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June 1, 2007
5 Min Read
OUTSTANDING QUALITY AND REGULATORY TEAMS
Try building a quality system and regulatory affairs structure virtually from scratch. At the same time, throw in a clinical trial and an inexperienced staff that needs extensive training. Despite what seems like an impossible task, the regulatory and quality team at Stereotaxis Inc. (St. Louis) was able to overcome these obstacles and lead the company to commercial success.
What was the key? Getting FDA to understand the firm's technology quickly. Once that happened, Stereotaxis could be aggressive in its regulatory approach and confident in its quality strategy.
The trek began in 1998, when Peter Takes joined Stereotaxis to direct regulatory affairs. Although the start-up company had been around since 1990, Takes's hiring marked the beginning of the quality and regulatory department.
Stereotaxis was getting ready for an aggressive push on its first clinical trial involving a prototype magnetic system for neurological biopsy. Up until that point, the company had been working on experimental devices. It received an investigational device exemption and needed someone to step in and establish a quality and regulatory system.
“When I first came into the company, the biggest challenge was that most employees didn't have medical device experience, so they didn't fully understand the requirements and how to approach a clinical trial, [which included] setting up a quality system to support the trial,” says Takes, PhD, senior director of clinical and healthcare compliance. He was faced with educating the 12-person staff and finding the right people who could complete the trial.
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“Most of the people on our team had never dealt with this type of product before, so it involved a learning process,” says Takes. “To establish the proper regulatory process, you first must understand the technology. We had to train ourselves on the technology, learn the scientific and clinical aspects, and then transfer [that knowledge] to a regulatory perspective.” Takes was fortunate enough to have management support and a staff that was receptive to learning.
Takes credits the team members' success to mutual respect and a lack of egos in the department. After they learned about the technology and how it worked, they needed to move forward and engage in a significant amount of communication with FDA.
“The initial introduction of the technology to FDA and other regulatory agencies around the world was an interesting challenge,” says Melissa Walker, senior vice president of regulatory, quality, and compliance. “[At the time], the only other magnetic device was an MRI, which is a significantly different use of magnetics.” She adds that there's still a unique educational process each time the company expands the application of its magnetic system, because it sometimes involves a new reviewer from FDA.
The initial process involved carefully written submissions and a number of face-to-face meetings with the agency. During the discussions, the team explained the technology's approach, which had evolved into a method of controlling devices for cardiac catheterization.
The team had in-person meetings with FDA about once a year and engaged in a series of conference calls. It also took the same educational approach when it began introducing the technology in Canada, Europe, China, and Japan.
The company's first large clinical trial, which led to its first commercial device, involved a magnetic system and catheter that mapped the electrophysiology in the heart. The FDA-approved device was called the Telstar magnetic navigation system with the Telstar imaging system and electrophysiology catheter.
As the quality and regulatory department has grown, Walker credits its success to good communication and the team's open-minded attitude. “As the head of the group, it always amazes me to get a group of people who mesh like this,” she says. The team has worked together to learn each other's responsibilities, so there's never a gap or delay in moving procedures forward.
The department also promotes professional development. “Part of maintaining quality employees is maintaining their professional development,” says Takes. “We encourage people to pursue professional certifications, because that encourages them in their job. It's vitally important.” Each member of the department also is expected to attend at least one professional education event per year. About half of the department has one or more certifications.
Takes characterizes the team as a family. Most of its current members have been together for at least six years. When the company hires new people, it strives to balance the team's talents not only from an intellectual, regulatory, and quality perspective, but also mentally and socially.
“If I had to sum up our approach as a department, I would say that quality and compliance practices beget quality products,” says Takes. “Everyone has confidence in everyone else, and that's very important for the cohesiveness of this department.”
The Stereotaxis Team
Jim Awerkamp, quality assurance manager; radiation safety officer
Mark Bubalo, quality engineer
Robert Callahan, director, corporate quality
Barbara Clarke, quality engineer
Todd DeBaker, director, quality system, MN
Brian Edwards, director, regulatory affairs, MN
Barb Karolevitz, quality assurance associate and document supervisor, MN
Jaime Kirsch, quality assurance analyst
Mabel Michel, executive administrative assistant
Rhonda Morgan, document control coordinator
Dennis Pozzo, senior regulatory affairs specialist
Gary Rauvola, director, regulatory affairs
Kelly Rowland, regulatory affairs specialist
Peter Takes, senior director, clinical and healthcare compliance; clinical compliance officer
Melissa Walker, senior vice president, regulatory, quality, and compliance; corporate compliance officer
Copyright ©2007 Medical Device & Diagnostic Industry
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