As the cost of developing state-of-the-art medical devices grows and competition becomes more intense, medical device manufactures must balance the needs of the industry with patient safety and their bottom line. Management at every level must have visibility into the top risks that are affecting their time-to-market, regulatory compliance and the cost of quality. Given the fact that quality risk documents are often not centrally managed or standardized, reporting of quality controls can be very difficult and time consuming. Not only does manually preparing reports require time and effort, but also the data is inherently out-of-date and subject to human error.
Consumers are more involved than ever in product design and globalization has increased competition and expanded the supply chain. As the requirements from patients, doctors, suppliers and regulatory bodies mount, so too does the need for transparency and traceability into the product lifecycle. Medical device manufacturers must use a lifecycle approach to managing quality from cradle to grave. Closing the loop to ensure post-market feedback is incorporated into the design and manufacturing process provides a higher quality product and improves regulatory compliance.
| Challenge | Solution |
| Repeat failures or recalls | Gain Risk Visibility – Real-time visibility into quality & risk information, enabling Management to participate in the quality system and ensures timely communication and governance of risk. |
| Inconsistent quality reporting leading to faulty post-market feedback, product failures and increased risk to patient safety | Act Decisively – Knowledge libraries allow the efficient use of lessons learned to enable continuous improvement, also reducing effort and improving consistency. These capabilities avoid the risk of repeat failures across products or sites. |
| Disparate documents and risk assessment systems | Link Information – Lifecycle approach to all risk management related documents - linking documents such as Voice-of-the-Customer (VoC), Design Input, Validation & Verification, Preliminary Hazards Analysis (PrHA), Design FMEA, Process FMEA, Control Plans, etc., allowing for full disclosure and accurate impact analysis, as well as better future design decisions. |
| Compliance with FDA and European Medicines Agency regulations and traceability of risks | Integrate Workflows – Dyadem’s Stature solution provides corrective and preventive action (CAPA) workflows with various root cause analysis techniques, such as 8D or 5Y. Stature can also integrate to existing CAPA systems. |
| Isolated and separate risk management systems | Centralize Risk Management – The centralization of all risk assessments and related documents in a single database allows searching and reporting across all risk analyses for post-market surveillance and ISO 14971 compliance. |
| Inconsistent risk culture and weak or unenforced policies for managing quality risk | Drive Quality Culture – Using Stature you can develop a consistent framework for quality across your operations and embed quality risk management and governance into your culture. |
| Minimal transparency into Quality Risk Management practices by senior leaders | Gain Critical Risk Visibility – Stature empowers you with information to identify critical safety risks, events, hazards, key performance indicators or trends. |
| Lack of a consistent, standard format for quality risk identification, analysis and mitigation, making information sharing across functional groups difficult | Reduce silos – A common quality framework across your enterprise ensures that everyone is speaking the same quality language, helps develop a unified quality culture and ensures that you are always aware of the risks that could impact patient safety and your business. |
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Long reporting cycles that render information out-of-date and limit immediate action |
Automate Key Quality Processes – Stature takes mission-critical business processes and makes them actionable. By automating the business process, leadership can be confident that key risk processes are being actively managed, monitored and mitigated. Integrated escalation, notification and scenario-based lifecycles ensure all aspects of the risk process are covered. |
| Reduced budgets and resources to effectively manage quality risks | Maximize Resources – Stature ensures that your risk management and audit teams are spending less time gathering information and more time lowering risks. |
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