BadTesting Accelerates FDA Approval for Digital Therapeutic

When Innovation Meets Roadblocks: The Challenge of Bringing a Digital Therapeutic to Market

Picture yourself creating a healthcare breakthrough—one that has the potential to change lives—but hitting roadblock after roadblock when it comes to actually getting it into the hands of patients.

That’s exactly what happened to a pioneering healthcare company that had developed a first-of-its-kind, FDA-cleared digital therapeutic for IBS-related abdominal pain. Their app was designed to deliver gut-directed hypnotherapy—a science-backed treatment proven to help people with IBS manage pain—directly to patients via their smartphones or tablets.

It held enormous promise. But before they could get their innovative solution approved and in the hands of those who needed it most, they faced a set of critical challenges:

Regulatory Hurdles That Could Delay FDA Approval

Bringing any digital therapeutic to market means dealing with strict regulations. Without a clear testing and compliance strategy, even the best products can get stuck in an endless loop of approvals, revisions, and delays.

For this company, the goal was to become the first prescription digital therapeutic of its kind—but that meant ensuring every part of their app met FDA standards.

Software Bugs Threatening the User Experience

A groundbreaking treatment is only effective if patients can actually use it. Small glitches, usability issues, or crashes could lead to poor patient adoption—or even worse, concerns from regulatory agencies.

The company needed to guarantee that their app was not only functional but also seamless, intuitive, and reliable.

Testing Inefficiencies That Slowed Everything Down

With a fast-approaching launch deadline, the team needed a way to accelerate their testing process without cutting corners.
They knew that if they didn’t get this right, they risked:

• Regulatory setbacks that could push back their launch indefinitely.
• Negative patient experiences that could undermine confidence in the product.
• Missed market opportunities—allowing competitors to move ahead.

They had a great product, but without the right software testing and regulatory support, they risked losing their competitive advantage.

The Guide They Needed to Get to Market Faster

At BadTesting, we specialize in helping digital health companies eliminate software defects, ensure regulatory compliance, and accelerate approvals.

We know that launching a medical digital therapeutic is about more than just writing code—it’s about proving that your product is safe, reliable, and ready for real patients. That’s why we worked alongside this company to fine-tune their app, streamline their testing, and ultimately get their product FDA-cleared faster than they thought possible.

Here’s how we helped:

1. Identifying and Fixing Software Issues Before the FDA Did

• We conducted a deep-dive quality assurance (QA) audit of the app, testing it across multiple devices, operating systems, and user scenarios.
• We found and eliminated hidden software bugs that could have caused user frustration or regulatory concerns.
• We optimized performance to ensure the app functioned smoothly—every time, for every user.
• We improved the user experience (UX), making it easier for patients to follow their hypnotherapy sessions without distractions or confusion.

2. Aligning the App With FDA Regulations to Speed Up Approval

Digital therapeutics are held to the highest medical standards—and without a clear strategy, even the most innovative solutions can get stuck in approvals.

• We provided documentation support so the company could confidently present their therapeutic’s safety and effectiveness.

3. Streamlining Testing to Avoid Costly Launch Delays

Time was of the essence. The company needed to move fast—without sacrificing quality.

• We optimized the company’s internal testing process, helping them move through development cycles faster.
• We ensured that every function of the app worked flawlessly, allowing the company to focus on their launch strategy instead of fixing last-minute bugs.

The Outcome: FDA Clearance Achieved—Faster Than Expected

The company successfully secured FDA clearance in record time, making their app the first prescription digital therapeutic for IBS-related abdominal pain.

• They were able to launch ahead of schedule.
• Doctors can now confidently prescribe their digital therapeutic to IBS patients.
• Patients now have a non-drug, science-backed option for managing their symptoms.

And the results? Patients love it.

Real People. Real Relief.

Thanks to a successful launch, the company now has a proven, FDA-cleared solution that is improving lives every day.

Is Your Digital Therapeutic Stuck in Development? Let’s Fix That.

If you’re building a digital health solution, you know that delays can cost you everything. BadTesting is here to help you:

• Get your software ready for regulatory approval—faster.
• Eliminate glitches before they derail your launch.

Accelerate your testing process so you can get to market ahead of the competition.
Let’s talk about how we can help you get your product FDA-approved and into the hands of patients—faster. Schedule a consultation today!