How to get FDA buy-in and unlock more funding for your health tech startup • TechCrunch

Many years agoOil from Chinese water snakes has been successfully used to treat joint pain. Times have changed, but the medical industry continues to walk a fine line between optical dreams and real solutions.

Now, with venture capital funding in health technology down 41.2 percent compared to the same period last year, it’s even more important that new technologies deliver beyond expectations.

By achieving high standards and regulatory certification from institutions such as the US Food and Drug Administration (FDA), startups can demonstrate to investors and customers that they have undergone the necessary inspections to ensure a safe use in healthcare, creating a long-haul opportunity. – Success time.

FDA Discovery Device Designation

The influx of artificial intelligence into healthcare is exciting but often met with public skepticism, and rightfully so. The stakes in a poorly designed digital health product are higher than in any other industry, and the costs of failure are severe.

There are many regulatory organizations that provide credibility and certification for healthcare solutions, but the FDA is the best place to start. why? The large US market and a reputation with a strict framework around approval makes it easy to expand. Also, the FDA is one of the few agencies that has created a separate pathway for software as a medical device (SaMD) to obtain approval.

Startups need to see privacy, security, and clinical validation not as niceties, but as key components of the user persona they’re building for.

FDA’s Discovery Tool Program focuses on technology that makes sense of the overtaxed system. It’s an increasingly well-supported way of making it easier for innovators to bring products to market faster, and it’s one of the world’s best examples of how regulators can respond and work with innovations.

Devices must meet two criteria to qualify for discovery device designation. First, the device must provide effective treatment or diagnosis of a life-threatening or irreversible human disease or condition. Secondly, the device must meet at least one of the following: the device represents process technology; There are no approved or cleared options; The device offers significant advantages over existing approved or cleared options; And the availability of the device is in the best interest of the patients.

Even if the FDA gives you a chance, it’s your startup that must rigorously test its effectiveness and meet high standards when the time comes. The first criterion will be the hardest bar to clear because you have to demonstrate clinical efficacy. The Discovery Device Designation Program is based on pilot studies of the technology.

How to ensure clinical effectiveness

Recently, a Journal of Medical Internet study identified more than 224 venture-backed digital health startups with more than $2 million in funding. The study gave each company a rating for “clinical strength” on a scale of 0 to 10, with 10 being the highest score. 43.8% of all starters score zero. No wonder venture capitalists are pulling back.

Startups hoping to secure regulatory approval from the FDA should try to verify that the device is available More Effective in treatment or diagnosis of chronic disease. This means conducting studies that compare not only the device’s effectiveness with existing approved treatments.

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