Click to play
MassDevice Podcast: Soteira CEO Larry Jasinski (MassDevice)
Soteira CEO Larry Jasinski talks to MassDevice about overcoming the odds with spinal fusion devices and managing a 510(k) win even after the FDA switched things up mid-stream.
Soteira CEO Larry Jasinski is no stranger to adversity.
In the last 5 years the spinal fusion device maker has overcome criticism from the research community and mid-application surprises from the FDA, but its newest 510(k) win is a testament to its persistence.
The Natick, Mass.-based vertebroplasty firm emerged from stealth mode once again at the end of last year to announce that it finally landed clearance for its Shield kyphoplasty system and is preparing for market launch
Being low-key is part of the company's character, Jasinski toldMassDevice, but so is tenacity.
When the FDA suddenly shifted its expectations of the Shield application, after having agreed to a pathway to clearance with Soteira, Jasinski didn't fight the reviewers – he went over their heads.
"For any companies that are working in this space, I would have to encourage you to work further up the chain with the FDA if you have challenges along the way, because yo...
