A Leader in Medical Device Development
Rajesh Pandey '93, has a career that has always been on the fast track.
In 1996, at his first job out of graduate school — a time when most new graduates are just getting their feet wet — Pandey was appointed technical project leader at Stryker Instruments, where he was charged with designing a new high-speed surgical drill.
The specialized surgical drill, devised for intricate orthopaedic, spinal, craniofacial and neurological applications, was the first Stryker product ever to be released before its target date, and became one of the company’s best-selling products.
Over the next 12 years, Pandey would lead medical device development at three other companies, designing and bringing to market innovative new products such as a fully implantable heart pump and the tools to implant the pump, and an intravascular implantable defibrillator.
Today, at age 36, Pandey directs advanced product development at SurgiVision, a company at the vanguard of a new wave of medical devices for Magnetic Resonance Imaging (MRI)-assisted procedures.
“With the MRI-guided products we are developing at SurgiVision, we can improve people’s lives quite significantly,” said Pandey, who graduated from Mercer in 1993 with a Bachelor of Science in Engineering, specializing in biomedical engineering. He earned a Master of Science degree in biomedical engineering from the University of Alabama at Birmingham in 1995.
MRI is the best available technology for gaining high-resolution images of soft tissue, such as the brain, heart, liver and other organs. It provides the clarity and detail needed to guide the surgeon and implement highly selective surgical procedures, such as removing tumors while leaving healthy tissue undisturbed, delivering drugs and other biologic agents to very targeted, localized areas and improving neurological function through deep brain stimulation (DBS).
“Currently, however, most surgical devices are not compatible with MRIs,” Pandey explains. “They can move uncontrollably due to the forces created by magnetic fields or can heat up dramatically. In either case, healthy tissue can be seriously damaged.”
At SurgiVision, Pandey and his colleagues are developing MRI-safe components and devices.
“What we have done is develop configurations that make medical devices safe and compatible in virtually all MRI procedures,” he said. “All the MRI procedures that couldn’t have been done before now can be done safely.”
The company’s advances in MRI-assisted surgical safety have forged the way for a prominent partnership with Boston Scientific, the world’s largest medical device company dedicated to less-invasive medicine.
Among the newest SurgiVision technologies that Pandey is developing are MRI-compatible “leads” or wires for pacemakers, defibrillators and neurological devices that generate electric pulses. A lead is the conduit for carrying electrical signals. In a pacemaker, for instance, a lead delivers electrical signals directly to the heart to steady heart rhythm.
“These new MRI-compatible leads have the potential to significantly improve safety and expand healthcare treatment for many people,” Pandey said. “Currently, people with pacemakers and defibrillators are generally not allowed to receive MRI-assisted treatment because their devices can negatively react to the magnetic fields of the MRI.”
This same MRI-safe lead technology SurgiVision is developing can be used to send electrical signals to areas of the nervous system, such as the spinal cord, to alleviate pain and achieve other clinical benefits.
“Our focus is to enable all patients to safely get the full diagnostic and surgical benefits from today’s advanced MRI technology,” Pandey said. “And because we’re developing minimally invasive devices that deliver very targeted treatment, our technologies have great promise for reducing hospital stays and costs, increasing patient satisfaction and improving overall healthcare quality.”
Pandey’s work in medical device development involves considerable interaction with physicians, nurses and other medical staff to learn what they need and how medical devices could best suit them and meet their specific requirements.
“It’s essential that each product meets very stringent technical requirements as well as the real-world needs of healthcare professionals,” he said. “To be effective, a medical device must be practical and cost-efficient to use. We want to get to the point where patients can have a wide range of surgical procedures done quickly and economically, with the greatest clinical benefit.”
At Stryker Instruments in Kalamazoo, Mich., Pandey said he received valuable skills in all areas of product development and product management, from operations and quality assurance to manufacturing and field support. During his four years at the company, he directed the release of 14 products, including the highly successful surgical drill.
“As a device designer, it is particularly gratifying to hear how a product you designed directly improved a surgical procedure and benefited patient care,” Pandey said. “One instance that comes to mind occurred with the Stryker micodrill. I received feedback from a surgeon who said the device was instrumental in removing an eight-year-old girl’s ear tumor and implanting a device that saved her hearing.”
In late 2000, he left Stryker to join Z-KAT, a Fort Lauderdale-based developer of computer-assisted surgery technologies to build the company’s infrastructure and serve as project manager for a product release in the fall of 2001.
By 2002, Pandey was eager to embark on a new challenge. In the spring of that year he moved to Kriton Medical, which was later renamed HeartWare, in Miramar, Fla. While at HeartWare, Pandey designed the subsystems for a fully implantable heart pump and the tools to implant the pump. As director of product development, he helped HeartWare complete a successful human trial of its heart pump in March of 2006.
“The development of this heart pump was very rewarding,” Pandey said. “It dramatically reduces surgical time and enables heart patients to enjoy more active, normal lives.”
Pandey left HeartWare in May of 2006 to serve as principal engineer at InnerPulse, a Durham, N.C.-based developer of intravascular implantable defibrillators. Through Pandey’s direction, InnerPulse created its first fully functional prototype in September of 2008.
Later that year, the lure of a new career challenge drew him to SurgiVision and his current position in Raleigh, N.C.
“At the time I graduated high school, Mercer was one of the very few colleges out there that had biomedical engineering at the undergraduate level,” Pandey said. “The curriculum at Mercer was outstanding. Particularly fascinating to me were the courses in orthopaedic biomechanics and biofluid mechanics, and when we examined the core physics and science of how things work in the body.”
Pandey says the University’s emphasis on product development played a pivotal role in determining his career interest and direction.
“I always had a leaning toward building and creating things, but my studies at Mercer, especially in the area of product development, really drove home the fact that I wanted to pursue a career in medical device design and development,” he recalls.
“Mercer prepared me so well to move ahead. Once I had that foundational knowledge in science and engineering, I was intent on going into industry to design devices that could be used in actual clinical settings and make a difference in healthcare.”