Many years agoChinese water snake oil was successfully used to treat joint pain until peddlers made “snake oil” synonymous with cheating. Times have changed, but the medical industry continues to walk a fine line between optical illusions and real solutions.
Now that venture capital funding in health tech is down 41.2% from the same period last year, it’s even more important for emerging technologies to come up with more than just promises.
By striving for the highest standards and obtaining regulatory certifications from institutions like the US Food and Drug Administration (FDA), startups can show investors and customers that they have passed the necessary validations for safe healthcare use, and so more opportunities manage to drive long -term success.
FDA Breakthrough Device designation
The influx of artificial intelligence in healthcare is exciting but often met with skepticism by the public, and rightly so. The stakes in a poorly designed digital health product are greater than any other industry, and the costs of failure are far more severe.
There are many regulatory agencies that provide credibility and validation to incoming healthcare solutions, but the FDA is the best place to start. Why? The large US market and its reputation for strict regulatory frameworks will make it easier to expand later. In addition, the FDA is one of the few agencies that has created a clear path for approving software as a medical device (SaMD).
Startups should not consider privacy, security and clinical validation as nice-to-haves, but as key components of the user personality they are building for.
The FDA’s groundbreaking device program focuses on technologies that meaningfully help an overstressed system. It’s an increasingly well-supported avenue that makes it easier for innovators to get products to market faster, and it’s one of the best examples of how regulators are responding to and collaborating with innovators in the world.
Devices must meet two criteria to be eligible for the Breakthrough Device designation. First, the device must enable effective treatment or diagnosis of a life-threatening or irreversibly debilitating human disease or condition. Second, the device must meet at least one of the following criteria: The device represents breakthrough technology; there are no approved or approved alternatives; the device offers significant advantages over existing approved or approved alternatives; and device availability is in the best interests of patients.
While the FDA gives you the opportunity, it’s up to your startup to rigorously test effectiveness and meet the highest standards when the time comes. The first criterion is the most difficult bar to erase since you need to demonstrate clinical efficacy. The breakthrough product labeling program is based on pilot studies conducted using this technology.
This is how you prove the clinical effectiveness
Recently, the Journal of Medical Internet Research analyzed over 224 venture-funded 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 possible score. Of all startups, 43.8% scored zero. No wonder venture capitalists are pulling out.
Startups hoping for FDA approval must test to see if the device is more effective in treating or diagnosing a serious illness. This means not only testing a device’s effectiveness, but also conducting studies comparing it to existing, approved treatments.