Title: Development of the “BreathEasy”: a Non-Contact, Hand-held Device for Measurement of Respiratory Rate (CPRM).
Funder: Department of Health (England)

Abstract: The overall objective of the Project Plan is to produce a functional prototype CPRM appropriate for clinical use. This will be visually acceptable to patients, particularly children and ergonomically optimised for professional users. The prototype CPRM is to be a non-contact device, an important feature since one prime application will be in monitoring acutely ill children. With no direct contact, the CPRM will be tolerated, providing an accurate measure of RR without causing distress. The Project Plan comprises a series of WPs which are summarised above by content (see Aims and Objectives). WP 0 – Project Management Resource framework for effective coordination and management by the PI of other WPs in order to meet the overall objective. When the CPRM progresses to commercialisation it will be the first accessible and feasible contactless device for routine monitoring of RR in acutely ill patients. WP 1 - Analysis and Product Specifications for the CPRM Broad-based, including electrical circuits, software (digital signal processing, device control and management), a user interface and communication ports to a PC. In addition, the outer casing, including materials and infection control requirements will all be specified. WP 2 - CFD Modelling – Heat Chamber Design will be CFD modelling dependent; this will address chamber expired air capture efficiency; heating, direction of heated air; commercial software to be used for algorithms and to derive turbulence models; comparisons using wind tunnel at UoL. Chamber volume, respiration-point-to-capture-point distances, air directionality and velocity to be established. Final CFD-derived chamber sizes to be rapid prototyped and wind-tunnel tested at UoL. WP 3 - Electronics and Software Development Integrate on-board microprocessor; develop user interface (to read data from user and display information); transfer of recorded data to a PC; design and integration of battery power supply unit. PCB design and manufacture; standards-compliant component selection; modular approach; miniaturisation favoured e.g. by using programmable hardware. Software mostly written for effective signal processing and hardware communication; bench-testing of overall integrated CPRM electronics. WP 4 - Hygiene Mechanisms The CPRM must not harbour nor spread pathogens; potential sources/nidus locations will be identified and eliminated; potential infection/contamination limiting solutions: micro-filter at air inlet and outlet, disposable heat chamber, virus resistance component coatings; disinfection docking mechanism. WP 5 - CPRM Prototype Case Design Follows WP 4 and comprises aesthetic styling and ergonomics; includes involvement of and contact with professional and patient focus groups by the designer. WP 5a – Product Integration – Produce First Prototype CPRM Outputs from WPs 2–5 will be tested as sub-assembled componentry and subsequently integrated and hand assembled. The full assembly will be tested and a 3rd party ISO 13485:2003/12 compliant medical device manufacturer engaged to produce a small number of proof prototypes. MILESTONE 1 WP 6 - Regulatory Affairs Documentary preparation for compliance with prevailing legislation including Directive 93/42/EEC and applicable ISO standards. Timely preparation and submission of documents seeking ethical clearance and MHRA approvals. WP 7 – Clinical Evaluation A volunteer study of the CPRM against gold standard RR measurement devices to validate function and compare performance. WP 8 - Market Research, Health Economic Modelling Basic market research and construction of a partial health economics model was done for this Application; both areas to be significantly expanded and developed. Translation of findings supporting the CPRM into a business case to for commercialisation. WP 9 - IP and Commercialisation Prosecute IP and expand, if possible. Potential partner review will be revisited by RE throughout the Project. Investigation of potential for market segmentation e.g. into acute medicine and, say sleep medicine. All conventional paths to market including licensing, spin-out and joint venture to be kept open.


Research activity codes: 6.3 MEDICAL DEVICES;5.3 MEDICAL DEVICES
Health categories: GENERIC HEALTH RELEVANCE