Hey, thanks a lot for your comments and for your encouragement! :)
Have you or anyone you know gone through this process before?
I ask because I’m a programmer (my friend is the cell biologist) and so what I’m familiar with is making a quick MVP to show to a party responsible for doing the purchasing.
To answer your questions: the research is all done and we can make a demo of the diagnostic in a long weekend; our results so far are not on patients, just culture lines; and there’s no need to do comparative trials since antibiotic tests in use in hospitals all require culturing which takes far longer than our method.
I haven’t gone through the process, but I work at a publishing house specialized in medical literature, and I’ve learned some things about drug development.
After you file your patent, I recommend you partner with a university hospital to run trials on patients. (As a routine step, the hospital’s ethics committee will ask to review your study protocol to check that it complies with the Helsinki Declaration on human experimentation.)
It’s very important to test your method on samples taken from patients, though you may start with lab animals divided in groups whose infection status you’re blind to. With culture lines you already know what’s in the Petri dish; now you need to see whether it detects the right organism when you don’t know what the patient has, or whether it’s actually an infection in the first place. Parameters other than speed (namely, diagnostic sensitivity and specificity) will be essential in positioning your method against the existing ones.
Edited to add: you also need those trials to find out whether there’s any class of germs that your method cannot detect. I don’t think you have tried with all possible pathogens.
Hey, thanks a lot for your comments and for your encouragement! :)
Have you or anyone you know gone through this process before?
I ask because I’m a programmer (my friend is the cell biologist) and so what I’m familiar with is making a quick MVP to show to a party responsible for doing the purchasing.
To answer your questions: the research is all done and we can make a demo of the diagnostic in a long weekend; our results so far are not on patients, just culture lines; and there’s no need to do comparative trials since antibiotic tests in use in hospitals all require culturing which takes far longer than our method.
I haven’t gone through the process, but I work at a publishing house specialized in medical literature, and I’ve learned some things about drug development.
After you file your patent, I recommend you partner with a university hospital to run trials on patients. (As a routine step, the hospital’s ethics committee will ask to review your study protocol to check that it complies with the Helsinki Declaration on human experimentation.)
It’s very important to test your method on samples taken from patients, though you may start with lab animals divided in groups whose infection status you’re blind to. With culture lines you already know what’s in the Petri dish; now you need to see whether it detects the right organism when you don’t know what the patient has, or whether it’s actually an infection in the first place. Parameters other than speed (namely, diagnostic sensitivity and specificity) will be essential in positioning your method against the existing ones.
Edited to add: you also need those trials to find out whether there’s any class of germs that your method cannot detect. I don’t think you have tried with all possible pathogens.