Does the FDA Slow Medical Technology Innovation?

Even a progressive understands the harm of excessive regulation:

I’ve been using the metaphor of “throwing pebbles in a stream” to describe the effect of regulation on innovation. No single regulation or regulatory activity is going to deter innovation by itself, just like no single pebble is going to affect a stream. But if you throw in enough small pebbles, you can dam up the stream. Similarly, add enough rules, regulations, and requirements, and suddenly innovation begins to look a lot less attractive.

There are now more than one million federal regulations. For medical device manufacturers the regulatory approval process takes 54 months in the U.S., compared to only 11 months in the EU. Some would say this protects us from harmful devices. But the flip side is that potentially life-saving devices are denied us for years.

A simple compromise is to let the government identify a product as safe or not, but let it be advisory, not prohibitory. Let consumers be free to choice. If a patient and her doctor decide that a not-yet-approved device is the best chance to save her life, let them be free to choose that device. If another patient and his doctor decide not to try an unproven device, then let them wait for regulatory approval.

Leave a Reply

Fill in your details below or click an icon to log in: Logo

You are commenting using your account. Log Out /  Change )

Google photo

You are commenting using your Google account. Log Out /  Change )

Twitter picture

You are commenting using your Twitter account. Log Out /  Change )

Facebook photo

You are commenting using your Facebook account. Log Out /  Change )

Connecting to %s