The challenge
Reduce air leaks, pressure points and discomfort in CPAP/NIV therapy while meeting clinical, anatomical, functional and regulatory requirements.
Ongoing R&D project · 2025—2028
RESEARCH & DEVELOPMENT
SereniOxy: better breathing starts with a perfect fit
A project led by NM3D Ibérica to develop CPAP/NIV oronasal masks tailored to each person's anatomy, combining mobile facial scanning, engineering, advanced materials and additive manufacturing.
SCANNING · DESIGN · MANUFACTURING
OperationSereniOxyCOMPETE2030-FEDER-01493900
Period05.05.2025Expected completion: 03.05.2028
Eligible investment1 977 691,36 €Collaborative R&TD projects
ERDF grant1 433 011,45 €Total approved funding
Co-financing72%Centro and Norte regions
THE PROJECT
Clinical personalisation through a complete digital and industrial chain
Anatomical differences between users can affect the seal, comfort and effectiveness of conventional masks. SereniOxy is researching a personalised, scalable and traceable approach based on actual facial geometry.
The solution
An intuitive app captures the face using a mobile device and generates the data needed to adapt the mask's flexible interface to each user.
Industrialisation
The personalised cushion is produced using additive manufacturing; the rigid frame is designed for injection moulding, combining personalisation, repeatability and scale.
FROM USER TO SOLUTION
A mask designed around each person.
SereniOxy connects facial anatomy with engineering decisions. The research aims to adapt the mask's contact area to each user, considering fit, seal and everyday use.
The context of use guides the design.
Rest, movement and home routines help define requirements for comfort, stability, fitting and interface maintenance.
Home use · Concept visualisation
Personalisation begins with facial geometry.
Mobile capture provides the basis for reconstructing facial shape and studying how the flexible cushion can be adapted to its anatomical features.
Facial capture · Concept visualisationFROM FACE TO PRODUCT
A coordinated, traceable digital workflow
The process connects data acquisition, engineering and production in a single chain, with validation at each stage.
01Facial captureCapturing facial morphology using a mobile device.
023D reconstructionProcessing and validating geometry before development.
03Personalised modellingAdapting flexible contact to the captured anatomical features.
04Manufacturing and assemblyAdditive manufacturing of the cushion and integration with standard components.
05Delivery and follow-upMonitoring production, logistics, use and lifecycle.
NM3D'S ROLE
Engineering to connect data, product and production
NM3D Ibérica leads the project and its technical management, contributing to requirements definition, 3D scanning, manufacturing-resource analysis, prototyping, dimensional validation, technology monitoring and integration of the digital workflow with manufacturing.
3D scanning and metrologyGeometry acquisition, CAD-to-part comparison and non-destructive dimensional inspection.
Medical additive manufacturingSLA prototyping with materials suitable for validating shape, assembly and performance.
Product engineeringTechnical requirements, tolerances, concept iteration and integration of rigid and flexible components.
Industrialisation and traceabilityConnecting the app, data, production, inspection, logistics and product follow-up.
WORK PROGRAMME
Eight activities, from research to validation
The plan combines clinical knowledge, technical development, prototyping, evaluation and preparation for future adoption.
A1Knowledge and requirementsRegulatory framework, clinical and anatomical parameters, and material, product and process requirements.
A2Concepts and construction solutionsConcept generation and selection, mobile app, materials and industrial resources.
A3Product, processes and digitalisationModelling, structural and fluid simulation, prototypes, facial capture system and assembly.
A4Prototype manufacturingTooling, manufacturing-process refinement, functional prototypes and final assembly.
A5Preclinical evaluationFunctional and operational testing of safety, performance, ergonomics, comfort and usability.
A6Product monitoringDurability, service life, lifecycle assessment, recyclability and technology monitoring.
A7Promotion and disseminationSharing technical and scientific results and showcasing national capabilities.
A8Technical managementConsortium coordination and monitoring of technical, scientific and financial implementation.
APPLIED RESEARCH
Data-driven iterative development
The concept evolves through successive cycles of scanning, design, manufacturing, measurement and correction, reducing uncertainty before validation stages.
Explore the project at PIEPNote: SereniOxy is an ongoing research and development project. Clinical use and commercial availability depend on completion of the applicable testing and regulatory validations.
01
Benchmarking and requirementsAnalysis of existing CPAP solutions and definition of fit, seal, material, safety and process criteria.
02
Scanning and CAD3D scanning of the reference and facial models to support geometric concepts and CAD iterations.
03
Additive prototypingIterative SLA production to check fits, thicknesses, assembly, finish and the behaviour of flexible components.
04
CT inspection and comparisonCT inspection of prototypes and comparison with the nominal model to locate deviations, deformation and thickness variations.
05
Simulation and validationDevelopment of structural and CFD methodologies, material selection and preparation of preclinical and environmental testing.
DIGITAL ECOSYSTEM
More than a personalised component
The solution envisages an app to support facial capture, ordering and production tracking. The architecture under study combines accessible RGB cameras with higher-precision depth sensors where appropriate.
View the operation on COMPETE 2030
COLLABORATIVE INNOVATION
A multidisciplinary consortium
Combining engineering, clinical knowledge, polymers, software and production creates an integrated approach focused on safety, performance and future adoption of the solution.
NM3D IbéricaLeadership, technical management, scanning, prototyping, metrology and production integration.
EnsooriginsMobile app, user experience and facial scanning technologies.
PlastarInjection-moulding engineering and industrialisation of rigid components.
ESEnfCClinical and anatomical requirements, ethics, usability and preclinical evaluation.
PIEPProduct design, materials, simulation, testing and lifecycle assessment.
FUNDING
Research and innovation supported by the ERDF
An operation under objective RSO1.1 — promoting research and innovation — and the “Projetos de I&DT (SI)” category, covering SME research and innovation activities, including networking.
Lead beneficiaryNM3D Ibérica — Sistemas de Metrologia Industrial, Lda.
CodeCOMPETE2030-FEDER-01493900
Total eligible cost1 977 691,36 €
Approved funding1 433 011,45 €
Co-financing rate72%
RegionsCentro and Norte
OFFICIAL INFORMATION
View the project and its framework
HAVE A RESEARCH CHALLENGE?
From a need to a practical solution
Share the problem, the context of use and the result you want to achieve. NM3D helps structure the technical workflow, bring together the right expertise and turn knowledge into a product.