Kid-Sized Medical Devices

Bad-Medical-Devices Blog asks Are Financial Incentives to Encourage Kid-Sized Medical Devices a Good Idea? I believe the answer for that is yes. The company I work at initially thought we would submit our device and a smaller one for pediatrics. The boss called the FDA and they indicated it would undergo extra scrutiny, so we nixed the smaller device and left any reference to pediatrics out of the initial filing, we don't need to go looking for more trouble initially.

Getting approval for pediatric use is now somewhere off in the future, probably forgotten for a few years. The development work required is pretty minimal- the design wouldn't take long at all and the validations would basically be repeats of what has already been done. But a pediatric device was never projected to be a big market to begin with, so other projects will get priority.

I think the blog article completely misses the point when it says:

The government should be offering financial incentives to device corporations who promise to increase scrutiny over manufacturing practices

We already have plenty of incentive to manufacture quality products, the regulations ensure that, I promise you, no medical device company wants a recall. What we don't have is incentive to go through lengthy approvals to chase small markets.