Testing Regulations

To produce a safe and useable product, testing is emphasized in this section. Testing ensures that the product will meet the design criteria that we have established and to make the treatment safe for patients. Our product holds limitations due to the need for testing. For example, the CGM must firmly attach to the skin. DHCA has not been tested on skin, thus biocompatibility must still be tested. Also, the true cause of the adhesive properties must be found, be it the catechol groups alone, or extensive hydrogen bonding [23]. The hydrogel, which we are using to minimize an immune response and aid in glucose diffusion, could potentially pose a problem in diffusion, and the thickness of the hydrogel could cause difficulties in needle insertion and/or discomfort. Thus, proper production and porosity need to be confirmed.

We would also need to test each component of our CGM. We would need to test the sensors in cultures containing glucose to see how well the chemical mix works and how much solution needs to be applied in each insertion.

We will need to make sure that the magnet in our wireless charger does not interfere with the blood glucose readings along with making sure that the percent mean absolute relative difference [%MARD] for our CGM software is lower than 10%.

We will need to test the mussel-mimetic glue adhesive to see how strong it must be for the transmitter.

We need to test which probable regions the sensor can be inserted into the skin in a clinical trial setting to confirm that multiple locations are eligible than what was previously established for ease of treatment.

Lastly, we will need to conduct a clinical trial to have our product readily be utilized by patients.

This will give us feedback to fix any bugs in software or to adjust measurements. Once we have refined our products, we will need approval by the FDA as it is considered a class II classification due to the similarities among the devices created already [34]. This is because our model takes inspiration from other CGMs such as Freestyle Libre Flash and eversense®. We could hopefully achieve substantial equivalence for a class II 510 (k) premarket notification to more quickly get through clinical trials.

FDA approval takes a long time and requires a large sum of data, but this is a crucial step in order for us to deliver our product to the public.

 

 

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