This blog series is jointly based on the expertise of Randy Armstrong, Chief Technology Officer at Velentium, and Jama Software’s experience working with developers of Class II and III medical devices. To download our joint whitepaper on this subject, click here.
Tip #1: Tell Legendary Stories
The big ones make news headlines: “Company A’s defective medical device doesn’t perform as it should.” The story tells what went wrong and how it could have been prevented. The company scrambles through press conferences, people lose their jobs, and the company may even go out of business.
On some scale, every organization has stories about “the one that got away.”
Fortunately, every company also has tales of “the big catch” — the heroic detective work that stopped a major defect from going into production. The found error that kept the company out of the media’s crosshairs.
Telling these legendary stories within a development organization can help build a culture of quality reviews. It can encourage contributors who are eager to ensure their work is reviewed and corrected, and thus secured against potential pitfalls. It can also foster individuals excited to be the curious sleuth.
These stories remind people that “to err is human,” and it’s everyone’s job to find mistakes.
Tip #2: Use Appropriate Tools
Velentium is pleased to point out Jama Connect Review Center as a prime example of a well-designed review management tool. Jama Connect™ Review Center acts as a central hub designed to simplify the review process for all parties involved. Within Review Center, teams are better equipped to collaborate in real time and stay aligned throughout the review process. The result is quicker response times, faster review cycles, and fewer questions during audits or regulatory approvals.
With Review Center, teams can quickly and easily solicit and gather input from a diverse range of stakeholders, which enables holistic thinking about customer needs. This safeguards against blind spots further on in development, thus reducing late-stage changes and delays.
Stakeholders can also easily provide feedback where required so they are not mired down in a litany of materials they are not meant to cover. This helps lessen the likelihood of “review fatigue” and makes stakeholders more likely to spot defects. And for those overseeing the review process, Review Center shares information related to which stakeholders have made progress in their reviews and how much work still needs to be done.
Furthermore, good collaboration improves risk management and compliance. Since reviews and approvals are all tracked as proof that the right participants reviewed the required materials, risks are mitigated in compliance.
Review Center can also be used as a tool to achieve compliance objectives like FDA 21 CFR Part 11 with workflows designed to meet requirements for electronic signatures and records.
Going one step further than most platforms, Review Center also allows organizations to maintain reviews as electronic records. In terms of the storage, security, and maintenance of electronic records, Review Center provides organizations with the ability to:
• Add specific electronic signature roles
• Prevent reviews that have captured electronic signatures from being deleted
• Review activities that may modify electronic records for audits
• Export reviews in a readable format to a formal system of record such as a quality management system (QMS)
Designed with both compliance and user-friendliness in mind, Review Center makes it easier to prepare for audits and gain regulatory approvals.
Industry-leading medical device development customers praise Review Center for its ease of use and its impact on the process overall: shorter and fewer meetings and increased confidence in what they are building. To visualize
ABOUT RANDY ARMSTRONG
Randy Armstrong is the Chief Technology Officer at Velentium. In 30 years of designing medical devices – specializing in active implantables – Armstrong has more than 25 commercially available product designs and 54 U.S. patents. He is also a U.S. delegate to ISO for the development of medical device standards.
ABOUT JAMA SOFTWARE
Jama Software provides the leading platform for requirements, risk, and test management. With Jama Connect and industry-focused services, teams building complex products, systems, and software improve cycle times, increase quality, reduce rework, and minimize effort proving compliance. Jama’s growing customer base of more than 600 organizations includes companies representing the forefront of modern development in areas such as automotive, medical devices, financial services, industrial manufacturing, and aerospace.