Roadmap for Medical Device Startups

Hello, this is Hall T. Martin with the Startup Funding Espresso -- your daily shot of startup funding and investing.

The path for a medical device startup is clearly defined.

In building a medical device startup or diligencing one, consider this roadmap.

Market requirements -- establish the current state of the market, including size, needs, and current solutions.

Product requirements -- define the requirements a medical device product must have to be successful with customers.

Clinical unit -- a prototype that is used to run initial clinical tests.

Preclinical validation -- initial test results with the clinical unit.

First in human test -- clinical trials with human subjects.

Clinical validation -- in human clinical test results.

CE Mark -- regulatory approval to sell a product in Europe.

First European orders -- initial sales of the product in Europe

510 K clearance -- regulatory approval to sell the clinical device in the US.

First US orders -- initial sales of the product in the US.

Break even -- sales equal operating costs.

Growth then scale -- sales continue to grow.

In reviewing a medical device startup, it’s important to know the steps ahead and plan your fundraising for it.

Thank you for joining us for the Startup Funding Espresso where we help startups and investors connect for funding.

Let’s go startup something today.

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