Creo Medical: True Quality is Possible with the Right Approach
Creo Medical is a UK-based medical device and advanced energy company, transforming lives by delivering pioneering solutions to healthcare providers across the world. Founded in 2003 by Professor Chris Hancock, Creo initially targeted the treatment of cancers through the use of high-frequency microwave energy.
Since then, the company has expanded its offerings into a complete suite of solutions for clinicians and hospitals targeting critical procedures in the field of gastroenterology for therapeutic endoscopy.
Creo Medical’s innovations and breakthrough technologies were being slowed by an inefficient and burdensome quality process. Their stitched-together approach of paper, email, and e-signature tools was creating difficulty with visibility, traceability and document control across the organization.
“We were managing design controls in five different spreadsheets for five different areas of work,” said Shaun Preston, Global Head of Advanced Technology and Biomedical Research at Creo Medical. “This made it difficult to get a single view across all documentation, and hard for more than one person to work with the documents at a time.”
On top of that, Creo was finding that audits, approvals, and training were taking much longer, and ultimately not keeping up with the pace of a global innovator they had become.
The Solution: Greenlight Guru
In order for Creo Medical to get back on the trailblazing path, it needed an end-to-end eQMS solution that could finally provide a single source of truth for all documentation, design controls, audit reports, and more. Thankfully, in Greenlight Guru everything is linked and traceable, making it easier to keep up with rapid changes, rather than before when it could potentially take weeks to get sign-off on a change.
They also needed a solution that was purpose-built for the unique needs of MedTech. Greenlight Guru workflows save time in the design process, and time spent tracking down documents or updating spreadsheets, allowing companies to get their products submitted for FDA approval and to get them to market faster.
This closed-loop quality system would enable Creo Medical to develop and maintain best practices, and improve product and quality processes, to significantly reduce its non-compliance risk. And because Greenlight Guru’s software comes pre-validated and aligned with 21 CFR Part 820, ISO 14971:2019, ISO 13485:2016, and FDA requirements, the Creo team was able to ensure compliance from the start without lifting a finger.
The Results: Benefits of Using Greenlight Guru
By choosing Greenlight Guru for its eQMS, Creo Medical has seen major improvements in its efficiency and communication, as well as a faster and streamlined product development lifecycle.
Up to 50% faster responding to audits
Preston estimated that Greenlight Guru had saved Creo Medical 10-50% of the time that used to be spent addressing audit findings. The ease with which they can now create technical files, and access the needed files for audits, are big wins.
“With the click of a button, we now can see how the information for audits or internal quality assurance reviews all links together,” he said. “We can also answer auditor questions right away by just clicking on the search function.”
80% reduction in the number of documents to be tracked
Prior to choosing Greenlight Guru, Creo Medical struggled to find visibility and connectivity between design inputs, outputs, verifications, and validations—all of which created significant documentation that needed to be tracked. However, after signing on with Greenlight Guru, Preston reported a massive 80% reduction in the number of documents to be tracked, once all documentation was housed in a single source of truth. It also significantly increased visibility into the system and the number of people that could access documents at the same time.
That’s because Greenlight Guru enables easy access to the latest design documentation, the ability to link documents to design control and development activities, and to house all work instructions, process validations, SOPs, and lab test methods in a single location. There’s also the automated Design History File (DHF) which generates and updates automatically, allowing users to document device requirements and simplify traceability while iterating through design.
Employees’ time spent training cut in half
With so many innovative products and scaling into new global markets, Creo Medical’s employees were undergoing a significant amount of compliance training. And with a large workforce spread across the world, that meant anywhere from 20-40 people who needed to complete training at a given time.
That’s why Greenlight Guru provides an all-in-one solution that connects training activities with the rest of the QMS for a fully integrated workflow. With the ability to efficiently create, duplicate, assign, and track individual or role-based training activities within an organization, customers like Creo Medical are able to manage training like never before.
“With Greenlight Guru, we can assign a training event for every document that needs to be read, or every SOP we update. We can now assign this to be done remotely, and then track completion in the system, meaning we don’t have to keep manual training matrices anymore,” Preston said.
Rolling compliance means faster time-to-market
Paper-based approaches like the one previously used by Creo Medical can result in significantly more time being needed to bring a new medical device to market, as can using general-purpose quality tools that weren’t designed for the medical device industry, which can be clunky, and not ready out of the box.
Thanks to Greenlight Guru, however, Preston said this makes design reviews easier to complete, as they can easily pull items into review at various stages of development. These reviews are also auto-populated into their living Design History File. “This rolling compliance saves the time that would otherwise be needed at the end to pull together all of the documentation needed for submission, and speeds up go-to-market timing by a number of months,” Preston said.
What’s Next for Creo Medical?
Creo Medical is excited to continue its mission to improve patient outcomes by applying Advanced Energy to the emerging field of surgical endoscopy. With an increased focus on expanding its product lines and entering new global markets, they anticipate that Greenlight Guru’s eQMS software will play a notable role in its continued success.