The trend of using wireless technologies in medical devices is relatively new, but is expected to increase in the future due to its benefits in cutting healthcare costs and increasing accessibility for patients and healthcare professionals.

Beyond allowing doctors to care for patients from just about anywhere, wireless applications have the potential to greatly improve care by providing real-time access to a patient’s medical history including treatments, medications, laboratory tests and insurance information.

Such devices will also reduce patient stress, removing the burden of having to show up at the hospital every day for a blood pressure check for example. Instead patients can use wireless sensors that send their blood pressure information to the doctors in real time.

With any new technology, however, there is always risk, and with increased use of these devices, so increases the risk of data theft and attacks on device privacy. Another possible drawback is a lack of access to a dedicated wireless spectrum as well as the possibility of electromagnetic and other interference between devices.

Using detailed market data from GlobalData’s ‘Wireless medical devices – a market snapshot’ report, we examine the drivers and market forces behind a market likely to dominate the future devices market.

Continuous technological advancements

A few years ago patients fitted with a pacemaker or a defibrillator needed to visit the doctors regularly for checkups.

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“Wireless devices cut healthcare costs and increasing accessibility for patients and healthcare professionals.”

In August 2009, a woman from New York became the first person in the world to receive a pacemaker that can communicate wirelessly with a remote monitoring service that her physician can access. This was the pacemaker from the Accent and Anthem product family by St Jude Medical.

Bioengineers from the University of California have also developed an implantable wireless monitor for diabetics that can measure glucose levels continuously for up to a year before needing a replacement. This glucose monitoring system is implanted under the skin where it measures the glucose levels and transmits the data to an external receiver.

Aging demographic to drive the market growth

In 2009, there were 737 million people worldwide aged 60 years or over, representing 11% of the world’s total population. In Japan, 30% of the total population is represented by people aged 60 years or more.

An increasing trend in chronic diseases and elderly population presents a huge opportunity for companies manufacturing wireless medical devices for the remote monitoring of patients. These devices empower the patients, allowing them to manage their own health and reduce the overall costs for the hospitals. Studies have shown that telehealth in chronic patients leads to a 40% reduction in emergency room visits, a 63% reduction in rehospitalisations and a 22% reduction in total bed days, and cost of care is 27% lower in telemonitoring groups.

Security concerns

While wireless communications technology in medical devices greatly enhances their usage, it also brings with it the risks of data theft and attacks on device privacy. Since these devices use the internet as the communications backbone they are likely to invite attacks. There are several privacy enhancing technologies available for wireless medical devices but the cost related to these technologies far outweigh the benefits.

“Wireless applications have the potential to greatly improve care by providing real-time access to a patient’s medical history.”

In 2008, researchers from three US universities – University of Washington, Harvard Medical School and the University of Massachusetts at Amherst demonstrated how to use wireless hacking techniques to access a combination heart defibrillator and pacemaker.

These researchers used their wireless access to steal personal information from the device and to induce fatal heart rhythms by taking control of the system. They reported that the data from such devices can be stolen without the patient realising it.

After this study, the US FDA said that it was working on raising the standards of security of medical devices that receive instructions in a wireless manner but had not finalised them. The Medicines and Healthcare Products Regulatory Agency from the UK said that it has never received any reports of hacking associated with implantable devices.

Absence of a dedicated spectrum

A key factor affecting  wireless medical device safety and efficacy is the absence of a dedicated spectrum or limited amount of spectrum available and potential competition among wireless technologies for the same spectrum.

In the US, Wireless Medical Telemetry Service (WMTS) provides frequency bands in which medical telemetry devices are co-primary users and frequency coordination is performed by the American Hospital Association (AHA). However in some locations powerful television transmitters in adjacent bands may make portions of WMTS spectrum unusable, in military area locations military radars have the authorisation to use a portion of WMTS spectrum. Too many transmitters nearby can slow down or block the transmission of critical patient data and emergency alerts cannot reach the health caregivers in a timely manner.

Another limitation is that the frequency bands for WMTS are not harmonised among countries. For example the frequency band 608 MHz-614 MHz is used for WMTS on a licence-exempt basis in Canada but on a primary licensed basis in the US. In addition, in Europe this band is not used for WMTS because of its use by other radiocommunication services. Harmonisation of spectrum will enable the patients to move around freely without having to worry about the network coverage.

“In August 2009, a woman from New York became the first person in the world to receive a pacemaker that can communicate wirelessly.”

Electromagnetic interference (EMI) between wireless medical devices

The increased use of wireless technology in medical devices along with the rapid proliferation of other devices such as mobile phones using the wireless technology has resulted EMI among devices. In 2007, a study was conducted by scientists in the Netherlands to assess and classify incidents of EMI by mobile phones on critical care medical equipment.

A total of 61 medical devices were tested and 48 incidents were identified out of which 16 (33%) were classified as hazardous, 20 (42%) were identified as significant and 12 (25%) as light. On the basis of the results, scientists concluded that critical care equipment was vulnerable to EMI by new-generation wireless telecommunication technologies.

Industry standards require that all wireless medical equipment must operate properly when exposed to 3V/m of applied electric field power. Mobile phones emit varying amounts of electric field power depending upon the transmit power of the specific phone and the distance between the mobile phone and the medical equipment. Most mobile phones emit as much as 1W of power and at this rate, radio frequency (RF) transmissions from a mobile phone can reach the 3V/m immunity level for medical equipment when the phone is less than 10ft from the medical device. Since the growing use of mobile phones and wireless medical devices makes it impossible to control the distance between them, the only way to address this interference problem is by reducing the output power of a mobile phone.

More Details on the full GlobalData report.

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