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Out of the loop
A PERMANENT fallopian-tube implant that reportedly caused crippling autoimmune reactions. A plastic vaginal mesh, meant to address pelvic organ prolapse and incontinence, which led to patient complaints of debilitating pain and injury. These horror stories - the first about German giant Bayer's Essure contraceptive device, the second a scandal that has engulfed the British National Health Service - are some that made recent headlines worldwide and rattled the market in medical technology, or medtech.
Bayer eventually pulled sales of Essure from markets outside the United States last September, citing commercial reasons.
Essure had previously been available here. But the Health Sciences Authority said, in reply to media queries, that the device has not been supplied since 2015.
The agency has not received any local adverse event reports for Essure and has not registered any other similar sterilisation devices.
These developments came even as the sector, according to Ernst & Young, yielded over US$360 billion in revenue in 2016, up from around US$300 billion in 2009.
Deloitte, meanwhile, has forecast that medtech industry sales will hit more than US$510 billion in 2020, with the field of in-vitro diagnostics set to get the biggest slice of the pie.
But even with a range of factors at play - from improved gender representation in science, technology and business, to the rise of genomics - industry watchers here say the women's health segment in medtech remains both under-represented and under-served.
'Insane' lack of interest
Medtech can be a tough sell.
David Lai, a venture partner of private investment firm Venturecraft Group, puts key challenges as "finding entrepreneurial talent and funding the long runways to market".
That does not mean a complete dearth of money moving.
Patrick Yeo, head of PwC Singapore's Venture Hub for startups and investors, calls the Republic "clearly a choice location for medtech companies to innovate and test new technology". He points to the infrastructure, skilled workforce, and intellectual property protection.
Mr Yeo also notes that the growing affluence and ageing populace in Asia "will present investment opportunities in areas of obstetrics, gynaecology and dermatology".
But even if women hold up half the sky, Sunil Rai, corporate partner at law firm Dentons Rodyk, tells The Business Times that he has not personally seen early-stage venture entities or investments in medtech that focus on women's health in particular.
"Given a young local medtech ecosystem and lack of institutional investor focus in this sector", Mr Rai finds it likely that big multinational corporations, rather than early-stage entities, are the ones that will have the resources and capabilities to focus on research and development (R&D).
And multinationals, which hold the large purses, seem unwilling to stray from winning formulas.
Larger medical device companies tend to be weighted more heavily towards mature market segments, a McKinsey article said last September. It added that, in the device market, "few high-growth, high-innovation segments remain, although some exist, particularly in cardiovascular".
And that is to say nothing of innovation in therapeutics, which is still in its early days and requires, alongside trial and error, lots of patience. That's in spite of the long list of diseases and conditions that afflict women and women only.
Researcher Nir Arbel, chief executive of Singaporean biotechnology startup Carmentix, has strong feelings about the state of affairs.
His voice rises in excitement when the conversation turns to endometriosis - which a recent study pegged as affecting more than 10 per cent of women in their mid-30s to mid-40s - where womb lining tissue is found in other parts of the pelvic region, with pain and bleeding.
"Why isn't there a solution? Why aren't there diagnostics?" he asks.
Carmentix, which Dr Arbel co-founded in 2015, works on developing biomolecular tools to predict the risk of preterm births in pregnancy.
"It's insane. It's so common. Ten per cent of women have endometriosis and no one has ever thought about how to diagnose it? Think about how much money is invested in cancer and Alzheimer's. It's crazy to me that there's no solution."
He adds: "I think the fact that it is not life-threatening is part of the problem. But the bigger issue is that there are not enough women in key positions driving pharma companies into this space."
Sidney Yee, executive vice-president of Exploit Technologies Pte Ltd (ETPL), does not mince words either when it comes to the need for innovation in women's health.
"Our technology is so advanced now, yet the tools that remain available to us remain decades-old tools," says Dr Yee, from the public-sector Agency for Science, Technology and Research's (A*Star) commercialisation arm.
"That, I think, is not acceptable."
All about the money
Dr Yee, who is also chief executive, Diagnostics Development Hub, which aims to accelerate market adoption of scientific innovations, adds: "We continue to have a bit of a gap in the very early-stage, pre-Series A type of support.
"That's really the area where there's not quite enough for the startup to have something that is able to attract enough investor attention, because it's not a product yet so there's no market validation.
"And it's sort of in no man's land - or no woman's land - where you know that there is a product market fit but there is not quite enough support to get it to a product."
She adds: "As with everything else, unfortunately, things like these are generally driven by the industry seeing whether there's money to be made."
A Deloitte research report from 2017 corroborates this: "Many financially pressured large companies have avoided making risky investments in external innovation."
It adds that "these companies would only consider an external innovation that has been largely or fully 'de-risked'". That is, the technology must have already snagged regulators' green light, on top of demonstrating commercial success.
The gamble of innovating with lesser-studied conditions may be why big companies stick with tried-and-true market segments - such as breast cancer, which made up about one in three cancer diagnoses among women here from 2011 to 2015.
Siemens Healthineers' Singapore-based managing director Siow Ai Li tells BT in an e-mail: "Technology-wise, a lot has happened in the past 10 years in the field of breast care. We have introduced the automated breast volume scanning method which is suitable for patients with very dense breast tissue. In the field of breast MRI (magnetic resonance imaging), we have developed our first dedicated breast MRI scanner, as well as came up with a solution for 3D breast imaging."
With health and biomedical sciences one of four strategic domains in Singapore's S$19 billion Research, Innovation and Enterprise 2020 master plan, there may be no time like the present to dip a toe in the water.
Mr Rai, of Dentons Rodyk, has seen more scientists join the fray in the past two years, and has received more queries about investment deals involving general medtech.
He anticipates both the volume and quantum of investments to rise in the coming years given the quality of R&D in universities and institutions here, as well as existing capabilities in engineering, manufacturing and biomedical sciences.
"The local ecosystem would, however, need to continue working on attracting institutional investors and corporates to provide guidance on commercialisation of technologies in medtech while developing further capabilities for taking such technologies to market and also patience in seeking significant pay-offs," he adds.
Dr Lai, the Venturecraft venture partner and director of surgical research and development and research at the National University of Singapore (NUS), says: "I have not been involved much in women's health as a sub-segment in medical devices. I have come across some home-grown life science diagnostics tools in women's health, which have commercial potential."
He adds: "I am generally agnostic to the type of device technologies, be it medical diagnostics or therapeutics and will evaluate case-by-case."
Still, when it comes to medtech and women's health, public bodies have traditionally led the charge.
Molecular diagnostic firm Innovations Exchange Pte Ltd (Inex), which focuses on obstetrics, gynaecology, oncology and reproductive health, was founded as a spin-off from NUS. Since being set up in 2006, it has developed non-invasive prenatal testing and a rapid ovarian cancer detection kit - both in partnership with A*Star.
A*Star has also worked with medical imaging startup FITPU Healthcare - a joint spin-off of its Institute of Infocomm Research, and the National Cancer Centre, a public specialist institute.
And it tied up with startup incubator The Biofactory, independently validating genetic screening for potential hereditary disorders, which could help would-be parents in family planning. (Prenatal testing falls under the umbrella of women's health, which is another can of worms.)
Here come the VCs
But venture capital (VC) has been paying attention to medtech, and the women's health segment has not escaped canny investors' eyes.
Besides the screening tool validated by A*Star, home-grown incubator The Biofactory has also backed a drug infusion pump for pain relief during labour, as well as a new placental cord blood collection system.
Carmentix got its cash in hand from Esco Ventures, an evergreen stash funded internally by Singapore's Esco Group. Esco, a family business that supplies life sciences and laboratory equipment for everything from pharmaceuticals to in-vitro fertilisation (IVF), committed S$10 million back in 2014 to be spent on early-stage opportunities in life sciences, medtech and healthcare, with the option of a top-up.
Almost all of that has since been invested, says group president and chief executive Lin Xiangqian, who is also chairman of Carmentix.
According to Mr Lin, the initial focus on pregnancy and women's health - which Dr Arbel calls "completely underserved as a market" - was a business choice to differentiate Esco Ventures from other funds.
Its engagement with reproductive health began with an investment in Lithuania-based IVF device maker AT Medical.
With Carmentix as a flagship, Esco Ventures is also exploring other pregnancy-related conditions such as pre-eclampsia.
Meanwhile, Catalist-listed medical and agricultural investment company Trendlines Group opened a medtech incubator here in 2016.
It already had startups like Escala Medical, which is developing devices to treat pelvic organ prolapse, under its belt back in Israel.
Trendlines Medical Singapore CEO Eric Loh calls the medtech sector here "still fairly nascent", citing a relative lack of success models.
"There's been a lot more focus in terms of wanting to support early-stage companies," he says.
"But I think what needs to go in more, in this case, is not the monetary resources, but really how we provide help to the companies to know what those markets are and how we gear towards those markets from a clinical standpoint, from a regulatory standpoint, and then from a business standpoint."
Its mandate is to explore Asia-Pacific health opportunities, such as eye and kidney conditions. Still, the group partnered the Singapore General Hospital last year to hold clinical trials for a urinary incontinence product for women, under a grant from the bilateral Singapore-Israel Industrial Research and Development Foundation.
Mr Loh adds: "Big companies or healthcare organisations do not always have the in-house expertise to innovate. That's where entrepreneurs can come in and provide value."
Room to grow
Given Esco's history in IVF business, reproductive health startups were a natural progression when Mr Lin launched his life sciences fund.
"I don't want to rule it out, but oncology is very crowded," he says. "And there are so many smart people around the world investing in oncology."
He acknowledges the need for early-detection tests in gynaecological cancers, "but given that the incidence rates are fairly low, this is quite a high bar compared with preterm birth", in terms of the potential market size. About one in 10 babies are born premature, even as the rapid rise in Pap smears and the development of human papillomavirus vaccines has led the rate of cervical cancer to tumble over the years.
A*Star's Dr Yee also argues that "if you think about it, women's health is probably the only healthcare segment where we are actually taking care of the next generation".
She says that research in genomics has shone the spotlight on prenatal health over the past six or seven years. "To me, that sort of brought new light and a new dimension in how people perceive women's health. It's no longer just the women themselves but how it involves the next generation - prenatal, postnatal - as well as menopause, food and nutrition, the whole works."
Yet it also includes the sex-specific ways in which some diseases, such as cardiovascular conditions, are diagnosed and treated.
"More and more, we're becoming more aware that there are gender differences in almost every single disease indication that we're looking at, and a lot of it actually has been enabled by the advent of genomics research and all the technological advances that we have," she notes.
Home-grown Lucence Diagnostics is one life sciences company that found its way into women's health. About 70 per cent to 80 per cent of the biopsy technology developer's laboratory work is from female oncology patients, according to Tan Min-Han, its founder and chief executive - even though women were not the focus when the company opened its doors.
And it's not just for the "Angelina Jolie" genetic test - so named for the Hollywood star who raised the profile of breast and ovarian cancer marker screening after her preventive double mastectomy. The inexplicable rate of terminal lung cancer in non-smoking Asian women - while nowhere as widely discussed as breast or ovarian disease - has also brought more work to Dr Tan's lab.
"These are all real needs of people, and these are all growing," he adds.
The National Cancer Centre of Singapore saw demand for genetic counselling - the process through which individuals at risk of an inherited disorder are advised - nearly triple between 2011 and 2014.
Still, growth in women's medtech will take much mindset change.
Inex's chief operating officer Richie Soong tells BT: "Challenges include achieving the recognition that women's health is a promising sector by itself, as well as the passage of time and education needed to introduce improvements."
Carmentix's Dr Arbel surmises that another reason for the relative novelty of women's health medtech - "probably the main reason", in his words - is that "you don't find many women in top positions at VCs around the world".
"So there's no vested interest in these VCs to actually address the unmet needs in this space," he says. "But it's still 50 per cent of the population."