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Interview: Doug Bernstein PECA Labs on the challenges and methodologies of pediatric cardiac devices

November 17th, 2015

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Doug Bernstein, PECA Labs

Doug Bernstein, PECA Labs

Founded in 2012, PECA Labs is a Carnegie Mellon and UPMC spin-off dedicated to bringing better medical devices to orphan populations, with an initial focus on the pediatric cardiovascular system.  Their first product, the MASA Valve, is a surgeon-created, engineer-optimized, clinically-implanted and validated heart valve that will save thousands of children every year from repeated open heart surgeries, with a significantly reduced input cost compared to the typical heart valve. PECA Labs recently completed a $2.8 Million Series A Financing Round.

Co-founder and CEO, Doug Bernstein (DB) and ViVitro Lab Manager, Rob Fraser (RF) discussed the unique challenges and methodologies of the pediatric cardiac space.

RF:  What’s unique about the work PECA Labs is doing?

DB:  We’re one of the few device companies solely focused on the pediatric space—especially for complex class III devices.  Other companies have created pediatric devices in the heart valve space, but very few have taken it as their sole focus.  A lot of that is because of the uniqueness of the pediatric cardiovascular system. The complexities that exist around pediatric cardiac surgery are not similar to adult cardiac surgery.

I think it’s an important niche to be filled.  The fact that it is our sole focus has allowed us to approach the field differently and to build our relationships with surgeons and institutions differently in order to bring devices to the kids who need them at a greatly reduced cost compared to normal development.

RF:  How is PECA Labs approaching this differently?

DB:  We take an approach that starts with a high degree of collaboration with the surgeons doing these surgeries and with universities as well.  Because there are often very few devices that are off the shelf applicable to patients, there’s a lot of off label use, a lot of customization and a lot of “in the suite innovation” by surgeons.  Because of the market size associated with the pediatric market, these are often not taken up and acquired by larger device companies to be brought to market as a product.  So you end up with a lack of standardization, a lack of quality controls, and ultimately more liability on the surgeon than should really be there and is often not there for other fields.

We work directly with the surgeons and the engineers at the university research level  who are focused on this and all the time having to create new ideas to approach the complex problems of pediatric cardiac surgery.  We work with them to translate those ideas and to productize them so we can get them back to the surgeons in a quality controlled, standardized and (eventually) FDA approved or CE mark approved fashion. We can take away a lot of the questions and non-standardization that go with custom and off label use and give them products that are still going to work with their patients.

RF:  You are taking the big company approach and taking it to a market not being served by them.

DB: Yes.  And because we are focused on such a small market and there are so few surgeons that do pediatric cardiac surgery compared to the adult market, we are able to build very strong relationships and collaborations directly with the surgeons that we work with. We are able to have relationships in a different way than you would see with the larger device companies. We‘re able to get closer and more collaborative.  That’s a big benefit for us and eventually a big benefit for the surgeons and their patients.

RF: How is the work progressing?

DB: It’s going well.  As anyone in this field knows, it’s never as quick as you would want it to be. There’s inevitably going to be some slowdowns and hiccups in the road.  Over the three years the company has been around we’ve managed to move forward at a relatively quick pace for the industry. We started out with one product and we’re up to three products in development that are all moving down their FDA pipelines in a way that we’re very happy.  Hopefully we’re going to see products on the market in the next year or two that will address certain pediatric populations.

RF:  What reactions have you had from colleagues in the industry?

DB: Colleagues in the industry have had very mixed reactions. We’ve seen it change a lot from when the company started.  When the company first started out and before it even started, it was more in the development stage and planning what the company would be and what our approach would be. We got much more negative feedback or people just not believing that we’re trying to do could be possible.  Because of the historical time and cost of the types of devices that we’re developing and the past experiences of some of the larger companies in these markets, people tended to think it was not possible to be able to do what we’re doing.  Let alone do it in such a way that you could raise the proper funds from investors to bring such products to market for these relatively niche groups.

As we’ve been moving forward and as we’ve seen the results of our devices be really excellent compared to anything else that’s out there, we’ve shown that we are able to move forward along our pipeline with costs that are significantly lower than the normal medical device company.  The conversations with either industry partners, potential investors or previous investors has changed a lot. It went from “this isn’t really possible” to “Oh wow, this might actually happen.” And that’s definitely a nice change in attitude to see.

RF: Yes, it would be tough to start out knowing you have such a noble cause to bring these devices to children and to be met with such pessimism at the start. I’m glad to hear that’s turning around.

DB: Especially in the last year or so, it’s started to change dramatically.

RF:  Is that when you started to secure funding, when the attitudes shifted that this was actually possible?

DB: Yes.  The last pushes of our funding round, closing the funding round and sort of accelerating afterwards has really changed the way people looked at what we’ve been doing and what we’re going to do.

RF:  How has ViVitro Labs services helped you and your efforts?

DB: We haven’t started our testing protocols or testing yet, but we’ve been looking around the field and getting ready for testing. Because our space is in the pediatric space, we end up having these unique anatomies that in a lot of ways are vastly different than in adult devices. It’s crucial to be working with a partner that’s able to customize, develop and adapt to our needs.

After this interview we’re going to continue our conversation about the customizations we need in order to test the devices.  That’s something we’ve had good experiences working with ViVitro. It’s been really important to us because when you’re dealing with the regulatory side, you need to show these things and prove these things, and whether it’s easy or not to get the machine to do that isn’t part of the conversation.  It’s important to work with fine industry partners like ViVitro that are able to adapt and work with you to meet your needs.

RF: You mentioned already you have three novel devices in the pipeline. What are the next steps for PECA Labs?

DB: The MASA valve is the most visible and the furthest along. The other two we’re keeping a bit quiet. They’ve gone through their benchtop and ex-vivo studies. We’ve been working with a number of surgeons and institutions to get them into realistic in-vivo animal studies that are going to be happening over the next few months.  The results have been looking great and we’re excited to show that when we put them in animals, we maintain the results that we’ve seen. They’re not late stage, but they’re moving forward.  If they continue to show what we’ve shown in our testing data, they have the opportunity to revolutionize the field of pediatric cardio-thoracic surgery. We’re very excited about this, but will have to wait a bit longer to go into the details.

RF:  Do you have any advice for cardiovascular researchers or start-ups?

DB: Yes.  Especially in the pediatric space, direct collaboration with surgeons is key.  If you’re a researcher and you’re not talking with the surgeons doing it, you’re going to have a hard time even attacking the proper concept. When you read these things in textbooks, or even when you look in the publications, the reality of doing these surgeries– and every patient with a congenital heart defect has a different anatomy than the last one with the same congenital heart defect– is a big thing to take into account when you’re trying to develop devices that are going to be applicable to all of these differences in the patients that have it. Talking with surgeons that have hands on experience is crucial.

Separate from that, a huge amount of persistence is necessary.  If you’re working in the pediatric field as an entrepreneur, you’re inevitably going to face people not believing what you’re trying to do is possible. Often times that’s because of their past experiences with larger markets and different markets than your own.  The fact that people don’t think it is possible doesn’t mean that it isn’t.  Being stubborn and very persistent is critical in this field. 

RF:  How did you choose cardiovascular and pediatric?

DB: I was born with a congenital defect.  When I was born, my life was saved by a pediatric cardio-thoracic surgeon.  That certainly had a part to play in my getting involved in this research. I had an opportunity to be involved in a project looking at right ventricular outflow tract reconstruction trying to develop a better methodology while I was at Carnegie Mellon University. Because of my own history, I jumped on that opportunity.  Luckily, it was a great collaboration between engineers and surgeons that produced some promising results that led to PECA Labs.  A little bit of serendipity, a little bit of personal history definitely went into that.

Read more interviews with Cardiovascular Pioneers.


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