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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. His 10-minute video, slides, and transcript at http://medgroup.biz/nextrials 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: And Jim anticipates your question: “There’s so many EHR systems, how could we ever begin to integrate with them?” Check out http://medgroup.biz/nextrials for his answer and I shared his direct LinkedIn profile address at that link if you want to follow up with him. What do you think of the concept? Would it save you money? And if you’re already in a 510(k) or PMA process, is it too late to take advantage of the idea? Ask Jim in private or in today’s comments. ++++++++++ Discussions The U.S. Election, Device Tax, and Industry Outlook Medical Device Testing Most likely cause of a Theranos II? Recall Correspondence to the FDA ++++++++++ Make it a great week. Joe Hage P.S. We’re hosting Jon Speer’s 13485:2016 webinar in a few hours at http://medgroup.biz/iso13485. Register now or, if you miss the live event, click through for the replay. Julie Omohundro I do think a good number of people in this industry will raise more than one eyebrow at the statistics you quoted, so unless they are central to your product presentation, perhaps you might wish to reconsider. I read that report for the first time some time ago now, and have not yet been able to bring myself to read it again. However, I don’t remember it as having provided any details regarding what expenses were included under “FDA dependent and/or related activities.” Might you be able to provide a page number? Julie Omohundro How much more efficiency remains to be realized in this area, I can’t say, but I agree that it would probably be…well, maybe not so much product specific as study specific. There is probably limited efficiency to be gained in the collection of data for a small feasibility study, for example, regardless of product. I also think a good bit of study data can be unique to the study and not get entered into the EHR. If you have to set up a system to capture these data, it may be just as efficient to use the same system to capture all the data, rather than trying to consolidate data from two separate systems. It will be interesting to see where this goes. Julie Omohundro Jim Rogers Julie Omohundro Julie Omohundro When I said “past Statistics 101,” I did mean “past,” not “passed.” Statistics 101, like most introductory courses, is designed to “introduce” students to a discipline, not to teach them how to practice it. For that it is necessary to go on to a more advanced class or, preferably, classes. I wasn’t referring to the background of the author, who might or might not have taken Statistics 101. Since the study has been completed and the report has been released, his background is now moot. I was referring to the background of the audience. There are many people in the device industry who have the ability to assess the likely validity of these statistics for themselves. There are also many who do not. Julie Omohundro Julie Omohundro Jim Rogers The full report is here: http://www.medtecheurope.org/sites/default/files/resource_items/files/01112010_FDA%20impact%20on%20US%20medical%20technology%20innovation_Backgrounder.pdf. My only point was to highlight the regulatory-related costs associated with developing medical devices. Julie Omohundro However, for anyone who knows a modest amount about what is involved developing a 510(k) device and a PMA device, including any clinical trials and regulatory submissions, and who got past statistics 101, it’s not hard to work out that the percentage spent on clinical research and regulatory submissions for “a 510(k) device” cannot be remotely close to the percentage spent for PMA devices, given that over 77% of 510(k) devices aren’t supported by any clinical trial at all, and that putting together the average 510(k) requires a fraction of the time and effort of a PMA. Joe Hage Ananth V. Matthew Bell Anil Bhalani Are you talking of FDA 510(k) and FDA PMA. Because the cost to develop a 510(k) or a PMA is very minimal compared to the cost of developing and testing the product. It is miniscule for smaller companies as their fees are substantially reduced. The challenge with an FDA 510(k) and PMA is the timelines, which in the case of the 510(k) are approx. 90 to 120 days, which are not much if you plan your project right. I can cite many experiences where the device was approved and the product was not ready for shipment. In fact I have one example now where the 510(k) was approved over a year ago and the company is working through its manufacturing automation issues to place the product on the market. Of course if you add the cost of demonstrating that the device is safe and effective: cost of testing a device into 510(k) cost that will make it expensive. Lisa Bacon Marked as spam
 Posted by Asked on October 4, 2016 8:02 am
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