Incisional hernia is a significant and costly problem that affects over a quarter of a million people annually. The current state of the art to repair hernia involves suturing a piece of prophylactic mesh over the incision. This process is too time-consuming, too variable, and most importantly, it is ineffective, as 1 in 3 reparations fail. To address this issue, we propose the SafeClose device, which standardizes and automates the mesh affixation process. The SafeClose device stretches the mesh so that it holds the optimal amount of tension and, with the press of a button, it deploys tacks so as to safely affix the mesh onto the abdominal wall.
This week Paradigm focused on figuring out what the ecosystem that our company fits into currently looks like. We spent a lot of time trying to understand who the important players in our ecosystem are and how all of those players interact with each other. With a better understanding of this ecosystem, we will learn exactly how we will fit in and how our product, the SafeClose device might impact that ecosystem.
Through this exercise, we found that one of the biggest players in our ecosystem is insurance companies. We plan to try to set up some interviews with insurance company representatives in the upcoming weeks.
We spent a lot of time last week interviewing surgeons. Surgeons are also very important players in our ecosystem, as they will be the ones using our SafeClose device. Our goal in these interviews was to find out how surgeons feel about current mesh fixation practices and to try to find out what features they think are important when using the prophylactic mesh augmentation (PMA) technique. We found that across the board the 2 most important factors that surgeons are looking for are ease of use and speed. This is nice to hear, as our proposed technology would provide both of those features.
This week the team interviewed more surgeons to try to get more data on the user side. We also focused on trying to get some interviews set up with insurance personnel. Although initially we had some meetings set up with some representatives from Blue Cross Blue Shield, these meetings fell through and we are still working on finding other contacts to speak to.
The team is excited to have gotten some key interviews done in the last week with some leadership within the Penn Health System. We had the opportunity to speak to some nursing leadership and learn about what they think the important factors are when it comes to hernia prevention and the adoption of new technology in the OR. We were also lucky enough to get to meet with the Chief Medical Officer and learn more in depth how our company and our device would fit into the ecosystem and about the process by which new technology is brought into a hospital or health system.
The team realized that it would be in our interest to begin focusing on the process of getting FDA approval, as this will be vital in getting out device into any health system. In order to help us understand this process better, we were able to get an interview with an FDA specialist who gave us quite a bit of insight into the process. This made us aware of the various pathways that we could potentially go down in the upcoming months to get our technology approved. Aside from that, we interviewed a venture capitalist to get some more insight from the financial end of this.
Also, the first prototypes of our device have been completed and will be undergoing testing this upcoming week.