Premature birth is the #1 cause of infant mortality in the United States. Improving the quality of life matters, especially from the moment the most delicate type of patient is born.
Today’s guest is Amir Fassihi, CEO and founder of Amnion Life. The company is developing AmnioBed, a medical device that aims to save the lives of preterm born infants.
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Some of the Episode highlights include:
- Any minor insult or trauma from the environment that a baby born early suffers from could have devastatingly decades-long consequences to the human body.
- To help prevent complications, Amir dreamt that preemies should be in synthetic amniotic fluid called, Amnion. He started Amnion Life to turn a dream into reality.
- Due to the cost and complexity of developing the AmnioBed medical device, Amnion Life selected to work on it with qualified Serbian engineers.
- In 2019, Amnion Life plans to do testing and verification of AmnioBed. In 2020, it will begin conducting clinical trials.
- Amir hasn’t faced typical issues that founders of startups experience. He doesn’t need to take salary from the company, works remotely, and has flexible hours.
- Why didn’t anybody develop such a medical device sooner? Proper guidelines and standards didn’t exist years ago to know how to build a safe device.
- Amnion Life creates the same content of a womb’s amniotic fluid, but purifies it by filtering out toxins and other substances to become dialysis-grade water.
- Be patient and take things in stride. Startup founders/CEOs don’t need to be an expert on everything; surround yourself with the right people.
FDA Medical Device Guidance
Memorable Quotes from this Episode:
“The things that you’re developing and bringing to market are really about trying to improve the quality of life of maybe the most delicate patient group there is.” - Jon Speer
“Any minor insult or trauma from the environment could have devastatingly decades-long consequences for the human body.” - Amir Fassihi
“Entrepreneurs - they have to put their heart and soul and time into the company, and they need to pay rent, too.” - Amir Fassihi
“This is a live human being going into a system at a very, very critical stage in life. It has to be as safe as sending an astronaut on a spaceship to the moon.” - Amir Fassihi
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MedTech True Quality Stories Podcast, powered by Greenlight Guru, takes listeners on a storytelling journey through personal narratives of MedTech executives who offer real-world, actionable advice to industry leaders for guidance towards future imagination, implementation, and innovation of True Quality medical devices.
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