“The best way to predict the future is to create it.”

Peter Drucker

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Medical device patent law: Experts discuss what you should know

Originally posted on MedCity News The patent protection landscape’s been turned on its head in the past couple years, ever since the Leahy-Smith America Invents Act went into effect. A discussion at trade group Biocom’s DeviceFest in San Diego this week addressed some of these changes and subtleties as they apply to medical device companies:

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ARCH Venture Partners builds massive $400M fund

ARCH Venture Partners, one of the largest U.S. technology venture firms investing in the development of seed and early-stage advanced technology companies, today announced that its eighth venture fund closed with more than $400 million in subscriptions. ARCH Venture Fund VIII exceeded its $250 million subscription target by more than $150 million.

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Steve Blank’s advice on what it takes to be a life sciences lean startup

Originally posted on MedCity News by Stephanie Baum What’s the difference between an extrovert and introvert in the world of principal investigators? Answer: Are they staring at your shoes or their shoes? The joke Steve Blank told during a fireside chat hosted by NYCBio illustrates the uphill challenge SBIR grant applicants face when they’re asked to break away from the insulated world of…

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FDA simplifies process for novel medical devices

Truly innovative devices that do not have a “substantially equivalent” predecessor are automatically lumped into Class III, reserved for high-risk devices, and need a costly clinical trial to gain approval. But not all new products are high risk. To fix this barrier to innovation, FDA created the de novo approval pathway in 1997, enabling applicants to apply…

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