Control: risks, costs and product quality
Reduce: development and test cycles
Master: compliance and audit complexity
Medical technology companies have always had to innovate quickly to be competitive and profitable.
Team collaboration and alignment, without introducing new risk or reducing existing risk to customers and stakeholders alike, is key to that success, as is documenting and mitigating requirements, risks, verifications and validations, and demonstrating compliance.
As medical device development complexity increases, infrastructure safety concerns and evolving regulations reflect new risks. Yet, the pressure to move fast persists.
To be quick, accurate and efficient, teams need to be able to work in real-time data, act on it and navigate it like an interactive map. People need to see what’s broken, ask questions and understand the impact of each choice before making it. Everyone involved needs the ability to focus on the trends, patterns and data they’re concerned with, without data overload.
The solution: Real-time traceability with thorough upstream and downstream tracking.
How Jama Benefits Engineers & Stakeholders
- No more data silos:See the traceability for data you’re interacting with, whether it’s a set of requirements found navigating the tree, through filters or a set of items tied to a release. Want to know what’s connected? Trigger the Trace View
- Build traceability as you work:The Trace View makes it easy to see what relationships are missing so you can quickly fill the gaps and never lose context. Working with a shared view of the world, rather than versions of documents, you create relationships as you go
- See relationships during reviews: Feedback makes sense when reviewers have the context of related items. Users can see all upstream and downstream items related to those being reviewed
- Bookmark your key data: Use bookmarks to make returning to the data you care about in any location in Jama easy
- Make more informed, successful decisions, daily: Traceability data is too valuableto be referenced only at audits. Live traceability makes decisions easier by not only showing how requirements are decomposed, but also includes comments, past decisions and reviews, and the impact of changes
How Jama Benefits the Business Needs of the Enterprise
- Keep hardware teams, software teams and stakeholders aligned within your tool ecosystem: Everyone sees upstream and downstream to understand the dependencies and relationships of even the most complex products
- Accelerate innovation: Speed up and maintain innovation cycles as mergers and acquisitions bring new technologies, distributed teams and tools together
- Capture every critical detail of every complex product: Jama organizes complex, interrelated requirements, changes and critical data clearly, and in a structure that works with your chosen tools and processes
- Smoother audits and major milestones preparations: Jama maps your data as you work so you can see and manage risk, anticipate changes, stop potential problems and demonstrate compliance with regulations
- Quick and painless data reuse: Teams can quickly leverage existing requirements to kick start development of new versions and variants
Use Jama to Reduce the Cost of Compliance
Modern medical device compliance requires exacting document and information management, and organized and detailed communications. An example: A medical manufacturer for home products approached Jama after an FDA audit suspended its production rights. The FDA required the company to document its RM process, complete traceability and meet standards including ISO 14971, ISO 13485 and 21 CFR Part 11. The company partnered with Jama to redesign its processes and configure a solution to support them. Within one year, our customer had reduced risk and produced the necessary evidence to give the FDA confidence that its product was safe for consumers.
Why Jama for Medical Technology Development? 6 Reasons
- Trace requirements end-to-end: Link and decompose program-level capability requirements and operational requirements to system requirements, and then down to lower-level software and hardware requirements. Traceability in Jama increases efficiency, drives alignment and mitigates product and company risk.
- See the impact of change quickly: Fine-grained impact analysis provides instant data insights. Use the analysis to make informed decisions as requirements evolve during long development cycles or due to shifts in technology.
- Design verification and validation: Seamlessly manage V-model traceability including test cases used for verification and validation, and provide evidence to comply with government regulations and standards, like 21 CFR Part 820.
- Conduct organized reviews and approvals: Maintain the chain of approval and increase stakeholder participation. Within Jama, tie electronic signatures to specific reviews or baselines.
- Manage risk analysis: Create a customizable view with calculated fields to mitigate risk and manage analysis within Jama. Understand the impact of each decision. Ensure that your product is safe and meets regulatory standards.
- Maintain audit trails with reports: Customizable, real-time reporting and baselining allows you to track all changes to information within the system, including time-stamps and associated users.
Customer Success Snapshot
For 30+ years, Fortune 500 companies have turned to Plexus engineers to design, develop and test Class II and III medical devices and life sciences products. Plexus is ISO 13485 and Quality System Regulation compliant with 13,000 employees, 23 facilities and 500 engineers worldwide. Regulatory approval requires Plexus to guarantee traceability and documentation. After considering a variety of solutions for collaborative, compliance- and audit-friendly RM, Plexus chose Jama.
“Our main performance measurement is repeat business from our customers. They don’t come back if we’re not meeting the schedule and project budget. And these are things that Jama helps us do. It makes us more efficient, leading to repeat business. Customers have stated that our mature process for managing requirements is a reason they select Plexus as a partner,” says Dave Strandberg, Director of Engineering Solutions.