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Medical Device Design Flaws for Children With Medical Complexity at Home

Peter Walsh1, Sofia Seewald1, Leo Castillo1

  • 1Stanley Manne Children's Research Institute, Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago, Illinois.

Pediatrics
|February 9, 2026
PubMed

Insights

Parents of children with medical complexity (CMC) report significant issues with in-home medical devices, including design flaws and access barriers. These problems can lead to safety risks and impact health outcomes for CMC.

Area of Science:

  • Pediatric Healthcare
  • Biomedical Engineering
  • Health Services Research

Background:

  • Children with medical complexity (CMC) represent a growing population requiring extensive home-based medical devices and supplies.
  • Existing home medical devices have been linked to adverse events, including emergency care visits and hospitalizations.
  • Understanding parent experiences is crucial for improving the safety and efficacy of these essential technologies.

Purpose of the Study:

  • To investigate the lived experiences of parents managing in-home medical devices for children with medical complexity (CMC).
  • To identify specific challenges, unmet needs, and desired improvements in the design and accessibility of these devices.
  • To uncover opportunities for enhancing the support systems surrounding home medical device use for CMC.

Main Methods:

  • A qualitative, cross-sectional study involving semistructured interviews with parents of CMC.
  • Inclusion of photographic evidence and descriptions of device use to supplement interview data.
  • Application of thematic and content analysis to identify recurring themes and design preferences.

Main Results:

  • Five primary themes emerged: inadequate communication regarding product availability, frequent and significant device design flaws posing safety risks, parental improvisation to overcome device limitations, structural barriers to accessing quality devices, and specific valued design attributes.
  • Seventeen interviews and 97 submitted images provided rich qualitative data.
  • Parents actively engaged in problem-solving due to device shortcomings.

Conclusions:

  • The current provision of in-home medical devices for CMC is insufficient, presenting safety concerns and negatively impacting patient health.
  • Medical device design flaws are a significant issue, potentially compromising the well-being of CMC.
  • Future interventions must integrate parental feedback into medical product design and coverage policies to better meet the needs of CMC.
Abstract

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