Tackling an Uncomfortable Problem
The fourth class of Singapore-Stanford Biodesign fellows arrived at Stanford eager to dive into health technology innovation and entrepreneurship. The team included Prusothman Sina Raja, a biomedical engineer; Benjamin Tee, an electrical engineer; Rena Dharmawan, a surgeon; and Cecelia Wang, a biotechnology and materials science engineer. They spent six months learning and practicing the biodesign innovation process at Stanford before returning to Singapore to apply the approach to addressing problems affecting patients in Asia. Specifically, they were focused on identifying and solving important unmet health-related needs in the area of colorectal health.
Back in Asia, the team conducted observations in hospitals and clinics in Singapore, as well as multiple care facilities in Indonesia. What surprised them most was that one particular unmet need was prevalent across the board; whether they were immersed in a high-end tertiary care setting in the US, the emergency room of a small, rural hospital in Indonesia, hemorrhoids were a major problem with no good solution.
“It was at Stanford when we first realized that roughly 20 percent of the patients in the colorectal clinic at any given time were there because of hemorrhoids,” said Sina Raja. “And most of them weren’t being medically helped. The problem was that these people had early stages of hemorrhoids and surgeons don’t want to operate at that point because hemorrhoid surgery is actually quite painful and difficult to recover from. So the doctors recommended a conservative approach, telling the patients to go home, drink more water, and eat more fiber.”
When the team interviewed the patients, however, they realized that they were experiencing considerable pain and discomfort, as well as emotional distress. “One patient stood out in particular, an elderly man who came to the hospital. He was visibly shaken to see his underwear full of blood, only to learn that the early stage of his condition meant that the hospital was unable to provide definitive care,” recalled Sina Raja.
He continued, “The only non-surgical alternatives available to these patients are over-the-counter ointments and creams that reduce the pain but don’t stop the bleeding. They also take a while to have an effect.” Sina Raja noted that most of them contain steroids, which over time can thin the mucosal lining of the anal canal and make the hemorrhoids worse. Another problem is that one of the largest patient groups is pregnant women -- up to 80% will develop the condition during pregnancy -- and this group is understandably reluctant to use any drug-based therapy.
Another discovery the team made through patient interviews was that many individuals strongly disliked the feeling of hemorrhoid ointments or suppositories, which could be oily and uncomfortable, as well as likely to stain clothing.
“We really empathized with the patients,” said Sina Raja. “We got interested in the need for a better hemorrhoid solution when we were at Stanford. But what convinced us to take the need forward was when we saw the same problem again and again in Singapore and Indonesia.” Clinician interviews and research further validated their decision, especially when the team learned that the prevalence of hemorrhoids in Asia, and particularly in East Asia, is three times that of the West (although the reasons for the disparity are unclear).
After deeply researching the problem, the team defined a series of key requirements that their solution would have to meet. “It had to work quickly, since people are experiencing very uncomfortable symptoms, and it had to be drug free, said Sina Raja. “And it needed to address both the bleeding and the pain.”
Using these criteria as a guide, the team began brainstorming solution concepts. Over time, they were increasingly drawn to the idea of using cold to help address the problem. “The genesis of the idea came from thinking about how pain, bleeding, and swelling are solved in other parts of the body,” noted Sina Raja. “We also learned that in some hospitals in Asia, patients who come in with bleeding and pain from hemorrhoids are treated with the finger of a glove that has been cut off, filled with water, frozen, and then inserted into the anal canal.”
Although the basic concept seems intuitively simple, developing the actual product proved challenging. “First, because this is a product that people use at home, there is no trained medical expert to deploy a device,” said Sina Raja. “And we are asking people to access a part of the body that’s not regularly accessed and is difficult to see. And so the design had to be very straightforward and intuitive. We ended up modeling our product somewhat like an enema in terms of the mechanism of insertion and squeezing. As it turns out, many people with hemorrhoids have experienced constipation and are familiar with this mechanism.”
Another important barrier the team encountered was people’s reluctance to talk about hemorrhoids. “When we were doing validation interviews during product development, we would build prototypes and it was very important to get feedback about how the product looked and felt. And so we wanted to speak to as many hemorrhoid sufferers as possible. But many people are hesitant to talk about their hemorrhoids and uncomfortable talking candidly about their experiences. But we kept trying and eventually found enough people who were open to sharing and giving feedback,” said Sina Raja.
Ultimately, the team formed Privi Medical to bring their solution to patients. The technology was recently cleared by the US FDA and Privi is now preparing for a a preliminary launch in several regional markets in Southeast Asia.
Looking forward, Sina Raja plans to start more companies to address other important unmet clinical needs and help build the entrepreneurial ecosystem in Southeast Asia. “The health technology ecosystem is not as well developed here as it is in the US,” he said. “So the best way to make it more robust is to continue developing solutions, starting companies, and helping other innovators succeed.”