Case Study
3D-printed custom-made non-invasive ventilation masks for respiratory failure
LONG-TERM CONDITIONS IN CHILDHOOD THEME
Ensuring children, who have small or asymmetrical faces, can receive comfortable and effective breathing support with custom-made non-invasive ventilation masks.
Unmet Need
Fitting masks appropriately for non-invasive ventilation (NIV) in children remains a significant challenge, particularly for patients with craniofacial differences. Poorly fitting masks can reduce the efficacy of the treatment due to leaks, discomfort, and disrupted sleep. Without NIV, invasive ventilation and surgical procedures may be needed which reduce patient quality of life and cost up to £130,000 per patient per year in the NHS.
Solution
A good fit between the mask and the patient’s face is essential for effective respiratory support and comfort over long periods of time. This project designed and created a process for developing custom-made NIV masks with 3D scanning and printing methods for individual patients, ensuring each child needing NIV gets a bespoke, properly fitting mask that delivers comfortable and effective respiratory treatment.
Support Provided by the HRC
Professor Heather Elphick, Clinical Lead for our Long-Term Conditions in Childhood Theme and Consultant in Paediatric Respiratory and Sleep Medicine at Sheffield Children’s, led the project alongside the clinical and research teams.
PROJECT MANAGEMENT
PATIENT & PUBLIC INVOLVEMENT & ENGAGEMENT (PPIE)
SECURING FUNDING
Project Progress
FROM
TRL STAGE 1
TO
TRL STAGE 5
Outcomes & Impact
So far, the project has engaged with patients and healthcare professionals to successfully design, develop, and pilot prototypes of custom-fit masks.
INCLUSION IMPACT
Children and young people and other key stakeholders have been actively involved during the development process to ensure the masks are developed with the patients’ needs in mind. Patients, families and healthcare professionals will soon get the opportunity to choose the final mask/headset prototype in a series of workshops led by the NIHR HRC PCH.
CLINICAL EVALUATION
An early study with adult volunteers was instrumental for developing a functioning prototype of the headgear and mask system.
A pilot evaluation with children and young people demonstrated that customised masks and headgear may improve the comfort and clinical efficacy of NIV.
FUNDING LEVERAGED
This project has leveraged nearly £1 million from competitive funding streams and prestigious organisations including NIHR, NHS England, Medical Research Council, Action Medical Research, and Sheffield Children’s Hospital Charity.
Funding so far has supported prototype development, early proof of concept work and subsequent clinical evaluations, patient and public involvement and engagement (PPIE), health economics analysis, and development of an automated design pipeline.
PUBLICATION & DISSEMINATION
There are multiple publications showing the progress of this project including PPIE (Barker 2019), prototype development and evaluation with adult volunteers (Willox 2020), materials review and review of scanning technologies (Willox 2021), and a pilot clinical study for children (Broadbent, 2026).
Sheffield Children’s Hospital charity shares Leo’s story and how this project transformed his night-time routine.
This project has been presented at several conferences, including the Child Health Technology Conference in 2023 and 2025, and was awarded Best Paediatric Project in 2021 and the Lyn Davies Innovation Award in 2025 by the British Sleep Society.
Quotes
“It’s been amazing, the difference is night and day. His quality of life, his sleep, his comfort, all of it, amazing.”
Lucy
Mum of Leo, a nine-year-old patient at Sheffield Children’s
“You are unique and could be the kernel of a national service that would reduce our inadvertent discrimination against patients with facial deformity. Such a service would fall under DOH’s remit to use innovation to improve healthcare access in the 10 Year Plan”
Endorsement
Association of Respiratory Technologists and Physiologists (ARTP)
Next Steps
Building on the success of the trial and a pilot evaluation in children, funding is being sought to begin a multi-centre trial sponsored by Sheffield Children’s Hospital.
Children and young people will continue to be involved throughout the project and ensure the end product provides the right support: comfortable and effective respiratory treatment during NIV.
Partners
