ALM’s Daily Business Review reported on Shook Of Counsel Sonali Gunawardhana’s work to obtain FDA approval for client 3B Medical Inc., a small medical device manufacturing firm headed by CEO Alex Lucio.
In “‘Thinking Ahead’: Shook Hardy Attorney Gets Quick FDA OK to Switch Apnea Devices to Ventilators,” Lucio praised Gunawardhana and her leading of the regulatory approach.
“She is amazing. I love her to death,” Lucio said, of Gunawardhana. “She was able to get us visibility at a very high level.”
Gunawardhana returned the admiration.
“These people were innovative enough to come up with these products, really thinking ahead,” Gunawardhana said.
3B Medical has already converted 2,000 sleep apnea machines to ventilators and is planning on making 10,000 per month for COVID-19 patients.
Gunawardhana, a former FDA attorney, provides FDA counsel to clients on the most effective and persuasive approach to overcoming regulatory challenges.