From concept to FDA trials: how GCMI & T3 Labs helped Strataca fight AKI

Acute Kidney Injury (AKI) a.k.a. “The deadliest complication no one’s ever heard of” leads to 300,000 deaths and $10 Billion additional expenses in just the US each year. According to the Society of Critical Care Medicine, AKI affects approximately 50% of the five million U.S. ICU admissions each year and has doubles the mortality rate of a heart attack. John Erbey created Strataca Systems around an idea to help revolutionize kidney care.

With a PhD in epidemiology, John Erbey has spent most of his 17 year career translating science into business. He was hired by St. Jude Medical in late 2011 to move to Atlanta to launch CardioMEMS. Prior to this he spent 12 years in the pharmaceutical industry, including roles in drug safety, outcomes research, pricing, new product marketing and in-line marketing.

“Dialysis is a black hole for everyone.” Erbey says. “It is an expensive therapy that does not address the underlying problem. The kidneys are remarkable organs that do so much for our bodies; including removing waste, but also making red blood cells and helping to form bones. When the kidneys fail, the body quickly follows suit.”

Last summer he only had an idea and a provisional patent. Erbey selected GCMI to navigate the critical steps in the medical device development process, ideation, design, engineering and prototype development. Connecting the engineering resources of GCMI with the preclinical and cadaveric resources of T3 Labs allowed Strataca to ideate, iterate and identify good solutions in a timely and cost efficient manner.

“I wanted to convince myself the science worked before putting serious money behind it. I’m a firm believer in pressure testing the idea early. That’s what they helped me do.” According to Erbey: “I wouldn’t have a company if not for the support of both T3 & GCMI. I had quotes from other design firms, locally and nationally – they were by far the greatest value for the money, for where I was in the design process.”

Erbey gives these 3 tips for other physician innovators looking to bring a new medtech or medical device idea to life.

Tap your passion and experience

“Throughout my career my positive moves have been about doing something that fit what I was looking to accomplish. All of my career development opportunities gave me perspective on what to look for, how to get things done and also help me figure out who knows the information if I don’t. Starting a company is hard work, but it’s not rocket science. There are a million things to constantly advance and monitor. If you love what you’re doing – it amplifies it. I’ve had the best year of my career and we’ve gotten a ton accomplished. Ideas are easy, it’s developing the right plan and executing against it – making sure that you are following the right North star.. ”

Plan and execute

“You have to be committed to figuring out every step. How will you set up your own email domain? Will you be willing to send faxes and schedule meetings? Do you know who to you talk to for questions or advice? You must be willing to hear people ignore you or call you crazy… you have to have thick enough skin to get through it. Knowing you’re right is only half way, you need a plan to prove it. The rest of it is time and motion.”

Engage potential customers and access available resources

1. Protect your idea with a provisional patent.
2. Once the patent is filed and a confidentiality agreement is in place, talk to some customers and find out if there really is a pain point. You don’t have to share the details! Would your customers pay for whatever end benefit you think you might have?
3. Access the considerable medtech ecosystem resources available by connecting with GCMI.

Contact GCMI today to learn about how we can help evaluate your ideas, support your product development, and connect with experts across the medical device ecosystem who can provide guidance along the journey from concept through commercialization. Or simply email info@devices.net.