5 min reading time

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

She says, “Our clients tend to fall into one of three traps.

1 – “We don’t need any data.” We’re a 510(k) and didn’t need data for FDA clearance so we won’t need it for market access. Facilities will love us and want to use our technology.

2 – “We need a ton of data.” We need a randomized controlled clinical trial, but we can’t afford it so we’re either going to ‘make do’ or wait until we get more money.

3 – “We’ll get investigator-initiated data.” That way, we don’t have to fund all the evidence. We’ll get well-known academics (our key opinion leaders, anyway) to do it.

Most clients miss the nuances. First, you ALWAYS need data.

It doesn’t have to be ‘perfect’ and relying solely on investigator-initiated studies is not a good strategy.”

Beth and I will co-host a free “What’s Your Clinical Evidence Generation Strategy?” in two weeks. Register at https://medgroup.biz/evidence if you have anything to do with commercialization or reimbursement.

“Another thing,” Beth continued, “is to look at each technology as a unique opportunity to benefit the market in a unique way. Your market access strategy should reflect that.”

If you attend the live event (Wed, May 15 at noon EST), you’ll get to ask Beth your specific question. Free advice from Beth is a good deal, trust me.

See you on the 15th: https://medgroup.biz/evidence.

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YOUR TURN

Thanks again to group member Emanuel Weisgras who contributed to last week’s email about Medical Device Documentation at .

Now it’s your turn if you can educate a global audience of busy medical device executives.

Reach me at JHage@MedicalDevicesGroup.net and suggest a topic!

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Make it a great week.

Joe Hage
Medical Devices Group Leader

P.S. Marketers, check out https://medgroup.biz/Un-Conference. It’s in two weeks, ask me for a discount code.

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Joe Hage
🔥 Find me at MedicalDevicesGroup.net 🔥
Ack! That’s TUESDAY, May 15. I’ll be in this 🕳️ hole if you need me. 😳

Joe Hage
🔥 Find me at MedicalDevicesGroup.net 🔥
Emily Stephens, you should definitely attend the webinar. Beth is top notch.

Emily Stephens
Chief Executive Officer at Global Medical Writing & Translation
I’m signed up. Thanks!

Paul M. Stein
Chief Scientist, Inventor, and Entrepreneur – Dedicated to the Treatment of Critical Unmet Medical Needs
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.

Emily Stephens
Chief Executive Officer at Global Medical Writing & Translation
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.

Suzanne Metro
Global Marketing Communications Manager
Always need data!! YES!!

Eugene Salole
Principal, Value-Based Access P/L – specialists in Market Access and HTA for medical devices & diagnostics
Salutations all! David Norby’s hit the nail on the head: enough data to convince the ‘buyer’, aka Regulator or Reimbursement Agency, is what’s needed. If a supplier believes their product is innovative and deserves a premium, then even if the 501k gives it an easy regulatory pass (in the US), there must be some substantive basis for demanding the premium. This is especially true in Europe and the large and growing markets of east Asia, where (i) being granted reimbursement, (ii) being awarded a premium, and (iii) the level of that premium all depend on data – and comparative data at that (for ii & iii). Apparently the medical device sector has been very slow to understand this.

Greg Freiherr
Writer Editor Columnist Market Analyst
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.

Jodi Akin
Health/Tech Executive, BOD, Advisor, Investor and Entrepreneur
To strive for a launch without data is like trying to get to Mars without enough fuel. Data drives not only the obvious-commercial approvals and claims, economic strategies around reimbursement and pricing, but also collective knowledge for product iteration/cadence and building core competency and therefore leadership in the market. The solution is not less data, but more innovative and efficient ways to get it.

David P Norby, PhD, CQE (ASQ)
Consultant in Quality Improvement – Process, Product, Productivity and Profit; and in Compliance Improvement (CAPA)
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.

David P Norby, PhD, CQE (ASQ)
Consultant in Quality Improvement – Process, Product, Productivity and Profit; and in Compliance Improvement (CAPA)
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).

Patricia Shragher
Account Executive, UDI/GDSN Compliance • Regulatory Data Management • Medical Device Quality and Safety Analytics
Today, medical device manufacturers cannot take a random approach to data collection or a make do approach unless they are willing to calculate a lot more risk into their equation…who can do that? Check out Reed Tech’s Navigator, cloud-based tool which is very robust, and allows for benchmarking and product comparisons of ALL class ll and class lll devices registered with the FDA!