STAT July 26, 2024
“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 Looking across the industry, I believe the real culprits behind slow innovation in medtech are outdated compliance practices.
Modern software companies are known for moving fast. That certainly isn’t the case for medtech companies. Manufacturers’ antiquated processes and tools hinder productivity and time to market, making compliance programs more expensive and less efficient over time. By...
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