3 min reading time

This is one of my better posts. You’ll want to bookmark and share it.

And you’ll want to watch http://medgroup.biz/substantial, a 19-minute compilation from 2014’s 10x Medical Device Conference.

It features Ed Black, Tom KraMer, Pat Kullmann, Doug Limbach, and Bruce MacFarlane on the tricky path for device innovation.

On one hand, you want to be THE SAME.
• If you’re substantially equivalent to an existing device, you get to save on clinical trials.
• And you likelly shorten the time for FDA clearance.

On the other hand, you want to be DIFFERENT.
• If you’re materially the same as an existing device, why should CMS give you a reimbursement code?
• If you’re materially the same, do you deserve a patent?

From the http://medgroup.biz/substantial talk:

“When you go through to clear your product,
• You do all these clinical studies among homogenous group of patients who have the same disease,
• You isolate the fact this is the only condition they have,
• You take your clinical experiments and you take them to the best universities and the best surgeons in the country,
• You prove your device is exactly what it’s supposed to do,
• You really isolate the treatment effect to FDA that this product is safe and effective.

So why won’t Medicare and third-party payors just automatically cover it? (Ed answers this in the transcript.)

It’s very important for you regulatory folks to be talking to your patent folks because you’ve got one side talking to one federal agency, the FDA, saying, ‘Oh, we’re just like this device,’ and another side of your company talking to another federal agency, the patent office saying, ‘Oh, we’re nothing like that.’

And then you tell CMS you want to be paid a third way. You tell the patent office it’s X, you tell the FDA it’s Y, you tell CMS it’s Z.

If any of these are significantly different, you’ve got an opportunity to make a case for a CPT code:
• the work expense and the manner in which the technology is used,
• the capital expense associated with the device or the technology,
• and the malpractice exposure.”

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The talk was far to rich to capture entirely here. Go to http://medgroup.biz/substantial for the video and transcript.

For today’s discussion: Have you played this we-are-similar-but-different game to get to market?

How did that work out for you? What were the pitfalls? Any advice for our members?

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Make it a great week.

Joe Hage
Medical Devices Group Leader

P.S. I have a 9-page transcript of the substantial equivalence discussion waiting for you at http://medgroup.biz/substantial. While you’re there, ask for information about next May’s 10x event. I’ll send it right to you.

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Fadi Fakhouri
Director Of Information Technology at MicroPort CRM
Very intersting so true.

Karl Schulmeisters
Principal and Founder at ExStreamVR
Interesting.

Gavin Ritz
CEO at International Health Group
This is exactly the problem I just had in OZ with the Patent Examiner and prior art. Luckily in my case the clinical efficacy is so clear and distinctive as to make that problem go away fast on the medical side of things.

Joe Hage
🔥 Find me at MedicalDevicesGroup.net 🔥
I was fascinated by the talk. Honestly, before I had a reimbursement specialist, designer, and patent attorney talk during the same panel, I’d never put it together before.

Gavin Ritz
CEO at International Health Group
Joe the more I think about this the more realize how critical this issue is. Another problem is that Patents and engineering design are sometimes at odds. Patents can be junk science at times. A problem I just had.

Tom Overmyer
Owner, Prescience Inc and Pharmaceuticals Consultant
Well done Joe! Nice way of illustrating the need for cross-functional communication and a cohesive corporate perspective.

Amy Easterly
Project and Client Success Manager at Smart RIA
Excellent!

Marion Tong
Principal of MPT Consulting in Madison, WI
Very informative, thank you.

Gavin Ritz
CEO at International Health Group
Ed Black is right Joe, at its heart the medical world is about mankind’s well-being which encompasses a lot of value-ful stuff material and mental.

Dione Benson
Commercial Photography & Video – We Shoot – Your Aim is Our Focus.
Joe Hage – thanks for the post. Good stuff.

Arlance Jenkins
Branch Manager at Keurig Dr Pepper Inc.
Great information and insight thanks for posting