A Developing Story: Grifols Reduces Medical Device Development by 80 Hours Using Jama Connect

Jama Software

Grifols Improves Medical Device Development

Spanish multinational pharmaceutical and chemical manufacturer Grifols is the leading producing of blood plasma-based products. With over 21,000 employees in its four divisions—Bioscience, Diagnostic, Hospital, and Bio Supplies— Grifols develops, produces, and markets innovative medical device solutions and services in more than 100 countries.

As a leader in the future of healthcare, Grifols strives to set the standard for continuous innovation, quality, safety, and ethical leadership. On an operational level, it knew that its requirements and risk management processes played a key role in facilitating innovation, and its current solution wasn’t up to the task.

Grifols Sees Opportunities for Process Improvement

When Grifols’ Diagnostic division began a new project in 2018 to improve the management of disease detection in blood bank laboratory operations, the company knew it had an opportunity to improve its requirements and risk management processes. While the company’s legacy solution had served its purpose for many years, the task of reviewing requirements was arduous. The solution was also unable to facilitate the collaboration needed to keep the project’s team — split between Spain and the United States — on the same page.

Read our eBook to learn more about risk management for Class II and Class III medical device development.

“Our globally dispersed teams need to work on the same projects and using our previous legacy solution was very slow,” said Carmen Pazos, Diagnostic Divisions R&D Instruments Senior Manager at Grifols. “We experienced performance issues. We were looking for a way to expedite the process.”

Legacy Solutions Impede Innovation in Medical Device Development

Not only were the processes tedious and error-prone, but since Grifols’ products are considered medical devices, they must also comply with ISO 14971 — the standard for the application of risk management to medical devices. So, on top of Grifols’ manual process being time consuming, it also made things difficult to document and prove compliance.

It was then that the Diagnostic division was introduced to the solution that Grifols’ Hospital division had been successfully using. “When I saw how Grifols was already using Jama Connect, I thought, ‘I really need that,’” Pazos said.

Learn more about how Jama Connect helps teams improve medical device development.

Grifols Improves Risk Management and Speeds Development

Within two or three months, Grifols began working from a medical device pre-configured template within Jama Connect on a small, low-risk project to test its capabilities. Things went well and Grifols began implementing Jama Connect into more projects.

The immediate benefits the Diagnostic team saw from Jama Connect were how user-friendly and intuitive it is, while also keeping people in different time zones instantly in synch. The ability to comment and facilitate robust discussion within Jama Connect helps remote teams drive clear agreement on project items while also automatically building an audit trail for compliance.

And the results are also worth mentioning. Within months of onboarding Jama Connect, Grifols reported:

  • Savings of 80 hours or more per project
  • Review cycles reduced from three months to fewer than 30 days
  • Requirements linked to risks, tests, and executions for traceability
  • Improved communication and efficiency
  • Reduced rework

Read the full case study to see how Grifols was able to increase efficiency and cut costs by optimizing their requirements and risk management process with Jama Connect.

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