Director Michelle K. Holoubek is quoted in the article “How Firms Can Help Medical Device In-House With Patent Struggles,” published by Managing IP. From the article:
“Michelle Holoubek, director at Sterne Kessler in Washington DC, says companies might have to apply for patents that are very narrow in scope and be very specific about how the invention operates if they’re seeking protection on software as a medical device (SaMD).
‘Or you might have to identify a lot of different uses and practical applications that the software could contribute to,’ says Holoubek…
Holoubek at Sterne Kessler says that if companies are developing SaMD, they might have to look at whether there’s some other product that the SaMD is being incorporated into.
‘If it’s intended to be tied to some other product, they might just rely on trying to protect that product. So the software itself isn’t protected, but it’s not useful until it’s tied to a product,’ she says.”
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