The Fertile Area of Women’s Health -Part Two

In part one of this blog, published in June, I started by looking at the ever-growing industry of fertility devices and some of the possible explanations for the growth boom in this market sector. Focusing more on devices to aid conception, however during my research I read some interesting articles a device being marketed for pregnancy prevention, alongside a large market for expectant mothers.

In part two I want to discuss the pregnancy prevention device and the can of worms it has opened within the FDA regulatory approval process.

The first ever Smartphone Contraceptive App was cleared by the FDA in August of 2018, the now widely known, Natural Cycles was able to gain clearance thanks to a streamlined process called the De Novo Classification, as it was a “novel” device, without a current market equivalent that had been designated of moderate risk. This app is a fertility tracker that instructed women to take their temperature orally, immediately after waking each day, and record this in order to track ovulation. So far, a similar process to those devices discussed during part one, where women would use this map to determine their most fertile period in order to increase the chance of conception. However, Natural Cycles was not marketed as a device to assist with conception, but as a contraceptive. It is advertised as 98% effective (with perfect use), although normal use gives a 93% effectiveness. When you consider the failure rate of other contraceptives; the pill 9% and condoms 18%, this sounds good.

The controversy around this particular app, stems from the approval process that it went through, the qualifying criteria and the methods and results achieved during testing.

The effectiveness of the application was studied in Sweden and all the women that took part had purchased the app for themselves and were using it in a ‘real world setting’. Rather than being invited to be part of a trial conducted in a clinical setting with medical intervention, also there was no control group, so the trial was not randomised, and the study was more of an observational study than a traditional trial.

Concerns regarding the app were raised by the Swedish authorities due to an increased report of unwanted pregnancies and termination requests, in fact 37 at one hospital alone, all of them Natural Cycles users. Reports also suggest that there was a high number of dropouts by users in the study, that were not followed up. Although it is impossible to know the reason for each one because of this lack of follow up, investigators were concerned that unwanted pregnancy could be a reason in some cases.

Since the streamlined De Novo Classification system was put into place in 2017 there has been a marked increase in the number of devices cleared, in comparison to the pre streamlined process. There is a great deal of balance needed between getting new drugs and devices swiftly to market, so as not to stifle innovation and protecting the end consumer/user. The 21st Century Cures Act of 2016 aimed to expedite the process and was whole heartedly backed by pharmaceutical manufacturers but widely opposed by Consumer Groups, as it was feared that the reliance on “real world evidence”, patient collected data and data summaries would provide weaker evidence on which to base the approval. It seems that this may have been the case with regards to the Natural Cycles app and the change of protocol has understandably left consumers worried. The FDA/MHRA/CE marking attributed to such devices acts as a real seal of approval for the end user and a general assumption that it is safe to place such a reliance in it. This app was under investigation in Sweden at the time that it received its FDA approval, for exaggerating its efficacy and has since been told by the UK Advertising Standards Authority that is cannot claim itself to be “highly accurate”.

The Swedish Medical Products Agency has since published documents to say that the Natural Cycles App works as reported by the company but required the company to more clearly clarify the pregnancy risks, which supports the FDA clearance. However, it seems that the new FDA approval process is flawed as to the criteria to classification. It has also been widely discussed by experts in the fertility field that the device should have been exempt from this streamlined process as it is not a low/moderate risk device. Its risks should have been classified as much higher, due to the risk factors involved in pregnancy, not to mention the financial responsibility of a baby.

In the future similar devices will find their way to market much easier now that Natural Cycles has paved the way. Competitors will be able to release similar device(s) to market via a 510(K) premarket notification (in the case of Class II devices). Simply demonstrating that their device is “at least as safe and effective” as an existing legally marketed device. With two thirds of these applications being cleared within six months. There has been some mention of special controls for contraceptive apps, including the need to go through “clinical performance testing”, however there has been no minimum level set.

No one would argue that the women that use these devices should not be key in the trial and usability assessment of them but healthcare professionals need to be include also, so set protocols and strong clinical evidence can be gathered and a resulting FDA approval instils trust in the consumer population. Also, so that mitigating factors that can affect measuring criteria can be eliminated. In the case of basal body temperature- this can be affected by a whole host of outside factors, from diet, alcohol consumption, illness and stress to name but a few. With this area of devices on the rise, and currently second only to fitness apps, the incomparable risk of an unwanted pregnancy needs to be given a greater risk assessment that that of miscalculating the number of steps taken that day.