Developing products for the regulated medical device market requires meticulous, organized and sustained collaboration, especially when teams are distributed globally. With product development centers in North America, Europe and China, bringing new products to market takes a minimum of six months to one year, and can take up to two years. Jama’s customer, a global leader in the manufacture and distribution of innovative home and long-term care medical products that promote recovery and active lifestyles in over 80 countries, is no different. Their design engineers oversee a large portfolio of hundreds of products, and most of them have multiple iterations. Team efforts extend far beyond development: the design engineers oversee the complete product life cycle, from pre-production through life span to product transition planning. They rely heavily on Jama Software.
Here’s the challenge the global product development centers were running into:
- Meeting quality objectives
- Verifying user safety
- Demonstrating regulatory compliance
As a large, well-established company with products already in global markets, our customer realized its future success would depend on anticipating, responding to and satisfying the growing needs of a world population that is aging at once, and creating unprecedented demand for product innovation.
While product development under these conditions is difficult enough, FDA governance adds greater complexity: The top three business pressures for any company in the medical device industry are meeting quality objectives, verifying user safety and demonstrating regulatory compliance without increasing or introducing unnecessary patient or company risks.
In order to navigate the complicated maze ahead, they realized that staying competitive required a faster, more efficient start-to-finish build process, which, in turn, required establishing and maintaining developer and stakeholder alignment—no small feat for an international company with thousands of distributed employees.
- Dynamic, end-to-end traceability
- Change control and management
- A single source of “live” contextualized data that’s easy to learn and use
Modern medical device compliance requires exacting document and information management, and organized and detailed communications; trying to manage it all with the wrong solution is a guaranteed way to slow down, not speed up, product development. Our customer realized that traditional methods wouldn’t work, so the company partnered with Jama to re-evaluate and redesign its development processes and configure a solution to support them.
Solution must-haves included: Ensuring start-to-finish traceability for FDA audits, documenting the entire requirements management process, verification and validation, and meeting standards.
Using Jama, the large, well-established med device company not only manages the requirements, but also the change control process. Teams are now easily able to keep track of critical quality elements.
When the company added its software engineers to Jama, it gained immediate efficiencies as well: previously, product development engineers were only able to provide traceability for the end product. Now, software and hardware engineers can easily tie together data, decisions, actions and the people involved, throughout the entire process.
They are particularly enthusiastic about Jama’s dynamic Trace View feature. Traditionally, traceability has been a static snapshot of requirement data, something to see and absorb. Jama’s Trace View makes data navigation interactive. Teams can fix what’s broken and ask questions such as, Is this covered or tested? Who wrote this? Why are we building this? When was this built? Teams can see and understand the impact of a choice they’re considering before they decide.
In addition, the company chose a deployment model that allowed for container-based delivery and complex enterprise security needs. Powered by Docker and Replicated technologies, the simple installation packages Jama’s hosted environment and experience for customers to deploy securely behind their firewall.