Opinion: Medtech compliance — not regulation — is stifling innovation
“Regulation is stifling innovation” seems to be a prevailing opinion among medtech leaders who believe the Food and Drug Administration’s rules are slowing medical device advancements — especially when it comes to software. I couldn’t disagree more.
As someone who has led artificial intelligence (AI) and machine learning (ML) efforts at Amgen, I’ve seen firsthand how vital these regulations are for keeping patients safe. Looking across the industry, I believe the real culprits behind slow innovation in medtech are outdated compliance practices.
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