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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.
On the other hand, you want to be DIFFERENT.
From the http://medgroup.biz/substantial talk:
“When you go through to clear your product,
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 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?
Lots of Good Recent Discussions
Are non-profit medical device companies sustainable?
Risks for Device Investors
Why Should Hospitals Purchase Your Device?
Healthcare Insurance, is this really insurance at all?
Thoughts on device clinical studies, esp. for regulatory approval
Who is Our Customer?
ISO standards versus EN ISO standards
Wireless communication in medical devices
Who will be the next Uber for healthcare?
Make it a great week.
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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