A Four-for-One Special

When an aspiring entrepreneur imagines sitting down with a medtech idol, she probably imagines a successful medical device exec. Or maybe she thinks of a serial physician entrepreneur? A Super Bowl champion linebacker? A VC?

….wait what?

If your pattern recognition algorithm is going berserk, it’s with good reason. But the exception to prove the rule is Milt McColl, who is not just one, but all four of these! A four-for-one special? Talk about bang for your buck. Our alumni group hosted him for a tableside chat earlier this year and got to chat intimately with him.

Listening to Milt describe his career, you immediately realize that the humble man you’re having dinner with is quite the opposite of the man you would come face-to-face with on the line of scrimmage. The Milt you meet is humble and unassuming, and he tells his story in a way to suggest it’s nothing more than him being in the right place at the right time. But listening closely, you realize quickly that this is not the case. It’s not that Milt is just a lucky guy, but rather it’s his open mind, tenacity, and ability to seize an opportunity that others may overlook that have made him the medtech leader he is today.

Milt started his professional career with determination when he decided to ignore the UCLA School of Medicine dean’s proclamation that Milt could not play in the NFL while also attending medical school. Instead of choosing one or the other, he went up the street to Stanford and the 49ers. As Milt described it, “The guy in front of me got injured, so I got to play.” And just how did he attend med school and play pro ball at the same time? Quite successfully, as the 49ers won the Super Bowl that year! As year two of med school and his football career was heating up, the NFL went on strike, so he had plenty of time to study.

After med school and completing his internship, Milt was, as always, open to whatever experiences came his way. With two Super Bowl wins under his belt, he looked for his next challenge. As a 49er, VCs wanted to meet with him, but rather than just bask in the fame, he networked himself into a job with Jay Watkins at Origin Medsystems, a laparoscopic surgical device company that was later acquired by Eli Lilly/Guidant Corporation.

From there, Milt went on to a string of rewarding positions in medtech, from women’s health to neurovascular devices. He was a VP at Gynecare, President and CEO at CSFluids (a.k.a. Eunio), President and CEO of Genitope, and CMO of Embolic Protection, Inc (EPI, acquired by Boston Scientific). He also was a Venture Partner with New Leaf Venture Partners and served on the board of IlluminOss Medical, Glumetrics Inc. and Interlace.

Just as he was winding down his time as a VC, as always open to new opportunities, he met and mentored Siddarth Satish, the founder of Gauss Surgical, as Siddarth was a student in the Biodesign graduate class. That summer, Gauss Surgical was formed, Milt joined the board, and he is now the company’s CEO.

Gauss Surgical was founded to take the guesswork out of blood transfusions in the operating room. The company’s first product is Triton, an FDA-cleared, real-time monitoring system for surgical blood loss that runs on an iPad. As Milt describes it, the unmet need was clear, and he had seen it 20 years prior when he was doing surgeries. To estimate blood loss during surgery, standard practice is to just “eyeball it.”

Excited to use the power of computer vision to solve a problem that had been around for decades, Milt and the Gauss team built the company. Moving quickly, as their product was only software, they prepared for what they thought would be a relatively straightforward 510(k) through the FDA.

But alas, it wasn’t quite that simple. The FDA pushed them to pursue the 510(k) de novo pathway. Not only did the team now need clinical data to support their submission, but the FDA also required them to get clearance for the iPad on which the software runs. Though again, not one to accept the hand he was dealt, Milt and his regulatory lead, Peggy McLaughlin, worked closely with the FDA. They were able to use the strength of the relationship they had built with their reviewer ultimately trimming down the amount of testing required. How can others achieve similar results with the FDA? Milt’s advice: “Be reasonable with them. Gather the facts, don’t lash out, and ask ‘What can we do to help the process?’”

This open mind and determination paid off. Now with their FDA clearance in hand, Gauss is scaling, developing its clinical data, and rolling out with customers. The company recently joined an accelerator in Houston, Texas: TMCX, the Texas Medical Center accelerator. TMCx’s mission is to provide a gateway to the facilities, resources and network of the world’s largest medical center in order to help digital health startups move their scientific innovations into the hospital setting and improve quality of life. Gauss Surgical is a part of the inaugural class of startups there, angling to get its feet in the door with health systems. While some may have overlooked an opportunity on an unknown incubator outside of Silicon Valley, the Gauss team has taken full advantage and makes the commute because, in line with Milt’s whole career, they’re keeping the doors of opportunity open.

Gauss Surgical’s technology is revolutionary in how it can impact patients’ lives and hospitals’ bottom lines, and is just one more example of an opportunity embraced. A study featured on its website from Premier, a healthcare performance improvement alliance, found that hospitals could save over $1 million per hospital, per year through more appropriate use of blood transfusions. And while value in healthcare is a huge theme is our industry, and our collective conscious, it’s hard not wonder if companies like Gauss Surgical, at the vanguard of value, are too early for often slow-moving bureaucracies to respond. Is our industry’s money where its mouth is yet?

If anyone can build a business in this environment, I think it’s Milt and the Gauss Surgical team. My money is on the Super Bowl champion 49er (sorry Aaron Rodgers, I’ll always be a cheesehead, you’re great in the red zone but I just don’t think you have the same ability to convert in front of a value analysis committee).