Stuart Bradley is the founder and CEO of not one, but two companies – Carolina Speech Pathology LLC and Altaravision. We caught up with him on a busy Monday afternoon in between meetings, and he was gracious enough to take some time to talk with us about his experience as founder of Altaravision and the interesting journey of their flagship product, NDŌʜᴅ.

Put simply, NDŌʜᴅ is the most portable, high-definition endoscopic imaging system on the market today and an invaluable tool for speech pathologists. It has been extremely well received by the medical community, but its path from concept to market was not without its obstacles.

Where did the idea for NDŌʜᴅ come from? Because it is a very specific product.

It came from a need. Specifically, the need to be able to do machine vision on a Macintosh. Surprisingly, there really wasn’t any software that addressed it anywhere in the marketplace.

Would you mind just briefly explaining what machine vision is?

Sure. Machine vision is the ability for a computer to view imagery or an object, take that information and then display it. Essentially, it is a computer’s ability to see.

And the capacity to do that wasn’t on a Mac? That’s interesting.

Well, no. There was plenty of software out there, but it was all secondary purpose. The bigger issue was that nothing had the capabilities you would need in a medical setting.

It all comes down to video capture. All of the off-the-shelf software could capture images, but they suffered from significant lag. What you saw on the screen might be a full second behind what was happening in real time. That might not seem like much, but when you are dealing with medical procedures that kind of lag isn’t going to cut it.

I played around with off-the-shelf software for a number of years and finally found something I thought might work, but there were a ton of features that I didn’t want or need. I reached out to the developer to make me a one-off, but he was ultimately unable to deliver a final product. That’s what led me to Oak City Labs.

Once you had your software developer in Oak City Labs, what was the hardest part about going from this idea you had to an actual finished product?

By far, the biggest hurdle was doing it in a way that maintains compliance with FDA regulations. Jay Lyerly, the one who was doing the coding, knew that from the start and was able to work with my FDA consultant in a way that we could survive an FDA audit.

The thing is, FDA audits are worse than IRS audits and you’re guaranteed to get one, whereas IRS audits are random. As a medical device company, we are audited every two years by the FDA. Thanks to Jay and Carol at OCL, we’ve been able to pass every single audit with zero deficiencies, which is nearly unheard of.

Was there a moment when you got NDŌʜᴅ out into the world and thought “ok, we did it.”

Yea, there was. With FDA-regulated software you actually do have to draw that line in the sand. Unlike other software development cycles, where updates are always being pushed out, you can’t do that with medical devices. It has to be the finished product from the day it comes out. If you add features, it has to go back through the FDA approval process, which, as you can imagine, is pretty lengthy.

If you could do it all over again, is there anything that you’d do differently?

We bootstrapped the entire thing, with CNP essentially acting like an angel investor for the product. That was really tough, especially when there are people out there actively looking for good products to invest in. If I had to do it again, I would have taken the time to seek out some outside investment instead of just jumping in and doing it all myself.

When you think about where you are today as a business owner, is there anything that sticks out to you as the thing you are most proud of?

Honestly, being able to take on, create, sell and make an actual viable business out of a medical device when I had no prior experience in that industry. I had owned Carolina Speech Pathology for years, but the journey with Altaravision and NDŌʜᴅ was an entirely new one.

What’s your favorite part about doing what you do?

It has to be the satisfaction I get from solving hard problems, and the fact that it’s never boring.

Finally, whenever you have clients or colleagues that are talking about Altaravision or the NDŌʜᴅ product, what do you want them to say or know about it?

I want them to know two things. First, I want them to know it works, and always works. Second, that it is designed to be incredibly easy to use. If you can use Facebook, you can use NDŌʜᴅ.

For more on Oak City Lab’s work with Stuart Bradley and Altavision, check out this article Jay wrote on Computer Vision for Medical Devices via Core Image. If you have an idea and need a software development partner, or if you just have some questions about the development process, we’d love to talk to you. Follow the link below to contact us!