CASE STUDY
Materials development and pilot evaluation of 3D-printed custom-made non-invasive ventilation mask
LONG-TERM CONDITIONS
THEME
UNMET NEED
Children with craniofacial anomalies frequently require non-invasive ventilation (NIV) due to a compromised airway and obstructive sleep apnoea.
However, because of their unique anatomy, finding appropriate fitting face masks is challenging, and failure to effectively ventilate can lead to severe complications such as chronic hypoxia, cor pulmonale, and premature death. Ineffective NIV can also result in the need for a tracheostomy with care packages exceeding £130,000 per year.
Mass produced NIV masks frequently perform poorly on this population as no single mask design can satisfy the needs and requirements of patients with a wide range of characteristics.
PROJECT CONCEPT / SOLUTION
A good fit between the mask and the patient’s face is essential to effectively deliver treatment, which relies on adequate breathing support, but also on the comfort of the mask.
A bespoke NIV face mask prototype for children has been developed using 3D scanning and 3D printing methods during a previous project. The current project builds on this previous work and consists of a review of emerging materials prior to a pilot evaluation of the prototype efficacy, which will de-risk a future multi-centre clinical trial.
SUPPORT PROVIDED
PATIENT INVOLVEMENT AND ENGAGEMENT
Our team helped to facilitate a co-design development process, in which parents, patients, and healthcare professionals were consulted about the design of the 3D printed NIV mask.
PROJECT MANAGEMENT
One of our project manager swas assigned to this project to oversee the work packages and ensure the protocol was followed and timelines adhered to.
FUNDING
This project was funded via the Medical Research Council Impact Acceleration Account funding scheme (£49,000),
STAGE OF DEVELOPMENT
BEFORE SUPPORT
BASIC IDEA
CONCEPT DEVELOPMENT
PROTOTYPE DEVELOPMENT
PROTOTYPE VALIDATION
CLINICAL TESTING
REGULATORY APPROVAL
MANUFACTURING
COMMERCIALLY / PUBLICLY AVAILABLE
CURRENT STAGE
BASIC IDEA
CONCEPT DEVELOPMENT
PROTOTYPE DEVELOPMENT
PROTOTYPE VALIDATION
CLINICAL TESTING
REGULATORY APPROVAL
MANUFACTURING
COMMERCIALLY / PUBLICLY AVAILABLE
POTENTIAL IMPACT
This project aims to further de-risk the technology by applying for and conducting a larger, multi-centre clinical trial using the 3D printed NIV mask prototype.
It is hoped that the results of this trial can lead to an eventual end-point of delivering a clinically adopted bespoke 3D NIV mask service for children in the UK, improving the quality of life of patients, and saving the NHS the significant financial costs associated with supporting a ventilated child with a tracheostomy.
NEXT STEPS
Having been through a material review and an iterative design process, the team is entering into a small scale feasibility trial with patients using the 3D printed mask prototype overnight and comparing it to the commercially available mask they already use. The results of this trial will inform future funding applications for a multi-centre trial.
PARTNERS