- Isolated and manually integrated tools inhibited transparency
- Ensuring traceability of requirements all the way down to source code
- Exporting comprehensive documentation for Food and Drug Administration (FDA) compliance audits was problematic and labor-intensive
This case study explores how the Neuromodulation department of Medtronic, a global leader in medical technology, has implemented Codebeamer to overcome issues that their previous software ecosystem wasn’t able to efficiently address. The organization set out to make the transition from legacy systems to state-of-the-art solutions and processes. Codebeamer has efficiently assisted the department in realizing their vision of scaling Agile, while building processes to support compliance in this highly regulated industry. In effect, Medtronic’s Neuromodulation department has completely reshaped their processes, and has used Codebeamer to drive this change.
Medtronic is the world’s largest standalone medical technology company headquartered in Dublin, Ireland, with its operational headquarters in Fridley, Minnesota. The company, founded in 1949, was among the first to use electrical stimulation to treat irregular heart rates, and has since evolved to develop and manufacture high-tech devices and therapies for several chronic diseases, such as Parkinson’s disease, heart failure, Down’s syndrome, obesity, chronic pain, and diabetes, among others. Operating in more than 155 countries and employing over 85,000 people worldwide, Medtronic is a global healthcare solutions company with a revenue of over $20 billion in 2015. Aligned by the company’s mission of “alleviating pain, restoring health, and extending life,” Medtronic is composed of several business units. Neuromodulation is the second-oldest and third-largest Medtronic unit, accounting for $1.9 billion, or 11%, of Medtronic’s revenues in 2014.
In a tool evaluation, selection, and purchase process, Medtronic Neuromodulation implemented Codebeamer in April 2015 with 50 reviewer users and 200 Application Lifecycle Management (ALM) users, which they shortly expanded to include all 250 of the department’s developers, as well as 50 reviewer users. In his role as Director of Patient Care Software, Medtronic Neuromodulation, Sarb Singh-Kaur is responsible for the development of all health software products, R&D, innovation and mobile, cloud, and data sciences infrastructure development.
His vision that Codebeamer helps accomplish, however, is greater than the sum of these activities:
Led by a visionary software executive, Medtronic’s Neuromodulation department has developed a framework that combines the use of scaled Agile processes and the advanced capabilities of a cutting-edge Application Lifecycle Management solution, Codebeamer, to help the world’s largest medical technology company stay ahead of its competition in terms of agility, velocity of software innovation and development, and product quality.
ALM to alleviate development pains
Before implementing Codebeamer, Medtronic Neuromodulation was relying on an elaborate software ecosystem to manage their ALM and Agile needs. Jira, VersionOne, PTC Integrity, SharePoint, IBM Rational RequisitePro and ClearCase, GitHub, and several ingrown tools were all in use.
While the team was happy with the functionality that the combination of these software platforms provided, integrating this plethora of standalone solutions was a difficult task. Using isolated and manually integrated tools inhibited transparency. Ensuring the traceability of requirements all the way down to source code and exporting comprehensive documentation that needed to be submitted to FDA for compliance audits were problematic.
Therefore, the Medtronic team started looking for a tool that could help them implement integrated ALM and Agile software development at the same time, all in a scaled environment to allow the collaboration of all 250 developers, as well as other stakeholders.
Diagnosing pain points
The traceability of requirements down to source code was one of the most critical issues the team was facing. But it wasn’t the only one. Below is a list of the essential problems Medtronic’s Neuromodulation team had to overcome, and how Codebeamer addressed those issues.
Products developed by Medtronic’s Neuromodulation team are subject to a number of regulations, amongst which FDA Part 11 governs the use of electronic signatures. In their legacy environment with several software solutions, adequate process and access control were difficult to achieve.
Codebeamer’s advanced capabilities allow the granular management of access and process control. FDA Title 21 CFT Part 11-compliant e-signatures may be configured to be required at any point in the lifecycle, and a preconfigured IEC 62304 Medical Template is available to support compliance with other standards. The Medtronic Neuromodulation team chose to create custom workflows to tailor their ALM system’s capabilities to their internal process needs.
Medical compliance requirements
As a medical device developer, Medtronic Neuromodulation’s products are subject to various standards and regulations. Therefore, achieving compliance is a critical requirement. Medtronic factored in this aspect when evaluating ALM solutions, and found that Codebeamer adequately supported compliance either through its out-of-the-box functionality, or due to its highly adaptable nature that enables the use of custom configurations.
Among the standards relevant for Medtronic Neuromodulation are:
- IEC 62304: Medical Device Software – Life Cycle Processes
- IEC 82304: Health Software
- ANSI/AAMI HE75: Human Factor
- AAMI TIR45: Guidance on the use of Agile practices in the development of medical device software
- IEC 60601-1: Medical electrical equipment
- ISO 13485: Medical devices—Quality management systems
- ISO 14971: Medical devices—Application of risk management to medical devices
- FDA Title 21 CFR Part 11, and other FDA regulations
Achieving compliance with the above regulations requires flexibly configurable custom workflows that allow the execution and monitoring of fully controlled processes, complete traceability, and comprehensive documentation. The evaluation found that all of these requirements are aptly fulfilled by the features and capabilities of Codebeamer.
While Codebeamer’s preconfigured Medical IEC 62304 Template supports compliance with various healthcare software standards, like most other users, the Medtronic Neuromodulation team has tailored ALM workflows to their needs, taking advantage of Codebeamer’s process control features with BPM capabilities, its risk management, quality assurance, and testing features, as well as its FDA-compliant e-signatures.
Thus, Medtronic’s Neuromodulation team was able to fully configure Codebeamer to support their specific compliance needs. The effort required to prove compliance at validation audits has significantly decreased thanks to Codebeamer’s automatic documentation and custom-configurable reporting functionalities. Pulling reports in Codebeamer about the development processes used is convenient and efficient.
Quite naturally, compliance accounted for only a fraction of aspects and criteria considered during the search for, and evaluation of, ALM solutions at Medtronic Neuromodulation.
ALM evaluation criteria
Medtronic Neuromodulation initiated the tool evaluation process in September 2014. In order to be able to support Sarb Singh-Kaur’s vision of transitioning Medtronic Neuromodulation from legacy to cutting-edge development processes, the team needed a fully integrated, robust, yet flexible cloud-hosted ALM solution. The hunt for a suitable software platform started with establishing the criteria for evaluation.
First and foremost, the Medtronic Neuromodulation team was looking for an easy-to-use solution that offered complete clarity of visualization, as well as convenient navigation of requirements. Traceability and flexible configuration options to support compliance were as important as strong core capabilities (requirements management, source code control, quality assurance, and testing features). Document management features were also highly valued criteria.
Finally, there was, of course, the consideration of costs: Codebeamer’s total cost of ownership (TCO) was deemed reasonable. Our ALM solution’s integrated nature enables advanced functionality right out of the box, sparing the costs and frustration of installing and maintaining additional plug-ins or other software. The Medtronic Neuromodulation team found that the basic training offered by Codebeamer was affordable, sufficient, and thoroughly educational, but they expressed a need for more advanced training options.
Alternative ALM solutions considered
Among the software solutions the Medtronic Neuromodulation team has chosen to evaluate were: Atlassian Jira, Jama, Polarion ALM, PTC Integrity, VersionOne, Rally, and Codebeamer.
Generally, competitors fell short in their Agile capabilities: VersionOne was the only tool deemed satisfactory at Agile, but it needed additional tools to adequately perform requirements management. Their inherent lack of complete integration, and the need to install plug-ins or other additional elements ruled out the use of Jira, Jama, and Rally. Besides the lack of real Agile support, PTC was considered too heavyweight by the Medtronic Neuromodulation team, with a poor user interface and the need for extensive customization. Polarion’s shortcoming was its document-centric view, leaving Medtronic’s Neuromodulation team wondering if it was “optimized for those who like to view the world as a Word Document.”
Codebeamer’s complex asset management capabilities, complete traceability, advanced testing features, and best practices offered around ALM and compliance were its most highly valued features. Being able to configure custom trackers for different object types, and to create relationships between all work items are Codebeamer features that the Medtronic Neuromodulation team simply can’t imagine living without. The ability to show these relationships via the Traceability Browser, and to export documents and reports, greatly facilitate compliance and were therefore considered key assets when Medtronic’s Neuromodulation team evaluation ended with the decision to purchase Codebeamer.
Deployment and rollout process
Once the purchase decision was made in April 2015, Medtronic’s Neuromodulation team deployed Codebeamer in less than two weeks. A pair of Codebeamer’s engineers flew over to the Medtronic headquarters for an intensive week of technical rollout (configuration and training the trainers), helping the team get up to speed with Codebeamer’s features right away.
The Medtronic Neuromodulation team migrated data from their previous tools using APIs and Codebeamer’s import capabilities, staging their new ALM software on a test server to perform the migration. After the primary tool validation was done in four weeks, the entire team started using Codebeamer, and was surprised to see how user-friendly it was.
Benefits and value realized with Codebeamer
Medtronic’s Neuromodulation team has configured trackers, projects, roles, and workflows to establish their new internal processes—process change and Codebeamer went hand in hand. Essentially, Codebeamer has helped them transition a department of the world’s largest medical technology company from legacy solutions to state-of-the-art processes, greatly facilitating the efficient production of innovative mobile and cloud software medical systems.
Calculating the ROI on complex tool investments is a difficult task. At the end of the day, it’s all about the capabilities and process improvements that the new solution brings to the organization. When asked about the bottom-line value that Codebeamer delivers, Medtronic’s Neuromodulation team has quoted the following:
- Predictability and well-traced adherence to established software development process
- Software portfolio management
- Compliance with regulatory requirements
- Complete transparency
- Better project management
Overall, Sarb Singh-Kaur’s ambitious and forward-thinking goals of replacing legacy processes with leading-edge ones to create a powerhouse of innovation and improve value creation were aptly supported by the robust capabilities of Codebeamer. Medtronic’s Neuromodulation team was able to start quickly and realize value almost immediately after implementing their new ALM solution. Codebeamer has helped them address issues faced by many, if not all, medical device and embedded software development teams globally—and has helped resolve these problems in a matter of weeks.
Soon after the initial 200 ALM licenses were deployed, Medtronic Neuromodulation purchased an extra 50 licenses, and as of March 2016, is investigating how other Medtronic departments could benefit from using Codebeamer.