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Two researchers of the Cardiovascular Pathology Lab at work.
Biomedical engineering students evaluate medical devices in the Cardiovascular Pathology Lab at Texas A&M University. The relationship between the lab and the department has led to the approval of numerous lifesaving medical devices. | Image: Texas A&M Engineering

Life-changing medical devices that impact people around the world are being designed, created and tested at Texas A&M University. The collaboration between the Department of Biomedical Engineering and the Cardiovascular Pathology (CVP) Laboratory is proving that an interdisciplinary approach improves patients’ lives and reduces medical device development time by pairing device creators and evaluators together on one campus.

Researchers in the biomedical engineering department work daily to solve complex medical issues by translating ideas into medical devices. As engineers, they design and build these lifesaving devices. However, before a device can enter the commercial market, it must be evaluated to ensure that it is safe and effective. This evaluation, done by the CVP Lab, is a vital step in the process.

The CVP Lab, part of the Texas A&M School of Veterinary Medicine and Biomedical Sciences, has the goal of providing innovative and objective pathology support to improve medical devices and patients’ lives. The partnership between the CVP Lab and the biomedical engineering department has existed for the last decade and has produced numerous life-changing devices.

“Our lab’s goal is to answer the question of is a device safe and effective?” said Dr. Fred Clubb, CVP Lab director and pathologist. “My whole career in medicine has been with devices. When I arrived at Texas A&M, I quickly linked up with the biomedical engineering department so that we could work together to bring new devices to the market.”

Researchers in the CVP Lab use both imaging and histological studies to evaluate the safety and effectiveness of the devices. In doing this, they look at how the device impacts the body on a cellular and system level.

“We use several imaging modalities to evaluate the device-tissue interface,” said Dr. Staci Horn, research assistant professor in the biomedical engineering department and CVP Lab manager. “It’s important to have biomedical engineers involved because the engineering perspective can enhance our pathology evaluation techniques. Our biomedical engineers design and create unique imaging mounts for each specimen during micro-CT scanning. During the histological evaluation, we look at the cellular impact of the device. Biomedical engineers are also involved in designing the appropriate embedding techniques so that we can best understand how the device impacts the body on the cellular level.” 

Translating research into life-changing devices

When a biomedical engineering faculty member develops a new device, they can take it to the CVP Lab for evaluation before commercialization. Dr. Duncan J. Maitland, Stewart and Stevenson Professor I in the biomedical engineering department, worked with the CVP Lab to evaluate the safety and effectiveness of his occlusion devices.

“Part of the reason I moved to Texas A&M in 2008 was because the infrastructure allowed me to make an impact through commercializing devices,” Maitland said. “The department and university leadership are supportive of making an impact through translation.”

Maitland’s company, Shape Memory Medical, was born out of his research in occlusion devices. The devices are noninvasively implanted into the cardiovascular system and expand to restrict blood flow. They are often used to reduce bleeding during surgery and to treat abdominal aortic aneurysms. The CVP Lab evaluated Maitland’s devices before he officially launched them in the market.

“Clubb’s team had the expertise to analyze the safety and effectiveness of the biodegradable device after it was implanted,” Maitland said. “His lab’s study quantified how my implants resulted in better healing than previous implants.”

Before a tested device can enter the market, it must be cleared by federal regulatory agencies. The CVP Lab’s research also assists device creators in receiving agency approval.

“The CVP Lab looks at the safety and efficiency of the devices in a way that gives regulatory agencies confidence that the device won’t cause unseen issues in the body,” Maitland said. “Dr. Clubb even went to the FDA with us to explain why our device was better than current technology.”

Without this collaborative effort between the CVP Lab and the department, patients’ lives are at risk. The partnership allows researchers to save lives by bringing more devices that are safe and effective to the market.

Translating knowledge from biology to engineering

The relationship between the department and the CVP Lab also benefits students. Many undergraduate and graduate students in the department work in the CVP Lab, conducting research and evaluating devices. 

“One thing that is unique about our lab is that it is almost completely student-run,” Clubb said. “Numerous biomedical engineering students work in our lab and are an integral part of our success.”

In the lab, students not only learn the technical skills of device evaluation, but also gain transferrable skills that prepare them to enter the workforce or pursue an advanced degree.

“My work in the lab has taught me a multitude of real-world skills,” said Matthew Bone, a senior biomedical engineering student. “I’ve learned everything from problem-solving to effective communication and critical thinking. My work at CVP has reinforced my decision to work in the medical device industry.”

As part of the relationship between the biomedical engineering department and the CVP Lab, Clubb and Horn also co-teach two graduate-level biomedical engineering courses that focus on medical device pathology. Clubb, whose background is in human pathology and medicine, teaches the pathobiology perspective, while Horn, whose background is in engineering, teaches the medical device perspective.

“It’s a really good interface course because students are presented with both the engineering and pathobiology perspective,” Clubb said. “It gives students a great step up because they see how devices impact a body at the cellular and system level.”

The two-course series teaches students foundational knowledge about pathology in the first semester and focuses on the body’s systems and how devices impact those systems in the second semester.

“The class challenges students to think about the biological aspects of the body when they design a medical device,” Horn said. “As future engineers, they will be able to design devices more effectively because they understand the biological impacts.”

The partnership between the Department of Biomedical Engineering and the CVP Lab has proven to be successful in both translating research into commercial medical devices and translating knowledge to students. Through this synergistic approach, the department will continue to develop lifesaving technologies and industry-ready students.