User Feedback

Since the L.A.S.S.O. was designed using input from the CF community we wanted them let us know how well it worked. It was essential to the team that possible future users could use the prototype. Therefore, we took the L.A.S.S.O. back to the our local CF clinic in order to get possible future users to have a go at testing the device.

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Audit

We had an ISO 13485 certified auditor look through our documentation for the L.A.S.S.O. and perform a mock audit to highlight any additional steps we could take to have a product that is as industry-ready as possible. In addition to receiving suggestions about how to improve our documentation (which have been acted upon) we were informed of the following:

In Europe, to obtain a CE mark there are three devices directives:

• Medical Device Directive
• Active Implantable Device Directive
• In Vitro Diagnostics (IVD) Directive

According to the auditor our device, while being “active”, is classed as an IVD and therefore if we were to optimise our device for uptake by a manufacturer we could streamline the process further by satisfying the criteria laid out in the IVD directive. This is being investigated currently.

A product life cycle is split into stages:

• Proof of concept/Feasibility
• Optimisation
• Verification
• Validation
• Launch
• Post Market surveillance
• Withdrawal from the market/end-of-life

We are in the early stages of the above list, with Proof of concept/Feasibility being our main achievement thus far. Optimisation is being carried out currently by testing our device with variable levels of luminescent input. Verification will be carried out by clinical trials with homogenised sputum samples, a portion of which would be analysed by microbiological means (serial dilution and culturing for CFU count and sequencing/PCR for bacterial species identification) to ensure that our device is accurately and reproducibly giving readings of bacterial species and load.