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Archives for October 2016

How to Save Costs on Your 510(k) or PMA

Did you know 77% of the cost to develop a 510(k) device is spent in clinical research and regulatory submissions? It’s 80% for PMA devices.

“A lot of that cost is due to how poorly we handle data,” explained Jim Rogers, President of Nextrials, at the 10x Medical Device Conference.

Jim’s solution is “why didn’t we think of this before” simple: Re-purpose electronic health record (EHR) data as the source data for clinical research.

Jim: “FDA wrote a Guidance. It came out September 2013 to give people action items around using electronic source.” If you re-use the data you already have, you’ll:
• Eliminating duplication of data entry.
• Eliminating or reducing transcription errors.
• Remotely accessing your source data.

And Jim anticipates your question: “There’s so many EHR systems, how could we ever begin to integrate with them?” Watch the video for his answer.

Click for the transcript and slides. »