Monitoring the medical monitors

A CHINESE-BASED medical device maker has become a world leader in its field in just two decades. But the company never stops trying to come up with innovative new products and improvements to existing ones. 

Mindray, a medical device company founded two decades ago in the Chinese boomtown of Shenzhen, is continually making technological advances. It is a world leader in the development, manufacture and marketing of medical devices and has three business areas: Patient Monitoring and Life Support Products, In-Vitro Diagnostic Products, and Medical Imaging Systems. But how does the company know whether a new feature truly improves a device’s usefulness and helps doctors to save lives?
That’s where Mindray clinical engineer Kun Fang comes in. Ms Fang researches innovations in patient monitors, which display a patient’s vital signs and other data on a screen. The faster she can get feedback about a device from doctors and hospitals, the faster Mindray can perfect it. “We work hard to get approval for our innovations as quickly as possible from the Chinese State Food and Drug Administration,” she says.
Currently, Ms Fang is gathering feedback on a new patient monitoring function designed for newborn infants with breathing problems. When babies are born and begin to breathe air, their circulatory system should start pumping blood through the lungs. But for this to happen, a fetal blood vessel to the heart – the ductus arteriosus – must permanently close. In rare cases when this duct does not close, however, a newborn may suffer from a condition called persistent pulmonary hypertension of the newborn (PPHN).
To check for this rare condition, doctors place a pulse oximeter on two of the baby’s fingers. The oximeter uses a light sensor to measure the percentage of hemoglobin saturated with oxygen. In a healthy person, this should approach 100 percent.
Ms Fang is researching Mindray’s new feature, which adds oximeter readings to the screen of its BeneView patient monitor. “We will need to get feedback from doctors to see whether the new measurements and functions are helpful in making diagnoses,” Fang says.

Digital records and better-connected networks will reduce human error, says Mindray clinical engineer Kun Fang (Photo by Trelleborg)
In addition to researching the effectiveness of the new software, Ms Fang also helps evaluate new hardware. Since the end of 2011, Mindray has been producing the BeneView T1, a small, lightweight patient monitor with a handle, making it easy to transport when a patient needs to be moved. “We started developing this device using a simulation scenario, and then collected feedback from hospitals,” she says. “Based on our findings, we suggested certain modifications. This process of getting feedback is often repeated more than once during the design phase.”
Ms Fang has worked as a researcher at Mindray for two years. She cooperates closely with five other team members dedicated to the same project. Outside the company, she communicates mainly with doctors and medical staff at various hospitals, as well as with hospital administrators and government regulators at the State Food and Drug Administration.

“My job requires good interpersonal skills,” Ms Fang says. “I’m dealing with extremely busy hospital staff members, trying to get valuable, constructive feedback within a short timeframe.”
Another challenge she faces in her job is lNIKE SB