Navigating the medtech approval pathway: lessons learned from physician innovator Dr. Steven Goudy, MD.

Dr. Steven Goudy, MD, is an associate professor and Director of Pediatric Otolaryngology for the Emory School of Medicine. He recently took the time to sit down with our CEO Tiffany Wilson during a webinar highlighting how physician innovators should approach the medtech development and approval pathway to increase the odds of successfully completing the concept to commercialization process.

Dr. Goudy is currently in the approval pathway for his medical technology “Bee Clear,” a start-up company focused on improving the ability of parents to help their children breath better. From analogies depicting a new medical device as a baby to the revelations and hiccups he has experienced along the way, Dr. Goudy uses this 30 minute program to share his experience and how GCMI has helped his team streamline the process.

Here are a few highlights from the information packed 30 minute webinar.

Tif
Innovators frequently want to start prototyping right away without answering critical questions like, Who is going to fund the project? What does the market for this device look like? How are you going to get reimbursed for it?

How did you make the transition from concept to prototyping?

Steven
I started by understanding what part of the healthcare system wasn’t working for me, then I took time learning how to communicate the need to others. Education is one thing, and getting information from books is obviously good but it is exponentially better to get advice from people.

Establishing a team that shares your interest and understanding of what you want to do is most important before you just jump in! I know it’s like a baby and you don’t want others to hold your baby. But if you want it to grow and develop, you have to let others do it or it might as well just stay in your garage.

Tif
Talk to us about timing. I know how long it can take going from concept to commercialization, and it is dependent upon a lot of factors. Sometimes it takes a long time but people are often unrealistic on both ends: they predict it taking longer or shorter than it actually takes. Tell us about your experience with timing.

Steven
Creating a medical technology is not something that is taught in medical school. I spent a lot of time understand the pathway first. What class is my device? What category?

There are some things you can do on your own, but then you have to get a team to help after that. Codify the idea first. Analyze who in the market has babies like yours, and what was their path.

You have everything an innovator would need at GCMI and it’s not adversarial. I promise they aren’t gonna steal your baby. It’s honestly like the super Walmart of innovation and design and provides an organic way to build your team, which saves a ton of time.

Tif
So the big takeaway is that it takes a village to help a baby develop. Do you have any nuggets of wisdom you would like to share?

Steven
There is a whole list of things of not to do. That list is easier to communicate. But if I have any advice it would be to:

1. Know your environment,
2. Find someone who gets it, and then
3. Build your team because you are, eventually, going to have to let your baby go. I personally sat on my baby for a while. It is important to balance your life. So I definitely spun my wheels a lot. I filed my own patent, and I don’t think that was a good idea because I filed it wrong, and now I have to redo it. I don’t think as physician innovators we should pretend that we are masters of everything because we aren’t.

Tif
Where is Bee Clear on the pathway and who is part of the team?

Steve
I consider the folks at Emory a part of my team. GCMI, of course, and Richard D. Monda has also been a helpful regulatory person for me. And, hopefully, in next 12 months our baby will be a household name in the retail home health community.

You can watch the information rich discussion between Steven and Tif here

If you are a physician innovator or engineer currently developing a novel medical technology, or if you have an idea and want to know how to navigate from concept to cure to commercialization, we want to know how we can help you! Contact GCMI via email or give us a call at 404-385-5191.