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Medical device students become part of clinical 'team'

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CMTI students such as Shwe Pyie and Martin Gitomer, at right, spend much of July and August in operating rooms and other clinical settings, learning firsthand from physicians such as Dr. Spencer Rosero, shown here in the cardiac electrophysiology laboratory (EP LAB) procedure room.  "It is similar to an 'OR,' but is installed with cutting edge electronic/software equipment," Rosero explains.  "We perform various procedures in this EP lab —for example, implantation of defibrillators, pacemakers, and cardiac resynchronization devices, and also perform electrophysiology studies and ablations for heart rhythm disturbances.  The screen shows the 3 dimensional maps of the heart created with special electrical catheters inserted through veins. The catheters  annotate the coordinates of the inside surface of the heart.  Once this is done, we begin to  measure the voltage and  timing  of heart beats and display them in 3D.   We then use catheters to deliver Radiofrequency energy to 'cut or burn' the abnormal circuits."

If you’re a student interested in working in the medical device industry, wouldn’t it be advantageous to experience firsthand what happens in an operating room and other clinical settings –to find out what physicians, anesthesiologists and nurses really need?

That’s what nine master’s students in the University of Rochester’s Center for Medical Technology and Innovation program are doing this summer.

Three days each week during July and August the students, working in teams of two or three, take a short, three-minute walk from the River Campus to the University of Rochester Medical Center to literally look over the shoulders of doctors and the medical-surgical team members as they conduct heart transplants and spinal and reconstructive surgeries. They witness first hand, high-tech 3D mapping and targeting of potentially life-threatening heart rhythms, and implantation of pacemakers and cardiac resynchronization devices that also provide wireless monitoring capabilities.

“The surgeries they are seeing this year are phenomenal,” said Greg Gdowski, Executive Director of the program.

Andrew Zeccola, for example, was intrigued to see a left ventricle assist device on a heart removed during a transplant operation.  “We learned about that (device) in class, and to see it in that kind of setting was pretty awesome.”

Erica Marron and her teammate have been observing an orthopedic team doing spinal procedures. “Our clinician has been really good about calling us over at a crucial point in the procedure to let us look over them at what they are doing, or stand on a stool at the head of the table.”

Equally important has been the opportunity for these students to hear directly from members of the medical teams what they like – and don’t like – about the tools they are using.

“We found out that a lot of things are currently on the market to solve a problem, but they could be improved,” Marron said.  “They’re not an optimal solution.”

 An edge with employers 

This intensive immersion in clinical settings is a key feature of the Rochester program, which is geared specifically to preparing engineering students for careers in the medical device and related industries. The experience in clinical settings gives the students ideas for the devices they will design and prototype for their capstone projects. It also gives them an important edge with employers when they look for jobs, said Gdowski.

And, with few exceptions, they have jobs waiting for them when they graduate – good jobs, Gdowski emphasized.  CMTI graduates have been hired by big national and international medical device companies, such as Smith and Nephew, DePuy Synthes, and Biotronik. By respected regional companies such as Transonic and Micropen. And also by the federal Food and Drug Administration, which regulates and approves the devices these companies make.

“In most cases the jobs are paying starting salaries of $50,000 to $65,000,” Gdowski said.

Spencer Klubben, a 2014 graduate of the program, now works as a medical optics application engineer for Corning Inc.  “Since I am the initial technical point of contact for our existing and future customers, the clinical experience I gained through the CMTI program has immeasurably helped me discuss, discover, and relate to the most pressing clinical needs Corning's technologies are most apt to solve.”

“It’s fascinating to watch the growth that occurs between when the students arrive to when they graduate less than a year later,” said Judy Principe, CMTI program director. "The program helps the students build the skills and confidence necessary for their success in either industry or medicine. They learn how to work as a team despite diverse personalities—an important attribute in the workplace."

 An array of skills         

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Erica Marron takes a turn at a Smithy 3-in-1 machine in the fabrication shop at Rettner Hall, as CMTI students are exposed to the basics of a machine shop. Jim Alkins, the Senior Laboratory Engineer, provides instruction.

“I told this year’s incoming students it will be a busy summer for them,” Gdowski said. He might as well have added the rest of the seasons.

By the time the students graduate next spring they’ll also:

  • Receive hands-on training in 3d printing, machine shop, basics of electronic design, solid works and additive manufacturing.
  • Learn about navigating the regulatory process and intellectual property issues.
  • Take a course on technical entrepreneurship.
  • Serve as mentors for biomedical engineering seniors working on their own capstone projects.
  • Visit medical device companies.

 “The ability of the program to supply us with such diverse skills in a short period of time is what makes the CMTI program unique and a great experience,’ said Mohammad Musleh ’14 who now works as a development engineer at Bausch + Lomb  -- and credits the CMTI program as “a very large reason for the opportunity.”

Another 2014 graduate, Matt Crilley, said the program “does a great job of familiarizing students with the entire scope of medical device development . . .  which makes transitioning into industry easier because you've already learned the basics and only have to adjust to the specific details of your company's procedures and product line once you are hired."

Crilley is a quality engineer at Martech Medical Products.

CMTI Academic Director Amy Lerner agreed that one of the most beneficial aspects of the program is the variety of activities and hands-on experience within the training process. 

"Students will develop their hands-on skill, refine their engineering knowledge, attend cutting-edge biomedical research seminars, learn about the business aspects of the medical device industry and enhance their project management experience,” Lerner said. "Because the students are actively involved in the needs-finding process, we have to be ready for anything, and the variety in their training helps us all stay flexible and ready for the next great innovation!"

 Ready to grow

 The CMTI program is now in its fifth year, and Gdowski is eager to increase the enrollment to 20, even 30 students.

“The more students we have, the more teams we can have. They could be larger and more multidisciplinary. Businesses would be more likely to become involved in sponsoring teams. And we would be able to work with more clinicians at the Medical Center,” he said. “That’s one of our biggest challenges. We have more requests from the medical center than we can actually support.”

Gdowski plans to expand recruiting efforts beyond biomedical engineering students to all branches of engineering.  “We feel we can provide the biology background (for students not coming out of biomedical engineering),” he noted.

A big part of his recruiting pitch is the close proximity of Goergen Hall on the University’s River Campus -- where the students take many of their classes -- and the Medical Center, where they work with clinicians. Gdowski has measured the distance precisely: a mere 981 feet.

That’s a huge selling point over other programs, where students may be driving back and forth from a University to a medical center a half hour or more away, he said.

“It’s less than a 5-minute walk,” Gdowski said. “That means that if they have time between classes, there may be time to walk over to the medical center and interview a surgeon or visit the operating room."

Rosero joins the team

Spencer Rosero, Assoc. Prof. of Medicine and Director of Cardiology Clinical Research at the University of Rochester Medical Center, has joined the Center for Medical Technology and Innovation as Clinical Director. He is also CMO for Efferent Labs, which won $500,000 in last year’s 43North business competition. Rosero and his team created the technology for the company’s implantable biosensor platform that will provide physicians and patients with real time health data to help guide therapy.

He joins CMTI Executive Director Greg Gdowski, an Associate Professor of Biomedical Engineering, and Academic Director Amy Lerner, also an Associate Professor of Biomedical Engineering.