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iCat Solutions Success Story

iCat Solutions completes FDA eSTAR submission in less than two months after deploying Matrix

Radiography specialist rapidly achieves FDA clearance for innovative macOS medical imaging software.

ChallengeThe team at iCat Solutions struggled to manage quality management and application documentation, delaying FDA eSTAR submission for essential medical certification.
SolutioniCat Solutions replaced manual documentation processes with integrated MatrixALM and MatrixQMS solutions, taking advantage of best-practice, streamlined workflows to optimize requirements management.

Results

6 monthsless time to produce documentation
2 monthsfrom implementation to first FDA submission
FDA eSTARsubmission made possible by Matrix
Device type:Software
Device class:Class II
Medical speciality: Radiology [Part 892 RA]
Geography:United Kingdom, United States
Solution components: MatrixALM, MatrixQMS

Transforming medical imaging

Born from a desire to “do things better,” iCat Solutions creates innovative medical imaging software, offering groundbreaking, intuitive 3-D views of intricate anatomical details. Alongside its educational products—CT Anatomy and iRad Xrays for iOS—the company has developed its flagship Horos MD for iOS and macOS, enabling clinicians to explore images in whole new ways. The software will assist diagnosis, and ultimately support enhanced patient outcomes.

With more than 150,000 downloads, Horos MD™ is clearly on the path to success. To realize its true potential in healthcare, founder and Chief Executive Officer George Michalopoulos aimed to achieve FDA approval and certification to ISO 13485 as rapidly as possible.

“As a former radiographer, I became frustrated by the lack of sophisticated image visualization capabilities. Now, after more than 10,000 hours of development, I am confident that Horos MD provides one of the most advanced viewing solutions, optimized for both iOS and macOS,” explains George Michalopoulos.

“However, for healthcare professionals to use Horos MD for primary diagnosis, we needed to obtain FDA approval. With a small software development team, the documentation burden severely impacted our productivity, and I doubted that we were even capable of submitting an application. To succeed, I wanted to automate and accelerate our quality management and application lifecycle management, ultimately enabling our FDA submission.”

Working to ISO 13485

The Horos MD application can display images from multiple sources, including ultrasound, CT, MRI and more, using the Digital Imaging and Communications in Medicine (DICOM) standard. Working towards ISO 13485, iCat engaged consultants to assist in developing rigorous quality management processes with a view to FDA approval.

“After several false starts, rather than seeking advice we looked for a practical, robust way to manage our requirements processes. Manually updating documents by replicating changes across multiple locations was killing our productivity and was clearly not a sustainable process,” says George Michalopoulos.

It had soon become clear that to achieve FDA approval, managing the underlying application lifecycle was one of the most important processes. For example, if a changed policy or user instruction was not reflected correctly in documentation, the FDA approval would fail.

With automation in mind as a way of eliminating errors, iCat took up a two-week trial with MatrixALM to assess capabilities. The review included ease-of-use, a particularly important factor for a hyper-busy team, quality management functionality, and the ability to accelerate document production for the all-important FDA submission.

“After experimenting with MatrixALM for a few days, I decided to populate the test environment with real data, to learn how it would perform and discover the possible advantages. Within a day my main concern was whether I could sign up with Matrix and transfer the data to a production environment, the benefits were so clear. Even our most cynical developer was hugely impressed by what MatrixALM offered,” continues George Michalopoulos.

“MatrixALM handles everything from the software's birth to its retirement, helping us to manage every aspect of development. As developers, we use the Jira platform for issue tracking. By linking Jira with MatrixALM we have streamlined our workflow, making sure everything from development to compliance is smooth sailing. These integrations are all about visibility and efficiency, making sure we’re all on the same page and using our resources wisely. In addition, we have also now deployed MatrixQMS, to ensure we are always on track with quality and compliance, and the two solutions provide integrated operations, which is perfect for iCat.”

Enabling FDA eSTAR submission

By deploying MatrixALM, iCat Solutions transformed its capabilities, replacing cumbersome manual processes with integrated, centralized application lifecycle management.

“In the past, generating complete documentation for the FDA submission took us around six months. Because software development does not stand still, every update caused multiple changes, all of which had to be traced and proved for audit,” comments George Michalopoulos. “With MatrixALM, changes automatically replicate across dependent documents, complete with audit trail. After two months working with MatrixALM, we were essentially cutting the FDA preparation to near zero, based on a continuous process.”

In addition, iCat takes advantage of the branching and merging feature within MatrixALM to reduce complexity, as George Michalopolous explains: “Our software shares the same codebase across multiple platforms (mobile, desktop etc.), which essentially share the same core application lifecycle. Branching lets us manage these different ‘versions’ without turning our main development line into a tangled mess of spaghetti, especially as FDA requirements are slightly different for each platform. MatrixALM enables iCat to keep an orderly record at every moment, which is critical for FDA approvals.”

Importantly, MatrixALM and MatrixQMS bring embedded best practices into the company. Essentially, while the workflows are highly customizable, the core processes adhere to ISO 13485 with templates for FDA eSTAR submission. iCat has now received premarket approval from the FDA—and the Matrix Requirements solutions played an important role in the success of the company’s application.

“At the start of the eSTAR process we stumbled a little, with one section missing, which normally would have prompted a near-complete rewrite to check pagination, references and much more,” concludes George Michalopolous. “With MatrixALM, we were able to provide the relevant material, regenerate the documentation and update the submission with minimum effort. MatrixALM enables iCat to focus on our core software development tasks, eliminate administration, and cut our time to FDA approval for Horos MD—and help care for thousands of patients.”

Honestly, without the Matrix solutions, iCat would not have been able to submit our FDA eSTAR approvals application.

George Michalopoulos, Chief Executive Officer