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Pre-Validation

Playing within the lines of non-medical wellness toys is fun, but lets get serious. If you want your product to be seriously meaningful with direct impact to saving lives through diagnosis and treatment, you should expand your medical technology into the world of medical devices and undergo the submission process with FDA. Here’s why.

1. High Impact

Those who follow me know that I’m from San Francisco and now live in Korea. It’s been half a year and I’m going to share with my readers my experience on how Seoul views Health and Technology compared to San Francisco. Hopeful this will provide you with some market insight. Lets dive in.

Attitude Towards Tech Gadgets

Here’s a common short-sighted view that many medical device startups have:

The 510(k) submission is the End-All-Be-All