Many years agoChinese water snake oil was successfully used to treat joint pain until peddlers made “snake oil” synonymous with fraud. Times have changed, but the medical industry continues to walk the thin line between optical illusions and real solutions.
Now that venture capital funding within health technology has fallen 41.2% compared to the same time last year, it is even more important that emerging technologies deliver more than promises.
By striving for the highest standards and obtaining regulatory certification from institutions such as the U.S. Food and Drug Administration (FDA), startups can demonstrate to investors and customers that they have passed the necessary checks for safe use in healthcare, increasing their opportunity arises to drive long-term success.
FDA breakthrough device designation
The influx of artificial intelligence into healthcare is exciting, but often met with public skepticism, and rightly so. The stakes for a poorly designed digital health product are higher than any other industry, and the cost of failure is much more serious.
There are many regulatory organizations that provide credibility and validation for inbound healthcare solutions, but the FDA is the best place to start. Why? The large US market and its reputation for a strict approval framework will make it easier to expand later on. Also, the FDA is one of the few agencies that has created a separate path for software as a medical device (SaMD) to gain approval.
Startups should not see privacy, security and clinical validation as nice-to-haves, but as important components of the user persona they are building for.
The FDA’s pioneering device program focuses on technology that will meaningfully assist an overtaxed system. It’s an increasingly supported path that makes it easier for innovators to get products to market faster, and it’s one of the best examples around the world of how regulators are responding to and collaborating with innovators.
Devices must meet two criteria to qualify for Breakthrough Device status. First, the device must provide effective treatment or diagnosis of a life-threatening or irreversibly disabling human disease or condition. Second, the device must meet at least one of the following: the device represents breakthrough technology; no approved or approved alternatives exist; the device offers significant advantages over existing approved or approved alternatives; and availability of the device is in the best interest of the patient.
While the FDA gives you the chance, it’s up to your startup to rigorously test for efficacy and meet the highest standards when the time comes. The first criteria will be the hardest bar to clear as you need to demonstrate clinical efficacy. The breakthrough device designation program is based on pilot studies conducted on the technology.
How to prove clinical efficacy
Recently, the Journal of Medical Internet Research analyzed more than 224 venture-backed digital health startups that have raised more than $2 million in funding. The study rated each company on a scale of 0 to 10 for “clinical robustness”, with 10 being the highest score possible. Of all startups, 43.8% scored a zero. No wonder venture capitalists are pulling back.
Startups looking to secure FDA regulatory buy-in must test to make sure the device is Lake effective in the treatment or diagnosis of a serious disease. This means not only testing for a device’s effectiveness, but conducting studies that compare it to existing, approved treatments.