In December 2014, Dr Rena Dharmawan, a Duke-NUS M.D. alumna was part of Team Privi that trumped 298 teams for a S$100,000 cash funding in NTUC Income’s Future Starter competition. Apart from Dr Dharmawan, the Privi team consisted of Mr Prusothman Sina Raja, Dr Benjamin Tee Chee Keong (PhD), and Dr Cecilia Wang Yao (Dual-PhD).
Their winning product was a Class 2 Medical device called Privi that can be used at home to alleviate pain caused by haemorrhoids. In January 2018, Privi Medical Obtained FDA Clearance for their InstaliefTM Hemorrhoids Treatment
Following interview is a conversation with Team Privi to know more about their interesting and useful invention.
What are Haemorrhoids?
Rena: Haemorrhoids (commonly known as ‘piles’) are blood vessels in the anal canal that function as anal cushions that assist in maintaining continence. Occassionally they become symptomatic with the most common symptoms being bleeding, pain and prolapse. Patients with risk factors such as obesity, constipation and pregnancy are at higher risk of having symptomatic haemorrhoids.
Currently, available treatments include conservative managements such as lifestyle modifications, drugs and ointments, and more invasive procedures such as rubber band ligation, sclerotherapy and surgery (conventional or stapled).
What was the basis of your idea and how did it all begin?
Pru: We met as fellows as part of the Singapore-Stanford Biodesign Fellowship Office program, which is a partnership between the Agency for Science Technology and Research (A*STAR), Economic Development Board (EDB) and Stanford University. The year-long fellowship is designed to bring together four people from different backgrounds and make them work together on a project for 6 months at Stanford and 6 months in Singapore. The fellowship is about inventing new medical devices with a prime focus on needs. Since it’s a needs-driven innovation, a large part of our time involved locating problems existing in a specific field in the medical industry.
In our case, the focus was on gastro-intestinal tract- from the mouth to the anus. We followed the colorectal surgery team in Stanford and a team at NUH, Singapore to assess possible issues which we could solve. Apart from this, we also spent three weeks in Indonesia in the hospitals where we followed surgery teams, clinics, doctors, nurses etc. Only in the last 1/3rd of the project, did we get around to thinking about how do we solve the problem and start our invention.
What was the result of your analysis?
Pru: We generated about 300-400 needs which we shortlisted as ‘problems’ based on our observation. After that, we identified a problem and analyzed the missing need by a filtering process.
Ben: The Biodesign thinking process is about finding a problem first, then developing the technology to solve the problem and monetize it so that we can sustain the technology. We singled out the best problem we could work on, based on the skills sets we had within the team. In our case, we had a gastro-surgeon, biomedical engineer, and a Pharma person in our team. So, the idea was to use our skills sets as a filter to focus on a problem.
What was the problem you chose to focus on?
Pru: Since our focus was on the different problems in GI tract, we looked for a problem that we could solve in a reasonable time frame rather than looking for big research projects. We shortlisted 3 or 4 ‘needs’ eventually and chose the project on helping people manage Grade 1 and Grade 2 haemorrhoids at home.
Hemorrhoids or piles is a condition caused by swollen veins in the anal canal. It is a very common problem which is quite painful, but is usually not serious.Veins can swell inside the anal canal to form internal hemorrhoids; or they can swell near the opening of the anus to form external hemorrhoids. The symptoms and treatment depend on which type you have.
There are four grades of haemorrhoids, with Grade 3 and 4 being the worst in terms of severity. However, they can be treated by painful procedures which provide good relief such as rubber band ligation or surgery. However, Grade 1 and 2 haemorrhoids do not have any proper solution. There are some topical drugs or oral medication which can be taken, but there is not much scientific proof showing their efficacy.
Ben: The other insight we had was that almost 80% of all pregnant women suffer from haemorrhoids. Lot of them had grade 1 and 2 condition, (90% of all haemmorhoid belongs to these grades) and usually doctors prescribed them drugs, which most pregnant women were hesitant to take. Even though there is no toxicity associated! So we felt that there is a need for a product, that they can use comfortably in a hygienic way that will help them manage their symptoms. So that was the starting point for our invention.
The funny thing about grade 1 and 2 is that, a lot of people suffer from it, they know its not a great thing to have, it bothers them but they think its not bad enough for them to go and see a doctor. The thought of a doctor analyzing it with a proctoscope makes them very uncomfortable, that they usually delay the problem or hold it back, until it reaches grade 3 or 4. So, we felt there was a large group of people who didn’t want to take drugs for grade 1 or 2, and even if they took it wasn’t effective.
Approximately, how many people suffer from this problem globally?
Ben: In the US about 20 million people have haemorrhoids while globally, an estimated 300 million people suffer from this problem.
It’s a very big problem and it is difficult to prevent and hard to manage. Its almost as if most of us, at some point will have this problem. Most cannot prevent it but there is no way to manage it either. That is what we are trying to solve; the way for people to take control of the symptoms.
How do you tackle this problem?
Our product is not a cure, but we help people manage Grade 1 and Grade 2 haemorrhoids at home.
What is the product about?
So the product is something like a tampon, but for haemorrhoids. The user flow would be very similar as it helps to stop the bleeding. Right now, there are no ways to tackle the internal haemorrhoids as it is hard to reach. In our case, all you need to do is use our product which has a proprietary technology to reduce pain. Eventhough many people take drugs to reduce the pain, it produces systemic relief, affecting all parts of the body which is not preferred by pregnant women. Our solution is non-drug based and helps stop bleeding inside.
Have you started clinicial trials?
We are going to start clinical trials soon. The initial trials are just going to prove that symptomatic relief is possible and there is a lot of demand in this market for relief. People are bothered about the pain, and we want to deliver in that front.
In the long run, we also hope to demonstrate that using our products actually helps stalling progression. But that will come much later and requires a lot of time.
Will you be marketing it as a kit?
The eventual vision is to sell it in pharmacies.
How far are you in realising this vision?
Ben: We hope to hit the markets in 2017. We are finalizing our designs right now. The next stage will be to perform a series of studies to generate data for a class 2 medical device like ours.
In the US there are three classes of devices- Class 3 device signifies life-dependent devices requiring high stringency such as implants. Class 1, on the other hand, involves simple products such as plasters. Our product falls in to Class 2 devices category meaning it is not life-dependant, but it is important for such products to adhere to certain regulations so that they can be deemed safe.
The next big thing is in the second half of this year where we will try to generate clinical data and by end of 2016, we want to have our regulatory dossier prepared and hopefully, in 2017 we can enter the market.
What is the market need for a product like this?
It has tremendous potential, especially considering how widespread the problem is. One of the doctors whom we consulted while making this product remarked, “Your product is 15 years too late to enter the market!”
One of the judges in the NTUC Income’s Future Starter competition, Mr. Marcus Chew Senior Vice President of Strategic Marketing & Communications, NTUC Income had said: “Privi’s idea, which is borne out of extensive research, has a global reach and huge potential commercial success. The team has a strong panel of advisors and its idea, while sustainable, can have a strong social impact on people across the world. This differentiates them from the other finalists.”