Blue Oceans for Health   Smarter, Better Healthcare Through New Products, Services, and Ideas

I recently came across FoetoH, a fetal heart rate monitoring device that has been developed at the University of Oxford. Unlike other forms of fetal health monitors, FoetoH is designed to be used by laypeople and in a real-time manner. Rather than giving health information output in complex jargon or graphs, the device provides a stoplight-style assessment (green, yellow, red) of a developing fetus’ current health. The scientific breakthrough was developing an exercise belt-like device (think exercise heart rate monitors) that a mother-to-be wears all the time that communicates with a handheld unit (or iPhone app) which facilitates data storage and interpretation.

The idea of FoetoH is attractive because of its synthesis of the latest technology trends (i.e., mobile-based health applications, user-oriented design) and advanced health monitoring devices. The marketing materials of FoetoH are excellent and describe this device as potential breakthrough to help address the more than 2 million stillborn babies born each year around the world. The basis of this claim is that mothers who know their pregnancy is in trouble (indicated by a “yellow” or “red light” on the device) could receive emergent medical care to improve fetal outcomes.

Unfortunately, such a simplified product and health solution obscure some major logical flaws in their existing argument. For FoetoH to contibrute to a reduction in worldwide stillbirths, the device needs to prove itself to be more than just effective at measuring fetal heart rates. FoetoH’s founders need to be able to demonstrate that identifying changes in fetal heart rates is an effective way of identifying AND preventing still births. Why do I raise this issue? The limited data available on still births demonstrates that the majority of still births are due to genetic and environmental insults that go well beyond impaired cardiovascular support of the fetus. Many of these stillbirths are due to unknown  genetic causes, infectious disease, or severe malnourishment, and fetal distress (erratic fetal heart rates) is an end-stage sign of imminent still birth. In these cases, last-minute emergency care would have virtually no chance of preventing “fetal demise” (technical term for still birth). It is also unclear that FoetoH’s real-time monitoring is any more effective than current guidelines for antenatal care which include regular physician visits and routine ultrasound scans at pregnancy milestones.

Moreover, it is unlikely that most mothers at risk for stillbirth would be able to gain access to the FoetoH device. Its currently reported cost of manufacturing is approximately $80. A public sector price is likely at least twice as expensive with a market price even more. Given that the vast majority of stillbirths occur in impoverished women from developing countries, the target population who could potentially benefit from such a device would be unlikely to be able to afford it. Even if such devices were provided free of charge to high-risk mothers, the limited benefit of using the device I raised in the prior paragraph would likely outweigh the high cost to health systems.

These issues are not lost on healthcare device makers familiar with the product. At Oxford’s recent TATA Idea Idol business plan pitch competition – where FoetoH was a finalist – judge Will Chadwick of TATA Interactive Systems noted that the only realistic market for FoetoH were overly concerned mothers from the industrialized world who were willing to pay for a device that provided peace of mind rather than a clear-cut medical benefit over existing practices.

In fairness to FoetoH, its TATA Idea Idol team went on to win this year’s competition despite Chadwick’s misgivings (so someone clearly thinks FoetoH has something going for it). In the end, the science and potential commercial market for the device were convincing enough to beat out a number of strong competitors. FoetoH is a useful reminder for clinicians. Sound science and commercial availability do not make good medicine. Healthcare providers have to always maintain a critical eye and question new healthcare good and services to ensure that they are consistent with the individual provider’s aims and means of care as well.