GessNet
De-risking Medical Products

As network-connected medical products become a key cornerstone for modern healthcare systems, medical device and drug manufacturers are facing increased challenges to manage risks of safety, cybersecurity, quality and regulatory compliance. An effective risk analysis involves multiple tools, including Hazard Analysis, Fault Tree Analysis, Failure Mode and Effects Analysis, Risk Traceability Analysis and more. This makes it difficult to connect all output cohesively and maintain it together, reusable and in sync throughout the product life cycle. The connected medical products and its derivatives require risks can be managed at individual derivative product, subsystem, component, or use environment level, as well as be integrated and connected systemically. The complexity of today’s medical products and its continuous evolving use environments make risk management error prone, which can lead to product recalls, new product regulatory approval delays, and/or other regulatory or legal problems. Addressing all these issues is GessNet™, a company founded by people who have worked in the medical industry for many years, providing software solutions and expert consulting for medical product risk management.

Being equipped with all you need risk analysis tools, GessNet’s TurboAC™ automates, streamlines safety and cybersecurity risk management activities, maintains records and results throughout the product life cycle. It makes it easy for manufacturers to adhere to industry standards (e.g. ISO 14971) and FDA requirements, and integrates safety assurance case method into the risk management process as needed. With TurboAC, multiple processes, including hazard analysis, security threat and vulnerability analysis, fault tree analysis, attack tree threat modeling, failure mode and effect analysis, safety and security risk assessments, assurance case development, post market product risk vigilance and risk management file maintenance, can all be performed jointly in one electronic system throughout a product life cycle. Also, the risk information can be analyzed and reported in multiple formats to suit various needs. “Based on engineering science for safety, TurboAC is specifically designed for medical product risk management, and is highly flexible and configurable for generating various reports to meet various regulatory compliance or business practice needs,” remarks Fubin Wu, Co-Founder. In addition, the company’s risk management consultants help manufacturers gain the latest insights for staying ahead of the curve in industry’s best practices for safety, regulatory compliance, time to market, and engineering productivity.

As an innovative risk management solution, TurboAC has quickly gained recognition by professionals of medical device and pharmaceutical manufacturers ranging from large corporations (such as Medtronic PLC) to small startups across the globe. For instance, Cellnovo, a British mobile diabetes management system company, wanted to link Failure Mode and Effects Analysis (FMEA) with Hazard Analysis to ensure cohesiveness and transparency in information. “Cellnovo originally trialed a number of different risk management and safety Assurance Case software packages but quickly discovered there was no single package that fulfilled all of our needs,” says Ross Gunton, Safety Engineer, Cellnovo. “The automatic generation of Assurance Case Graphics and Fault Tree Analysis within the tool represents a huge augmentation in performance.” Gunton further states that since installing the GessNet TurboAC software, the training and customer support received from the team at GessNet has been of the highest levels. Online facilities, screen sharing and remote access tools were made available by GessNet to assist clients with any questions. More recognition can be found at http://www.gessnet.com/ testimonials.

Based on engineering science for safety, TurboAC™ is specifically designed for medical product risk management, and is highly flexible and configurable for generating various reports to meet various regulatory compliance or business practice needs

Having served many manufacturers over the years, GessNet’s mission has always been to advance medical product risk management and make it a competitive advantage for the clients. Moving forward, the firm plans to build on their mission. Wu reckons that risk management is the central intelligence unit for medical product manufacturers to implement risk driven quality and business management systems, and risk management should be connected to any safety related systems or information intelligence centers to comprehensively manage risk. “Our future releases will continue expanding TurboAC’s connectivity to other electronic systems or information centers,” concludes Wu.