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Archives for March 2015

Why FDA Rejected Nearly 60% of All 510(k) Submissions in 2013

jorge ochoa exponent

Jorge Ochoa, Principal Engineer at Exponent, asked the 10x Conference crowd last year,

“What’s the #1 complaint about FDA?” and answered, “That it takes too long, right?”

So in December 2012, FDA finalized guidance on its Refuse To Accept (RTA) Policy, a draconian measure used to shorten FDA response times.

Exponent’s Carrie Kuehn explained if there is a mistake on your submission – any mistake – your 510(k) can get kicked back to you within 15 days without further consideration. The clock stops and FDA gets to say, “You asked for a quick turnaround and you got one!”


Click for the slides and transcript »

The “So What” of Wearable Health

Stephen D Pierce IBM

IBM’s Global Medical Device Business Development Leader Stephen D. Pierce joined us during the May 2014 10x Medical Device Conference with his unique perspectives on wireless innovation’s impact on healthcare.

“Wearables are not new,” Pierce says. Today’s hype comes from the “‘the three I’s – interconnection, insights, and integration’ with data from discrete devices, being aggregated across multiple data sources to provide a more complete picture of the patient.”

The fitness market is already being commoditized and just providing a smartphone app or providing analytics associated with patient data silo isn’t necessarily a significant value to the patient or the provider.

On the other hand, he says, “Chronic disease management is the primary opportunity that we see as far as driving healthcare transformation… As you look at the majority of spend on healthcare… the focus on reducing cost by taking action earlier in the process, during the earlier intervention stage or even the healthy stage, is critical.”

Click here to download Stephen’s transcript. PDF


His advice to medical device clients »