After completing his degree in mechatronics engineering at Stellenbosch University, Edmund Wessels, 30, enrolled for a master’s in biomedical devices at the University of Cape Town (UCT) in 2016. (He recently submitted his PhD.) “Every student is allocated a doctor who has a problem,” says Wessels. “I was paired with an incredible gynae, Carol Thomas, who identified the need for an affordable, portable hysteroscopy system.”
Thomas has since died, so the FM interviewed Kendall Brouard, an obstetrician-gynaecologist at Groote Schuur Hospital, who’s a clinical adviser on the FlexiGyn project. “A hysteroscopy is an examination of the inside of the uterus, using a camera inserted into the vagina which then passes through the cervix,” she says, adding that there are several reasons a woman may need the procedure, including post-menopausal bleeding, which can be a symptom of cancer. “It’s very important to see what’s going on inside the uterus.”
Brouard says Groote Schuur has state-of-the-art equipment that allows those who work there to perform hysteroscopies on outpatients while they are awake. District hospitals and clinics are not generally as well equipped: they either have scopes with larger diameters that require a general anaesthetic (the procedure can be extremely uncomfortable) or no scopes at all.
Statistics show that 25% of women will experience abnormal bleeding at some point in their lives. And in the public sector in South Africa patients can wait up to six months for a hysteroscopy, during which time the disease may progress.
Working closely with Thomas and UCT’s Prof Sudesh Sivarasu, a medical device innovator, Wessels set about designing a hand-held hysteroscopy device. “As a 20-something male I knew nothing about women’s health care,” says Wessels. Thomas saw to it that he observed procedures, worked with existing equipment, and spoke to women who’d had the procedure. “At first the idea was simply to make a mobile device,” he says. “But these experiences inspired me to make the whole process much more comfortable for patients.”
In 2016 Wessels completed the prototype of the FlexiGyn, an all-in-one system that fits comfortably in your hand with a built-in display, camera and light source. He’s now on version five. The device’s 4mm guidable flexible tip (Wessels is working on reducing this diameter even further) allows for navigating the patient’s anatomy with minimal discomfort while a single-use disposable sheath keeps it sterile between use.
Wessels and Meunier believe the product has the power to transform both private and public health care
In 2020, realising his entrepreneurial shortcomings, Wessels teamed up with Chris Meunier, a university friend with a background in commercialisation and communication, to found Vas MedTech, the company that hopes to bring FlexiGyn to market. In 2022, Vas MedTech entered the Africa Prize for Engineering Innovation, a continent-wide competition founded and administered by the Royal Academy of Engineering. As part of the competition, 16 shortlisted entrants were put through an eight-month training programme that included access to business and technical expertise and sector-specific engineering mentoring.
But the best was yet to come: in July 2023 Wessels and Meunier shared first prize with Anatoli Kirigwajjo from Uganda, a software engineer who developed a low-cost community-based home security network. Winning the prize didn’t just provide a financial injection (£25,000) for Vas MedTech, it also gave FlexiGyn significant exposure. The two men are hoping to leverage this to bring the product to market in the next two years.
Wessels and Meunier believe the product has the power to transform private and public health care. They say gynaecologists can perform affordable hysteroscopies without general anaesthesia. And they hope that with training, nonspecialists in rural clinics will be able to do the same (though not interpret the results), slashing the time women have to wait for hysteroscopies in the public sector.
Brouard agrees that the tool promises to be cost-efficient, but says “a hysteroscopy is a procedure performed by specialists and specialists-in-training” that can result in a perforated uterus and other complications if performed by someone unfamiliar with the procedure. Meunier assures the FM that health-care workers in other countries, including nurses, are already receiving training in hysteroscopy and that responsible hysteroscopy training is an integral part of their product development pathway.
Wessels and Meunier have a working prototype of FlexiGyn that’s been tested by gynaecologists on cadavers and models. They are speaking to investors about securing the $2.6m to develop a market-ready beta device, which they plan to launch in South Africa in 2025. They will use the lessons from the process to launch V1.0 on the international market a year later. They are targeting a price of between R30,000 and R40,000, about a third of the cost of the closest competition and 35 times more affordable on operational expenses.
Meunier says the team has successfully secured the US patent, and is awaiting the EU patent. “We want to take this product global,” he says. “South Africa isn’t the only place that needs FlexiGyn.”
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