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At this year’s 10x Medical Device Conference, Seth Goldenberg Ph.D., Senior Principal Scientist at NAMSA, gave an illustrative talk entitled, “Thinking Globally During Medical Device Development: Accelerating Products to International Markets.”
The full recording and transcript at http://medgroup.biz/intl-development
• Bringing a medical device to market becomes very complicated very quickly, yet there are strategies to begin your medical device development early on while thinking about other countries.
• If you’re an R&D group at a large company and you [want to] convince a product manager who has P&L responsibility to pick up your product, or you’re a startup looking to an investor, both of those decision-makers want a global strategy.
• The traditional model – go to Europe first – is faster. It’s easier pathway. But as soon as you get European approval or any kind of approval, you’re going to start getting emails from distributors all over the world. They want to sell your product, and unless you have that home country approval requirement and meet that, you can’t do anything.
• There are several ways to bring products into the marketplace…. You can think creatively: Could I do a series of three or four, 510(k)’s to get there? Could I develop some precedents, get some revenue going along the way, ease my path to market?
Give a look at http://medgroup.biz/intl-development
And if you’ve entered a foreign market, what lessons can you share (in the comments below) with the group?
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DISCUSSIONS THIS WEEK
Which metrics to evaluate early-stage medical device startups before investing?
Why do you think lab-on-chip personalized blood testing hasn’t taken off?
What’s needed (regulatory, notification) to enter the German market with CE marked, sterile syringes with special protection against needle-injury?
If you were under FDA consent decree or warning letter, how to remediate?
Is “suing medical device sales reps” common?
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