Developing Comprehensive, Cost-Effective Hardware and Software Solutions for the Cardiac Device Market
By Jose Villasenor Fernandez, M.D., Global Medical Applications Specialist, Freescale Semiconductor and David Niewolny, Medical Product Marketing Manager, Freescale Semiconductor
According to the World Health Organization, cardiovascular disease is the leading cause of death globally. An estimated 17.5 million people died from cardiovascular disease in 2005, representing 30 percent of all global deaths. Of these deaths, 7.6 million were due to heart attacks, and 5.7 million were due to stroke. By 2015, an estimated 20 million people will die from cardiovascular disease every year, primarily from heart attacks and strokes. Many of these deaths may occur with no previous symptoms of cardiovascular disease.
Electrocardiogram (ECG) monitors are vital tools used by health care providers to help identify cardiac conditions and monitor patient health. An ECG monitor can come in many forms, ranging from handheld devices for remote monitoring to sophisticated patient monitoring systems used by hospitals. Regardless of the system design, market demands are driving cardiac device manufacturers to develop lower cost, lower power products with increased functionality. An added demand is getting these next generation products to market quickly.
As medical device designers begin their design processes they start by addressing their product requirements. These product requirements continue to get more demanding as competition in this space grows. The main concerns these designers have are power consumption and functionality. This is especially true in handheld, battery powered applications, such as a tele-health monitor or a cardiac event monitor. In these devices, Microcontrollers (MCUs) must have very low-power run mode and stop currents, but they still need to be highly accurate and more capable than previous products, offering additional features, such as wireless capability.
In order to best meet the specific power consumption and functionality requirements, it’s important to have a variety of MCUs to choose from. A large portfolio of software compatible MCUs, such as Freescale’s Controller Continuum or Texas Instruments’ MSP430 family makes for an ideal solution for medical device designers with increasingly demanding and always changing power consumption and functionality requirements.
In addition to creating systems that offer improved functionality and lower power consumption, designers are also tasked with lowering system cost. This can be accomplished by choosing highly integrated MCUs with on-chip memory and peripherals, eliminating the need for external components in the system design. Lowering the number of components has the added benefits of reducing the board size, cutting cost and improving the overall form factor.
One last concern that is becoming more critical in the medical device arena is time to market. In addition to the standard board layout and hardware and software integration issues, medical device designers have another obstacle to overcome, FDA approval. The FDA approval process often becomes a bottleneck in many medical device project schedules. One way device designers can speed the approval is to integrate FDA 510(k)-cleared software into their devices. This is no guarantee the FDA approval process will be any less rigorous, but in many cases prior clearance on the system software has been shown to speed up the process and helps minimize last minute surprises.
Meeting all of the demands of a medical device designer is not easy, but fortunately silicon and software providers are finally taking notice. Recently, semiconductor giant Freescale Semiconductor announced a partnership with a specialized software company, Monebo Technologies, to help medical device designers simplify the system design process, lower cost and speed time to market.
Freescale and Monebo are offering an ECG-on-a-Chip platform solution that enables medical equipment designers to choose the functionality of one of the five Kinetic™ ECG algorithms available from Monebo, all 510 (k) cleared, and match it with one of more than 500 embedded processors available from Freescale. This flexibility allows the designer to focus on meeting customer requirements with a solution that has been optimized for processing power and memory and power efficiency.
The Kinetic algorithm is designed to provide an extremely accurate, scalable solution that can be used in a variety of forms, from battery powered ambulatory monitors to large hospital bedside monitors. It is able to analyze ECGs from one to twelve leads in real time, beat by beat, with no warm up period and provide measurements of ECG intervals and beat classification and detect main cardiac arrhythmias. Its highly efficient operation, small code size and low battery usage make it an excellent choice for embedded applications.
Freescale offers a broad range of 8-, 16- and 32-bit MCUs and 32-bit microprocessors. Access to these diverse hardware platforms enables the system designer to choose an optimal processing core and peripheral and connectivity options for the desired application. To learn more about Freescale’s processor and MCU portfolios, visit www.freescale.com .