There are an estimated 1.5 million different medical devices available worldwide and thousands of new and innovative medical devices are introduced in the market every year. Each year, the FDA receives several hundred thousand medical device reports of suspected device-associated deaths, serious injuries, and malfunctions.
The RdQCC (Risk driven Quality Consulting Company) is dedicated to research, develop, and consult product risk analysis for medical devices and complex projects. RdQCC has been consulting for many top medical device companies and start-up developers to reduce their product risks in the course of product development process during the past decade.
Jerry(jinxing) Xiao, Founder of the RdQCC, was with the CEOViews team to share the story of their journey and what they envision.
CEOViews: RdQCC is a pioneer in dedicatedly developing product risk management software for healthcare industries. How did you come across this whole concept?
RdQCC: Medical device developers shall be responsible to reduce product risks as far as possible per ISO 14971:2019 requirements. 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 engineers need to predicate potential new risks as quickly as possible, 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.
CEOViews: As a Risk Management Software Provider for the Medical Devices, what do you strive for the most?
RdQCC: The core values and common ethos are to improve the safety of medical devices, protect patients, and promote public health. RdQCC strives innovation to improve safety, detect safety risks earlier, identify the root causes of failures, and develop risk control measures for medical device developers.
CEOViews: RdQCC has been recognized as Best Innovative Companies of the Year 2022, what is the next step?
RdQCC: After many years of hard work, RdQCC is developing a risk predication tool (risk-discovery.com) which allows users to parse the statements into lists of potential risks. On next step, the tool shall be embedded within the FMEA/HA worksheets to support daily risk analysis activities; the tool shall be embedded within the risk document remediation process to deal with volumes of legacy files; the tool shall be embedded within risk training process which allows users to exercise risk analysis and evaluate skills.
In the further future, the risk predication tool shall be embedded within other product development system (e.g., requirement management) in order to implement the risk assessment activities parallel with the product development activities.
CEOViews: What are the major problems/difficulties/ challenges you have faced and overcome throughout your journey so far?
RdQCC: It is possible that different professionals may do risk analysis differently and identify risks differently for the same case. The quality of risk analysis is dependent on personal experience and interdisciplinary knowledge (e.g., mechanical, electrical, software, system, regulatory, cybersecurity, and manufacturing). The challenge is to identify critical risks (e.g., high frequent risk, high severity risk) under a limited time.
Since the risk prediction tool was launched, RdQCC constantly receive users’ feedback daily basis and get chance to expanding more wide-range of major medical devices. fuelled by fast growing
AI technologies, the predication tool is able to improve its accuracy and resolution of predication significantly. Just like a chief software quality engineer said to her team during a meeting: if you have no idea about risks you are working on, use the tool to find clues.
CEOViews: How do you manage to meet the expectations of your clients while developing risk management software for them?
RdQCC: We know users are struggle about the time lag between product development and its risk mitigation. The risk predication tool (risk-discovery.com) fills this gap and allows users to predict potential risks within 20 seconds.
The tool is able to extract risks from design planning requirements (e.g., user needs, market, compliance, cybersecurity, regulatory, system), design input requirements (functions, performance, safety, standards, human factors), design output specifications (e.g., software, hardware, user interface, IFUs), design verification failures, design validation failures, post-market data (complaints, recalls, failure analysis).
The tool is able to predict risk characteristics which includes failure modes, hazards, hazardous situations, harms, severity levels, and risk regions. The tool is able to perform root cause analysis and provide risk mitigation measures across levels of safety by design, protective measures, and information for safety.
Due to constantly standard revisions or regulatory requirement upgraded, there are huge legacy risk documentations which need to be updated. RdQCC tool is able to convert data from old worksheets into the new templates, update specific risk items quickly and accurately.
CEOViews: What are the technologies that help you most significantly in dealing with risk management of the product?
RdQCC: Cognitive Science, Quality Engineering, NLP (Natural language processing), Big Data, Machine Learning, and AI (Artificial Intelligence).
CEOViews: What are the major goals and objectives of your company?
RdQCC: Reduce project uncertainty, shorten development periods, cut development costs, eliminate potential product risks, and promote system(product) quality.
CEOViews: According to you what are the major things to keep in mind before researching, developing, or consulting product risk? RdQCC: Patients and users’ safety is the first priority.
CEOViews: What does your company’s logo signify? Any special reason behind keeping this as your company logo?
RdQCC: Our logo reveals a true: when any user needs are implemented on the way, the product functionality (white zone) and the product risk (dark zone) are created at the same time. RdQCC shall always watch risks (human profile).
CEOViews: What type of philosophy do your company undertake?
RdQCC: “You change the world, we secure it”. Since FDA premarket approval process is to review and evaluate the safety and effectiveness of medical devices, product risks can lead to failure of a new product development. RdQCC aims to be as a protector for those great innovation.
CEOViews: What type of trends and technologies according to you, will be trending in the future in medical equipment manufacturing companies?
RdQCC: Technological innovations continue to present new opportunities to improve existing healthcare solutions in the field of telemedicine, AI augments healthcare process, medical robots, digital therapeutics, biometric devices and wearables, 3D bioprinting.
CEOViews: Any piece of valuable advice you would like to share with your peers in your industry?
RdQCC: I would like to speak to innovators “take risks, since we are watching your back”.
