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.
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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, Risk Management for Class II and Class III Medical Device Companies, to learn about the top three challenges that modern medical device makers face and how to overcome them.