What is the need that Spiracur seeks to address?

The Spiracur project came out of the graduate-level Biodesign Innovation course. The founders, Moshe [Pinto], Kenton [Fong], and Dean [Hu] wanted to find a way to treat chronic ulcers earlier, when they are less severe, in order to prevent them from worsening and leading to amputations and other, often fatal complications.

What key insight was most important to guiding the design of your solution?

The initial insight was related to negative pressure, which is a common treatment for chronic wounds. Negative pressure wound therapy, which is delivered using a sealed wound dressing attached to a vacuum pump, promotes healing by drawing fluid from the wound and increasing blood flow to the area. Typically, the negative pressure, or suction, is generated by a large electric motor plugged into the wall. But what Moshe, Kenton, and Dean realized is that it doesn't matter if the negative pressure is generated by an electrical motor or through another mechanism. And they figured out how to make a small, inexpensive, disposable product that generates the same negative pressure as an electrical pump.

The other key insight was that even though negative pressure wound therapy was relatively widely used, it was not optimized for patients—especially those with smaller, earlier-stage wounds. Many of these people were ambulatory and didn’t want to be tethered to an electrical pump. To help these patients be compliant with their therapy, the team envisioned a solution that was fast and wouldn’t require the patient to carry around a large, obvious piece of equipment. So they designed their pump to be small enough that someone could discretely attach it to their leg or belt.

“Even though negative pressure wound therapy was relatively widely used, it was not optimized for patients—especially those with smaller, earlier-stage wounds.”

When I joined the company as R&D Manager the basic design was in place, but I led the charge to optimize the product for patient use. This involved carefully observing the way that the clinical trial product was being used at each step of the treatment process. The team, including Ken Wu [another Biodesign Innovation Fellowship alumnus who joined Spiracur], and I spent hours and hours refining every minute detail of the design to create a convenient form factor and to allow the quickest and easiest application of the product.

Previous products had been designed to treat huge, gaping wounds in hospitalized patients who were at risk of amputation or other horrible complications. But the design requirements for treating people with smaller wounds at an earlier stage were totally different.

For the patients, it was about being untethered and making the pump small and discreet. But from the perspective of the nurses who did most of the dressing changes, it was important minimize the time and complexity of that activity. It couldn’t take an extended period of time to apply and deliver the treatment. By redesigning the patch to reduce the amount of manual labor needed to size and seal it appropriately, we were able to cut down the length of time that it took to apply a negative pressure wound care system from 21 or 22 minutes to seven or eight minutes.

These kinds of changes really helped promote product adoption. People loved what we were doing. Once patients used the SNaP Wound Care System, which is what we named the product, many would refuse to use the old electrical pumps. They would come back and say, “I'm not using that anymore. I want the SNAP System."

How does the solution work?

Instead of using an electric motor plugged into the wall, the SNaP wound care system uses tension springs that exert a constant force to resist uncoiling. Other key elements of the system include a hydrocolloid dressing layer with an integrated nozzle and tubing, a holster with strap, and a foam wound interface layer. The system is small enough to be worn on a patient's leg, arm, or belt, and it can be completely hidden under normal clothing. It’s also lightweight but has enough capacity for 60 ml of wound exudates. Because there is no electrical pump, operation of the SNaP technology is completely silent. The SNaP wound care system is also entirely disposable, eliminating the added administrative and support costs of a rental-based system currently utilized by most electrically powered pumps.

At what stage of development is the solution?

The SNAP system was commercially released in 2009 and it's been out in the market ever since. Spiracur, the company, was acquired by Acelity back in 2015. But I'm happy to say that the product is still being sold.

Tell us about a major obstacle you encountered.

Reimbursement was a major obstacle for Spiracur that hampered the company’s growth. First, it took longer than we expected to get our reimbursement code since we had to apply for a different code category than the product we were replacing, which was covered under durable medical equipment.