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Barriers to and facilitators of paediatric medical device innovation: a scoping review protocol
Lynn Kysh1, Grzegorz Zapotoczny2,3, Lisa Manzanete4
1Innovation Studio, Children's Hospital of Los Angeles, Los Angeles, California, USA.
Insights
This scoping review examines barriers and facilitators for pediatric medical device clinical research infrastructure. Findings will inform strategies to improve pediatric device development and address inequities.
Area of Science:
- Medical Device Development
- Clinical Research Infrastructure
- Pediatric Health
Background:
- Paediatric medical device development lags behind adult devices, leading to inequities and safety concerns.
- Despite legislative efforts, a significant gap persists in paediatric medical device innovation.
- Clinical trials are a known bottleneck, yet effective research infrastructure components remain unclear.
Purpose of the Study:
- To conduct a scoping review to understand infrastructural barriers and facilitators for paediatric medical device clinical research.
- To inform the Pediatric Device Consortia's (PDC) multimodal research strategy.
- To identify key factors influencing the successful development and implementation of paediatric medical devices.
Main Methods:
- Scoping review of health sciences literature from 2007-present.
- Databases searched include Medline, Embase, Cochrane CENTRAL, Web of Science, and IEEE Xplore, supplemented by grey literature.
- Studies focusing on paediatric populations (0-21 years) and medical devices (FDA classification) involving human research will be included. Screening and data extraction will be performed by two independent reviewers using Covidence and REDCap.
Main Results:
- This section is to be filled upon study completion.
Conclusions:
- This research will provide crucial insights into optimizing clinical research infrastructure for paediatric medical devices.
- Findings are expected to guide future initiatives aimed at reducing the paediatric-device gap and improving patient outcomes.
- Dissemination will occur through peer-reviewed publications, conference presentations, and professional networks.
Introduction:
The development of paediatric medical devices continues to lag adult medical devices and contributes to issues of inequity, safety, quality and patient outcomes. New legislation and funding mechanisms have been introduced over the past two decades, but the gap remains. Clinical trials have been identified as a pain point, but components of effective clinical research infrastructure are poorly understood. As part of a multimodal research strategy, the Pediatric Device Consortia (PDC) will conduct a scoping review to better understand infrastructural barriers to and facilitators of paediatric medical device clinical research identified in the health sciences literature.
Methods And Analysis:
The following databases will be included for this review: Medline, Embase, Cochrane CENTRAL, Web of Science and IEEE Xplore. Additional grey literature will be sought out through Google Scholar and reviewing the citations of included studies. Included studies will discuss medical devices according to the U.S. Food and Drug Administration classification, focus on the paediatric population (ages 0-21 years) and involve human premarket or postmarket research. All study types that were published in 2007-present in English, Spanish, French or Italian will be included. Using Covidence web-based software, two independent reviewers will screen the resulting titles, abstracts and the full text of potential studies. Conflicts will be resolved by the primary investigator during both phases. REDCap will be used for quantitative and qualitative data charting, generating data tables and narrative synthesis.
Ethics And Dissemination:
This research did not require research ethics board consideration as it does not involve human participants and all data will be collected from published literature. We will share our findings through peer-reviewed manuscripts, clinical and research conference presentations and professional networks available to the PDC.
Study Registration:
Open Science Framework (https://osf.io/k72bn).
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