Neopenda and the fight against COVID-19.

Now more than EVER we need Medical Innovation to WIN the fight against COVID-19! When we helped our client Neopenda to become regulatory and quality compliant to develop the neoGuard, a vital signs monitoring device for newborns in the developing world, we HAD NO IDEA that we were actually helping to develop a device that can now be on the frontlines of our global war on COVID-19.

Yet that is exactly what happened. The World Health Organization recently declared pulse oximeters as critical items for COVID-19 response, and the neoGuard does just that. These devices are helpful in detecting oxygenation problems and elevated heart rates, significant signs of COVID-19.

The neoGuard was not always ready to fight COVID-19. Neopenda is an amazing female founder company innovating technologies to save the lives of newborns in the developing world. We immediately recognized the impact of this genius invention that must exist in this planet and wasted no time to swipe right on them! They had been working on this technology for 3 years, and they thought they were close to regulatory submission. However, once we applied our DNA Launch Plan, they were MISSING 98% of the procedures and records required... so what now?!

#nobueno... what else were they missing? Are you missing these too? Find out here!

The neoGuard can now be a WARRIOR against COVID-19. Neopenda has submitted for FDA Emergency Use Authorization (EUA) of the neoGuard. The EUA translates into the FDA "relaxing the rules" to expedite and get devices to patients who need them under this pandemic. However, it is not enough for the FDA and companies to be Speedy Gonzales, as we MUST also respond correctly because what is worse than not having oximeters, is having oximeters that don't work and could harm patients!

In fact, the FDA has now issued nearly as many warning letters to companies with COVID-19 products as the number of EUA's issued thus far. Because of all the work we did with Neopenda, I am proud and confident to say that Neopenda has a robust regulatory and quality system that shields them from warning letters and ensures the neoGuard is safe and effective for patients.

What do I do with this information now? If you know a visionary innovator whose brilliant invention has the potential to help WIN the fight against COVID-19 and to shield and save patients, please forward this email.

And if YOU ARE that visionary innovator, click the BOOK A CALL button below to learn more about how Genius Shield can help you bring your invention to market and or through the FDA's EUA program to get your test kit, IVD, PPE, or other applicable product expedited approval like only the Genius Shield team can!

May the innovation force be with you!