OUTSTANDING QUALITY AND REGULATORY TEAMS
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The road to success for a small medical device company is beset by challenges on all sides. Staying on FDA's good side, knowing what and where to outsource, and fending off larger competitors are just a few of the hurdles such a company has to overcome. But thanks to its tireless quality and regulatory teams, AtriCure Inc. (Cincinnati) has thrived in its niche of tissue ablation products.
The regulatory team, headed by Elsa Abruzzo, is involved early on in the product development process. In theory, regulatory teams at all medical device companies can make that claim. But Abruzzo insists that her team's involvement is not the type of “superficial and perfunctory” contribution made simply to comply with design review regulations. Instead, the regulatory team forms a partnership with the project's engineering team.
“Although problems should be identified as early as possible, a good rule of thumb is to never present problems without providing potential solutions, or at least offering to help find the answers,” Abruzzo says.
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Top row: Madonna Katenkamp and Rebecca Robbins. Bottom row: Cheryl Kulesza, Elsa Abruzzo, and Alison Grimaldi.
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Of course, AtriCure's regulatory team wears the requisite hats: It helps develop regulatory and clinical strategies. It helps guide the project teams through preclinical submission testing phases. And it works on clinical studies, FDA reviews, and international product registrations.
Abruzzo believes that by serving a particular medical area, certain companies are easier to track and “are constantly under the magnifying glass.” Indeed, AtriCure's regulatory team has dealt with its share of problems. In 2005, the company was issued a not substantially equivalent (NSE) decision on a 510(k) for one of its expanded product lines. The company appealed and had a supervisory review meeting to present its case. With the help of some key surgeons and electrophysiologists, AtriCure offered solid evidence that FDA had cleared similar devices—so solid that FDA changed its mind.
“FDA overturned its NSE decision, which is rare, and has allowed us to present clinical data from prospective studies demonstrating the safety and efficacy of our product in support of the original 510(k),” Abruzzo says. The project is still pending FDA review.
“Having a successful regulatory strategy is the key to AtriCure's success,” says Mary Beth Privitera, a consultant who has worked with both the quality and the regulatory teams to ensure that the company's products meet user requirements of human factors standards. “This includes an understanding of FDA's current thinking, keeping track of competitors, and thinking creatively when selecting predicate devices for 510(k) submissions.”
But the quality and regulatory teams do more than focus on AtriCure's products—they are involved in outreach as well. Privitera, who is also a professor at the University of Cincinnati, works with the teams in a unique cooperative education program. AtriCure selects a handful of the university's biomedical engineering students to work with the company in product development, regulatory, and quality areas. Several of the students have been hired after graduation, and another is set to join them this year. Abruzzo has also come to
Privitera's classes to help students gain a real-world understanding of the regulatory aspects of the development process.
The regulatory team prides itself on a relaxed atmosphere despite the daunting work it faces. “The hours are long, the projects are challenging, and the deadlines are aggressive. But we try to work smart and have as much fun as we can,” Abruzzo says.
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Top row: Anupam Bedi, Mike Broadhurst, Kevin Engemann, Cindy Cory, David Gibson, Joe Hoffman, Sherry Gilman, and Jim Lucky. Bottom row: Lisa McCord, Shelia Reynolds, and Michelle Donato.
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The quality team, led by Jim Lucky, often evaluates past practices to make the next project or process better. That evaluation may translate into new methods of document control, complaint and report handling, or the incorporation of misuse and overstress environments into product testing.
“The culture in the quality group is cooperative, supportive, and exciting. We enjoy a challenge. It is rewarding to witness the [team members'] unselfish attitudes as they shift their focus to assist each other,” Lucky says.
Most members of the quality team have engineering backgrounds. As a result, they have easily coalesced and contributed to the project teams. Having been at larger medical device companies with mature quality systems hasn't hurt either.
“Building a quality system for a small or midsized company can be challenging. This type of foundation helps many of us envision where we need the company to develop,” Lucky notes.
The company believes that one of its strengths is getting high-quality, ergonomic products to the market before its competitors. AtriCure's quality team is involved from the beginning to develop the strategy for getting products developed, verified, validated, and manufactured. One persistent challenge for many quality teams is maintaining a high energy level and avoiding burnout, but AtriCure's quality team has developed some strategies.
First, the quality engineers have the flexibility to work on projects in which they have an interest. The group also overhauled what Lucky calls the “start-up company quality system” and transformed it into a comprehensive system that was mindful of long-term goals.
“We all realized that the existing quality system foundation would not support our long-term growth initiatives,” Lucky explains. “We first identified and prioritized the systems, procedures, and processes that required updating and compared them with our company goals. Balancing FDA, ISO, and company requirements enabled us to develop a plan that supported product development and our continuous improvement activities.”
And not all help comes from within. AtriCure's teams have consulted with third-party reviewers, notified bodies, international regulatory agencies, and FDA for guidance on projects.
“[FDA reviewers] have been a good resource for us, but they are often untapped by others. It is important to know your products, data, quality systems, and submissions inside and out,” Lucky says.
The AtriCure teams understand each other's roles within the company. They anticipate potential problems and rectify them before product launches are affected. They maintain transparency with FDA and other regulatory bodies. AtriCure's quality and regulatory teams work hard and work smart.
The Atricure Team
Regulatory
- Elsa Abruzzo, vice president, regulatory and clinical affairs
- Alison Grimaldi, clinical research and regulatory engineer
- Madonna Katenkamp, director, clinical operations
- Cheryl Kulesza, clinical programs coordinator and clinical research associate
- Renee Palmer, director, clinical research
- Rebecca Robbins, clinical research and regulatory engineer
- David Sabine, clinical education specialist
Quality
- Anupam Bedi, senior quality engineer
- Mike Broadhurst, senior quality engineer
- Cindy Cory, document control coordinator
- Michelle Donato, quality engineer
- Kevin Engemann, quality engineer
- David Gibson, quality assurance inspector
- Sherry Gilman, quality assurance inspector
- Joe Hoffman, quality technician
- Deborah Langfritz, quality assurance inspector
- Jim Lucky, vice president, quality assurance and healthcare compliance
- Lisa McCord, biological services manager
- Shelia Reynolds, quality assurance inspector
- Emily Thomas, manager, document control
- Tamala Wampler, project manager, quality assurance
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