Hello Breathalyzer Team, A few things to keep in mind to increase the chances for a successful project (from a regulatory perspective):
- Clearly define the area of application: wide area of application (e.g. aeroports, public spaces, schools, etc.) or more restricted area (private use in companies for example). This will have an impact on your need for scaleability.
- Scaleability: can the device easily be manufactured in large numbers?
- Manufacturing/production: What would be the bottlenecks for production? What is the time needed to produce a device (days, weeks, months,..)? Is there a need for special production areas (sterile, low bioburden,...)?
- Device design: Is it complex? Is it simple? How many components will the device have? Is the assembly easy? (for example: would it be possible to make the device in areas that have less complex production sites - such as developing countries)
- Is the device reusable or is it a disposal? (always aim for reusable if possible)
- Important: will the device be used quantitatively (provide a number?) Semi-quantitatively (e.g. reported number is above a certain threshold value)? Or qualitatively (yes/no, positive/negative answer)? This will drive the complexity of the validation/qualification of your device. For a qualitative test it will most likely be sufficient to validate the specifcity and the LOD. For a a quantitative test you are looking at a whole set of validation/qualification parameters (very complex).
- Will this be a broad-spectrum screening device? (meaning: other related viruses will also be detected, or does it have to be very specific to COVID-19)? If the idea is to identify people from the workforce that could also have flu or a cold (and send them home), then broad spectrum may be enough. if it is to be used in a setting where access is denied (e.g. boarding a plane), then the device should probably be very specific.
- Device complexity: keep in mind that the more complex the device, the more components will have to be go through a QC release. You may be able to get away with QC release of the final product, but typically each component has to meet certain quality specs/standards. I will look a bit more into the requirements for medical devices.
- Life expectancy and storage. Can all components be stored at room temperature or are special "cold chain" supply conditions needed? What would be the expiration of the detection components?
- Is detection fast? Is it easy? Does it require complex reactions? I will let you know if I think of some other points.
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