Healthcare facilities in the US generate millions of pounds of medical waste every year. Most of that infectious material gets picked up by trucks, hauled away, and incinerated in a process that environmental groups say produces toxic emissions and ash residues. Enter Sterilis, a company based in Boxborough, Massachusetts, that makes a device for handling the waste safely onsite.
Their self-contained portable machine sterilizes waste for 30 minutes using steam and then grinds it into a confetti material. That step reduces the waste volume by 80%, according to the company. From there, the ground material can be safely transported and even recycled.
“We can take highly infectious waste that is handled with kid gloves and transform it into benign sterilized waste,” says Sterilis CEO Bob Winskowicz. He adds that the company wants to identify more secondary uses for that waste. “The circular economy is evolving for us and we’re very excited about it.”
This summer the Sterilis device won an Environmental Leader Award. One of the judges highlighted how the product addresses the enormous medical waste problem. “The ability to reduce the volume and danger earlier in the medical waste life-cycle impacts downstream handling issues and costs,” the judge commented.
We recently caught up with Winskowicz and Sterilis president and CFO Jeff Bell to learn about their process for designing and developing a sustainable device.
What were the motivating factors that prompted you to start developing this device?
Jeff Bell: Three of my grandparents got infections while they were in the hospital and passed away. My father had a medical device company and I’d always been around the healthcare industry. Even when I was an accountant, we had a large healthcare practice I was running. I started doing due diligence on ways to address the market need. Medical waste was being treated through incineration — one of the worst polluters. I set about trying to find other ways to treat the waste and stumbled across documentation from the CDC that said steam is the most effective and efficient form of sterilization.
Bob Winskowicz: My background was in consumer goods. I held positions such as director of sales, executive VP of sales and marketing, and then started my own technology firm. After a 14-year period, I sold out my position to an entity and came to work with Jeff in the fall of 2012. People in healthcare were looking at containing costs. We also wanted to address the archaic “haul and burn” system.
What were you discovering from your research?
Bell: We knew that some large hospitals had [sterilizing] autoclaves onsite. Having waste hauled away is extremely expensive. The industry was controlled by one dominant player that shipped potentially infectious waste on federal roads and incinerated it. Small- to medium-sized waste generators don’t have the ability to negotiate prices down. My first step was to look at what other devices had been developed.
There was one piece of equipment that used a chemical to disinfect the waste that has been linked to adult onset asthma by the CDC. Another one used dry heat, but the cycle time was about two and a half hours, and it had a very toxic odor during the process. I had looked at a microwave technology, but we found there are only two approved methods of sterilization in every state: incineration and steam.
We wanted to develop a piece of equipment that would be small and movable within a facility so it could be placed close to the point of generation. It couldn’t have fixed plumbing or fixed drainage, just a plug that goes into the wall. We looked at giving customers the flexibility to do away with their hauling contracts and treat the waste quickly close to the point of care to eliminate any chance of cross-infection.
What was your approach for designing the first Sterilis device prototype?
Bell: We chose the development firm Continuum Advanced Systems. As part of their standard operating procedure, what they call user needs research, we went into six different facilities reaching different parts of the healthcare industry: a hospital, a surgery center, a nursing home. The intent was to get feedback on what they wanted out of this type of equipment without actually telling them what we were doing. Those answers, along with the concept of equipment that was able to sterilize and grind waste, formed the basis of what we ended up manufacturing.
How did you work with them to get to the prototype phase?
Bell: Through research, they knew that the people handling this waste are typically female. And, if you are in the bottom 5% of the height range, that’s around 4’9” to 5’ tall. Continuum mocked up a device and had people come in who were around that height to test it. Through that process we set the design specifications and the targets for each of the engineering subsets, be it electrical, software, hardware, and mechanical.
What were the biggest challenges and how did you overcome them?
Bell: We only had a certain amount of space we could fit a grinder and a sterilization chamber. We spent nearly $2 million just on designing and developing the grinder itself. It’s a very broad waste stream that we’re trying to deal with, and with an output size that is no greater than a half-inch by a half-inch. Consider a syringe that’s going through — that’s fairly easy to grind up. But then you add rubber gloves or gauze or drapes and that’s another ball game.
We also recognize that not all of the people who are going to be using the machine are going to be literate so how do you deal with that? The system is based on iconography and only requires the user to press some pictures. It took a lot of design and research to get right.
The only way was to build, test, redesign, build, test, redesign. The process ended up being two and a half years until we got our first working prototype.
Winskowicz: Once we had the basic machine designed, it was a matter of getting it perfected. We started hiring our own mechanical and software engineers to further the development and bring everything in-house.
We’ve refined some things. One of the changes was we built an onboard system so that after every cycle it would lubricate the grinder. We investigated types of oils and found that one of the best and most environmentally sound was simply canola oil.
Bell: We investigated a lot of lubricants, from WD40 to motor oil. Canola oil gave us the ability to help green healthcare practices.
How do you determine whether a particular oil is going to be “green”?
Bell: Oil on the grinder gets onto the waste load that could be going in for recycling. That was our main concern. If we’re going to send this sterile waste off for recycling, it couldn’t be contaminated. We also didn’t want something toxic if the waste was going out into the landfill. For availability and sustainability, canola oil checked the boxes.
Were there particular lessons you learned from the product development process?
Bell: Never stop. You can always improve on the benefits you’re providing for your customers.
Winskowicz: Listen to your customers. Everybody is looking to cut costs, remove inefficiencies, and do the right thing. They’re pursuing sustainability initiatives and they have ideas. Are there ideas we can internalize and deploy into our system?
What’s next for your company?
Bell: We spent a lot of money, time, and effort proving that we could sterilize the waste as well as designing and fabricating a grinder that would allow us to reduce the volume of the waste by 80%. Our customers are interested in the circular economy. We’ve got a number of facilities asking, ‘Do you have a solution for the remaining 20%?’ We’re working on it.
Winskowicz: We look at healthcare in segments. One that generates a tremendous amount of medical waste is dialysis. We have seen that it generates about 2 billion pounds of medical waste annually. The good news is that it’s a very homogeneous waste stream — 95% is the dialyzer and the tubing. The dialyzer, the filter that cleanses the blood, is made of some high-value recyclable materials. We have embarked on a new program and should have data back in October that substantiates the secondary uses for this material. It can have another life.
The Sterilis medical device won a 2017 Environmental Leader Award. Learn more about the product here.