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.