Dr Tang says agreements have been signed with distributors and manufacturers in Sri Lanka, Taiwan, Egypt, Qatar, and Hong Kong to register and commercialise Wondaleaf in their respective countries. For now, the product awaits the approval for its 510(k) application submitted to US FDA.
GYNAECOLOGIST Dr John Tang, the inventor of the world’s first-of-its-kind unisex condom is encouraged by the response from the people to the product, which was launched in the market over two years ago.
According to him, thousands of Wondaleaf unisex condoms have been sold since.
“The market response has been immensely encouraging. So far, the number of repeat orders had continued to rise, which reflects the consumer’s need for this unisex condom.
“I believe part of this success also comes from their (his company’s) willingness to listen to consumer’s feedback, and we are very grateful to our customers for providing continued suggestions on ways to improve,” he told thesundaypost in Kuching.
Ongoing studies
Since Dr Tang and his team started, they had conducted studies on the condom and worked on complying with international regulations to make the product available all around the world.
Wondaleaf is a new Class C medical device that needs to undergo a high amount of scrutiny in each new jurisdiction.
Dr Tang said they had the opportunity to be involved in a major clinical trial, which was published in a peer-reviewed medical journal, the ‘International Journal of STD & AIDS’, at the beginning of this year.
“The results have been very encouraging, showing non-inferiority against the existing FC2 female condom. Using the now published clinical trials and all the relevant test documents, we’ve submitted our 510(k) application for the US Food and Drug Administration (FDA)’s approval, which we are very excited about.
“It is big step forward in bringing Wondaleaf to the international consumers,” he said.
A 510(K) is a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective as – that is, substantially equivalent to – a legally marketed device that is not subject to premarket approval.
Dr Tang also said they were invited by the industry to attend ‘2022 International Conference on Family Planning’ (ICFP) in Pattaya, Thailand running from Nov 14 to 17, which gathered over 3,000 people.
Dr Tang in a media interview during the ICFP 2022 in Pattaya, Thailand.
“I was happy that the unisex condom was very well received. It was a fantastic platform for making Wondaleaf known abroad and getting the product and name out there.”
It was also a good chance to get to meet other leaders in the industry and work on collaborative opportunities to better improve sexual and reproductive health, he said.
“It was a really great conference, and we would love to come again.”
Dr Tang (left) and Liang (right) with some officials attending the ICFP 2022 in Pattaya, Thailand.
Inspiration behind Wondaleaf
Asked on what inspired him to come up with this invention, Dr Tang said: As a gynaecologist, I’ve both seen and dealt with the paradoxical and controversial topic of human reproduction.
“Sex, or reproduction, is an instinctive and integral part of human existence, but it also comes with legal, ethical, and cultural consequences – consequences that can be detrimental emotionally, physically and socially to both men and women.
“The repercussions of unintended pregnancies and STIs (sexually-transmitted infections) are often long-lasting and harsh. Perhaps it is hubris, but I wanted to think of a solution that would be able to prevent such repercussions – a contraceptive solution that is simple, without side effects or contraindications, reversible and effective against all forms of STIs.
“Also, we’ve always had a barrier contraceptive for men. For women, the female condom isn’t widely available here, so they have no contraceptive that protects them against STIs.
“So, I wanted to design a device that could be used by anyone, regardless of gender or orientation, and provide them with the dual protection against STIs and pregnancies.
“And so, Wondaleaf came to be.”
According to Dr Tang, Wondaleaf, as a condom, has an integral ultra-thin adhesive shield that acts as both anchoring means and an extra protective cover for the entire base of the penis or vulvae.
“The application is also different. Condom is a roll-on, a female condom is by insertion, while the unisex condom is by insertion and adhesion.
“Adhesion sounds complicated, but it can be done well under one minute.
“How it can be used is also different. Both male and female condoms are much more prone to slipping and spillage, and can be difficult to be deployed beforehand as compared with the unisex condom, which really can be put on at any time before intimacy and removed any time after.”
Elaborating further, Dr Tang said of all the contraceptive methods available to date, only barrier methods (namely, male condoms and female condoms) could prevent STIs.
However, neither could give complete barrier protection on other equally vulnerable areas, such as the base of the penis or the vulvae, he pointed out.
Furthermore, unlike condoms, the unisex condom did not rely on an erection to be usable, he added.
“By being gender neutral, the unisex condom returns sexual and reproductive control back to the individual, without having to rely on the other partner.
“Currently, women bear most of the physical and emotional aspects of contraception, and in doing so, it just makes sense not to subject women to constant exogenous hormonal exposure as seen in the pills, injectables, devices or implants.
“Having a non-hormone-based, gender-neutral option is game-changing, and can help even the playing field in this area,” he said.
‘A lot of work’
Regarding the research and development (R&D) process to create the unisex condom, Dr Tang said it was ‘a lot of work’.
“There was a lot of design, prototyping, lab-testing, clinical trials and regulatory compliance that happened behind the development of a whole new medical product.
“This process took time, effort, and money.”
In this respect, Dr Tang said he was really lucky to have an incredible team of young professionals working full time to run the pilot factory.
“They were very capable and committed to the same vision, and they were all working hard to see the unisex condom project through.”
Dr Tang said the idea of a unisex condom was simple, but it was still a paradigm shift for most people.
He stressed that there were challenges in explaining the novelty of the design, the application of it, the need of lubrication and how to deal with removing a sticky film from a hairy part of the body.
“To be honest, the hardest part has been talking about it publicly in our conservative society.
“Fortunately, social media has been a really great help, where a step-by-step instructional video can be uploaded and followed in the comfort of people’s homes.
“And on the issue of hair, as discovered during one of our clinical trials, it’s not at all a major concern as the shield is designed to just the right level of adhesiveness. It is also not an issue for the people who have trimmed or shaved their pubic hair.”
Dr Tang said as opposed to the regular condom or female condom, which gave partial coverage of the genital, the unisex product could provide potentially complete coverage as well as protection over the whole duration of sexual activities.
“There is less slippage and spillage, and can be applied well before intimacy – so a lower chance of disruption or forgetting in the heat of the moment.
“So overall, I think it really removes many of the current barriers towards contraception use, whilst essentially having the advantages of all of them. I am confident that this really is a great step forward towards safer sex practices and STI prevention.”
Product assurance
The unisex condom, according to Dr Tang, is made from a soft, strong, hypoallergenic, and ultra-thin material called polyurethane. It is only 0.03mm thick, which makes it as thick as around four red blood cells.
It is this material, combined with its non-strangulating design, which gives the unisex condom its soft, natural feeling.
Clinical trials and studies suggest that the unique adhesive shield reduces the clinical failure rate such as slippage, spillage, misdirection, invagination of the unisex condom compared with a regular external condom.
Dr Tang said they had already signed agreements with distributors and manufacturers in Sri Lanka, Taiwan, Egypt, Qatar, and Hong Kong to register and commercialise the products in their respective countries.
“We expect the unisex condom to be available in other countries soon.
“Here in Malaysia, we are working closely with the Federation of Reproductive Health Associations Malaysia (FRHAM) and Sarawak Family Planning Association (SFPA) to make the unisex condom more accessible to all Malaysians,” he said.
Dr Tang (second left) seen at a FRHAM event, with Dr Alex (centre), Liang (second right) and other officials.
Dr Tang also expressed hope that the unisex condom would help in reducing STIs and unwanted pregnancies around the world, while kickstarting the Sarawakian medical device innovation industry.
He said the current challenge was to educate the world on the way to use the unisex condom, and to improve supply chains so that the unisex condom would be more accessible to everyone.
“The current version of Wondaleaf Unisex Condom is the result of hundreds of design changes, thanks to the constructive feedback they have received from thousands of users,” Tang said.
“So while we’re not working on any major modifications at the moment, we’re keen on receiving feedback to constantly improve the device. In the future, there will be enhancements on the aesthetic aspect of the device, especially on the colour and shape of the shield.”
‘Everyone plays a part’
To Dr Tang, the future of sexual health, and health in general, is about empowering the consumers.
He said with many different contraceptive solutions being available for different people, he also believed that people must not shy away from sexual education so that they would be able to choose the best method for them.
Dr Tang (front, second left) in a photo-call, taken during a Sarawak Family Planning event in Kuching.
Accordingly, he applauded the proposal by Deputy Prime Minister Datuk Seri Ahmad Zahid Hamidi about increasing the study hours for lessons on reproductive health to raise awareness among pupils and students.
Nonetheless, Dr Tang said parents should also begin having mature conversations about this subject with their children.
He admitted that the unisex condom was met with both fascination and a healthy amount of scepticism by the industry. On the latter, he said it was understandable because of the amount of education needed to bring such products to market.
“So our team is working with their distributors and collaborators to invest more into getting the message and vision out.
“While the groups with high risk behaviours, such as men who have sex with men (MSM) and sex workers, are more likely to benefit from the unisex condom, the product is really meant for all sexual contacts, even those in any monogamous relationship.”
Dr Tang said unintended pregnancies and STIs aside, he said vaginal infections from contamination, especially faecal, was almost universal among sexually-active women.
“The unisex condom is able to address such problems by providing the coverage needed to keep things safe and clean.”
‘A humbling journey’
To make Wondaleaf accessible, Dr Tang’s team needed to bring down the cost of production and transportation, and also worked with both governmental and non-governmental organisations (NGOs) in bringing the product to the groups in need of it.
In this aspect, Dr Tang said they were grateful that the FRHAM, the umbrella body for all the family planning associations in Malaysia, had officially endorsed the unisex condom.
“For me, the journey of inventing and producing the unisex condom has been a humbling and joyful experience.
“When I started the journey almost seven years ago, I did not know much about product design, marketing, user’s experience, manufacturing, or supply chains, but thankfully, we received invaluable support from the Deputy Minister for Education, Innovation and Talent Development Datuk Dr Annuar Rapaee, the Malaysian Technology Development Board, Matrade (Malaysian External Trade Development Corporation) and the Sarawak Research and Development Council, as well as industry experts such as Paul Liang and Dr Alex Matthews.
“Not to forget, the feedback from the users also helped in charting the design of the product,” he said.
The current version of Wondaleaf Unisex Condom is the result of hundreds of design changes, thanks to the constructive feedback from thousands of users.
Dr Tang did reveal that often, what he thought was important could turn out to be impractical for the end-users.
“For example, the earlier prototypes had the adhesive shield covering the entire lower abdomen as the intention was to prevent parasitic infestation from pubic hair.
“This, however, proved to be immensely unpopular, with testers likening it to ‘having a Brazilian wax’.
“Personally, venturing into innovation at the later part of my career is very challenging, but if it weren’t for my prior clinical experience, I would not have felt so compelled to do it.”
Dr Tang hoped that people would not think of the unisex condom simply as a device that would promote promiscuity.
“Despite the social restrictions, laws and taboos, there are still many abortions, infanticides, STIs, and abandoned babies. I hope that people could grow as a society and have mature discussions about sexual health and how to protect themselves and each other,” he added.