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Hello Breathalyzer Team, A few things to keep in mind to increase the chances for a successful project (from a regulatory perspective):

  1. 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.
  2. Scaleability: can the device easily be manufactured in large numbers?
  3. 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,...)?
  4. 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)
  5. Is the device reusable or is it a disposal? (always aim for reusable if possible)
  6. 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).
  7. 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.
  8. 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.
  9. 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?
  10. 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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