The Neuromodulation department of Medtronic is a global leader in medical technology. Recently, they implemented codeBeamer ALM to overcome issues. These were issues that their previous software ecosystem wasn’t able to efficiently address. The organization aimed to transition from legacy systems to state of the art solutions and processes.
codeBeamer ALM efficiently assisted the department in realizing their vision: Scaling Agile while building processes to support compliance in a highly regulated industry.
Medtronic’s Neuromodulation department has completely re-shaped their processes. Additionally, they used codeBeamer ALM 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, US. 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 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 ALM in April 2015. They had 50 reviewer users and 200 ALM users. The ALM users expanded to include all 250 of the department’s developers. Additionally, it included the 50 reviewer users.
In his role as Director of Patient Care Software at Medtronic Neuromodulation, Sarb Singh-Kaur is responsible for:
- The development of all Health Software Products,
- Research and development (R&)
- Innovation and Mobile.
- Data Sciences Infrastructure development.
“I am transitioning the organization from legacy embedded software systems to state of the art mobile and cloud software medical systems and processes.”
The Visionary Behind The Move
Led by a visionary software executive, Medtronic’s Neuromodulation department developed a framework that combines:
- The use of scaled Agile processes.
- The advanced capabilities of a cutting-edge Application Lifecycle Management solution.
codeBeamer ALM is used to help the world’s largest medical technology company stay ahead of its competition for Agility, velocity of software innovation and development, and, product quality.
We needed to capture customer needs and trace them down to product requirements, down to design, tests, and source code. codeBeamer ALM was the only tool that allowed us to do that in a smooth way.
ALM to Alleviate Development Pains
Before implementing codeBeamer ALM, Medtronic Neuromodulation relied on a complex software ecosystem to manage their ALM and Agile needs including:
- PTC Integrity.
- IBM Rational RequisitePro & ClearCase.
- Plus several internally grown tools were all in use.
The team was happy with the functionality this software platform combination provided. However, integrating the plethora of standalone solutions was a difficult task. And, using isolated and manually integrated tools inhibited transparency. Therefore, ensuring requirement traceability down to source code, and exporting comprehensive documentation for FDA compliance audit submissions were problematic.
So, the Medtronic team began looking for a tool that could help them implement integrated Application Lifecycle Management and Agile software development. Furthermore, they needed this to be in a scaled environment and allow the collaboration 250 developers, plus stakeholders.
Diagnosing Pain Points
The requirements requirement down to the 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 ALM addresses those issues.
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, they found that codeBeamer ALM 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 CFT Part 11, and other FDA regulations
Achieving compliance with the above regulations requires flexible, configurable custom workflows.
The workflows needed to allow for:
- The execution and monitoring of fully controlled processes.
- Complete traceability.
- Comprehensive documentation.
The evaluation discovered all of these requirements are aptly fulfilled by the features and capabilities of codeBeamer ALM.
Intland’s preconfigured Medical IEC 62304 Template supports compliance with various healthcare software standards. However, like most users, the Neuromodulation team have tailored ALM workflows to their needs. This allows them to take advantage of codeBeamer’s process control features with Business Process Management capabilities, its risk management and quality assurance & testing features, and its FDA-compliant e-signatures.
Thus, Medtronic’s team was able to fully configure codeBeamer ALM to support their specific compliance needs. The effort required to prove compliance at validation audits also significantly decreased. this was thanks to codeBeamer’s automatic documentation and custom-configurable reporting functionalities. Pulling reports in codeBeamer about the development processes used is now both convenient and efficient.
But, whilst compliance was a critical factor when scoping an effective ALM, it wasn’t the only factor.
ALM Evaluation Criteria
Medtronic Neuromodulation initiated the tool evaluation process in September 2014. And, 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. A suitable software platform started with establishing the criteria for evaluation.
Firstly, the Neuromodulation team searched for an easy to use solution offering complete clarity of visualization. Additionally, they needed convenient navigation of requirements. Equally, traceability and flexible configuration options to support compliance were strong core capabilities. For example:
- Requirements management.
- Source code control.
- Quality assurance.
- Testing features.
- Document management.
Finally, cost was also important: codeBeamer’s Total Cost of Ownership (TCO) was deemed reasonable. Our ALM solution’s integrated nature enables advanced functionality right out of the box. This spares the cost and frustration of installing and maintaining additional plugins or other software. Also, the Neuromodulation team discovered the basic training offered by Intland Software was affordable, sufficient and thoroughly educational. However, they expressed a need for advanced training options.
Alternative ALM Solutions Considered
Among the software solutions, the Neuromodulation team chose to evaluate were:
- Atlassian JIRA.
- Jama, Polarion ALM.
- PTC Integrity.
- codeBeamer ALM.
Generally, competitors fell short in their Agile capabilities as detailed below:
- VersionOne was the only tool deemed satisfactory at Agile. It required additional tools to adequately perform requirements management.
- Their inherent lack of complete integration, and the need to install plugins or other additional elements ruled out the use of JIRA, Jama, and Rally.
- Besides the lack of real Agile support, PTC was considered too heavy-weight by the Neuromodulation team, with a poor user interface and the need for extensive customization.
- Polarion’s shortcoming was its document-centric view. This left Medtronic’s team wondering if it was “optimized for those who like to view the world as a Word Document”.
- Complex asset management capabilities.
- Complete traceability.
- Advanced testing features.
- Best practices offered for ALM.
- Configuration of custom trackers for different object types.
- The ability to create relationships between all work items.and show these via the Traceability Browser.
- Export documentation and reports to greatly facilitate compliance.
These were highly valuable, and key assets considered when Medtronic’s evaluation ended. Thus, they decided to purchase codeBeamer ALM.
Deployment & Rollout Process
Once the purchase decision was made in April 2015, Medtronic’s Neuromodulation team deployed codeBeamer ALM in less than two weeks. A pair of Intland Software engineers flew over to the Medtronic headquarters for an intensive week of technical rollout (configuration and training the trainers). Additionally, they supported the team getting up to speed with codeBeamer’s features right away.
The Neuromodulation team:
- Migrated data from their previous tools using APIs and codeBeamer’s import capabilities.
- Staged their new ALM software on a test server to perform the migration.
The Primary Tool Validation was completed in four weeks. Then, the entire team started using codeBeamer ALM. And, they were surprised to see how user-friendly it was.
“The solutions is easy to learn and use. New employees find their way around in less than 2 weeks. They are able to do tracker configuration within 2-4 weeks.”
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 ALM helped them transition a department of the world’s largest medical technology company from legacy solutions to state of the art processes. codeBeamer has facilitated the efficient production of innovative mobile and cloud software medical systems.
“Here are the things we have been able to accomplish: We have completely re-shaped our processes and have used codeBeamer as the instrument to drive that change. We were up and running in less than 30 days. We have over 250 active users already. Intland Software has implemented specific features to satisfy our needs.”
Calculating The ROI
Calculating the ROI on complex tool investments is a difficult task. Essentially, it’s all about capabilities and process improvement that the new solution drives. When asked about the bottom-line value codeBeamer ALM has delivered, Medtronic’s Neuromodulation team listed the following:
- Predictability and well-traced adherence to established software development process
- Software Portfolio Management
- Compliance with regulatory requirements
- Complete transparency
- Better Project Management
Creating A Powerhouse
Overall, Sarb Singh-Kaur’s was ambitious and forward-thinking. Now, his goals of replacing legacy processes with leading edge ones have created a powerhouse of innovation and improved value creation. This has been supported by the robust capabilities of codeBeamer ALM. Medtonic’s Neuromodulation team who were able to start quickly, and realize value almost immediately after implementation.
codeBeamer ALM helped them address issues faced by many, if not all medical device and embedded software development teams globally. And, it 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 they are investigating how other Medtronic departments could benefit from using codeBeamer ALM.
Codebeamer is an Application Lifecycle Management (ALM) platform with unique configurability and product line configuration capabilities.
Codebeamer X is an integrated Engineering Lifecycle Management (ELM) platform for life sciences companies with regulatory process & compliance support.
To learn more, visit us at https://intland.com/. Follow @intland on Linkedin and Facebook.
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