After acquiring a product from Stryker, the experienced team of medical device professionals at Critical Care Diagnostics (C2DX) Inc. knew they had to ensure four things to be successful:
- Establish a quality-first approach to the company’s culture
- Complete the acquisition and continue delivering a high-quality device
- Quickly implement an electronic quality management system that could act as a foundation for both their initial needs and future growth
- Provide the same customer experience customers had grown to expect from Stryker
Putting Quality First
After previously starting and operating two medical devices companies, Kevin McLeod, CEO of C2DX Inc., came across the opportunity to acquire a product used for diagnosing Compartment Syndrome—known as the STIC Intra-Compartmental Pressure Monitor System. This device has been used for over 30 years and has clinical data supporting why it is the gold standard tool used by physicians to promptly diagnose and monitor compartmental pressure in patients.
The team at C2DX values quality and views it as the backbone of their organization. They know quality is about more than just product quality and it touches everything in the business. As a result, the company started with a solid quality system. To ensure customer satisfaction and deliver a gold standard product, C2DX prioritized quality first when starting the company.
Identifying the Need for a Digital Quality Solution
Knowing quality is the backbone of a medical device company, the team at C2DX was determined to find a quality solution that would create a solid foundation for their company.
Amy Papranec, VP of operations, came to C2DX after her 27 years at Stryker and work as an executive mentor at MATTER, a healthcare incubator in Chicago. In her prior role with MATTER, she witnessed early-stage medical device companies adopt manual processes, limiting them from further growth. After seeing the impact of manual processes on small companies, Papranec knew investing in quality up-front and establishing a robust quality system would be a differentiator for C2DX.
“It was very critical that we needed a good system coming out of the gate—one that we could get implemented quickly,” said Papranec.
Ryan Eggleston, director of QA/RA at C2DX, came on as a consultant initially before joining the team full time. From his prior experiences in quality, Eggleston knew implementing a QMS was not always as seamless as planned. He had first-hand experience with the cultural shift of using an electronic solution at a company, as well as the responsibility of monitoring and documenting procedures around the use of that system.
Papranec, Rick Huyser (VP of engineering), and the rest of the team at C2DX knew the advantages of investing in an eQMS. They were confident that by implementing a scalable quality system, they would continue to deliver a high-quality device and focus their time and efforts on growing the company.
Setting A Solid Foundation
Getting quality right from the start was very important for C2DX. They were in need of an out-of-the-box solution that would act as the cornerstone of how they managed quality moving forward. After recognizing the value of an investment in a robust quality system, C2DX elected to go with Greenlight Guru’s medical device QMS (MDQMS).
For C2DX, implementing Greenlight Guru was a quick and easy process due to the intuitiveness of the software. They were able to fully implement an audit-ready electronic quality system within 30 days.
“Greenlight Guru provides a great foundation. We don't have to reinvent the wheel. We don't have to spend a lot of energy on developing a quality system—it’s about growing our quality system,” explained Papranec.
After 27 years of experience in the medical device industry using predominantly paper, Huyser realized the transition to using an MDQMS was a big upgrade from carrying around binders of documentation. He led the implementation of Greenlight Guru and was pleased by the intuitiveness of the system as well as its efficiency when uploading documents, making revisions, and gathering signatures.
Huyser also values having a fully validated system. It is a huge advantage that “enables their team to focus on value-added activities” leading up to audits and the launch of their device in new markets.
Streamlining Processes and Impressing Auditors
From day one, the team at C2DX was able to easily adopt Greenlight Guru and incorporate its use into their daily activities from document management to post-market quality event workflows such as audits and non-conformances. Leveraging Greenlight Guru helped facilitate design transfer to contract manufacturers after they acquired the product, made training and bringing on new hires easier, and expedited their audit preparation efforts.
“There is a seamless integration between all of the modules and once you understand how one module works, you can really understand how the whole system then works,” stated Eggleston.
Along with MDQMS software, C2DX also purchased Greenlight Guru’s audit proven Standard Operating Procedure (SOP) templates, which allowed them to efficiently review and update their quality procedures. Through Greenlight Guru, Rick was able to instantly publish these procedures in their MDQMS and route them for signatures from distributed team members that were working in different locations at the time.
In addition to streamlining their efforts to manage quality, C2DX was also able to make significant progress toward their target timelines by getting FDA approval within 30 days and experiencing successful audits for MDSAP and ISO certifications—all after implementing the system only weeks before.
After experiencing his first truly paperless audit, Eggleston confidently accredits the timeline of their successes to Greenlight Guru. Papranec recalls that, during these audits, the auditors were thoroughly impressed by their quality system and its efficiency. When she asked auditors how their results compared to other companies like themselves, the auditors commented there was no comparison because they were a step ahead of the rest by using a software solution like Greenlight Guru.