For Tom Roberts, good healthcare starts with prevention.
It’s a mantra the CEO of San Antonio, Texas-based startup Invictus Medical holds close to his heart.
In 2010, interrupting a 25-year medical device career that had taken him to Boehringer Manheim, Roche Diagnostics and Kinetic Concepts Inc., Roberts took a leave of absence in 2010 to serve as a caretaker for his ailing mother.
"Shortly after I moved to San Antonio, my mom contracted breast cancer, and didn’t catch it early enough, and it spread to her brain," Roberts told MassDevice.com. "Through this process I took a sabbatical and returned to Washington for an extended period of time, because she wanted to stay in her own condominium. I helped provide care to her (along with my family) during the day and we brought in a caregiver in the evening, which allowed my mom to live her last several months at home. She passed in her living room with her family members around, which was how she wanted it."
Roberts told us that moving from the executive suite into the role of caretaker changed his perspective, providing a clarion call about how he wanted to spend the rest of his career.
"It taught me to take an introspective look at what I was doing and where I was at in my career. That was 1 of the reasons I came back to San Antonio and started looking at small device companies and startups," he said. "I wanted to apply everything I learned in those big companies and help commercialize an exciting new technology that really impacts people, which might not have been able to come to market without that expertise."
Roberts found that company in Invictus Medical, a small startup out of the University of Texas at San Antonio, which was developing a gel-filled bonnet for infants in neonatal intensive care that showed early promise in preventing a common cranial deformation. Plagiocephaly, or flattening of the skull, occurs in about 20% to 30% of all newborns, he told us.
"Prevention is the key, and early detection at that," Roberts said, harkening back to the lessons learned at his mother’s bedside. "That goes back to the importance of the bonnet, how important it is to catch these things early."
In a wide-ranging interview, edited for clarity, Roberts told us how Invictus Medical aims to improve the lives of the most vulnerable patients.
MassDevice.com: What’s the history of Invictus Medical and how would you describe the company’s mission?
Tom Roberts:Invictus Medical was started in 2011 by engineering students from the University of Texas at San Antonio. At that time, it was an innovative idea – a concept with great potential for commercialization. Our mission is an important one. In the broadest sense, we want secure early healthy development in newborns by conceptualizing and bringing to the marketplace products and services that our customers view as innovative.
Our technology interests focus on combating deformational plagiocephaly (DP), a cranial deformity exhibited in infants resulting from repeated external pressure to 1 area of the head. Historically, the most prevalent way to address the deformational plagiocephaly issue has been through the use of cranial orthotics. However, the cranial orthotic therapy currently available is corrective instead of preventative, can be costly, and may require multiple devices.
Our device fills an unmet need. It is designed as a preventive solution to significantly reduce cranial complications. As a cranial pressure protector, our device, which is mobile and unobtrusive, contains a proprietary gel solution specifically designed to dramatically increase surface area contact and greatly reduce peak pressure.
MassDevice.com: What is plagiocephaly?
Tom Roberts: It’s a cranial deformity exhibited in infants resulting from repeated external pressure to 1 area of the head. It clearly is a cosmetic issue, but there is much more at stake. According to a study published in Pediatrics in 2013, DP has been associated with heightened risk for developmental delays in infants and toddlers. An estimated 1.2 million U.S. newborns are at risk of DP, with the condition annually affecting approximately 20% to 30% of all infants.
MassDevice.com: What is your timetable in terms of getting to the market?
Tom Roberts: We’re getting ready to start our patient safety clinical trials with a prestigious hospital in Texas and we anticipate submitting our 510(k) application to the FDA in the 1st half of 2014. We then estimate launching our first product within the year.
MassDevice.com: I understand the incidence of plagiocephaly has increased dramatically over the past 20 years. Why is that?
Tom Roberts: It has become a growing issue, clearly. Back in the early 1990s, because of the risk of [sudden infant death syndrome], the government ran a national campaign that told new moms to place their babies on their backs when they were sleeping. They found that, when babies were placed on their stomachs to sleep, the risk of SIDS increased. By placing the babies on their backs, it reduced the risk of SIDS by up to 80%, but it significantly increased plagiocephaly.
MassDevice.com: So is it just an aesthetic problem, or are there connections to developmental or cognitive problems later in life?
Tom Roberts: There is a stated linkage. This study published in Pediatrics in 2013 underscores that DP has been associated with heightened risk for developmental delays in infants and toddlers.
MassDevice.com: How was the technology developed and what are the origins of the company?
Tom Roberts: First, many people may not know that San Antonio has a somewhat vibrant medical device and biomed industry that includes many young and promising companies. So those engineering students entered their concept into a medical technology competition here in the region and they won. One of the prizes was funding the formation of a company to take the concept to commercialization.
MassDevice.com: What did you see in the product that made you want to be a part of Invictus?
Tom Roberts: Obviously you do plenty of homework on the condition and the marketplace. To boil it down, I saw the potential for this technology to become a new standard of care and make a real difference in the lives of newborns and infants. So the mission excited me – it was a somewhat noble calling. Technically speaking, this also fell within my operational expertise – I have 25 years of experience commercializing medical device products.
I started my career with Boehringer Mannheim in the early 90s and in 1997 the company was purchased by Roche Diagnostics (PINK:RHHBY). I started as a hospital sales representative for Roche selling into NICUs. I spent 6 years in sales, then moved to leadership roles in marketing and sales. One of my highlights at Roche was having global oversight for the product development and strategic marketing of the Accu-Chek diabetes care product line, which grew into a $1 billion global business and became the #1 brand in its category at the time. That was a very satisfying assignment, given the impact it had in the marketplace and on patients. I ultimately came to San Antonio and South Texas several years ago for an executive position at Kinetic Concepts Inc., a multi-billion-dollar global med-tech and device company.
MassDevice.com: You spent years with Roche and KCI, there’s a big culture difference there compared with startups culture.
Tom Roberts: Yes and no. At first glance, some would say that. But I have always felt that innovation often occurs in smaller, somewhat organic and entrepreneurial environments – even at mid-caps or larger companies. I believe the most important point, though, is that in a startup environment you need a diversity of backgrounds and Invictus has that. Our leadership team and board have big-company experience, as well as a strong track record in successful startup environments. So there is a real proficiency here at capital raising, commercialization, business development, operations, governance and financial management.
MassDevice.com: How much have you raised through private investors?
Tom Roberts: We closed our seed round of funding in 2013 at 100% of target, having raised more than $2 million, and began Series A funding in the 1st quarter of this year.
MassDevice.com: What do you think resonated most with Invictus’ pitch?
Tom Roberts: Of course, at its core, it’s always about the fundamentals and the market opportunity. I think then it’s about having a highly experienced leadership team and board with a track record – within our industry and outside of it – of taking an idea from inception to implementation to sustained growth. We are humble, but very resolute – we believe that Invictus has the potential to become a world-class medical technology company.
MassDevice.com: Let’s drill down into the product – how are you looking to disrupt the standard of care?
Tom Roberts: There are 4 million births every year. Approximately 20% to 30% of those babies contract some form of plagiocephaly. There are different grades of cranial deformation, but if left untreated they become more severe. If they become more severe, then you have to use cranial helmets, and if that doesn’t correct the problem then the course of treatment is cranial surgery.
The issue is increased in the NICU, because those babies are compromised, they’re younger and their skulls are more vulnerable – basically, deforming under the weight of the head.
Our product is a cranial pressure relief device – though it will have a brand name when it comes to market. It encompasses the back of the infant’s head and, from a technological standpoint, it does 2 things: It increases the contact area of the head with the surface of the area the head is resting on, and decreases the peak pressure being applied to the head and causing the deformation of the skull. Our early studies show that we are able to decrease that peak pressure by 90%.
The 2nd thing we’re doing is using materials that significantly reduce shear and pressure, so we also believe we will be able to minimize pressure ulcers on the cranium of the babies in the NICU.
MassDevice.com: What would you classify as proprietary, the gel, the bonnet? What makes this unique?
Tom Roberts: Our patents are around the structure of the "gel shell" itself. The proprietary shell is what’s unique about the product. There’s a proprietary formation of the shell with which we are able to accomplish the 90% decrease of pressure.
MassDevice.com: Are there other applications for that technology?
Tom Roberts: There are common applications for gel-filled products in the medical device and consumer products space – there are gel-filled pillows and mouthpieces – but the use of this in our product is very unique.
MassDevice.com: What made you think, "I can take this and turn it into a world-class healthcare company?"
Tom Roberts: The 1st thing that excited me was the space – pediatrics and the mission. And then you look at the market opportunity, and the numbers are there, they add up. From a product standpoint, it attracted me that the device had great, intricate technology and IP, yet for the customer and patient, it’s an elegant and simple product that addresses a very significant problem.
MassDevice.com: When we say unmet need, is the standard of care a helmet?
Tom Roberts: We are all about prevention – big distinguishing factor. The intent of our technology is to reduce the incidence of plagiocephaly. Helmets are a secondary measure to correct the problem, after it has occurred. There also are positioning aids and pillows in the marketplace that have been developed to prevent this. However, when we see a 20% to 30% prevalence rate in the marketplace – and even higher in the NICU – then we don’t believe those products are able to accomplish what we at Invictus are able to accomplish.
MassDevice.com: In an ideal world, would all the NICU babies be fastened with the bonnet or just the kids at risk?
Tom Roberts: All prematurely born babies are at a higher risk because of the underdeveloped cranium. The hospitals we’ve spoken have indicated that they would put this product on a good majority of the babies admitted into the NICU, because you cannot distinguish which babies are going to contract this. I can’t tell you how all hospitals will use the product, but the ones we’ve spoken to, that’s how they will use it.
MassDevice.com: What’s your sales and marketing plan? Is this a reimbursed product?
Tom Roberts: Right now our target is the hospital, but we believe there are applications in the consumer market as well. We’re focused very specifically on the NICU market at the outset. We will not be seeking reimbursement at launch. In discussions we’ve had with hospitals, this product would be passed through and included in the cost of the stay in the hospital.
MassDevice.com: About how long does the baby have to wear the device?
Tom Roberts: We’re recommending they use it for the length of stay within the NICU; the length of stay is determined by how prematurely they were born, because usually they stay until they are full-term.
MassDevice.com: How big a team is Invictus and is this the first of other products you’ll be pursuing?
Tom Roberts: Our aspiration is to be a multi-product company and we’re tackling that from several points of view. First, we’re looking for different applications for our current technology; and 2nd, technologies that can be included in this product that will make it even more compelling and provide more utility for its users. Third, I would say we are looking for other technologies that match up well with our mission and the technology platforms that we’d like to develop.
We have an executive leadership team, a board of directors and a corporate advisory board consisting of industry experts across a number of professional disciplines. With product launch anticipated this year, we will begin to look at staffing our sales force and some other functions. We have every intention of growing, and in turn, becoming an attractive employer and a strong corporate citizen.