Archive for the ‘ultrasound’ Tag

FoetoH – Good science. Good medicine?   1 comment

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.

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GE VScan and Handheld Ultrasound Devices   9 comments

Why an amazing product can’t find a market

The Gold Standard: GE Vivid 7 (Courtesy GE Healthcare)

Medical ultrasound is considered one of the most effective imaging modalities for cheap, reliable diagnosis of many disease states from heart disease to infected abscesses. Since the technology’s inception, device manufacturers have been steadily miniaturizing components so that what used to be a desk-sized machine (The GE Vivid7 in the picture to the left is a modern version of these behemoths) has now been succeeded by a laptop bolted to a small rolling cart with a number of ultrasound probes hanging off the side.

In late 2009, GE Healthcare released its VScan (see picture on right) handheld ultrasound device to the American market. The VScan device was most notable for its size — only slightly bulkier than a classic clam-shell mobile phone — and a price that was 80% less than traditional machines. Although VScan’s introduction was accompanied by a number of competing devices from other major industry competitors (e.g., Siemens’ ACUSON P10, Signostics’ Signos) as well as enterprising start-ups, the VScan has generally been considered to be the superior product in the pocket portable product segment because it functions near-identically to larger laptop-based portables but in a smaller form-factor. (Still not quite following? See a short introductory video by GE here.)

GE VScan

GE VScan (Courtesy GE Healthcare)

The VScan’s entry should have been heralded by doctors in a variety of clinical settings. A device exists that a clinician can carry in his or her pocket that with relatively little additional training can be used to detect traumatic injuries, major vessel disease, heart failure, and other maladies all without the need for any further appointments (in the outpatient setting) or bulky equipment often confined to a poorly accessible imaging suite. Unfortunately, the VScan and its competitors have had little adoption in the years since their introduction.

The lack of interest in the VScan illustrates how the current reimbursement system of the American healthcare system has direct effects on how patient care is provided. An example of these skewed incentives can be readily seen in one of ultrasound’s largest markets – outpatient cardiac ultrasound. Without VScan, a cardiologist orders a comprehensive ultrasound study that typically requires a second visit and an advanced cart-based ultrasound machine. Each study performed earns the cardiologist a professional and technical fees exceeding $1,500. In contrast, current reimbursement policies (typically set by Medicare and then voluntarily adopted by private insurance companies) do not cover ultrasound procedures performed with handheld devices so physicians are unable to charge for this service. Thus, the $7,000 cost of each handheld ultrasound machine is not going to be recouped through additional procedural charges.

The only revenue stream from use of the VScan product is any potential efficiency gains met by being able to rule-out serious underlying disease quickly and thereby see more patients in the same amount of time. While such a hidden benefit may be difficult to convey to a private practitioner or a standalone healthcare system, integrated healthcare systems (e.g., U.S. Veterans Affairs Hospital Systems, National Health Service) stand to benefit more from lowering the number of unnecessary comprehensive ultrasound exams. It should be no surprise then that integrated healthcare systems in Europe have been some of the few markets where handheld ultrasound devices are regularly used and clinically studied.

Personally, I’m not convinced by proponents of the VScan that such devices will soon replace the conventional stethoscope. The price and relative ease of use the latter are so superior that any real competition between the two is still a decade or more away. Such a claim is analogous to saying the typewriter would make the pencil obsolete. What is far more likely is growing demand for VScan and its competitors as the American healthcare system wakes up to cost-effective care. A greater focus on comparative cost-effectiveness will lead to reimbursement policies rewarding physicians for at least the limited use of such handheld devices versus comprehensive ultrasound studies. As GE’s marketing efforts in the ultrasound industry demonstrate, the real success of such a product can only be evaluated as a component of a greater imaging ecosystem. For a GE, the real value of such a device is that it allows the company to offer an end of the spectrum poorly matched by any of its competitors.

Conflict of Interest Disclosure: I have never received funding from and have no financial stake in GEHealthcare or its subsidaries. In 2010, GEHealthcare loaned a LOGIQ i portable ultrasound machine to a humanitarian surgical trip I led to Hinche, Haiti.