Miniature wireless sensing and computing devices have the potential to improve people’s health, even save lives. Twenty years ago, working on microelectromechanical systems (MEMS) as a student at Michigan, Dr. Nader Najafi had a dream to be part of this future reality.
He turned that dream to action when he left a promising career at a large firm to return to Michigan and start his own company. As founder, CEO and president of Integrated Sensing Systems (ISS), Najafi is now leading the development of some of the most advanced micro-scale medical technology in the world.
The company’s flagship device, the Titan Wireless Implantable Hemodynamic Monitor (WIHM), monitor’s overall cardiovascular health in patients of all ages, and may one day help curb the growing epidemic of congestive heart failure. Building this device took vision, daring and heart.
Laying the groundwork
As a student at U-M, Najafi learned from the best. His advisors, Kensall D. Wise, William Gould Dow Distinguished University Professor Emeritus, were early leaders in the MEMS field and specialized in medical applications. Najafi also learned by doing. He built MEMS devices in the new Solid-State Electronics Laboratory (SSEL), which he helped ready for research during late 1980’s.
As Najafi was completing his doctoral degree, he talked about the possibility of starting a company with Wise and his older brother, Khalil Najafi (now Schlumberger Professor of Engineering and Chair of ECE), also a MEMS specialist. But the time was not yet right. Instead, he took a job as a research scientist at IBM in Vermont, which was one of the largest CMOS electronics manufacturers in the U.S. Just three years later in 1995, faced with a career that might not ever fulfill his grandest dreams, he took a step into the unknown.
“In the end, passion overcame wisdom,” said Najafi. “It was either very brave or very stupid.”
He returned to Michigan to start his company in a location familiar to young entrepreneurs, his one-bedroom apartment. This company, co-founded by Wise and Najafi, became Integrated Sensing Systems.
ISS built three major business divisions: a medical division to develop and commercialize wireless, batteryless, intelligent, miniature and sensing implants; an industrial arm that produces sensors; and a contract-based manufacturing arm that allows outside companies to use their facilities. The contract division provides wafer fabrication services, prototype development and contract manufacturing to more than 100 companies worldwide. ISS is the only company in the state of Michigan with its own MEMS manufacturing facility, centered on its Class 100 Clean Room for MEMS manufacturing.
The company provides employment for several dozen local workers. “In terms of job creation, 7 or 8 jobs in the nation out of 10 are generated by small companies,” said Najafi. He is proud to have created one of those companies.
It is in the sensor division of ISS that Najafi hopes to make his mark. By developing sensing systems for medical applications, the company is poised to make a genuine difference in people’s lives.
The heart of the matter
Medical monitoring devices are among the most important pieces of equipment in modern health care, and there are few diseases in need of more reliable monitoring than congestive heart failure (CHF). CHF, called the newest epidemic by the National Institutes of Health, affects more than 6 million people across the nation, with 300,000 new cases each year. The disease is the result of a damaged or overworked heart that cannot pump blood sufficiently to meet the metabolic demands of the body, and it can be deadly: 1 in 5 patients succumbs to complications from the disease within the first year of diagnosis, and half within the first five.
Once diagnosed, CHF is monitored primarily by direct observation, patient feedback and echocardiography. It is a clumsy system with much room for error.
ISS’s Titan Wireless Implantable Hemodynamic Monitor promises continuous and accurate monitoring of the left atrium or ventricle of the heart, and is the first heart-monitoring device to be anchored in this dangerous location. Any blood clot that forms in the left ventricle run the risk of dislodging and flowing to the brain, resulting in stroke. Yet the left heart yields the best insights into a CHF patient’s condition. This is because the filling pressure is the single most important parameter for medication adjustments in a long-term CHF patient.
Thanks to its size, its wireless capabilities and its lack of a battery, the Titan WIHM offers a safe solution for retrieving this data anywhere, in particular for regular home monitoring. Physicians can gather data from anywhere with an Internet connection.
“The difference in treatment will be night and day,” said Najafi. “And the cost savings will be dramatic. It is estimated that 20 cents of every dollar spent by Medicaid goes to CHF treatment, with patients needing to visit their doctors frequently to take measurements. The Titan promises independent home monitoring.”
And it works better than existing methods. In one trial, Najafi was told that the left-heart hemodynamics captured by Titan looked different than previous home monitoring samples. The medical staff asked ISS whether the implant was functioning properly. After reviewing the implant, he responded, “I think there’s a problem with the heart, not the monitor.” The home monitoring by the ISS implant indeed detected an early onset of a potentially-deadly condition. The patient went through an elective surgery and was saved.
Further testing proved him to be correct, and probably saved the individual’s life. The Titan WIHM is being selectively tested in Europe and pending approval, may be ready for public sale next year. It is currently awaiting FDA approval in the U.S.
In addition, ISS has a fluidics division that designs and manufactures a variety of gas and liquid density instruments and sensors for measuring density, viscosity, temperature, concentration and specific gravity.
Thanks to decades of innovation in MEMS technology, ISS is poised to make significant contributions to the healthcare profession, and in the process, realize the dreams of founder, president and CEO, Nader Najafi.
Integrated Sensing Systems