Medical device companies are under increasing pressure to release safe, regulatory-compliant devices on-time, on-budget and at a competitive price point— while continuing to innovate. At the same time, medical device product failures are on the rise. According to the Stericycle Expert Solutions Recall Index report, recalls increased 126 percent in the first quarter of 2018 alone. These statistics represent the medical device industry’s highest number of recalls since 2005. Software issues are cited as the number one cause of these recalls.
"Working with more than 160 medical device manufacturers globally, we have a deep understanding of the challenges they face in developing products in a regulated landscape. Identifying product risks, such as hazards and potential harm to a patient, is a fundamental part of the product development process,” said Scott Roth, Jama Software's CEO. “A solution that gives individuals and teams the ability to make the risk management process a living document, while incorporating medical device best practices for risk management and product definition, is absolutely critical in today’s environment.”
“From a systems engineering point of view, over half of the requirements for medical device development pertain to risk mitigation,” said Randy Armstrong, chief technology officer for Velentium, a medical device consultancy. “Jama’s new product enhancements bring much needed ease and simplicity to a highly complex product development process, while helping medical device companies adhere to standards such as ISO 14971 Annex E. We anticipate a quick and smooth transition to Jama’s solution for those still relying on Excel spreadsheets.”
The product enhancements and new service capabilities build on Jama’s ongoing investment in the Jama Product Development Platform, with the inclusion of risk and hazard analysis.
The Jama Connect Risk Management Center incorporates and enhances the risk analysis process within Jama Connect. As a result, teams can view and properly mitigate risks with confidence, enabling them to quickly move to the next phase of development. Further, development teams can:
- Participate in risk assessment such as Preliminary Hazard Analysis (PHA) and risk mitigation;
- Utilize out-of-the-box risk management templates aligned with ISO 14971;
- Connect verifications back to requirements; and,
- Export plans for sign-off
Jama Medical Device Services are designed for companies that are new to developing regulated products, are lacking a well-defined development process, or want to digitize a document-based requirements management process. This complete tailored solution eases the path to regulatory compliance by ensuring teams get up and running quickly with Jama Connect based on a process tightly aligned to governing regulations ISO 13485:2016 and 21 CFR 820.30. Jama Medical Device Services include an out-of-the-box configuration designed to reflect medical-device development best practices, along with training and documentation templates for relevant key assets required for Design History File (DHF) assets.
“Jama is helping customers better manage medical device requirements, compliance, risks, and design controls all in one powerful platform,” added Roth. “With resources, analysis and tools available in a centralized location, the process of regulatory submission and audit preparation is streamlined and efficient, so that engineers can sharpen their focus on achieving the next product milestone.”
Jama Software is a product development platform provider for companies building complex products and integrated systems. The Jama Product Development Platform helps companies establish a Predictive Product Development process—to mitigate risk, improve quality, identify opportunities and decrease time to market—via an integrated solution for guiding the product lifecycle from idea to launch. More than 600 innovative companies use Jama Software to modernize their product development process. The company is headquartered in Portland, Ore.