Eniware is looking to make safe surgery available everywhere. Two billion people in the world have little access to surgeons in large part because of challenges with sterilizing surgical instruments. The autoclave is the current standard for sterilization, and works by destroying pathogens with high temperature and pressure. However, challenges include equipment cost and absence of reliable electricity in many parts of the world.
Eniware has developed a new sterilization device, based on nitrogen dioxide gas (NO2). The sterilization gas works at room temperature, is 20 times faster than ethylene dioxide (another standard gas sterilizer), and is compatible with most medical materials and adhesives (excluding cellulosic, Delrin, nylon, copper, nitinol, and polyurethane). It works by damaging the DNA of microorganisms found on instruments loaded into the device’s chamber.
“There is a great need for a low cost, power independent sterilizer,” said Eniware CEO James Bernstein, MD. “This doesn’t exist anywhere. But we’ve made such a sterilizer with a 25L pelican case, into which you can put surgical instruments such as the International Red Cross Surgery set. You insert a small consumable, which generates NO2 and runs the cycle. At the end of the cycle, there is a pellet scrubber that absorbs the NO2. Then you open the case and you have sterile instruments.”
The sterilizer is expected to have CE Mark approval this year and the underlying NO2 technology will hopefully be FDA approved shortly. Eniware’s Portable Sterilizer will cost roughly $2000, and each consumable set will cost $15.
“We’re operating in a world where there’s no alternative,” says Eniware CEO James Bernstein, MD. “There are disposable male circumcision kits available, but they’re $20/kit. And you’ll laugh when you hear this, but disposal costs are $75!”
“We’re going to do the first field studies in June in clinics of several countries in East Africa. We’re looking at usability. We know the technology works, and the question now is: when we put it in a clinic, how does it work? Jhpiego, part of Johns Hopkins, is one of our big collaborators.”
We asked Dr. Bernstein about some of the challenges they faced as a start-up.
“Money is the first problem. Capital is an essential ingredient to doing what we do, but raising money for a solution for the developing world is not familiar to the standard investor and it’s not an easy task. I’ve raised well over $100 million in other endeavors, and by far, this has been the hardest to do. Our two biggest investors have come from Africa.”
“At the beginning we thought the technology risk was very small. You put stuff in a box, add NO2, and it sterilizes. On the surface, it’s very simple, but you have competing interests: costs, time, simplicity, and effectiveness. Number 1: it has to be effective – you can’t cut corners here. It also has to be safe. We’ve had over 100 risks we’ve identified and mitigated. One has to get the manufacturing right. Trial and error takes time and is frustrating. Additionally, you have to get approval by running various tests and getting data, which takes time and money. If you don’t have the willpower and courage and commitment, it becomes very difficult. We didn’t get any help from the big companies, but they’re all interested now. We stuck our necks out and came out with the disruptive technology that would change surgery in the developing world.”
When we asked him about what kept him going in light of these challenges, Dr. Bernstein mentioned two things: First, he knew that to succeed, he needed the right partner, which he found that in Huma Malik. “Huma is an expert in project management and conflict resolution, she is a skydiver and certified rescue scuba diver so you know she can handle pretty much everything.”
Second, he drew inspiration from his old mentor, Dr. Jonas Salk, who he worked with for two years: “After Dr. Salk discovered the cure for polio, he received many calls asking ‘Dr. Salk, why don’t you have a cure for cancer? Dr. Salk, why don’t you have a cure for diabetes?’ And so on. He was very depressed by the phone calls. He said ‘you don’t meet very many people who have done something really big, but when you do, you want them to do more. They never let up and never give me a break.’ My takeaway from that was that you don’t meet many people who have done something really big. So instead of taking care of one patient at a time, I decided to try to affect multiple patients with my time. The Eniware initiative struck me as something very big and something that Dr. Salk would be proud of. I am doing this because I feel like I must. Our company team is all like this and they all feel like this is a must.”
Eniware is a ten-person company with a strong passion for interns. In the past year, they’ve had eight interns, and to date the company has hired five former interns into full-time positions. “We love great interns,” said Dr. Bernstein. “For me, the most talented, motivated, creative people today are people who are in school. You put them in this environment and they go crazy because we’re doing something really worthwhile. We believe in growing talent and harnessing brains and passion. After all, these are the young people that will lead in the future.”