4 min reading time

“Of the 250 technologies I reviewed, we denied coverage for 67% of them. All were FDA cleared and many came from major medical device manufacturers,” said Nic Anderson, formerly the Senior Medical Technology Analyst at Intermountain Health.

Which one of these is a true statement?
• FDA clearance means your technology is no longer considered investigational or experimental.

• Launching a statistically equivalent but less expensive device increases your likelihood of adoption at your target accounts.

• Payers are more likely to reimburse if your technology can reduce procedure time by 33%.

Not sure? Check out the 2½-hour presentation Beth, Nic, and April made at last year’s 10x. I’m finally making it available to the entire group.

See https://medgroup.biz/reimb-wkshp for the full replay, slides, and transcript.

It’s only $59 for the whole package (attendees paid $325). The price will be $89 next week.

The workshop includes eight case studies including some similar to your situation.

Anyway, no hard sell here. Beth and company are my go-to resources for health economics and reimbursement questions. If that’s something you need, you’re welcome. 😀

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New: We cemented the 10x at MDTX agenda just this morning, see https://medgroup.biz/10x.

New topics include “How computational modeling can accelerate your go-to-market time” and “How to strengthen your test requirements for better device design.”

It’s three weeks from today. Join us if you can.

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Just sharing: My top three moments at SXSW 2018 this weekend.

3. Watching the “This is Us” season finale with cast members Milo, Mandy, and Justin.

2. Co-hosting the medical device marketing workshop with medical device video animator Dave Grossman.

1. Joining 1200 fans at the “Ready Player One” world premiere with the cast, author Earnest Cline, and director Steven Spielberg(!). It was so fun.

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Make it a great week. Me? I’m catching up on my sleep. 😴

Joe Hage
Medical Devices Group Leader

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Joe Hage
🔥 Find me at MedicalDevicesGroup.net 🔥
Caitlin Morse, the reimbursement workshop is appropriate for anyone with reimbursable devices. If you buy it at https://medgroup.biz/reimb-wkshp and find it’s not what you expected, I’ll refund your entire purchase. 😁

Julie Omohundro
Principal Consultant at Class Three, LLC
I think it would be interesting to know the percentage of these devices that were developed by established device companies versus startups.

Julie Omohundro
Principal Consultant at Class Three, LLC
Salvatore, can you characterize the 30 companies? Startups? Established? US based? Interested to know if some types of companies are more likely to bungle reimbursement than others. Hopefully the big guys have got it sorted out by now. Also, given how reimbursement has been evolving in the US, what type of time period are you talking about, and have you noted any trends?

Michael Branagan-Harris
CEO Device Access UK Ltd-Market Access & Reimbursement Consultancy for MedTech & Diagnostic Devices into NHS England
It’s great that the UK NHS healthcare system reimbursed procedures and not product therefore opening up greater opportunities for Market Access and value creation in the worlds largest single payer and public all funded healthcare system, along with the worldwide credibility and reputation of NICE approvals.

Kirk Zeller, DBA
Market Access and Commercial Development Executive, Board Member
Interesting.

Caitlin Morse
Medical Device Commercialization Consultant
This content looks interesting. I hadn’t heard of Intermountain Health before. It looks like it is a non-profit group focused on Utah and Idaho. Is this content also focused on this geography or does it cover a more broad range of reimbursement models and companies?

Marc Slabbert
CEO at Areta Health
Michael Branagan-Harris agreed Solutions not devices Medical devices will become like cell-phones & they must demonstrate 3 CLEAR aspects to survive -1. Evidence of reliability of Metrics (includes all Safety CE FDA clinical studies “as is expected”. 2. Validity of metrics QoL & CBA Health “de-risking” #EBM @patientcentric along with Impact and lastly (in my humble opinion) the most important. Patient Centric ADOPTION – Patients will determine ULTIMATE adoption based on UX , convenience , price etc. They will drive Actuarial opportunities through pt volumes. We are moving rightly to a point where patients ,who are informed & collaborate with physicians /healthcare workers determine THEIR need and wants THEY make these decisions accordingly. I believe insurance companies will find themselves outsmarted if they don’t respond to patient needs and will no longer be able to dictate T&C ..they are after all a business reliant on clients buy-in. @Shifthealthcare @aretahealth

Michael Branagan-Harris
CEO Device Access UK Ltd-Market Access & Reimbursement Consultancy for MedTech & Diagnostic Devices into NHS England
Put simply, the earlier the MedTech industry utilizes the principles of Market Access instead of the principles of Marketing (which are product price place promotion) the faster patients will receive better treatments and diagnosis.
The principles of market access are linking ;

1. Patient Benefit
2. Provider of care benefit
3. Payer of care benefit
4 Product/Profit Benefit.
These 4 benefits should form the basis of the very start of developing new technologies.

David Charlot, PhD
Bioengineer leveraging technology and capitalism to help humanity prepare for the future.
The medical device world is doomed. New technology can’t get developed if there is no customer to try it and help evolve it. Cellphones have no market barriers so we’ve seen amazing evolution. We haven’t had much evolution in med device.

David Charlot, PhD
Bioengineer leveraging technology and capitalism to help humanity prepare for the future.
The medical device world is doomed. New technology can’t get developed if there is no customer to try it and help evolve it. Cellphones have no market barriers so we’ve seen amazing evolution. We haven’t had much evolution in med device.

Rochelle Stahl
In Vitro Diagnostics / Life Sciences / Medical Devices / Product Management / Strategy / Marketing
Agreed. Patient centric should be the key!

Salvatore Domenic Morgera
Professor, Electrical Engineering & Biomedical Engineering and Director, University of South Florida
This is, of course, no surprise. I have reviewed 30 or more technologies (I should say, technologies and the applications of those technologies) and told companies in very specific technical terms why the technology is immature, or its application is inappropriate due to the fact that the fundamental phenomena associated with (in most cases) neurological dysfunction are not sufficiently known at this time. Of these, FDA cleared about 50%. Companies need to appreciate the importance of R&D, and I really mean R, for these devices.