How much clinical evidence do you need to launch?

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It depends, my market access and reimbursement go-to person Elizabeth Brooks said in this video interview: https://medgroup.biz/evidence. She says, "Our...

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Posted by Joe Hage (Discussions: 3, Comments: 4)
Replied on May 1, 2018 12:00 am
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It may sound like a trivial answer, but the correct answer is "enough." The follow up question is: "How much is enough." To which the correct response is "it depends." You have at least three groups with interest in the advisability of launching your product: regulators (e.g. the FDA), customers (either patients or clinical practitioners or both), and investors. Ultimately, all of them are interested in the product being safe, effective, reliable and readily available, and at least some of them are interested in pricing (actual cost and/or cost-effectiveness).
You should consider each and every claim you wish to publish as to why, when, where, who, how, etc the device is to be used. When you have the list, you will be expected to have data to show that your product is able to safely deliver the claimed performance with minimal risk of harm to user or administrator or others who may unwittingly become subject to risk of harm (e.g., small children).
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Posted by David P Norby, PhD, CQE (ASQ) (Discussions: 0, Comments: 2)
Replied on April 30, 2018 8:00 pm
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Each claim should then be assessed for the kinds of testing, scale of testing, and evaluation criteria are needed to show acceptability of the product. The testing should be based on sound statistics, with acceptance criteria that are suitable to the severity of risk of distributing an unacceptable or unreliable device.
Any testing involving human subjects will have to be conducted according to a pre-approved protocol (pre-approved by an appropriately accredited human subjects investigation review committee).
The type and amount of testing may be mitigated by showing performance that is at least not-inferior to a predicate device according to the rules generally referred to as 5110(k). Keep in mind, however, that testing based on a predicate device only allows you to proclaim your device to be substantially equivalent to the predicate device. If you wish to claim superior performance or make additional claims that are not covered by any predicate device, further testing is required.
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Posted by David P Norby, PhD, CQE (ASQ) (Discussions: 0, Comments: 2)
Replied on April 30, 2018 8:00 pm
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This discussion reminds me of the Canadian company whose CEO believed FDA clearance was not necessary -- because the device was being built by a Canadian company. I convinced him that it's not who builds the device but where it is sold.
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Posted by Greg Freiherr (Discussions: 1, Comments: 1)
Replied on May 1, 2018 8:00 pm
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My company specializes in CER authoring (the safety and performance report required to sell a device in EU Regions). We are constantly asking how much clinical evidence do you need to stay on the market? MDR requires rigorous, proactive collection of data. Determining what amount of data are needed to prove safety/performance is a challenge. You never stop asking the question, even after launch. It will be interesting to see how the EMA and Notified Bodies interpret these requirements as we near 2020. I've seen success summarizing historical clinical data (PMS, pre-market/post-market studies, all literature) and leveraging the literature of competitor devices and generic/unnamed devices by using a trending analysis of MAUDE/EUDAMED data to demonstrate comparability. As we near 2020, I imagine a lot will ride on the PMS and PMCF Plans. The pressure to invest in post-market clinical trials with long-term outcomes will be intense. We are working on smart cost-effective alternatives.
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Posted by Emily Stephens (Discussions: 0, Comments: 4)
Replied on May 2, 2018 8:00 pm
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Emily Stephens, you should definitely attend the webinar. Beth is top notch.
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Posted by Joe Hage (Discussions: 3, Comments: 4)
Replied on May 2, 2018 8:00 pm
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I'm signed up. Thanks!
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Posted by Emily Stephens (Discussions: 0, Comments: 4)
Replied on May 2, 2018 8:00 pm
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Always need data!! YES!!
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Posted by Suzanne Metro (Discussions: 0, Comments: 1)
Replied on May 3, 2018 8:00 pm
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Ack! That's TUESDAY, May 15. I'll be in this 🕳️ hole if you need me. 😳
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Posted by Joe Hage (Discussions: 3, Comments: 4)
Replied on May 3, 2018 8:00 pm
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I've never launched anything, but I'm working on something that could cost several million to develop. While there is a thin spread of pre-clinical evidence available that gives me confidence in the idea, I've been advised that before I spend a lot of my and others' money, I will need some direct clinical evidence that the concept will actually work. But, what I'm seeing is that it is a real bitch to convince any physician to simply give it a try.
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Posted by Paul M. Stein (Discussions: 0, Comments: 4)
Replied on May 5, 2018 8:00 pm
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