Presentation
MDD3 - A System for Customized Pediatric Medical Devices and Products
SessionPoster Session 2
DescriptionThe development of customizable medical device solutions for dynamic healthcare environments requires both device and process innovation, often incorporating many layers of transdisciplinary research. Despite the complexity of transdisciplinary research in the medical setting, there is tremendous need to develop customizable solutions for pediatric patients. Pediatric medical device innovation lags nearly 10 years behind their adult counterparts and, often, there are significantly fewer options on the market.
The purpose of this research is to present a case study for the design and process of creating on demand, customized and adjustable pediatric respiratory masks for long-term Non-Invasive Ventilation (NIV) in both hospital and home settings. The process presented is the first step in creating a portfolio of customizable devices for kids where standard form and fit do not serve all patients.
The process developed included human factors systems understanding, technology selection and aplication, design development, and robust bench and clinical testing. Through research and development, a procedure was developed and tested for on-demand manufacturing of customized NIV mask interfaces for pediatric patients in a hospital or home environment. The process steps included: 1) the evaluation of technology and establishment of a systematic 3D scanning process for dynamic PICUs and NICUs, 2) Customer discovery & System Understanding qualitative research, 3) Material and design parameter development for the facial interface, frame, and head harness of the mask, 4) the development of a post-data processing procedure to utilize pediatric 3D data for customization, 5) the creation of an automated parametric module to design custom masks, 6) the development of Good Manufacturing Practices for on-demand design components using 3D scans of the face and 3D printing, and 7) the development of a robust testing platform for bench testing and clinical evaluations of the design components on real patients for acute leak, fit, and comfort.
The purpose of this research is to present a case study for the design and process of creating on demand, customized and adjustable pediatric respiratory masks for long-term Non-Invasive Ventilation (NIV) in both hospital and home settings. The process presented is the first step in creating a portfolio of customizable devices for kids where standard form and fit do not serve all patients.
The process developed included human factors systems understanding, technology selection and aplication, design development, and robust bench and clinical testing. Through research and development, a procedure was developed and tested for on-demand manufacturing of customized NIV mask interfaces for pediatric patients in a hospital or home environment. The process steps included: 1) the evaluation of technology and establishment of a systematic 3D scanning process for dynamic PICUs and NICUs, 2) Customer discovery & System Understanding qualitative research, 3) Material and design parameter development for the facial interface, frame, and head harness of the mask, 4) the development of a post-data processing procedure to utilize pediatric 3D data for customization, 5) the creation of an automated parametric module to design custom masks, 6) the development of Good Manufacturing Practices for on-demand design components using 3D scans of the face and 3D printing, and 7) the development of a robust testing platform for bench testing and clinical evaluations of the design components on real patients for acute leak, fit, and comfort.
Event Type
Poster Presentation
TimeTuesday, April 14:45pm - 6:15pm EDT
LocationFrontenac Foyer