The mood is silent, and everyone is waiting with bated breath for the next phase of this startup journey. "You're going to be excited any day now," my Circuit developer says to me after I pay him the import tax fees for my latest shipment of circuits to his Pakistan workshop. I continue to receive pre-orders on the Housecallsmobile.com website for more stethoscope/otoscopes and continue to give people a vague answer for when the devices will be available for purchase. "Sometime in 2023," is my answer. I tell them that "We are waiting on FDA approval". The honest truth is more complicated than that. I'm still waiting on my circuits to be tested by my engineer in Pakistan so that we can complete our prototype. Once our prototype is complete, we can send our device to UL a testing lab in Chicago so that they can do a test called an "electrical safety test". This test makes sure that the medical device doesn't explode in your handbag when you carry it around. Once our device is determined to be safe, we submit this paperwork to the FDA for FDA approval. I wish this process would just take a few months, but in truth I think it will take many months.
My goal is to move this device through every step that is needed for it to be marketed and sold as a safe and effective medical device. I want all the steps completed and a device that is FDA approved. It MUST be safe and effective to use. I will not cut any corners. People will rely on this device to make accurate medical decisions. It must work perfectly! This is why it is taking so long for my prototype to be ready. I trust my engineer in Pakistan. He and I both know the importance of a safe and effective device. The stethoscope must have crystal clear sound when it is plugged into your smartphone. It also needs to recharge when the battery is running low for safety. If we do this right the first time, there won't be a second time. If we make sure everything works perfectly people will be happy with the device and not complain about its effectiveness. Doctors in developing countries will rely on this device to make remote diagnosis' all over regions of underserved and underdeveloped communities. There will be no other doctor for these patients to see. If the remote diagnosis isn't accurate there will be no other backup for these patients. Medications will be prescribed, and diagnoses will be made depending on what is seen and heard by this medical device. It must be perfect! It will be worth the wait!
