About this Customer Story
The combination of growing medical device complexity and intensifying competition is forcing teams to prioritize efficiency throughout the development process.
When RBC Medical Innovations was looking to cut down on the amount of time it was spending on semi-manual processes and maintain traceability, it turned to Jama Software.
Read our case study to learn how RBC leveraged Jama Connect to:
- Shed hundreds of team-member days during development
- Gain $150,000 in cost savings per project
- Obtain better visibility into tasks, tests and costs
Getting to market quickly requires a medical device contract development and manufacturing company to have exceptional team collaboration and outstanding workflow efficiencies.
When it was time to upgrade from semi-manual processes to a completely integrated and streamlined solution, RBC Medical Innovations turned to Jama Software.
With the Jama Product Development Platform, RBC saw opportunities for greater efficiencies, stronger requirements management and a better way to stay on top of Quality and Regulatory Compliance issues.
Earning Recognition in a Competitive Market
Based in the Kansas City area, RBC designs and manufactures a wide range of diagnostic and therapeutic medical devices for industry clients that supply hospitals and healthcare facilities. In business since 1994, RBC prides itself on its diverse product experience, skilled cross-functional development teams and deep expertise satisfying regulatory requirements.
Challenge: Improving Efficiency While Meeting Regulatory Requirements
The challenges of building medical devices that perform vital diagnostic functions and patient treatments go beyond the product design itself. The labyrinth of rules and regulations that impact the release of a medical device requires dedicated resources from the earliest stages of product development.
RBC was looking to upgrade its development to improve upon:
- Semi-manual processes that required significant labor and increased chance of error
- Lack of a central development process dashboard
- Traceability to ensure that essential requirements were linked to the necessary test coverage
RBC faced another ongoing challenge: maintaining their identity as an industry-leading product design and manufacturing firm using a development methodology that could outperform both internal research as well as external development and design organizations bringing medical devices to market.
Faster Time to Market With Less Risk
Workflow efficiencies are vital to RBC’s product development methodology. The company must be able to ensure that it meets customer and regulatory requirements in order to maintain its ISO 13485 and ISO 9001 certification, and FDA registration as a contract manufacturing facility.
Previously, RBC often built its own internal development tools to solve design challenges and meet specialized requirements. “The challenge of designing a tool on your own that would be competitive in a few years is increasingly difficult,” Scott Britt, Systems Engineering Manager at RBC, says. “Unless it is the focus of your business.”
While this strategy was successful for several years, as both products and the surrounding regulatory environment grew in complexity, RBC realized it had outgrown its internal tools.
“Over a period of years, we’ve been increasingly aware that we needed to improve our development workflow,” Britt says. “It wasn’t optimal and team members knew it could be improved.”
“A big symptom of the problem was noticeable when we would ask about our progress on verification,” Britt continues. “Previously, there was no easy way to know details concerning what progress had been made. It was challenging to know whether we were on track to meet the cost and schedule targets for the project.”
RBC chose Jama ConnectTM to:
- Unify their development environment
- Gain better visibility into tasks, tests and costs
- Keep team members informed on each aspect of a project
“As we onboard team members to Jama Connect,” Britt says, “There’s an immediate excitement as people start using it. It’s great to have them come in and say ‘Wow, this is awesome.’”
Solution: A Cost-Effective Way to Simplify Workflow, Collaboration and Compliance
RBC’s nimble approach to design and development means it is perpetually seeking solutions and technologies that enhance its efforts. Selecting Jama Connect to augment its development environment produced notable benefits almost immediately.
As a versatile solution that integrates collaborative efforts and streamlines workflow from design through product release, Jama Connect meets many of RBC’s primary development challenges. A key Jama Connect capability — flexible integration with many of the tools commonly found in development environments — meshed well with RBC’s design agility and desire to work with whatever tools prove most effective for the task at hand.
Jama Connect Capabilities for Medical Device Product Development
RBC is continuing to discover Jama Connect’s capabilities to improve medical device development. Through requirements management, workflow automation and collaboration tools, teams gain extended visibility into processes across the entire product lifecycle. The tracking and reporting functions also help meet regulatory compliance goals and drive quality assurance. Among the capabilities RBC finds particularly useful for developing medical devices:
- Reviews and approvals: To maintain the chain of approval and increase stakeholder participation, Jama Connect’s Review Center streamlines and expedites the review process and has the ability to tie electronic signatures to specific reviews or baselines in compliance with regulations.
- Design verification and validation: Jama Connect manages V-model traceability, including test cases used for verification and validation. It also helps when providing objective evidence of compliance with government regulations and standards.
- Audit trails with reports: Real-time reporting and baselining tracks all changes to information within the system.
“Jama Connect frees us up to focus on the design of the product, not the logistics of the work that needs to be done. We are able to spend our time more effectively – helping our customers.”
Scott Britt, Systems Engineering Manager at RBC Medical Innovations
Jama Connect Excels at Meeting Additional Challenges
Since its deployment, the engineering team at RBC increasingly trusts Jama Connect to speed development, using it for a wider range of tasks — such as test management and defect tracking synced through an integration with Team Foundation Server.
“After we understood our requirements, test case and defect management,” Britt says, “We tested some Jama Connect reviews and it became obvious how efficient it was. Then we began building other deliverables in Jama Connect, not just requirements documents. For instance, now we’re creating planning materials in Jama Connect as well.”
As numerous companies have discovered over time, and RBC confirmed in their project work, Jama Connect unifies a complex development environment and gives teams the ability to track progress, optimize quality and audit results — all of which are critical factors in the development of successful medical devices.