INTERVIEW: Stanton Rowe – Incubating ideas into startup companies

Mr. Stanton J. Rowe, also known as Stan, is CEO of the NXT Biomedical Incubator, has been the Chief Scientific Officer of Edwards Lifesciences Corp. since 2008, and serves as its Corporate Vice President of Advanced Technology. Mr. Rowe served as a Scientific Advisor at Ascent Biomedical Ventures. He Founded Percutaneous Valve Technologies (sold to Edwards).  He recently spoke with Joe McMahen, Mechanical Engineer, about NXT Biomedical, incubation, his career and innovation in a wide ranging discussion of his incredible journey.

Joe McMahen Please tell us about your current work.

Stanton Rowe I’m currently the CEO of NXT Biomedical, an incubator. One kind of incubator incubates small companies, creating an environment that helps the small companies progress. The second kind of incubator – and there are only two or three of these around – incubate ideas into startup companies. We’re one of these. We take early stage ideas and take them through a feasibility process, and the output is startup companies. We’re funded by Deerfield Capital out of New York (they manage eleven billion dollars), Johnson & Johnson, and Edwards Lifesciences. We have some really great backers that are interested in the brainstorming that we come up with and the output.

Joe McMahen How is the work going?

Stanton Rowe It’s the most fun you can have and still call work! I have a small team – five engineers and two physicians. Rob Schwartz is my co-founder. He’s a skilled cardiologist out of Minneapolis. And Abubaker Khalifa is a medical director who works as Assistant Clinical Professor Medicine (Adjunct), Critical Care Medicine at McMaster University and a Critical Care Physician at Joseph Brant Hospital & Foundation in Toronto.

Joe McMahen What are the reactions to your work so far?

Stanton Rowe We’ve already taken a whole bunch of different concepts through screening processes. And the first concept we’ve taken into First in Human. We’ve done early stage clinical work. We’ve demonstrated some benefit in patients. We’ve done already six month’s feedback from some of these patients – and this looks really promising.

I guess what’s different about us is that I love the idea of the big, hard problems. And that’s what we take on – often PMA devices that a lot of small companies don’t want to take on. And we’re willing to do truly novel things that no one has done before. If it’s a crazy idea, if it’ll never work, then it’s interesting. So that’s what we do for a living.

But what’s most fun is when you see patients that are benefiting from it. Then it’s really rewarding. Patients who come back and say, “I feel a lot better.” Or “I can perform better.” Then you know you’re doing something really important.

Joe McMahen It certainly would make for very exciting and fulfilling work.

Stanton Rowe Also scary as hell, I must add. We do stuff that no one has done before. The animal studies are typically fraught with problems because the animals we treat – their physiology, their anatomy – is different. Most animal studies are very poorly representative of the kind of questions we have. So then you have to go into man. And who do you treat? You treat patients where the risk-benefit makes sense. What is that? Those are the oldest, sickest patients who are not benefiting from standard care. Well, guess what? Those are the toughest patients to treat. So it is a really scary proposition. It’s not for everybody.

Joe McMahen That’s a very challenging landscape. You’ve also had great success at Percutaneous Valve Technologies (PVT). Can you tell us about that experience?

Stanton Rowe PVT was a company we founded in 1999 with the idea of creating the first percutaneously delivered heart valve for the treatment of aortic stenosis. It was Marty Leon, a very prominent cardiologist and Chief of the Cath Lab and Interventional Cardiology at Columbia, Alain Cribier who was the Chief of Cardiology in Rouen, France, Stan Rabinovich who was a talented engineer from Johnson & Johnson, and me.

At that time, the only opportunity for patients was balloon valvuloplasty which didn’t work well. That’s bringing a balloon into aortic stenosis and blowing it up. And there was open heart surgery. With the average age of patients being mid-60s to early 70s, going through open heart surgery is a pretty tough alternative to doing nothing. And doing nothing means a very bad prognosis. So it seemed there ought to be an option, especially for patients who were high risk and nonsurgical, which is where we started.

What did the experts say about percutaneous heart valves? The experts, cardiothoracic surgeons, said, “This is a stupid idea and it will never work.” So much for your market research.

It’s tough! It’s tough when you do something that is disruptive innovation, which is what this was – the idea of taking a procedure that’s done by skilled cardiothoracic surgeons and then putting it in the hands of a cardiologist. Surgeons didn’t want to have any part of losing procedures to interventional or what’s now called structural cardiologists. They didn’t think it was a good idea. But today it’s an eight-billion-dollar market.

What we saw was that most of these patients – or at least half of the patients out there – voted with their feet. They said, “I’m sorry, I’m seventy five years old. I’m not going to have my chest cracked open.” And they died of old age. They actually died of aortic stenosis. These patients really deserved an alternative. And I’m happy to say today the outcomes are astounding. Today, over half the patients go home the next day after this procedure. And there’s a large number of them that have a same-day procedure to have their heart valve replaced! Compare that to a nine-day hospital stay with open heart surgery and a six-month recovery. It makes an astounding difference to have these kind of alternatives that we can bring to patients.

Joe McMahen It sounds like taking the high road is a theme in your development. What else can you share about your experiences with Johnson & Johnson?

Stanton Rowe Johnson & Johnson is a great place. There’s a lot of talent and a lot of focus on patient outcomes, doing it right. But I also heard some of the same kind of stuff that I heard before. “You can’t put stainless steel in someone’s coronary artery. It will clot over and they’ll die. You ought to get a real job!” There was a lot of skepticism that stents would work on patients. It wasn’t as obvious as it is today.

I have to give J&J credit that they were very interested in this kind of innovation. They leapfrogged some of the traditional companies that were doing just angioplasty work to invest in stents and then they put it in its own little business unit. Imagine, most business units at J&J are thousands of people selling tens or hundreds of millions of dollars’ worth of product. This was a small group of 20 to 40 people that started this idea of developing both peripheral and coronary stents under a guy named Marvin Woodall – a great guy.

I don’t see them taking the same risk today. They are like many other big companies – they tend to be very risk averse. And it’s hard for big companies to do innovation because innovation means risk. And risk is hard to manage. The big companies think, “I’d rather you go work out all the details, get through all the risk, and then I’ll buy your company at a premium.”

There still is a place for innovation in big companies. How do you choose projects, how do you diversify risk, how do you manage risk? It’s really tough in big companies because if you’re going to do innovation, you have to be able to kill projects because not everything’s going to work. Nine in 10 projects would probably fail or if you’re doing an amazing job, seven in 10. Then you get tainted in a big company if your project dies. It’s kind of like, “You must not be good at your job because all of our incremental development works.” Of course, incremental development is low risk.

So it’s hard to create a culture of innovation that is supported in a big company. It can happen. We actually had that for quite a number of years at Edwards Lifesciences. Mike Musallem gave me that kind of room to innovate and we had a separate group called ‘Advanced Tech’ that allowed us to do that innovation. I would say the same was true at J&J. J&J was a great place to learn more and more about innovation. I was able to work on the coronary stent and then I did advanced technology where we looked at radiation with the first drug coatings for stents, and that eventually became CYPHER.

So J&J is a really great first class company. They’re a great investor in NXT. I have a lot of respect for them. But I think like many, many companies, they struggle with how to do real innovation internally despite having extraordinary engineers, the financial capability to do it, all the resources to do it. It’s hard for big companies, despite all of that, to be able to do innovation.

Joe McMahen That’s where companies like NXT come in.

Stanton Rowe Exactly!

Joe McMahen You are using ViVitro lab services for development with NXT. How does using an outsourced lab like ViVitro Labs compare to in-house development testing?

Stanton Rowe That’s a great question. I think that there are certain things start-ups should do in-house such as some of that early prototyping and early testing. That being said, to do validations and verifications internally is a huge investment. I guess it makes sense to do that product by product. Overall, I think being able to build and test externally makes a lot of sense. At the same time, you want to have some capabilities internally to do your own prototype testing because you never want to send into V& V something that you don’t have 95%+ confidence in before it goes in.

It’s a delicate balance between internal capability and external capability. And in that equation is speed and cost. Considering that, using thoughtful, capable labs externally makes a lot of sense for a lot of smaller companies.

Joe McMahen It’s a matter of time as well. That’s one of the key factors in development. We’ve talked about your past. What are your plans for the future?

Stanton Rowe You know, when I retired after 15 years at Edwards as the Chief Scientist, it was a great ride and I have tremendous respect for that company. I’m somebody who’s done a lot of development work and I think I’ve helped start nine different companies so I’ve written a lot of IP in my career. Rob Schwartz has written even more. The two of us thought it would be really fun to have a vehicle where we could develop these crazy ideas in an incubator. And now the future for us is to continue to innovate. For me, it’s so much fun to ask: What are the remaining issues for patients? What do physicians struggle with? What do hospitals struggle with? How do we improve patient outcomes? How do we improve cost? How do we keep patients at home or improve their quality of life? There are so many opportunities. It’s a real privilege to have the opportunity to sit somewhere in that triangle between biomedical engineering, medicine and the business of innovation. It’s complex. And yet the opportunity to impact patients and improve their outcomes is so significant.

Joe, the times I will always remember from my life are meeting the patients that benefited from the things I’ve developed. I remember this lady we treated early on in Rouen, France. I went to see Alain Cribier to talk about our next stages of development and clinical studies. And in the hospital in Rouen, one of the patients who we had treated early on learned that I was there. She hunted me down. And she said, “Thank you for saving my life. Last summer, I went to the Riviera in the south of France with my grandchildren and splashed in the ocean. And I know I wouldn’t have been able to have that life without this procedure,” because she was dying. You never have a good answer when someone says, “Thank you for saving my life.” You can only just feel the privilege. That’s the kind of job that we do.

Joe McMahen That would be an incredible experience. With all that said, do you have any final advice for our readers?

Stanton Rowe What advice do I have?  I think the essence of innovation is that innovation is a little bit about breaking the rules. You have to be a little bit of a nihilist to be a good innovator. You have to look at the way we do things and say, “Really? What? Why do we do it that way? Isn’t there a better way to do this?” And then you have to figure your way through that. You have to be a little bit of a scholar. You have to be able to go in and learn the medicine. You have to learn the business. You have to learn the engineering around each area. And then you have to be willing to fail. A lot. Because we spend 99% of our time running into brick walls and figuring out what doesn’t work.

As long as we have a good problem to solve on behalf of patients, that persistence comes pretty easy because of the service we provide to patients and the doctors. So what advice do I have? Keep at it! Let’s make the world better for patients.

Joe McMahen That’s good advice.

Read about other Cardiovascular Pioneers here.