Over the last few decades, we have seen many PC- and Web-based applications adapted to work on mobile phones, and more recently, we have seen applications exclusively designed for smartphones.
At the 16th Annual Global Mobile Awards, held in Barcelona, the ”Best M-Health Innovation” award was given to a company doing just that -- Mobisante, which has built a specialized medical device on top of a smartphone.
Mobisante has developed software that allows a Windows Mobile smartphone to connect to an ultrasound probe via USB, turning it into a fully functional portable ultrasound system. It uses the computing power of the phone to process and render images and built-in cellular or WiFi radios to transmit data.
While the device doesn’t replace high-end ultrasound equipment found in most US hospital radiology departments, it is perfectly suitable for taking “a quick look” -- for example, to confirm a pregnancy or determine the position of a baby. Such devices could thus expand the range of primary care services currently performed by specialists. This could be especially important for the many patients in America treated in community health centers.
Mobisante believes that if this technology can achieve scale, a single ultrasonic exam can cost less than a $1/exam. An exam can be conducted by a non-expert, and since the system uses a smartphone, it is portable and can be brought to the patient, providing care where it is needed.
Recently, the US Food and Drug Administration granted Mobisante a 510(k) clearance for its smartphone-based ultrasound system, MobiUS. Mobisante plans to sell several versions of it, with probes at different frequencies for different medical applications. Depending on the components included, the price could range from $5,000 to $10,000 initially and drop by half within the next few years.
Mobisante’s device is not the only handheld ultrasound device in the marketplace. Several others have also received FDA clearance, including GE's Vscan and the Siemens Acuson P10. But Mobisante's device has an advantage because it uses the smartphone, allowing it to connect directly to a cellular network or WiFi. The user can send images with the push of a button.
In contrast, handheld ultrasound devices currently on the market can't email images directly -- a user has to transfer them to a PC first, either with a docking station, or by removing the device's memory card.
Use of the smartphone as a platform also makes Mobisante’s device more accessible. The vendor says that 70 percent of the world population does not have access to ultrasonic imaging technology, but 90 percent of the world population does have access to the cellular network.
Irrespective of its success, Mobisante is among the first to take steps toward creating add-on hardware for smartphones for various functions in the medical industry. Research is underway for applications that analyze blood cells for malaria, test water for parasites, and even monitor the health of HIV patients by counting T-cells in their blood.
The success of such future hardware extensions to smartphones in America will depend largely on how the FDA regulates these devices. In the next few years, we will witness to what extent mobile phones with simple generic communication hardware become FDA-regulated.
FDA policies will determine the pace of innovation on such devices. Nevertheless, it seems some medical instruments and practices are set for a change both in developed and emerging markets in the near future, thanks to the combination of smartphones and medical apps.
— Pranay Mittal has been an IT/business management consultant for over 10 years.
@pcharles: I am not sure about rural areas in other parts of the world, but in countries like Pakistan, telecommunication development has progressed a great deal as compared to other infrastructure elements such as roads, water supply and transport network. Hence, internet and mobile communication is playing a great role in improving the living conditions in those areas.
Sounds like a novel idea, but aren't those same rural areas subject to the concerns of not having cellular and/or wifi coverage? I think those are the foundational issues that must be addressed prior to utilizing smartphones.
Absolutely, taimur. It can really contribute to the resources and information available to people. We need to think of new and better ways to use our resources.
I think smartphones have a great potential in the area of health-care and medical science. One of the biggest use is to provide upgraded health-care facilities and medical advise to people living in rural parts of the world.
In developing countries, the rural population is subjected to poor health-care facilities and lack of infrastructure. The doctors there do not have access to the latest research and other knowledge available to doctors in urban centers. Through the use of smartphones, with technologies such as video conferencing, the rural population can directly consult with urban doctors. This can greatly improve the medical facilities available to them.
One of the disadvantages of living in a global economy is that even if laws and regulations prevent Americans from getting their hands on such a device, I am sure this hardware extension or something similar would be available to Americans from other overseas companies.
Well, there are other institutions, besides FDA, who also keep an eye on such things and protect the end users in their respective countries. Probably their outreach is limited, but some level of protection still exists.
I see that this could be valuable given the price point, the reduced need for power sources given the mobile nature (I assume it is battery operated). This could open the capability to remotely send more diagnostic information.
There are two concerns that I would have - and maybe these have been solved. Given the recent uproar about the iphone tracking data, what are the issues with sensitive personal information on a handheld device being transmitted over the air?
My second concern relates to the the 90% of people have access to cellular. While I don't doubt this is a valid statement, I wonder what percent have access to the type of cellular service that makes it usable - I don't images sent via GSM dial will be very useful vs sending over a higher speed 3G technology. Also, given the cost of data, especially in remote locations, will it be cost effective? Or will cellular providers give you one for signing up on their network?
I think there is great value in the portability and capability and I am sure these issues already are addressed, or they will be addressed.
I understand your points, audreypeters. The regulation that he is referring to will be the requirement that any medical device is subject to FDA approval. What I was referring to, as you point out, is that hopefully the access to good business technology solutions (ipads, tablets, smartphones) will be recognized as an extension of consumer use, therefore bypassing the highly regulated costly medical applications.
The medical device regulation should really only come into play when it is used diagnostically, then the regulation and price makes sense.
I understand your objection to the high-priced companies, as the markets develop, hopefully the consumerism of healthcare will open up extended opportunities. At the present time, these companies, however, are the leaders in investing in the FDA-approved medical devices that can provide home-based support.
Careful indeed. I am not an attorney, but I see all kinds of new negligence claims coming over the horizon unless these innovations are really polished.
I dont think the device should be allowed for personal use. However the company says that the device can be used by a "non expert" and then images can be emailed to a doctor for consultation. Hence I feel the FDA will have to be careful on how such devices are marketed, sold and used.
As noted in most comments on this article it seems that everyone agrees that it is a smart innovation but we are all concerned how a medical device like this one will be used by patients and doctors.
One of the disadvantages of living in a global economy is that even if laws and regulations prevent Americans from getting their hands on such a device, I am sure this hardware extension or something similar would be available to Americans from other overseas companies.
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