Manufacturing medical devices is no easy task. The complexity of the human body–not to mention stringent standards imposed by the FDA and other regulatory agencies—dictates the need for streamlined internal processes to ensure every device meets regulatory requirements.
Exactech is an orthopedic medical device company that develops, manufactures, markets, distributes, and sells orthopedic implant devices, related surgical instrumentation, and biologic services to hospitals and physicians in the United States and internationally. The company has an active clinical research department that develops and manages multiple clinical studies at any given time. Most studies are multi-center, some are pre- or post-market regulated studies (i.e., IDE, PAS, and 522 PMS Studies), but a majority are post-approval, observational studies involving products developed by Exactech.
Exactech needed an EDC system that met the stringent requirements of 21 CFR Part 11, in which systems must maintain an accurate audit trail, among other regulations.
“We needed a system that would meet Part 11 regulations; for example the ability to track changes through an audit trail and the capability for appropriate electronic signatures,” said Matt Christensen, Manager of the Clinical Affairs Department at Exactech. “As we began researching new EDC systems, we found that many systems offer these functions, but we also found that not all systems are created equal.”
One process where Exactech felt new technology could offer greater assistance was in the method of data capture. Previously, research data had been collected on paper and scanned into the EDC system, which utilized character recognition software. This method called for visual verification of individual data characters.
“We were interested in finding a system that would provide reliable data with a much less cumbersome process for entering and managing the data,” said Christensen. “With our prior EDC system, productivity was often very low due to the extra time required by our staff in data entry and verification. This limited our department’s ability to increase capacity in line with the speed at which Exactech was growing. We needed a system that would allow us to focus on monitoring the data and working with our sites to ensure the success of our studies.” As Exactech began their search for a new EDC system, ease of use, flexibility, and increased productivity also topped their list of requirements.
“Since many of our studies are post-market, we needed a flexible, yet robust system that did not require having a programming background to use,” said Christensen. “In order to keep costs down, our post-market studies require a flexible system that we can manage in-house, from study set-up through electronic case report forms development, data monitoring, and data processing stages. We don’t have the time or budget to both develop and manage a homegrown or complex EDC system. We needed an easy-to-use system that was capable of capturing data quickly and accurately.”
Christensen said budget was also a consideration in ensuring the new system would be cost-effective, while meeting the needs of a mid-sized company like Exactech. “There were also financial considerations,” continued Christensen. “We found several systems that cost upwards of seven-figures for a single study that could not meet all of our needs. Working closely with our company’s information systems team and others in leadership, we were able to determine the true cost of each application, and whether it would deliver a positive return on our investment.”
The Exactech team began its evaluation of several systems. “It came down to a handful of vendors, and in our final evaluation, we found that StudyManager’s Evolve system met all of our needs more closely than any of the others, while maintaining a very competitive price,” said Christensen.
Since implementing Evolve, Christensen says, “The quality of data we receive is a benefit–we now are more confident that our data is pure and that it was not accidentally modified since Evolve only allows study sites to make data corrections and keeps track of those through its audit trail feature. This is not only a critical component in meeting the Part 11 requirements, but it also gives our internal and external stakeholders higher confidence in the data.”
Post-market studies require a high degree of flexibility. According to Christensen, the system meets Exactech’s changing needs, which includes the ability to change and modify forms in a controlled manner that will still fall within regulatory guidelines. “We needed a system that we could manage ourselves, allowing us to be in line with how things are done within the medical device industry,” said Christensen. “The system gives us this control, yet is flexible enough to allow us to make modifications as needed, while still maintaining appropriate regulatory compliance.”
With the previous EDC system and the labor-intensive data verification that had been required, it was difficult for Exactech to run multiple studies without adding many additional personnel to its clinical affairs department. However, Christensen says Evolve has helped streamline processes, allowing Exactech to conduct multiple studies more easily, with fewer personnel than would have otherwise been required.
Exactech has implemented Evolve in four studies to date, three post-market arthroplasty studies and an additional one currently in development within Evolve.
“Evolve is meeting the needs of our research sites as an easy-to-use data entry tool,” said Christensen. “Now that we’ve been using the system for a while, we need very little technical support from StudyManager’s professional services team and our sites have seldom required our assistance once we conduct an initial training.”
—Jeffrey K. West, Director, Professional Services, Sponsor/CRO Solutions, StudyManager