Mobile app-based medical devices that offer fertility analyses are paving the way for further research into using apps to provide medical care. Image Credit: Flickr user verkeorg

Fertility researchers in the United States and the United Kingdom are bringing new meaning to the phrase “There’s an app for that.” In the UK, an app that tracks fertility was approved as a class IIb medical device for contraception in February 2017. The app, marketed under the name Natural Cycles, measures a woman’s daily temperature and employs a complex algorithm to analyze the information and determine whether she is fertile. The app’s creators emphasize the fact that the technology provides a birth control method that is noninvasive and free from hormones and chemicals, so women experience no side effects.1

On this side of the pond, researchers at Brigham and Women’s Hospital and Massachusetts General Hospital have been working to develop an app-based medical device that measures male infertility. They described their prototype, which they plan to submit to the FDA for approval, in the March 2017 issue of Science Translational Medicine. Currently, the only way to test for male infertility is in a clinical setting, which is expensive, labor-intensive and time consuming. When setting out to create their device, the goal of the researchers was to “make infertility testing as simple and affordable as home pregnancy tests.”2  The device they came up with consists of an optical component and a collection component, which can transmit data to a smartphone. This data is then analyzed to identify any abnormalities that would indicate infertility.

App-based medical devices like these have the potential to revolutionize medical care in the field of fertility and in other areas. As researchers at life science companies explore new app-based medical technologies, using electronic lab notebooks to support their researcher can improve research efficiency and enhance quality and accuracy.

Handling Large Quantities of Data with Precision and Delicacy

When talking about the Natural Cycles app and the male infertility app, the main attractor is their high accuracy.  For instance, the male infertility app identifies sperm cell abnormalities with an accuracy of 98%, while the pearl index for Natural Cycles is only 0.5, which means that only 5 out of 1000 women who use the app properly will experience an unexpected pregnancy.3  Without this level of reliability, Natural Cycles would not have received the IIb classification from the UK government, and the male infertility app would be unlikely to pass through the FDA’s stringent regulatory process.

To ascertain the reliability of their apps, the Natural Cycles researchers and the scientists in Massachusetts both conducted extensive clinical studies. The Natural Cycles app was tested on over four thousand women. Harvard’s initial infertility study was smaller, since the technology is only in the prototype phase, but still analyzed 350 samples. For researchers developing new apps-based medical devices, it will be essential to collect large amounts of clinical data at every stage of the research process in order to make sure that they are investing in the development of useful, reliable technologies. Electronic laboratory notebooks simplify data organization and management, so they are ideal for this kind of study.

Moreover, electronic lab notebooks have the added benefit of ensuring information security, which is critical when dealing with sensitive patient data like fertility information. Indeed, the researchers at Harvard have pointed out that the stress and embarrassment of infertility testing is one of the main reasons why men choose not to get clinical infertility testing,4 so researchers who intend to recruit clinical study participants will need to be able to guarantee patient data protection. Electronic lab notebooks make this possible, even when digitally stored data is shared between different researchers within an organization.

Supporting Collaborations Between Biomedical Scientists and Information Technology Experts

Information sharing is another extremely important aspect of app-based medical device development. Without the expertise of both information technology professionals and biomedical scientists, a device is sure to fail. Consider the key app-based medical device features that rely on information sharing:

  • User-Friendly Interface

For an app to be effective and accurate, it has to be easy to use. Nowhere is this more evident than in the research on the Natural Cycles app; the researchers found that when the technology was used improperly, the pearl index jumped from 0.5 to 7, which means that 7 out of 100 women would experience unplanned pregnancy if they didn’t use the app exactly as intended all the time. Collaborative work between biomedical researchers and mobile developers can help ensure that users can easily provide the app with the medical information it needs to produce an accurate reading, no matter what it is testing for.

  • Cutting Edge Add-On Components

The components that hook up to the male infertility app-based device include a disposable microchip and capillary tube, among other parts. The Massachusetts researchers note that, without recent advances in microfabrication and electronics, their device would not have been feasible. Electronic lab notebooks make it easier for medical researchers and electrical engineers to pool their ideas to make sure that the latest technologies in both fields are being incorporated into app-based medical devices.

  • Multi-Use Apps

Right now, the male infertility app walks users through the sample collection and fertility analysis process. But according to the researchers, fertility analysis isn’t necessarily the only way to use the medical device they created. For example, it could be used to test men who have had vasectomies, eliminating the need for clinical follow-up visits to make sure the operation worked. It could even be used by animal breeders to verify the quality of a sample. Researchers who are developing multi-use medical devices will need multi-use apps to go along with them, so information sharing between scientists and developers will be essential to make sure that medical data collection requirements sync up with an app’s different functions.

Electronic lab notebooks offer the organizational capabilities, information security guarantees and information-sharing options that are required for success when it comes to app-based medical device development. BIOVIA’s Electronic Lab Notebooks support all of these critical functions. Contact us today to learn more about incorporating ELNs into your lab.

  1. “Natural Cycles Fertility Tracking App Approved for Contraception,” February 10, 2017, http://www.pharmaceutical-technology.com/news/newsnatural-cycles-fertility-tracking-app-approved-for-contraception-5737113
  2. “Using a Smartphone to Screen for Male Infertility,” March 22, 2017, http://news.harvard.edu/gazette/story/2017/03/a-smartphone-app-can-screen-for-male-infertility/
  3.  “Would you trust a smartphone app as a contraceptive?” April 15, 2016, https://www.ncbi.nlm.nih.gov/pubmedhealth/behindtheheadlines/news/2016-04-15-would-you-trust-a-smartphone-app-as-a-contraceptive/
  4. “Men rejoice! New smartphone app can now measure your fertility,” March 23, 2017, http://economictimes.indiatimes.com/magazines/panache/men-rejoice-new-smartphone-app-can-now-measure-your-fertility/articleshow/57789783.cms