The medtech industry has predominately been male orientated, with a lack of women in top positions and commercial companies commonly targeting white male consumers, it isn’t surprising that women have been underrepresented.
Last year it was revealed that only 9% of digital health start-ups had women CEOs, but recently a new industry has launched specifically aimed at women’s healthcare – femtech. Femtech encompasses a range of start-ups that are mainly fronted by women and which have developed products and services for women’s health. Among these products are fertility apps, designed for women so they can track their periods to help them get pregnant or to help them avoid unplanned pregnancy.
The abundance of fertility apps on the market and indeed the lack of regulation means that women are in danger of choosing the wrong app with potentially life changing results. To discuss the issue, DHA spoke to Dr Victoria Jennings from Georgetown University’s Institute of Reproductive Health. The Institute of Reproductive Health is currently conducting an efficacy study into the Dot fertility app to see exactly women are using it and to determine how effective the app is for pregnancy prevention. The study is expected to last until September 2018 and will monitor 1,200 women over the course of 13 menstrual cycles. We spoke to Dr Jennings about the Dot study, as well as the fertility app space and whether women should be cautious or optimistic about using these apps.
Q: With the FDA pursuing regulations on digital health products, do you think we’ll see any changes in regard to fertility apps?
I think it’s a very early stage, we’ve yet to see exactly how any new regulations might come out. I think the issue is that the FDA is interested in digital health in general, recognising that it has not been an area of their expertise, and they’re trying to kind of feel their way around. I expect that there will be some form of regulation, I’m not sure what form that will take – I don’t think anybody does right now – as I say it’s quite exploratory. So I think we’ll have to wait a while to determine what kind of changes will be forthcoming.
Q: Do you think the lack of regulation is why we’re getting such a crowded market in the fertility app space?
Well yes that’s always the case with anything new, that because it is new there isn’t any regulation. Our primary concern at the Institute for Reproductive Health in general is that it’s a very confusing space and there is very little guidance for women regarding which apps are appropriate for pregnancy prevention, which ones are appropriate just for tracking their cycles, which ones are appropriate for what. There are more than 1,000 of those apps out there and it’s very easy to put a fertility app into the app store. I would have to say there’s no roadmap for women. Someone who is looking for a fertility app for a particular purpose may end up using one that is either not intended for that purpose or that claims that it is but has not been tested. Let’s say you have an app that helps you track the number of steps you take over the day and it’s off by a few steps, it doesn’t matter. If you’re trying to prevent pregnancy and it’s off then that’s a big deal. We have to look at the magnitude of the possible effect of selecting the wrong app, so that’s really where our concerns lie. We’ve seen that there are several apps that make claims that are at best not well supported. That comes back to a lack of a roadmap. Women pick a fertility app the same way they pick any other app; they look at price, user rating, appearance but they don’t listen to the real scientific evidence.
Q: Do you think women can benefit from using fertility apps?
Our research has shown that many women do find that they benefit, but it’s a question of picking the right one so they can benefit the way they want to benefit. The particular apps we’re doing some research around, we have people saying where has this been all my life? I feel like it’s my friend who’s with me every day and helps me understand my body etc. For ones that we’re familiar with but aren’t directly studying, we see women saying similarly excellent things about them. But it depends on what the women is using it for whether she’ll be happy with the outcome and whether she’ll actually benefit from it. I think that family planning, the concept of contraception or birth control, has really been so hyper medicalised that it’s put the control in the hands of the provider and not into the hands of the woman. A fertility app that is based on evidence that really can help the woman achieve what she wants to achieve, that is a very powerful tool for women. Just because there are some bad apples in that barrel, I don’t think we should say they’re all bad, and just because there are some good ones, we don’t need to say they’re all good. It’s really about what a woman wants to achieve and how she feels about family planning methods. So, I do applaud the effort to put this back into women’s hands rather than the provider.
Q: It’s interesting you say that – as particularly in the digital health and medtech sectors -there’s recently been a rise in femtech.
Yeah, I think there’s a lot of opportunity – and I don’t mean to denigrate the importance of healthcare providers, we’re clearly grateful to them every day – I hope that women who are using apps will continue to see their healthcare provider and that their healthcare provider can support them in their choice to use an app and offer guidance on how to use them better. So I think it needs to be a partnership there, but I do think there’s a mentality that what we need is more women using IUDs, clearly because the provider inserts the IUD and that’s it – we know that the women is now protected from an unplanned pregnancy. It just puts it completely in the providers’ hands – if that’s what the women wants, that’s what she should have – but that may not be what she wants and she needs to be supported in that decision.
Q: A lot of these apps use a type of algorithm to predict a women’s cycles, has your research shown how accurate these can be?
Well you know the thing is there is so little evidence around that. Let me back up just for a minute. There are – as far as I’m aware – two kinds of apps that are meant for pregnancy prevention. One is a digital platform for an existing evidence based fertility awareness family planning method, which helps the women track her cervical secretions, her internal body temperature, her menstrual cycle etc., and give her information exactly as that existing methods tells her. Then there is the kind that is based on algorithms that are not based on another pre-existing method but is in fact a new method itself. It seems to be that there are basically zero of them that have undergone the kind of quality, prospective, efficacy trials that all recommended methods of birth control or family planning need to be subjected to. There is one that has undergone a post-marketing study on which they are basing efficacy claims. We are doing a prospective trial that follows the gold standard guidelines for a contraceptive study. I believe that other algorithm apps would need to undergo the same kind of rigorous study to qualify as a bona fide method.
Q: On the Dot study
As you know we’ve worked on the algorithm and it’s been published and it’s a registered clinical trial and it follows a clear protocol which has also been published. So that’s the sort of research sequence that’s required to actually produce the evidence that’s needed. I think that the research sequence – that begins with phase 1 trials and so on -is especially important. Unfortunately, some of the studies that have been going on have jumped ahead in the sequence, providing very interesting information but not producing the efficacy of that algorithm for helping a women prevent pregnancy. It may be great, it may be that they work extremely well, but the issue is we don’t know it from the published evidence.
Q: Do you think that’s why certain apps have been certified in the EU?
Well the certification in the EU is a confirmation that it is made according to the manufacturer’s specification. It’s not something that says ‘it has an efficacy of XYZ in preventing unplanned pregnancy.’ What it says is this app accurately reflects the information you put into it. So it functions well and that is basic, of course it has to function well, but it’s not the same as having it being an efficacy trial.
Q: With the number of apps available of women do you think there needs to more awareness about what’s on offer?
Yes I do, I think that comes back to my issue about the roadmap. I think we need to have a very robust discussion about that and I believe that somehow we need to be able to create a process for assessing these apps and to agree on what the standards of evidence should be and to provide that in a meaningful way to potential users. I think women deserve that. I think it’s so basic for those of us who are concerned about empowering women to achieve what they want and at the same time trying to give them the information that they can use to do that in a responsible and informed way. I think that a fertility app can be very appealing to women, many women are in a positon where they can use it successfully, they’re in the kind of relationship where the app might work well for them, or perhaps again they might want to try it to monitor their cycles. Regardless they require accurate information so I think it’s important that people understand the limitations of apps – and there are many I’m sure – but they also need to understand their potential and how to assess which one is right for them.
Q: What would you say to women who are wanting to use fertility apps?
I would say think about what it is you want to achieve, read the fine print, look before you leap, try it out for yourself, but take a look at the scientific evidence of which it is based and don’t be misled by false claims. The difficulty for women is that it’s really hard for the consumer to determine what is a false claim and to determine what is strong scientific evidence and what isn’t. So therein lies the problem so use it with a degree of caution.