By Bob Marshall, Chief Editor, Med Device Online
In a recent commercial for One-A-Day brand’s Pre-Pregnancy Couple’s Pack vitamins, a woman says to her partner, “according to Feng-Shui, the bed should face northeast.” The man promptly jumps over the bed and begins to re-position it with her assistance — a silly vignette demonstrating the lengths to which couples go when they experience difficulty starting or expanding their family.
But to those experiencing difficulty conceiving a child, the frustration is anything but silly. About 10 percent of women (6.1 million) in the United States ages 15-44 have difficulty getting pregnant, according to the Centers for Disease Control and Prevention (CDC). In exploring the female side of conception difficulties, sometimes ovulation problems are caused by polycystic ovarian syndrome (PCOS). A hormonal imbalance that can interfere with normal ovulation, PCOS is the most common cause of female infertility. Primary ovarian insufficiency (POI), where a woman's ovaries stop working normally before she is 40, is another cause of ovulation problems. These and other conditions, such as endometriosis and uterine fibroids, involve diagnosis and treatment by a medical professional, but infertility is defined as not being able to get pregnant after one year of trying (or six months, if a woman is 35 or older).
So what is a couple to do? Conception difficulties could be related to one of the problems above, or it could just be that an egg is only available to be fertilized for 12-24 hours each month during ovulation. Knowing the signs of ovulation have been the keys to improving the chances of conception. Women can measure and chart their basal body temperature, observe changes in cervical fluid, and measure for an elevated level of luteinizing hormone by using an ovulation test. All of these tedious methods have been well used by those seeking to welcome a little bundle of joy into their lives, but don’t science and medical technology have any improvements to offer us? They do, in fact.
“The Fitbit Of Fertility”
I first became aware of Ava, a medical technology company focused on innovations in women’s reproductive health, when the company issued a press release related to closing a $10M Series A fund-raising round in November last year. I must confess that my interest in the Ava cycle tracker was quite the opposite of its current intended use. Being an advocate of natural family planning (NFP), I viewed the Ava bracelet as a way for those practicing NFP to know which days to abstain from sexual activity each month to prevent pregnancy. When I recently spoke with Peter Stein, co-founder and VP of R&D at Ava AG, he explained that obtaining clearance of the cycle tracker for contraceptive purposes certainly is on the company’s product roadmap, but the device is not cleared for contraception at this time.
Two Things Other Startups Can Learn From Ava
Two things impressed me in my discussion with Stein: his company’s use of a progressive regulatory strategy, and his understanding that the company web site is considered “labeling” by regulators. First, when I asked Stein about use of the Ava cycle tracker for contraceptive purposes, he explained that the device certainly could provide that information. However, a contraceptive indication for the Ava cycle tracker would make it a Class II device in the U.S., and a Class 2B device in the EU, while use as a fertility device is Class I (510k exempt) in the U.S. and Class 1 in the EU. By focusing on gathering clinical data for use as a fertility device first, Ava was able to expedite commercialization of the cycle tracker. A focused strategy enabled the company to get on the market and begin generating revenue while continuing development of the contraceptive indication and planning for the associated clinical trial.
Second, the Ava website contains a clear statement on the ordering page, “Ava is not a contraceptive and cannot be used to prevent pregnancy.” Many companies forget that information on their web site is considered labeling by regulators, and I have seen FDA investigators show up for routine inspections at facilities where I was working with print-outs of pages from the company web site in their briefcases. In a few instances, let’s just say marketing had gotten a little ahead of R&D on the product roadmap…
Big Data From A Tiny Package
With Ava, it’s all about the data. The cycle tracker collects information on resting pulse rate, skin temperature, heart rate variability ratio, sleep, perfusion, breathing rate, movement, heat loss, and bio-impedance. It also performs quality checks on the data for validity. When asked about his current team at Ava, Stein indicated he has six data scientists, two data engineers, an epidemiologist, and a biostatistician. With the assembled collection of analytical horsepower and the multitude of information available, I imagine the initial fertility functionality of the Ava cycle tracker will provide a platform for many other applications, which Stein confirmed.
Building Community, One Baby At A Time
Currently, the Ava cycle tracker is sold only directly, via digital marketing on the company’s web site, to selected markets. I asked Stein about other channels, such as distributors, or directly approaching stores like CVS, Rite Aid, and/or Walgreens in the U.S., and he confirmed that the company is considering all options. In spite of its currently limited distribution channel, the Ava cycle tracker’s user base is growing.
I noticed a few user comments on the web site and asked Stein about them. The rather stoic, yet kind and soft-spoken Stein let out a hearty laugh and said, “Yes, we have a very lively user community. They give us good feedback. When an early version of the bracelet, which was really a prototype, had problems in the field, our users reached out to us and we made improvements and exchanged the bands.” Stein also noted that users are quick to share their good news when they become pregnant.
I’m sure the ability to conceive is a great relief for couples who achieve success using the Ava cycle tracker, or other means. Perhaps Ava should consider adding a compass to the cycle tracker to see if there’s anything to the Feng-Shui, bed-facing northeast thing? I think I will mention it to Stein the next time we talk. I bet I’ll get another hearty laugh out of him.