This startup journey is never dull! As I navigate this process from idea to delivered product, I continue to hit barriers I would never have dreamed would occur. A little recap for people new to this Startup-life story. I invented a 'virtual' stethoscope/otoscope in 2019. The concept came to me when working as a nurse practitioner and realizing I can only physically see so many patients in a day and I could care for so many more people if I could see them remotely. I worked with the local University (Cal Poly) to create a working prototype of my medical device. This device functions like a regular stethoscope and otoscope (tool medical provider uses to listen to heart/lungs and look into ears during physical exam), but it plugs into your smartphone or tablet and can be used during a telemedicine visit for a complete physical exam remotely. I invented this device before the pandemic when I knew telemedicine was the future of healthcare. I have a patent on my medical device which was issued this year and am now going through the process of FDA approval so I can manufacture these medical devices worldwide to increase access to healthcare for everyone, everywhere.
Currently I have been working with my circuit developer in Pakistan to make this device have crystal clear sound. We have made a circuit that filters out high and low frequency noises so that the sounds from your cloths don't interfere with the sounds of your heart and lungs. We also had to create some safety mechanisms for FDA approval including a low battery light, on off switch and emergency battery shut off if it overheats. After successfully making this circuit for my 'virtual' stethoscope/otoscope we made a updated prototype. My circuit developer was going to send me a copy of the latest prototype by mail so I can have my biomedical engineer update the design. He would just send me the box with the new circuit, wires and stethoscope attached by mail. Sounds good to me. Never thought this would be an issue. I'm so naive. One month goes by, two months go by.... Humm what’s the delay? Well, he gets a knock on the door by US customs officials. Why is he sending a box in the mail with wires, a battery, and a circuit from Pakistan?! Haha, you have to laugh, or you'll cry. Wonder what they thought he was sending me? Yeah, they thought he was sending me a bomb! Ugg! Ok, round two. We'll take out the battery and stethoscope and just send the box with wires. Meh, still no good. They flag him in Pakistan customs still asking him "Why are you sending a box with wires to the US?' Finally, he gives the package to his friend who lives in Dubai and sends it from a different country. Really! So sad! We discovered its easier to just have the product manufactured in China and sent directly to the US than have it sent from Pakistan. What a world we live in!
Now, dust ourselves off from the customs incident and with new prototype in hands onto the next step- design modifications and FDA approval. I have two summer interns working with me who are Pre-med students from UC Berkeley! I am so proud of them both! This summer we are going to put together the FDA 510K approval packet including our Safety testing from my circuit developer in Pakistan. My interns are going to help put the packet together for submission! Little by little, step by step this process is going to proceed! Onward we go!