Having a good quality system in place is not just a check-box activity for quality assurance and compliance; rather it promotes a data-driven approach to quality that accelerates time to market and enables growth into new markets without quality becoming the bottleneck for their company—even when at odds with a global pandemic. By prioritizing quality from the beginning, FlexLogical has put themselves into a good position by implementing the right QMS. For a team that works diligently to ensure great quality in their device(s), they were intentional from the start about what quality system would fit their needs and set them up for success.

Revolutionizing Surgery
As minimally invasive surgeries are becoming more common and surgeons are carrying out several in a single day, the need for high-quality, high performance ergonomic tools is widely apparent. Emil Cederfeldt, co-founder and CEO of FlexLogical, saw the opportunity to revolutionize surgical technology and enhance surgeons’ performance. FlexLogical is developing a series of innovative laparoscopic devices that increase the postural freedom of surgeons to minimize strain and reduce muscle fatigue, thus improving overall surgical performance and minimizing work-related musculoskeletal injuries suffered by surgeons.

Accelerating Time to Market
In a previous R&D role at a medical device company, Cederfeldt had worked with a paper-based quality management system where they also leveraged digital tools, like Excel, to manage their device requirements. This experience proved to be cumbersome, time-consuming, and full of complexity when it came to maintaining traceability and version control.

While starting FlexLogical, Cederfeldt had a strong sense of the importance of implementing a digital quality system. As they began solidifying their device concepts and adding more team members to focus on risk and developing their QMS, he wanted to ensure they approached quality the right way. Cederfeldt knew “using Excel would be too comprehensive” for their devices and would not support the integrity and quality of the devices they want to produce—leading to more cumbersome work in the long run.

FlexLogical identified several needs in a QMS software solution to make their team successful in managing quality. The features and capabilities they were looking for included:

• Supports the complexity and multitude of device requirements
• Enables full product lifecycle traceability
• Ensures correct documentation and controls
• Easy to learn, implement, and use

Making Quality Management Easy to Do
It was clear while searching for a software solution, the team at FlexLogical was focused on finding and establishing a QMS software that would set them up for success from the start. Simultaneously, as FlexLogical grew their team, they hired a quality manager to oversee the system they would ultimately put in place. This person had previous experience with Greenlight Guru’s MDQMS and brought along a recommendation of the software for Cederfeldt to consider

One significant concern was the time it would take to implement and learn a new software solution—especially for QMS activities. After just the software demonstration, Greenlight Guru proved to be an intuitive system that would also make quality management easy to learn for their team. Cederfeldt was especially drawn to how they could document traceability around their design controls and risk management within Greenlight Guru. As a newer and younger professional navigating the medical device industry, he found immense value in the ability to learn how to manage the quality system just by using it, which ultimately helped him decide that Greenlight Guru’s MDQMS would be the best fit for FlexLogical.

Quick Implementation
Cederfeldt attests to the speed and efficacy of implementing an MDQMS—one that proved to be easy to pick up and use. They were fully onboarded and using the system assuredly within just five training sessions, surpassing their expectations and timeline for implementing a QMS. Where they found immediate value was in building out their design control and risk matrices. With their many design inputs, the ability to then link together different items helped them build out the traceability needed.

“Showing traceability and documenting it takes seconds in Greenlight Guru, compared to hours in a paper-based system,” explained Cederfeldt.

Retrospectively, Cederfeldt imagines the time and resource strain that would have been felt with linking and building out traceability in Excel—being too comprehensive and time-consuming for their fast-moving team. More importantly, he realized critical links would have more than likely been missed between design inputs and risk mitigations—a vital component for ensuring the safety, effectiveness, and usability of their device(s). Streamlining these processes in Greenlight Guru has given Flexlogical clear visibility into their quality system as they can search within the system and matrices to easily find the information needed.

“I thought it was going to be a very comprehensive task to learn a new type of software—especially something as complicated as QMS—but with Greenlight Guru it seemed extremely easy,” admitted Cederfeldt.

Data-Driven Quality
With an MDQMS that enables thorough documentation and acts as a single source of truth, all of the information is readily accessible allowing the FlexLogical team to work collaboratively and effectively. Cederfeldt can attest that the clear view into their QMS has advanced their timeline by saving FlexLogical both time and money, enabling these resources to be reallocated to other value-add activities. As CEO, he is confident the processes and information within Greenlight Guru support the data-driven quality they need to demonstrate to ensure a competitive advantage in the marketplace. He is also confident the workflows and interconnectivity of the system lessen the chances for human error.

“Everyone can state that they have good quality, but not everyone can prove that they have it. We are going to use all of the data stored within Greenlight Guru to prove we have good quality,” said Cederfeldt.

Prepping for Paperless Audits
Cederfeldt and his team are continuing to operate business as usual, despite experiencing some minor impacts of COVID-19. Although their testing has been delayed, they are still nearing their design freeze and preparing for their next milestone—their first audit. Cederfeldt recalls preparing for audits in his previous experience, taking upwards of two to three weeks—several days alone just for the technical file audit. Come time for the audit, they would spend nearly 20 percent of the time searching for the documentation, and the traceability behind it. Knowing that it only takes mere seconds to display and share documents, records, and traceability within Greenlight Guru, Cederfeldt is looking forward to the experience of a paperless audit. He expects both the preparation and actual audit will require less time and run much smoother.

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Jon Speer is the founder and VP of QA/RA at Greenlight Guru—a medical device quality management MDQMS software—and a medical device guru with over 20 years of industry experience. Speer knows the best medical device companies in the world use quality as an accelerator. That's why he created Greenlight Guru to help companies move beyond compliance to achieve True Quality.