Tag Archive for: requirements traceability

SITA improves team collaboration

As globally-distributed teams become the new normal in complex product development, promoting team collaboration and keeping remote staff members on the same page can be challenging. That’s especially true when it comes to ensuring the backbone of product development is correct: requirements.

As a multinational company providing IT and telecom services to the air transport industry, SITA (Société Internationale de Télécommunications Aéronautiques) identified a need for a modern requirements management solution for its Border Management portfolio to help its distributed teams facilitate better team collaboration around requirements.

Read this brief to learn why Frost & Sullivan likes Jama Connect as a modern solution for risk management.

Ease of Use a Critical Factor for Global Team Collaboration

Founded in 1949 by 11 airlines that combined their communication networks to establish a cost-effective, shared infrastructure, SITA is the world’s leading specialist in air transport communications and information technology. And although the company is headquartered in Geneva, Switzerland, the organization has nearly 5,000 employees across 197 countries.

With an extensive communications network that covers nearly 95% of international destinations, it was crucial that SITA find a requirements management platform that allowed its team to effectively communicate and collaborate across international borders – and to do so, it knew it needed a solution that was easy to use in order to promote high adoption rates. After a lengthy selection process, SITA decided that Jama Connect™ was best requirements management solution available.

Learn how better requirements management helps better facilitate the collaboration process by watching our webinar.

SITA Finds Ongoing Success with Jama Connect

Shortly after onboarding Jama Connect, the team overseeing SITA’s Border Management portfolio found that the platform provided increased opportunities for stakeholder collaboration. They were also delighted to see streamlined review processes for requirements and traceability throughout the development cycle.

After three successful years of using Jama Connect, SITA has found that the robust requirements management platform has given the team:

  • An efficient, easy way for cross-functional teams to review requirements
  • A centralized, accessible repository for all its requirements
  • End-to-end traceability for requirements

In addition to the great success SITA has already found with Jama Connect, the organization continues to find fresh ways of leveraging Jama Software to gain more value.

“With Jama Connect, as we find new areas of either functionality or internal process requirements, we update our requirements process accordingly and train the team and roll out new aspects of it,” said Alistair McBain, Senior Business Consultant at SITA.

Read the full case study to learn more about how SITA leveraged Jama Connect to align its remote teams and facilitating effective team collaboration around requirements.

As medical device developers compete to push the boundaries on designing and building innovative, connected medical devices, the market continues to boom. It doesn’t look to be slowing down anytime soon, either. KPMG estimates that global annual sales of medical devices will rise by over 5 percent a year to reach nearly $800 billion by 2030.

Modern medical device makers are hyper focused on building innovative, connected solutions for the next generation of care. That continued innovation opens the door for new, lower cost technologies for early intervention and at-home care. But it also opens the door for more risk.

In the past, medical device software was generally used to control programs to simply switch the equipment on and off and display readings. Today, software and its functions dominate much of the features, making devices far more integrated, complex, and connected-and growing more so every year.

Growing Concern for the Security of Connected Medical Devices

While smart devices provide opportunities for instantaneous results and early medical intervention, connected medical devices are also more vulnerable to both deliberate attacks and undirected malware.

A survey released in October 2018 of 148 healthcare IT and security executives, conducted by Klas Research and the College of Healthcare Information Management Executives (CHIME), showed that an astonishing 18 percent of provider organizations had connected medical devices impacted by malware or ransomware in the last 18 months.

The threats against medical devices have become such a concern that two U.S. federal agencies recently announced a new initiative to address vulnerabilities. In October 2018, the U.S. Food and Drug Administration and the U.S. Department of Homeland Security (DHS) announced a memorandum of agreement to implement a new framework for greater coordination and cooperation between the two agencies for addressing cybersecurity in medical devices.

Read this case study to see how RBC Medical Innovations leveraged Jama Connect to unify processes and enhance traceability.

Modernizing Requirements Management to Reduce Risk

The reliance on connected medical devices isn’t going to ebb, and the increased complexity will only make the management and reporting of interconnected information across product definition and verification more difficult and inefficient. This inefficiency is only exacerbated by the use of document-based requirements management, which introduces more risk into the process.

To achieve better results with projects of mounting complexity, teams must get a stronger handle on their process and avoid gaps in development. A better solution for requirements traceability can do just that.

Traceability, normally a sub-discipline of requirements management, ensures that engineering design aligns with the identified needs of users and patients; manages scope by ensuring alignment between engineering work and actual user needs; confirms that device needs are addressed at all levels through gap analysis; and connects the design of the device directly to the verification.

Requirements Traceability is No Longer Optional

Small teams building simple products may be able to get by initially with spreadsheets, documents, and emails, but with the rise of software-driven, connected medical devices and increasing system complexity, requirements traceability quickly becomes too convoluted to be handled manually.

The reality is that the more complicated or distributed the product development process becomes, the more opportunities for error are introduced. Excel just can’t account for the wide array of risks and requirements involved in medical device development.

In fact, according to Stericycle’s Recall Index, software issues were consistently one of the top causes of medical device recalls through 2017 and 2018.

Learn how Jama can help you better manage risk with ISO 14971 by downloading our white paper.

Today’s medical devices are so much more than metal and plastic – they’re incredibly complex, connected devices that require complete hardware and software traceability.

Medical device development contains too many scope changes, remote team members and reviewers, and requirements to be easily managed in documents and emails. Using Excel or an internally developed requirements management solution or system diverts scarce resources and availability away from the important tasks of product development. Instead, team members have to focus on attempting to assemble and maintain traceability, usually resulting in the trace being hastily thrown together in the end for the design history file (DHF).

Traceability increases efficiency, drives alignment, and mitigates organizational risk. And with Jama Connect, teams can link and decompose high-level requirements to more detailed system and sub-system requirements, including associated risks and hazards, to ensure proper verification and validation before release.

Download our eBook, Conquering Connectivity, Competition and Compliance, to learn about the top three challenges that modern medical device makers face and how to overcome them.