on user-centered research project for an ongoing pediatric medical device development project, including healthcare system innovation.

Participants: 13 participants, including healthcare providers and caretakers within the inpatient and outpatient healthcare systems were recruited to participate in focus groups, participatory design activities, interviews, and site visits.

Years I Participated: 2022-2024

Impacts:

  • Specified the system-of-use components including the organizations, people, and technology.

  • Mapped multiple journey maps within the inpatient and outpatient healthcare systems.

  • Expanded the knowledge of specific medical device and healthcare system needs and barriers within the inpatient and outpatient healthcare systems.

  • Explored specific areas for opportunities that exist for medical device development and healthcare system innovation.

Pediatric Non-Invasive Ventilation (NIV) Devices are commonly associated with Obstructive Sleep Apnea but are also used to assists with a variety of respiratory disorders, insufficiencies, and failures.

NIVs have different parts (head harnesses, frames, interfaces, elbows, and tubes) that need to work together with a PAP Therapy Device to provide treatment.

Market Analysis:

Current market analysis shows that there are 12 FDA-approved and commercially available NIV devices for pediatric patients.

7 of the 12 pediatric NIV interfaces were nasal masks, 3 were oronasal masks and 2 were total/scuba masks, which are typically only used within the hospital system.

Focus:

Problems to Solve:

1

To understand the system-of-use components and process when a pediatric NIV device is implemented within the inpatient and outpatient healthcare systems.

2

To identify the needs and barriers that occur within the inpatient and outpatient healthcare systems when pediatric patients rely on NIV devices.

3

To identify the opportunities for innovation for pediatric NIV devices and within the inpatient and outpatient healthcare systems.

  • Focus Groups

  • 2 Sessions, 3 Participants per Session

  • Semi-Structured Interviews

    • 7 Participants

  • Site Visits

    • MHealth Fairview Sleep Clinic

    • Direct Medical Equipment Provider Office

    • Pediatric Department at MHealth Fairview Masonic Children’s Hospital

Research Approach: Qualitative Research

Emily tries a nasal mask!

I tried a nasal mask!

Results: System-of-Use Components

Above: Patient-Centered Map

Above: Hierarchy Map

Results: Customer Journey Maps

Above: Overview of Journey Maps (Each was mapped individually)

Device

  • Availability

    • Only 12 pediatric approved NIV devices are currently on the market, these are not always available within the inpatient or outpatient healthcare system

    • Many of the available NIV devices have single-sized parts

    • When multiple sizes are available, there is a lack of size differences between the sizes to accommodate the population

    • The parts are packaged as a bundle/all-in-one size, meaning if a patient needs different sizes for different parts, they may need to purchase additional pediatric NIV devices (example: small cushion, large harness)

    • Single-circuit or Dual-circuit PAP Therapy Devices accessibility

      • Some pediatric NIV devices can only work with Single-circuit or Dual-circuit PAP Therapy Devices, not both

      • The inpatient team has only so many of the Single-circuit and Dual-circuit PAP Therapy Devices in stock

  • Fit Issues

    • Areas where fit issues were reported: Nasal Bridge, Nose, Cheeks, Ears, Philtrum, Top of Head, Side of Head, Back of Head

  • Maintenance

    • Includes switching out devices, assessing skin injuries, cleaning device, and replacing device

  • Interactions

    • Sleeping positions differ beyond ‘preferred use’ and issues arise when pediatric patients use these while they are awake

Results: Needs and Barriers

Device

  • Alternative

    • Interface

      • Nasal pillows are available for adult use, but not pediatric use

      • More options with interface design, many devices are designed similarly

  • Versatile

    • Head Harness

      • More adaptability with the fit of the head harness, including the ability to switch out the pressure points

      • Quick release of the head harness is crucial for this population

    • Elbow

      • Single-circuit to Double-circuit adaptability to create more options for the inpatient healthcare providers

      • Being able to position the elbow in different ways would assist pediatric patients during sleep

  • Custom

    • Interface and Head Harness

      • Being able to customize parts based on the patients’ needs

Pathway

  • Workload Distribution

    • Pediatric Critical Care Nurses, Pediatric Respiratory Therapists, Direct Medical Equipment Provider Team Members, and Caregivers ALL stated they have increased workloads due to the maintenance of the NIV device.

  • Short-term Compliance

    • Insurance coverage ONLY if short-term compliance is achieved, which is 4 or more hours per day for 70% of days over a continuous 30-day period within the first 90 days of receiving the device (United States Center for Medicare and Medicaid Services (CMS)).

    • Short-term compliance is variable depending on patient (may take 3 months or up to a year)

Results: Opportunities

Pathway

  • Workload Distribution

    • Inpatient Healthcare System: Currently they are understaffed within the support and care positions within the inpatient healthcare system needed to keep up with the maintenance of the device. Creating more roles and providing training to others to assist would help with current reported burnout.

    • Outpatient: The outpatient healthcare system is not reimbursed for support and care. Even though they are putting in a lot of effort and energy to get patients to reach compliance.

  • Short-term Compliance

    • More realistic compliance, with a focus on efficacy instead of time