Medical Device Milestones Hello, this is Hall T. Martin with the Startup Funding Espresso -- your daily shot of startup funding and investing. 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. 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. _______________________________________________________ For more episodes from Investor Connect, please visit the site at: Check out our other podcasts here: For Investors check out: For Startups check out: For eGuides check out: For upcoming Events, check out For Feedback please contact info@tencapital.group Please , share, and leave a review. Music courtesy of .
