Joseph C. Guagliardo, a partner with Pepper Hamilton, a co-leader of the firm's Technology Group and chair of the Blockchain Practice, was quoted in the May 31, 2018 Healthcare IT News article, "As FDA Signals Wider AI Approval, Hospitals Have a Role to Play."
Joseph Guagliardo, partner at Pepper Hamilton LLP, specializes in technology and intellectual property commercialization, with a focus on emerging technologies such as AI and blockchain.
FDA has made it "pretty clear that it's got a number of (approvals) in the pipeline," said Guagliardo. "And I know from having clients in this space that are looking for FDA approval that they are very bullish on their products and the prospect of getting FDA approval as a medical device in the AI space."
He noted that, once specific types of devices gain approval, it generally "makes it easier for follow-on devices that are similar to get approved, assuming they're doing what they're supposed to be doing and have positive clinical results."
In the near team, Guagliardo expects to see "an exponentially greater number of companies seeking FDA approval," so much so that may even have start impact agency's "ability to get to all the innovative products that are in front of them."
Guagliardo added that it’s important to partner with the provider side that has the data.
"You could have two algorithms that perform differently, one from the other, but a big part of the success will be dependent on the partnerships they have on the provider side, who has the data. The clients that I advise right now are primarily watching what happens with the regulatory landscape,” said Guagliardo, gathering data so they'll be able to make sound presentations to the FDA eventually. "They're focusing on having the right relationships to get the right data."
Moving forward, he said he expects those relationships to lead to more and more useful devices that stand a good shot at gaining FDA approval.
"I think we'll see a greater number of lower-risk solutions," he said. "But I think we'll start to see an evolution where there are medical devices that will be used to diagnose more severe or higher-risk conditions. The FDA has been pretty clear that they're starting with lower-risk disease states and then they'll progress over time."