Alpha Omega Success Story

Pioneering advances in deep-brain stimulation

Alpha Omega specializes in developing medical devices that alleviate the signs and symptoms of conditions such as Parkinson’s, dystonia, and essential tremor. Electrodes implanted at targeted locations can deliver deep-brain stimulation (DBS) that delivers symptomatic relief, greatly improving the patient’s quality of life.

In the past, surgeons relied on pre-operative MRI scans to guide them to the electrode implant site. However, the procedure itself causes the brain to move slightly, reducing the location accuracy. Alpha Omega has developed a one-time-use electrode and guidance system that creates an electrophysical map that the surgeon can use even if the brain moves. The enhanced mapping allows the permanent DBS electrode to be implanted with much greater precision, offering improved relief for the patient.

As Alpha Omega extends its product range, all electrodes, implants, and associated robotic hardware and controlling software, are subject to stringent regulation, with hundreds of requirements to manage throughout the device lifecycle.

Nabeel Sakran, VP of Research and Development, Alpha Omega, comments, “In the past, we were using manual systems to document and manage our requirements. As the product portfolio expanded and we commissioned many more development projects, we did not have scalable processes. To continue the company’s growth, we wanted to streamline requirements management workloads, meet regulators’ demands as efficiently as possible, and reduce the time and effort to produce compliant documentation.”

Close fit for requirements management

The Alpha Omega team reviewed several possible requirements management solutions, and selected MatrixALM. Designed by medical device experts, the solution allows organizations to track design objects such as requirements, risks, tests and more in a fine-grained way, and manage the complex relationships between them.

“MatrixALM offers complete functionalities that allow us to comply with global frameworks set out by the International Organization for Standardization and the U.S. Food and Drug Administration, essential for a medical device company like Alpha Omega,” explains Sakran. “MatrixALM delivers the design, verification, risk management, test execution and related requirements management capabilities that we were looking for, including risk controls, risk mitigation, and full traceability.”

Intuitive solution

From initial deployment, the Alpha Omega engineers found the MatrixALM solution simple to use, with a clear, intuitive interface. All new projects are initiated in MatrixALM, with around 25 full users and a further 15 read-only users.

Sakran adds: “Another great advantage of MatrixALM is how easy it is to use. When we hire a new engineer and set them up with an account, they’re up and running with the Matrix Requirements solution in one or two days—it’s that intuitive.”

Gaining improved insight

Alpha Omega uses MatrixALM to store all requirements, specifications, and test results, which are securely accessible from anywhere.

“MatrixALM is great for documenting requirements and translating them into detailed traceability matrices,” says Sakran. “For example, when my regulatory affairs team asks about one of our user interfaces, with MatrixALM I can direct them to the architecture specifications document, and I know the answer will be there.”

Innovating deep-brain stimulation technologies

With MatrixALM in place, Alpha Omega operates a streamlined process for requirements management, with the team accessing the solution on a daily basis. Currently MatrixALM handles around 1,500 requirements, and Alpha Omega has automated around half of its regression testing. Test pass/fail results are written to MatrixALM, ensuring that up-to-date documentation is always available.

Sakran comments, “With MatrixALM, we see the benefit in ease of documentation and tracking of documents. Without MatrixALM, we would turn to documentation late in the game, whereas now we create it as we go. As well as the hours saved, we gain from the online documentation availability, which makes our development more efficient, and improves synchronization and communications between different teams.”

Moving to digital workflows

Moving to a digital workflow enabled by MatrixALM also helps with business productivity and reduction of error rates, which in turn help speed products to market.

With the previous, manual, way of working, the company documented test results incrementally, which absorbed a great deal of time. If there was a new requirement with its own design input and verification, then this would be added to the end of the document to avoid spending additional time re-ordering the pages, indexes and more.

“Previously, a lot of our documentation was ugly and difficult to use because information was not structured efficiently,” says Sakran. “Moreover, the time we spent creating documentation manually could add a further month to a project, and increase the risk of human error creeping in. With Matrix ALM, we can generate crisp, clean documentation at the touch of a button—cutting two weeks of work down to just one minute.”

Cutting time to market

The Alpha Omega team is devoted to the successful development of its innovative deep-brain stimulation technologies, potentially bringing palliative relief to millions of patients worldwide. By deploying MatrixALM, Alpha Omega can manage complex requirements efficiently for multiple global regulators, and bring products to market as rapidly as possible.

Sakran concludes, “MatrixALM allows us to take an agile and efficient approach to requirements management—it’s the perfect fit for Alpha Omega.”