Test tenacity drives neurostimulator success
Test Engineer of the Year Eddie Abshire drove the firmware-verification to system-level-test effort that brought St. Jude Medical’s Eon Mini device to market.
By Rick Nelson, Editor in Chief -- Test & Measurement World, 4/1/2009 2:00:00 AM
 In our October 2008 issue, we profiled the accomplishments of six outstanding test engineers from various industries, and we asked our readers to vote for the Test Engineer of the Year. Your choice? Eddie Abshire of St. Jude Medical. As part of his award, Abshire will designate an engineering or science program to receive a $10,000 grant, courtesy of award sponsor National Instruments. Photo by Jensen Walker, Getty Images. See also: T&MW Awards Program 2009 Test Engineer of the Year finalists 2009 Best in Test, Test Product of the Year, and Test of Time winners Read more on neurostimulation, including a time line of pain-treatment methods, profiles of patients who have benefited from neurostimulator devices, and video demonstrations. Read other articles from our April 2009 issue. |
PLANO, TX—Chronic pain sufferers may soon find relief, thanks to advances undertaken by the St. Jude Medical Neuromodulation Division. Those who benefit from the company’s latest product—the Eon Mini device—will owe a portion of their gratitude to Eddie Abshire, who brought to the project his skills in testing embedded software and hardware as well as his tenacity in identifying and solving system problems. Because of his accomplishments, Abshire was nominated for the 2009 Test Engineer of the Year award and was voted as the winner by the readers of Test & Measurement World.
The Eon Mini is a rechargeable spinal-cord stimulator that treats chronic pain of the trunk and limbs as well as pain from failed back surgery. The device is typically implanted above the buttock area and sends mild electrical pulses to percutaneous leads or surgically implanted paddle leads located near the spinal cord. These pulses interrupt the pain signals as they travel to the brain. Slightly larger than a silver dollar, the device is less obtrusive and more comfortable for patients and requires a smaller incision than earlier, larger models. In April 2008, St. Jude Medical announced that the device had received US FDA (Food and Drug Administration) and European CE Mark approvals. In February 2009, the company announced Australian TGA (Therapeutic Goods Administration) approval of the device.
As a senior test engineer in the Neuromodulation Division’s system-integration group, Abshire, whose 21-year career includes work in missile systems for Texas Instruments, helped St. Jude Medical verify the low-level firmware and electrical circuitry of the Eon Mini early in the project, and he worked closely with other engineers to characterize the functionality of the implantable device and to uncover potential problem areas. He then leveraged this knowledge to develop system-level tests to ensure correct functionality between the implant, the portable charger system, the programming software, and the controller a patient uses to adjust the stimulation program throughout the day. Finally, he provided support that helped guide the device through the approval process.
Evolution of pain treatment
Rohan Hoare, VP of R&D at St. Jude Medical Neuromodulation Division, described the background that led to the development of the Eon Mini. “Neuromodulation was born out of a 2000-year-old idea of treating pain with electrical stimulation.” An early proponent of such treatment was Scribonius Largus, a Roman physician who used torpedo fish for treatment of headaches and gout and described his efforts in his Compositiones Medicae in ad 46.
 The Eon Mini neurostimulator is approved to treat chronic pain of the trunk and limbs and pain from failed back surgery. Courtesy of St. Jude Medical. |
But the technology has come a long way in 2000 years, and the path that led to the development of the Eon Mini, said Hoare, began 40 years ago with the development of the first modern neurostimulator. Since that time, he said, neuromodulation has blossomed into a multibillion-dollar business. He added, “In the nearly 30 years our Neuromodulation Division has been in the business, the technology has evolved to provide a variety of patient treatment options and to give physicians more control over procedures and outcomes.” The technology not only treats pain through spinal-cord stimulation, but St. Jude Medical also has clinical studies underway in the US for deep brain stimulation to treat conditions including Parkinson’s disease and essential tremor and depression. Treatment for chronic migraine sufferers is now undergoing clinical studies.
“One of the most appealing and motivating factors for us is that as we continue to drive technology forward, we improve patient care and improve the physicians’ ability to use the devices,” Hoare said.
Ben Tranchina, VP of product development, described Abshire’s role in the evolution of St. Jude Medical’s neuromodulation products. “Eddie is involved early on in terms of helping to define the system and bring to it his knowledge of legacy devices,” said Tranchina. “He actively participates in the design process as well as the later verification and validation phases.” When asked if that makes Abshire a design engineer with test responsibilities rather than a member of a dedicated test group, Tranchina explained, “He is a true test engineer, but we found it’s important to have his involvement early on as part of a cross-functional team. Having team members with experience in multiple disciplines enables us to be more proficient in delivering a quality product.”
 The Eon Mini device is typically implanted above the buttock area and sends mild electrical pulses to leads located near the spinal cord. These pulses interrupt the pain signals as they travel to the brain. Courtesy of St. Jude Medical. |
Abshire’s responsibilities include supporting early device characterization as well as final system verification, which may involve testing prototypes in saline solutions. Although he’s not part of the team that builds automated test equipment for manufacturing test, he advises that group as well, Tranchina said.
Said Hoare, “Fundamentally, Eddie plays a bookend role—up front, making sure specifications are set appropriately, and at the back end, making sure we have achieved what we set out to achieve.”
Thanks comes at the end
Abshire is happy to play the bookend role, despite some reservations. Test at times can seem to be a pretty thankless job, he said, adding, “You work behind the scenes, and you report problems when everybody else wants the project to be moving along.” But the effort is ultimately worth it. “The entire team thanks you at the end when the product is successful,” he said.
Abshire’s technical career had its roots in courses he took at what was then the University of Southwest Louisiana, but, he said, family issues prompted him to suspend his studies and make money working in the oil industry. But after four or five years, he said, “I went running back to school—I wanted to get as far away from the Gulf of Mexico as possible”—except for the occasional fishing trip.
Abshire then completed an associate’s degree and immediately got recruited by Texas Instruments. “I came to Dallas in about 1987 and started working for TI in defense programs—in particular, missile systems.” In about 10 years at TI, he said, “I got a lot of experience as far as troubleshooting and testing systems—anywhere from board level and component level up to system level.”
 Ben Tranchina, VP of product development, described Abshire’s role in the evolution of St. Jude Medical’s neuromodulation products: “He actively participates in the design process as well as the later verification and validation phases.” Photo by Jensen Walker, Getty Images. |
“TI,” he added, is often said to stand for “training institute,” and he said he took full advantage, learning a lot about test at TI that he never would have been exposed to in a classroom setting. “It was good on-the-job training, and I rely on that experience in what I’m doing today,” he said. Not that he sells classroom training short—he has continued to accumulate college credits through educational programs at TI and St. Jude Medical, but he commented that test is not an issue formally addressed by most college programs.
Military to medical
Abshire’s work in defense coincided with the Gulf War, and he said, “We got to speak with a lot of military personnel who thanked us for building an effective system so that they were able to come home and see their families.” That, he said, reinforced his motivation to “get these systems right and make them effective so our guys come home.”
With the wind-down of the Gulf War, employment prospects in defense industries became more tenuous, although Abshire expressed the view that test remains a good field for job security: “It’s a good niche, because not a lot of people are willing and able to do it.” As for his own willingness, he said, “I really can’t explain why, but test fits me.”
In any event, Abshire was ready for a change and moved from defense to the medical industry, which, he said, shares a similar test philosophy. Both industries, he said, are regulated, with test requirements spelled out. In commercial applications, he noted, companies can go through the motion of testing or make a business decision to eliminate test altogether. That’s not possible in military and medical applications.
 Rob Egemo, system-integration and test manager, shared a defense background with Abshire: “We both apply the same structure and discipline toward medical products that we applied to defense projects.” Photo by Jensen Walker, Getty Images. |
Coincidentally, Abshire’s immediate manager, Rob Egemo, shared a TI background with Abshire. “Eddie and I worked in the same building but didn’t know each other then. I had a similar test background, working on military programs. I was an integration and test engineer back then, which served me well in becoming system-integration and test manager at St. Jude Medical.”
Abshire, too, said he found that his defense experience carried over into the medical applications he works with now. “It’s just as important to make sure that these systems are safe and that the patients enjoy a good quality of life. My approach with test is to make a system the best that it can be, whether for a military purpose or a medical purpose—both are just as important.”
Added Egemo, “As Eddie said, we both apply the same structure and discipline toward medical products that we applied to defense projects. I’ve appreciated having Eddie work for me. He works well with the software folks, with the hardware engineers, and with the marketing folks, and he understands how the product is supposed to work and can figure out the details of how it’s actually working.”
Serving patients
Abshire’s emphasis on test goes well beyond the minimum necessary for regulatory compliance: “You are at your most vulnerable when you are sick and go to a doctor to ask for help. What if the doctor implanted a device in you that would make you worse? I’d be ashamed to be a part of something like that.”
 Rohan Hoare, VP of R&D, said, “Fundamentally, Eddie plays a bookend role—up front, making sure specifications are set appropriately, and at the back end, making sure we have achieved what we set out to achieve.” Photo by Jensen Walker, Getty Images. |
As for quality, he continued, “We really take it seriously, and that comes down from Chris [Neuromodulation Division president Chris Chavez] and Rohan [Hoare, the VP of R&D]. They put a lot of trust in guys like us to make sure that the product is right. Of course we have schedules and budgets, but we’re determined to get the product right, whatever it takes.”
Hoare elaborated on the division’s focus on quality: “Clearly everything we do impacts patients. We are always striving for the utmost quality. These devices are being used to treat people, and we have to be cognizant of that in everything we do with regard to design, manufacture, and test. You asked about a dedicated test group—one reason we have that is so we can ensure that we have the highest quality products we possibly can coming out of this organization.”
VP of product development Tranchina added, “We believe, as Rohan said, in having the patient in the forefront when we are thinking about these products and understanding where they are going to be used. What value is it going to bring in terms of quality of life? We make an effort to both educate all of our teams, either through bringing in patients who have received therapy and having them speak, or having our employees travel along with some of our field representatives and see firsthand the good that the product is bringing to these patients—they are really changing their quality of life.”
Abshire said he has not worked directly with patients, but Egemo said he values Abshire as a resource when problems arise. “Eddie has indirectly supported me and some of the other engineers when we have some technical issue or question” when dealing with patients who aren’t responding as expected to the therapy. “I might fly out and meet with a field rep and doctor to figure out what the solution is.”
Said Abshire, “We are dealing with human bodies, and we have a solution that is going to fit pretty well across most normal demographics, but there are always going to be variations that will cause a specific problem with some person.” Egemo explained, “The problem could be physiological, a lead could have moved, the program might not be optimized, or it could be related to changes in a patient’s pain pattern. There are a lot of variables. It can be challenging, but Eddie is always there as a resource to help me brainstorm what could be going on and help get to the bottom of what helps each patient.”
Abshire concluded that although he’s worked on a variety of defense and medical systems and devices, he’s looking forward to extending his nearly four-year stint at St. Jude Medical. “I hope to work for this company as long as I can, because I really believe in the product, I believe in everything the company stands for, and the future looks very bright for us.”
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