The solution provides an integrated product where manufacturers and sellers maintain a master repository for sharing device information such as patient data, implant details, and Health Care Providers/Health Care Facilities(HCP/HCF) information.
Gathering and maintaining information for the tracking and monitoring of implanted devices is a tremendous challenge for any medical device manufacturer. Manufacturers must comply with FDA standards, conform with complex Federal regulations and comply with a wide variety of State regulations. Maintaining such a complex database and intricate system while conforming to the myriad rules and regulations is a challenging responsibility.
Manufacturers sell implantable devices that help patients lead a healthier life. Naturally these organizations are required to maintain very high standards by means of regular quality checks and transparent audit measures. It is one thing to manufacture quality equipment; when these devices are critical to human life, maintaining quality and reliability are imperative. This is especially important in the case of managing communication with patients, doctors and therapists (device recalls, upgrades,
etc.) when timeliness can significantly impact the quality of health care.
While tracking each medical device is indeed critical, maintaining a documentation and audit trail is also vitally important; audits are performed on a regular basis to ensure that standards of quality and control are being met.
Our client had an existing, older system in place for managing their process; but this system was reliant on a technology stack no longer supported by the supplier. Axis was engaged to analyze our client’s technology and help develop a strategy for a long-term solution and, if appropriate, propose a project to upgrade or replace the existing solution.
Axis Technical Group’s main goal? To keep your company one step ahead of the competition by continually optimizing and updating your technical components in the office.
The Axis team was able to efficiently identify and implement solutions that will increase our speed-to-market, while realizing significant cost savings.
As a result of the initial analysis project, it was determined to develop a new solution based on the current Microsoft technology stack as well as upgrade the hardware used to support the application and database. Senior Axis technologists architected a solution built on the .NET framework, primarily using the C# programming language and SQL database. The development team applied a WCF application layer, tools for document generation and conversion, custom reporting, batch-based process management and standardized user interface design methods.
Axis offers a robust Quality Assurance and testing process utilizing a hybrid of onshore and offshore resources which have many years of experience working together. As recommended by Axis and required by the client, rigorous testing and Quality Assurance methods were applied to the solution throughout the development cycle. In addition, exhaustive regression testing was performed before the application was submitted for User Acceptance Testing by the client.
In order to meet FDA compliance standards, Axis also developed robust documentation to comply with the client’s own audit and compliance procedures; including business requirements, system design, test case and test execution reports.
This new solution offers a full-service toolset, where the client can directly receive registration documents, handle follow-ups, support a dedicated investigative team and call center, and can quickly respond to changing FDA requirements. The solution also allows for the option to outsource business functions, including document scanning and indexing, data collection, validation and management and report writing.
Updated and industry-compliant technology has ensured business continuity and stability; in addition, FDA-compliant documentation has instilled a sense of trust and faith at the client. The highly stable and robust system, based on scalable architecture, effective reporting, data aggregation, efficient processes and seamless integration with related sub-systems have provided a platform to support the client’s planned growth.