To create a disposable OPEP device, eliminating the infection risk associated with re-usable respiratory devices.
The solution had to be simple to use, mechanically equivalent to commercial devices, and cost effective as a daily disposable.
The final design was successfully tested in both Cystic Fibrosis and COPD cohorts as part of an HPRA clinical investigation.
Patients with hypersecretory disease such as cystic fibrosis and productive COPD use OPEP devices as part of their Airway Clearance Therapy (ACT). OPEP device work by creating increased intra-pulmonary pressure to splint open collapsed airways, while oscillations help to thin the mucus in the respiratory tract making it easy to remove. OPEP devices are largely hand-help, reusable devices that require daily, or ever more frequent, cleaning to prevent the build-up of pathogens.
The Solopep project originated from an observation made by a paediatric CF patient attending clinic in UHL. The patient noted a discolouration in a component of their current OPEP device, which was found to be s. maltophilia – an emerging nosocomial pathogen associated with opportunistic infections in patients with cystic fibrosis. Stemming from that observation, a multi-disciplinary team was formed between UHL, the School of Medicine, and the School of Design in UL to address the issue of these reusable devices potentially acting as reservoirs for pathogens.
The project was supported under an Enterprise Ireland CF Grant of €460,000.
The objective of the Solopep project was to create a disposable OPEP device that had equivalent mechanical performance to commercially available devices but without the need for cleaning.
Using 3D printing to rapidly iterate concepts and garner feedback from patients and HCPs, the Solopep device was brought through the Medical Device design process and was successfully trialed in both CF and COPD cohorts. The design was granted patent protection in both the EU and US, and the spinout out company formed from the University, Solopep Ltd., was acquired in 2020.