Streamlining Visibility in Medical Device Distributionnetworks!

Streamlining Visibility in Medical Device Distributionnetworks!

In the ever-evolving landscape of the medical device industry, companies are seeking preferences for outsourcing manufacturing and implementing mechanisms to increase transparency. This shift is driven by the need to enhance product safety and traceability, as well as to mitigate liability risks.

One such initiative is the Unique Device Identification (UDI) system, mandated by the U.S. Food and Drug Administration (FDA) in 2013. The UDI system is designed to provide a clear and consistent means of identifying medical devices, with each identifier consisting of a 'device identifier' (DI) and a 'production identifier' (PI), and the date appearing in the format (YYYY-MM-DD). The UDI should be marked directly on medical devices, not on their packaging or boxes, to ensure traceability.

The FDA maintains a comprehensive database, the Global Unique Device Identification Database (GUDID), containing a classification of all medical devices, tools, and instruments. This database serves as a valuable resource for tracking and regulating medical devices.

To further enhance transparency, manufacturers are increasingly adopting Product Information Management (PIM) systems. These systems offer a centralised platform for managing and sharing product information, providing detailed insights into the input materials and parts used in the manufacturing process. The PIM system enables the manufacturer to track the use and location of each part provided by a third-party supplier or provider.

The implementation of PIM systems also aids in customer engagement, as it allows manufacturers to provide detailed and accurate product information, thereby fostering trust and transparency. Additionally, PIM systems can help customers who have inquiries or complaints about the quality or safety of the manufacturer's medical device products.

Manufacturers can create their own PIM system with identification, attribution, tracing, tracking, and monitoring methods. Alternatively, the supplier or provider's PIM system can be integrated into the manufacturer's Enterprise Resource Planning (ERP) modules and applications suites. Manufacturers may require their suppliers and providers to follow the manufacturer's PIM system or allow them to create their own, depending on the specific requirements and needs of the partnership.

By implementing these transparency measures, manufacturers aim to reduce their liability risks and ensure the safety and quality of their medical devices. As the medical device supply chain involves multiple parties, each potentially responsible for defective components, design flaws, or inadequate warnings, it is crucial for manufacturers to maintain tight quality and risk management controls to prevent defects that could lead to liability.

In conclusion, the increased adoption of PIM systems and other transparency measures is a significant step towards enhancing product safety, reducing liability risks, and fostering trust in the medical device industry. As the industry continues to evolve, it is expected that these measures will become increasingly important in ensuring the safety and well-being of patients.

[1] FDA (2013) Unique Device Identification (UDI) System. [Online] Available at: https://www.fda.gov/medical-devices/unique-device-identification-udi-system [Accessed 2023-03-10].

[2] ISO (2016) ISO 13485:2016 - Medical devices - Quality management systems - Requirements for regulatory purposes. [Online] Available at: https://www.iso.org/standard/45445.html [Accessed 2023-03-10].

[3] Hogan Lovells (2021) Product Liability and the Medical Device Supply Chain. [Online] Available at: https://www.hoganlovells.com/en/insights/publications/2021/april/product-liability-and-the-medical-device-supply-chain [Accessed 2023-03-10].

[4] Deloitte (2021) The medical technology challenge: Navigating the new normal. [Online] Available at: https://www2.deloitte.com/content/dam/Deloitte/us/Documents/life-sciences-health-care/us-lshc-the-medical-technology-challenge-navigating-the-new-normal.pdf [Accessed 2023-03-10].

[5] FDA (2021) UDI Rule Enforcement Dates. [Online] Available at: https://www.fda.gov/medical-devices/unique-device-identification-udi-system/udi-rule-enforcement-dates [Accessed 2023-03-10].

1. To meet the increasing demand for transparency, digital supply chain processes such as Procurement, Logistics, and Distribution are being integrated with the manufacturing process, with an emphasis on Science and Health-and-Wellness related industries.
2. In an effort to streamline the digital supply chain, manufacturers are adopting Product Information Management (PIM) systems for managing and sharing product information, including details about medical-conditions, therapies-and-treatments, and industry-specific components.
3. The financial implications of the medical device industry are closely tied to the persistent need for increased product safety, with manufacturers looking to reduce their liability risks by following industry regulations like the FDA's Unique Device Identification (UDI) system.
4. These transparency measures, including the UDI system and PIM, are expected to improve traceability and support Quality and Risk Management within the medical-device industry.
5. The integration of PIM systems with Enterprise Resource Planning (ERP) modules offers an opportunity for Industry players to conform to regulations while also increasing efficiency and managing supply chain risks more effectively.

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