RdQCC
Providing Risk Management Solution for Medical Devices

For decades, reducing product risks for users and patients has played a key role in the development of medical devices design. FDA premarket approval process is to review and evaluate the safety and effectiveness of medical devices. Risk analysis is a structured approach for assessing potential risks that could arise from utilizing a medical device. In both expected and unexpected situations, medical device developers shall predict potential failure modes during the design phase. If a potential risk is deemed intolerable, it must be mitigated to acceptable level by applying risk control methods (e.g., inherent safety by design, protective measures, information for safety). The first challenge is how to predict and mitigate potential risks sufficiently and effectively. Typically, once a new product requirement is created, or a product requirement is updated, design assurance professionals need to predicate its potential new risks as quickly as possible to predict potential risks, evaluate the risk levels, and request design engineers to update product requirements, or create new product requirements as risk control measures. The second challenge is how to implement design changes quickly prior to commercialization. However, therein lies the problem. For the decade or more, there is a significant time lag between product development and its risk mitigation. Consequently, over 90 percent of medical electrical devices have failed on the first submission in the last two years alone.



This is precisely where RdQCC makes a world of difference.

Technology Foundations:

Since its inception in 2013, RdQCC is dedicated to develop product risk management solution for medical devices and complex projects. Conceptualized by a group of professionals from risk management engineers, quality engineers, project managers, software engineers, and data scientists, the company embodies the best practices to eliminate the time lag between product development and its risk mitigation. They offer proven solutions powered by bleeding-edge technologies such as NLP, big data, and machine learning.

Real Time: “As a company, we aim to establish risk management solution for our clients to reduce product risks in the course of product life cycles to promote system (product) quality,” says Jerry(jinxing) Xiao, Principal Consultant, RdQCC. “With our risk search engine, users can identify potential risks within 20 seconds. Such intelligent tool allows the product risk analysis to work side by side with the product development.”

Broad Scopes: The RdQCC solution targets to predict product risks for development activities from design planning (user needs, market requirements, compliance, cybersecurity, regulatory), design input (functions, performance, safety, standards, human factors, labeling & packaging), design output (specifications, acceptance criteria), design verification (test protocols, test reports, system integration), design validation (clinical studies, usability tests and reports), design change (change analysis), product launch (complaints, recalls, post market surveillance).

At its core, the software consists of two components: electronic risk analysis (e.g., FMEA, hazard analysis) and web-based risk prediction engine (e.g., data trained models).

With our risk prediction tools, users can identify potential risks within 20 seconds

It is important to note that these two components can be used separately or integrated as one unit depending on the user needs.



Electronic Worksheets: Unlike traditional excel-based FMEA worksheets, the electronic FMEA worksheets are able to satisfy different type of FMEAs (DFMEA, PFMEA, Software FMEA, System FMEA, User FMEA); maintain all information at database; establish risk architecture to align with the product architecture; trace risks from the bottom (module-level) to the top (system level); quickly evaluate the impact of design changes inside the entire risk architecture.



Intelligent Prediction Tools: The tools can dynamically predict entire risk characteristics, including failure modes, hazards, hazardous situations, harms, severity levels, and risk regions from words, sentences, paragraphs, or technical reports. The tools can perform root cause analysis and predict potential failure causes from event statements (FDA Maude, customer complaints, field reports). The tools can predict risk mitigation measures across levels of safety by design, protective measures, and information for safety from event statements or design statements. The tools can be customized to provide Subject Matter Expert (SME) level service and high resolution based on the specific customer data. Furthermore, the solution is developed based on AI technology and will grow with the progress of technology for better customer service.

Embedded Prediction Tools within Others: The tools can be embedded within the electronic FMEA/HA worksheets to support daily risk analysis activities. The tools can be embedded within the risk document remediation process to deal with volumes of legacy files. The tools can be embedded within risk training process which allows users to exercise risk analysis and evaluation skills.

Stories: To put things into perspective, one of RdQCC’s clients needed to update its legacy FMEA worksheets (e.g., design FMEA, use FMEA, and process FMEA) into new templates as per the ISO 14971: 2019 version. It may cost 10 minutes on average to convert one row and update contents, including its severity levels and risk regions, manually. By using the RdQCC solution, the original document is uploaded into the system at once, and the data is updated based on the preset rules and then mapped into the new templates. It was able to reduce the project time by 10 percent and helped avoid user errors, such as data misalignment and data integrity issues.

Needless to say, RdQCC stands as the most sought-after partner for varied medical device organizations for solving their complex technical challenges. Going forward, the company aims to enhance its solution from a quality, efficiency, good user interface perspective by collecting user feedback, creating more value for its users. “We understand customer needs and what the customized solutions should be. Your challenges inspire our solutions,” concludes Xiao.