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Definition: Premarket Approval (PMA) and 510(k)

Premarket Approval (PMA) is a process of regulatory review to evaluate the safety and effectiveness of certain medical devices. By contrast, a 510(k), also known as premarket notification, is a submission to the FDA that a product is safe and effective by comparing it to at least one similar device already on the market.

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Christina Hernandez Sherwood
on June 04, 2014
Category:  Execution 
Definition: Interaction design

The term "interaction design" refers to designing a product or service by focusing on how people will use it.

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Christina Hernandez Sherwood
on May 28, 2014
Category:  Ideation 
Definition: Access

The term "access" can have a variety of definitions for healthcare entrepreneurs, depending on the phase of their company's development.

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Christina Hernandez Sherwood
on May 21, 2014
Category:  Growth 
Definition: Elevator pitch

With an elevator pitch, an entrepreneur should be able to articulate their business concept in 30 seconds or less.

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Christina Hernandez Sherwood
on May 14, 2014
Category:  Ideation 
Definition: Licensing

An alternative to debt, equity or grants is revenue through licensing.

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Christina Hernandez Sherwood
on May 07, 2014
Category:  Creation 
Definition: Strategics

Unlike traditional venture capital investors, strategic investors invest on behalf of their parent company.

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Christina Hernandez Sherwood
on April 30, 2014
Category:  Creation 
Definition: Evergreen funds

Evergreen funds are a more patient alternative to venture capital funds.

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Christina Hernandez Sherwood
on April 23, 2014
Category:  Creation 
Definition: Co-founder agreement

Once you've settled on a co-founder or co-founders, it's necessary to set up a written agreement.

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Christina Hernandez Sherwood
on April 16, 2014
Category:  Creation 
Definition: Co-founder

Co-founders are the people healthcare entrepreneurs work with day-to-day on developing their product or service and making it successful.

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Christina Hernandez Sherwood
on April 09, 2014
Category:  Creation 
Definition: Business model validation

Every healthcare entrepreneur needs a business model to get their startup off the ground. But a business model needs to be validated to ensure a startup's success.

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Christina Hernandez Sherwood
on April 02, 2014
Category:  Ideation