Unlisted & Unlimited: Cover Story:It's a wrap

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This article first appeared in Unlisted & Unlimited, The Edge Malaysia Weekly, on April 11 - 17, 2016.

 

Dr John Tang, an obstetrician and gynaecologist, was tired of listening to the same old complaints from his patients — unwanted pregnancies and sexually transmitted diseases (STDs) — even when they were “protecting” themselves with contraceptives or prophylactics.

“I have seen young people get pregnant at 15 or 16 with no idea of what to do. I have seen older women with six or seven children get pregnant while on contraception. So, I kept wondering what the solution should be because none of the contraceptive methods out there are 100% effective,” he says.

Take condoms. “The principle of a male condom is flawed because it is put on something that changes in size dramatically. When a man is erect, the condom stays on. But the moment he is not, it comes off easily,” Tang points out. This can result in leakages and thus, pregnancy.

But if the condom is not foolproof in preventing pregnancies, it is even less so in preventing STDs. “The condom only covers the penis, it does not cover the man’s pubic area. A lot of infections, such as herpes simplex or genital warts, occur at the base of the penis,” he says. 

“The same thing applies to women. The condom is only good for protection in the vagina. Outside the vagina — the vulva, the labia — they are not protected by the condom. During sexual intercourse, a lot of abrasion occurs down there and the cervix is traumatised. That is how the human papillomavirus (HPV) gets into the cervix and causes cervical cancer.”

Tang says there are many STDs — gonorrhoea, chlamydia, HIV, herpes simplex, HPV. “All these are transmitted through sexual intercourse. So, the idea is that [the vagina] is a vulnerable area. The rest of the body does not get STDs, so if you just cover that area properly, you will solve all the problems, right? And you will solve the problem of unintended pregnancies as well.”

The more he considered the problem, the more he realised that women should take contraception and their reproductive health into their own hands. They should not depend on men to use condoms because even when they use them (and they usually don’t like to because most condoms are thick enough to dull sensations during intercourse), the condoms are not 100% effective in preventing pregnancies or STDs.

“What was the best way to wrap everything up down there?” Tang wanted to know. He looked at the female condoms that were in the market and found a lot of problems with them. 

First, they were not very well designed, were difficult to put on and came off easily during sex. Second, they were either too thick, so they were off-putting, or too thin and flimsy, so they could not be put on.

So, Tang came up with his own version of the female condom — 

Wondaleaf. He has since set up Twin Catalysts Sdn Bhd to market this product. “The concept is very simple. I wear gloves to do operations every day, and I use polyurethane film all the time.”

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Polyurethane is a kind of plastic used for intravenous drips and wound dressing. It is chemically inert so the body does not react to it and there are no side effects.

“I thought it would be good if I could develop a product that could line the whole vagina as well as the lower abdomen with polyurethane. It would solve a lot of problems,” he says.

Tang started working on Wondaleaf five years ago. “Initially, I thought it was just a daydream and it couldn’t be done. I searched on the internet to see if anyone else had come up with a similar idea but found that nobody had. So, I started developing it.”

First, he looked to see what was already out there. “Google has a special website called Google Patents, which has all the patents in the world. I googled terms like ‘female condoms’ and ‘adhesive condoms’, and there were hundreds and hundreds of patents with these words in them. I read every single one of them, looked at the flaws and good points, and learnt a lot.”

After reading so many patents, Tang internalised the writing style and was able to write his own patent. “For the first generation Wondaleaf, I wrote a patent and submitted it to one of the local patent firms in Kuala Lumpur. They didn’t change a word and actually charged me RM7,000 just for submitting it.”

What he learnt through this process is that a patent attorney does not necessarily know better than an inventor. “The patent attorney may not know the science behind what I am inventing as well as I do. If I have basic English, I will be able to write the patent myself without going through them. That is what I did two years later when I came up with the second generation Wondaleaf. I submitted it to the Patent Convention Treaty (PCT), which represents more than 150 countries. The PCT comes under the World Intellectual Property Organisation (WIPO).”

When you submit a patent application to the PCT, you are covered for 30 months in any of the member countries. “Basically, you have 30 months to apply for patent protection in the individual countries. In the meantime, you can study the markets and see if it is worthwhile pursuing a patent in a particular market,” says Tang.

When he started his journey, he did not know all this. It was something he learnt along the way. “I applied for a Malaysian patent first. This normally takes four to five years, but I applied for the expedited patent examination and got it within two years.”

Tang helped his own cause by applying to the WIPO patent office during this time. “The PCT approved the application, saying that my product was patentable around the world. I brought that letter here and when the Malaysian side saw it, they granted me the patent because the Malaysian Patent Office uses the WIPO PCT report as a reference.”

He expects other countries to do the same. “The 30 months are over and I have filed for patents in more than 35 countries and regions. The EU is one and the Russian bloc is another. The last time I counted, my patents covered my product in 129 countries, including Canada, the US, Japan, China, Australia, New Zealand, Singapore, India and Nigeria.

Tang has spent about RM1.5 million on the process, of which RM300,000 came out of his own pocket. “Initially, I spent my own money. Then, I started to look for government funding,” he says.

At first, he had no idea how to go about it. “I think it is something all inventors go through. When you first come up with something, there are a lot of things to consider such as whether your invention is worth it, or has sufficient novelty, or has industrial applications,” he says.

“Once that is settled, you need to look for the money to do it. I went to the Ministry of Science, Technology and Innovation (Mosti) first. They turned me down because they said I was not ready yet.”

Tang went back to Sarawak and looked to his state government for help. “The state government turned me down because there was no statutory body that could handle Wondaleaf as a commercial product,” he says.

The state government did try to help him in other ways though. “Dr Charlie Yeoh, CEO of Sarawak Biodiversity Centre, pointed me towards PlaTCOM [Ventures Bhd, the national technology commercialisation platform], which ended up giving me RM700,000 in funding,” says Tang.

But there were a lot of rejections before this. “When I first approached the state government, Dr Jared Susil, Sarawak’s assistant health minister, who is a medical doctor in his own right, saw the product and was sold on it immediately. He told Datuk Seri Wong Soo Koh, a senior minister in the Sarawak cabinet and they brought me to present it at Agensi Inovasi Malaysia (AIM). At the time, PlaTCOM hadn’t been formed yet.

“I was turned down by all of them — AIM, MTDC [Malaysian Technology Development Corp] and Mosti. When I went to PlatCOM, I downloaded the form and filled it out. Then, there was an interview. The rest is history,” says Tang.

One thing that helped his case when he approached PlatCOM was that he had become savvier. He managed to get recommendations from top international gynaecologists and obstetricians, which helped his case considerably.

The biggest recommendation came by accident. Tang was attending the annual congress for obstetricians and gynaecologists, and Professor Sabaratnam Arulkumaran gave the keynote address. “During his address, he told us that the world was suffering from HIV and it looked like it was fighting a losing battle. There were so many teenage pregnancies in the world that they were difficult to control anymore.

“I was sitting there thinking, ‘I had a product that could change all that.’ So later, I walked up to him and said, ‘I have an invention that I think will solve all the problems you mentioned.’ He asked what it was, so I asked him if he could give me 15 minutes then and there. But he asked me to see him the following day.

“So I did, and spent 1½ hours with him. He totally bought the concept and wrote me a recommendation letter. I told him I was having a lot of trouble raising funding in Malaysia, and he said he would be more than happy to help me get funding from international sources.”

Arulkumaran was one of the most prominent gynaecologists in the world, so his recommendation carried a lot of weight. At the time, he was president of the Royal College of Obstetricians and Gynaecologists as well as the British Medical Association, one of the most powerful medical associations in the world. He was also president of the International Federation of Gynaecology and Obstetrics.

Arulkumaran said this in his recommendation. “Based on my opinion, having considerable knowledge about the subject of contraception and sexually transmitted infection, Wondaleaf may be the ideal contraception that can revolutionise sexual and reproductive health … I think it has a great potential and the production and clinical trials should be encouraged to revolutionise contraction and at the same time prevent sexually transmitted infections.”

Tang also managed to a recommendation from Dr Alex Matthew, a national consultant on the subject. “He was convinced as well, which is why he wrote me a letter of recommendation. I brought these two letters to PlaTCOM and told them, ‘Look, even the experts in the field concur with what I have said.’”

There was a time when he lost hope of ever raising money in Malaysia. Like many entrepreneurs before him, he considered taking it to Singapore. “I went for a medical fair there and made an appointment to see Dr Theodore Tan of The Biofactory, a biomedical incubator. The Singapore government gives it pre-approved grants to do new projects.

“He agreed to meet me, but rather reluctantly, and we spent a lot of time talking about Wondaleaf. I was going to leave the following afternoon and he called me up at 6am, saying he wanted his innovation and technical director to meet me — Ron Wight, an Australian from Adelaide.”

Tang says Wight looked at the product and told Tan that it was totally doable. “He asked me how I had such a fantastic idea. I said, ‘Day in, day out, this is what I do. This is my domain.’ Most medical devices are invented by people not in the medical line. This was the reverse. 

“Anyway, he when told Tan it was doable, Tan wanted to team up with me and bring the product to Singapore — within days of meeting me. He was also on WhatsApp with me, guaranteeing that the Singapore government could bring in S$1 million.”

The only problem was that Tang would have to move everything to Singapore. And he didn’t want to. Why? Because he loved Sibu and didn’t want to move away from the town. “I was one of 12 Malaysians in my class doing our MBBS (Bachelor of Medicine, Bachelor of Surgery) at the University of Queensland in Australia, and I was the only one who returned to Malaysia. The rest stayed on in Australia,” he says.

“So, I was reluctant to move. I talked to Tan for about a year but I didn’t want to take it up. He waited for me and in the end, I told him I was going to stay here. This was partly because of PlaTCOM. Later, when I needed more money, I applied to the Cradle Fund and got another RM500,000. That was RM1.2 million in total and it was enough to get the product off the ground.”

The product is undergoing clinical trials. The initial results have been positive. “Because it is so thin, neither the females nor their male partners notice anything down there. In fact, they say it feels like there is no difference at all [compared to having unprotected sex],” says Tang. 

“They put it on, have sexual intercourse and there is no exchange of bodily fluids or skin contact down there. So, as long as Wondaleaf doesn’t break, it is 100% effective against pregnancies and STDs. And it is difficult to break because there is nothing sharp down there. And because polyurethane is chemically inert, there are basically no side effects.”

Before this, Tang was already a businessman, but he tended to invest in hospitals rather than medical devices. “I am the major shareholder of the Rejang Medical Centre, a private hospital in Sibu, the Bintulu Medical Centre [in Bintulu] and Borneo Medical Centre [in Kuching]. My core business is the medical line. This product is more of a hobby,” he says

Tang hopes to launch the product in Sibu. “Yes, we are producing it commercially now. But we still have to go through the ISO standards and things like that. It will take another three to six months before I can get the report. We will launch this product hopefully by this year.”

Much of his reading now is on conformity and compliance. “Before I go international, I will need to see the response from Malaysia first. Then, I will need to clear it with the US Food and Drug Administration. This is a Class 3 medical device and there are a lot of requirements. I am doing a lot of reading right now on ISO requirements,” he says.

Ideally, Tang would like to do everything in Sibu. But the reality is that the state just does not have the facilities to handle his product. “It is only now that I realise there are so many difficulties in doing things in Sarawak,” he says.

“For example, to ensure the conformity of my product to international standards, I need to fly in people from the West Malaysia to do checks. I am applying for the ISO 13485 for medical devices and I have to get a consultant from Peninsular Malaysia to fly here and prepare the system for us. There are many things that we have to comply with so a lot of flying around is needed.”

Another thing Tang laments is the lack of a gamma radiation machine in East Malaysia. “I have to have an office in Kuala Lumpur because I want my product, unlike the male condom, to be sterile. So, I need to send it to KL for gamma radiation and then they send it back to me for distribution. The easier way of doing this is to do it in Peninsular Malaysia. Yet, this is a Sarawakian product and it is so unfair that until now, the state does not have a gamma radiation machine.”

Naturally, he is pushing the state government to invest in one and is reasonably confident of success. “If I can put Sibu on the map, they might agree,” he says.

The inventing bug has bitten him and he is not content to stop at Wondaleaf. “I have other things in the pipeline. Like the timing and erection-independent (TAEI) condom. A normal condom requires a full erection to put on. By my condom won’t. So, a man can put it on, go out for dinner, watch a movie and then carry on. It is a spin-off from Wondaleaf,” says Tang. 

“After studying so many different patents, I keep coming up with new ideas. And while Wondaleaf is one-fourth the thickness of a condom, the TAEI condom is only eight microns thick — about the thickness of a red blood cell.”

Tang is also looking at mechanical devices. “Once you start, you become bolder and think more courageously about all this. I am learning fast,” he says.