The medical device startup has a well-defined list of milestones to achieve to bring a product to market.

Here’s a list of key milestones for the medical device startup:

Market requirements — defines the current status of solutions and unmet needs of the market.

Product requirements — defines the features and specifications of the proposed product.

Prototypes — intermediate implementations of the product for testing, customer feedback, and fundraising with investors.

Clinical unit — a version of the product to be used in clinical testing.

Pre-clinical validation — clinical tests to determine safety and efficacy.

Clinical trials — animal and human tests with the clinical unit.

CE Mark — certification to sell the product in Europe.

FDA 510K approval — for non-invasive products in a sector with previously certified devices this is the shortest path to FDA approval.

First orders from customers — the initial purchase of the approved product.

Break-even — the product achieves break-even on revenue with cost to build and sell.

A typical medical device will take three to five years to gain FDA clearance and reach the market.

Consider these steps for your medical device development.

 

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