Shawna Gvazdauskas has a knack for bringing medical devices to market. The 53-year-old is on the third start-up of her 30-year career. In March, she left insulin management maker Insulet, where she helped bring the company’s flagship Omnipod to market, for a new challenge at Isis Biopolymer Inc., which is developing a new generation of non-invasive drug delivery patches.
A “true New Englander,” Gvazdauskas, who is chief commercial officer at Isis, makes the long journey south from her home in New Hampshire all the way to Warwick, R.I. But, she tells MassDevice, it’s worth the grueling commute to help what she calls “a truly revolutionary technology” make the long journey from concept to commercialization.
In a quick chat with MassDevice, she explains why the Isis patch is a transformative technology, why she enjoys the gunslinging atmosphere at startups and how new methods of delivery can help big pharma protect patents.
MassDevice: Tell us about Isis Biopolymer. What’s the elevator pitch?
Shawna Gvazdauskas: Isis was founded in 2006. We’ve developed an active transdermal drug delivery system based on the concept of iontophoresis. Two things make our product unique. The first is its selective barrier membrane and the other piece is the single electrode design, which ensures a safe and accurate, non-invasive, transdermal drug delivery. Our goal is to work with pharmaceutical and biotechnology companies for existing and pipeline drugs. Our product is a platform; we’re not interested in bringing a drug to market, just bringing the platform to market.
MassDevice: The drug delivery market is vast and competitive. How can Isis Biopolymer compete and succeed?
SG: Well, nobody else has this technology. There are other companies out there in this space, but none of them have those two key components of the selective barrier and the single electrode design.
The other thing that’s important is the cost of manufacturing the product. Having lived through that in my last position, I know how important it is to have a low cost of producing goods. Our team here has an excellent history with that.
MassDevice: Why did you leave Insulet? Weren’t the fruits of your labor there starting to pay off?
SG: The technology at Isis is very exciting and the opportunity to have a non-invasive drug delivery system was very appealing. The Isis has a broad spectrum for drug delivery. In addition, it also has bio-sensoring capability, so it can sense certain incidents in the body, like cardiovascular incidents or other shocks to the system.
Plus, the fact that it’s non-invasive is important as we look at compliance for patients, who look for less-invasive and noninvasive platforms that lead to good healthcare outcomes. They don’t want it to hurt, they want it to be easy, they don’t want to take pills multiple times a day, or take injections.
Also, I’ve got 30 years in the pharmaceutical and medical device industries. This is my third startup. I like the newness of a startup, of rolling your sleeves up and digging in. As companies mature, it takes longer to get decisions made; you go to more meetings. I like to say the chief commercialization officer is the chief cook and bottle washer. It’s a big change, but there’s not as much turmoil in terms of stock results. It’s great that if you have a question here for somebody, you just walk to their desk, instead of having to schedule a meeting through Outlook. And the lab is right upstairs, so I can walk up and see what’s going on myself. It’s just constant learning here and it’s fun.
MassDevice: What’s the challenge you face at Isis? Is it similar to what you saw at Insulet and developing the OmniPod?
SG: I would say they’re different. At Insulet the target audience was the end user. Here the end user is pharmaceutical companies and biotech companies and potentially medical device companies. Another point of difference is that our goal is not to bring a proprietary technology to market, but to license our technology, or sell our technology to pharmaceutical companies. We’re not looking to build a national sales force with 1,500 people out there. Pharma has the drugs but not the delivery system. We have the opportunity to be synergistic with them.
MassDevice: You’ve been involved in multiple commercialization efforts. Have you developed any specific formula for commercializing a product? What are the most important factors to successfully launching a new medical device?
SG: I would say the most important things are having something that’s truly innovative, something that drives patient compliance, that drives health outcomes on the healthcare side. Also, you have to be very cost-efficient. You can have a great technology, but if it’s too expensive to manufacture then nobody’s going to pay for it and then you don’t have a business model.
There’s $55 billion worth of drugs that are at risk of going off-patent in the next few years. But if you’re able to develop another appropriate method of delivery you can extend those patents. This technology can extend patents. So in addition to having a very viable healthcare benefit, there’s also a real business benefit as well.
MassDevice: Are you saying that the potential market size is $55 billion?
SG: I don’t know about $55 billion. But it’s a huge potential market. If you look at Pfizer as an example, and I’m not saying we’re working with them in particular, but if you look a Pfizer, in the next three years a significant amount of their portfolio is going off-patent. Lipitor is one of those going off-patent and that’s a $12 billion worldwide drug.