It is time to apply our DNA Launch Plan

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Spoiler Alert: Missing 98% of procedures & records!

The first step of our unique process is the DNA Launch Plan, which allowed us to know exactly where Neopenda was in the Product Development Lifecycle through a deep assessment of their design, process, risk management, regulatory, clinical, testing etc. This information also resulted in a clear strategy and blueprint to make Neopenda compliant and with a bulletproof process that executes high quality product launches, which translates into early de-risking that makes you more attractive to investors, #regulatorysexy!

What we uncovered: Ready to Launch?No Way Jose!

MISSING 98% of Procedures & Records. Without these requirements, it would had been nearly impossible for Neopenda to develop a safe and effective device that could be cleared by the regulatory bodies. In addition, they would had never passed an inspection by regulatory bodies. I can promise you that if you are missing these requirements, a regulatory inspection will be one of the most tense and painful experiences costing you tens, maybe hundreds of thousands of dollas to adddress any observations to fix your quality system - design controls process.

MISSING Critical Certifications. Their desired contract manufacturer at the time was missing its heart 🙉: the ISO 13485 certification! Neopenda had communicated to us that the contract manufacturer was ISO certified. However, when we asked for a copy of the certification, it was revealed that it had been dropped a couple of years ago. They had procedures in place but simply put, without this certification, a Notify Body would not grant a CE Mark, and subsequently there would be no chance of launching the neoGuard to the market.

Open to RISKS. They had previously consulted out the creation of a Product Design Specification matrix, which documents all the necessary requirements and constraints the new design must adhere to. However, the sources for user needs were recorded in an improper manner that made them susceptible to have challenges during an audit and potentially fail such audit. In addition, no risk management activities had been conducted and considered in the design specification. If the latter had not been addressed, they would had also been susceptible to design issues, and in the worst case scenario recalls. 75% of FDA recalls are due to design, #nobueno!

You don't know what you don't know...

Sona and Tess, CEO and CTO, are very intelligent and capable female innovators who had every reason to believe that they were ready to go. Medical device regulation is like black holes that only start making sense after spending many years studying them at NASA, and in this case many years in medical device product development. Hence, they had no way to learn this prior, and of course they thought they were ready as most new med tech innovators do after spending years optimizing and testing their tech.

This knowledge is not readily accessible which is one of the main reasons for Genius Shield existence! Genius Shield is here to bridge that gap, educating how to best navigate and implement regulation and quality like the top med device corporations. This should not be the reason for your brilliant possibly world changing medical solution not to get to market!