The COVID-19 pandemic has highlighted the importance of healthcare supply chains like never before. From personal protective equipment (PPE) to ventilators, the pandemic has brutally exposed critical vulnerabilities in many healthcare supply chains, straining them to the breaking point and forcing hospitals and health facilities to scramble for vital equipment and supplies.
In addition to these challenges, however, another problem is increasingly coming into focus: transparency concerns. Recent scandals and failures related to quality and safety underscore the need for greater transparency and accountability in healthcare supply chains.
A complex and global world
One of the biggest challenges in addressing transparency concerns in healthcare supply chains is the complexity and global nature of these chains. Healthcare supply chains include a wide range of parties, from equipment suppliers and manufacturers to distributors and shippers to healthcare professionals and patients. Supply chains can span different countries, regulatory environments and legal frameworks, making it difficult to achieve transparency and hold all parties accountable. Furthermore, the lack of standardization and harmonization of supplier evaluation, procurement and reporting processes further exacerbates the problem. Collecting, managing and sharing data is another challenge often faced, especially by smaller companies that cannot afford to invest in complex technology or process management systems.
But despite these challenges, addressing transparency issues in healthcare supply chains can bring tangible benefits. This can significantly improve the quality, safety and reliability of the devices and products patients rely on for their healthcare. Sustainability and ethical business practices can be important components of a transparent supply chain system, and initiatives that promote these business practices can help protect the reputation of the organizations that implement them. Additionally, more transparent supply chains can help reduce costs by avoiding expensive recalls, rework, and stock-outs.
What should managers consider when considering how to address transparency concerns in their healthcare supply chains? An important aspect is building a culture of transparency throughout the supply chain – from supplier to customer – to achieve better visibility into how supplies and products are created and delivered. This often requires working closely with suppliers to standardize processes, build trust and collect data to better assess and manage supply chain risks. Additionally, managers must ensure that transparency initiatives are integrated into their corporate strategies and regularly reviewed to assess their effectiveness.
Another important aspect is keeping up with the regulatory environment. Government agencies are increasingly focused on supply chain transparency, with initiatives such as the U.S. Food and Drug Administration’s Drug Supply Chain Security Act (DSCSA) and the EU Medical Device Regulation (MDR) requiring companies to monitor their products throughout the supply chain to trace away chain. Compliance with these regulations requires significant investments in technology, people and processes to meet traceability and transparency requirements. Ultimately, however, this investment can lead to a more efficient and resilient supply chain.
Another important aspect for managers to consider is the increasing role of technology in healthcare supply chain visibility. Advanced technologies such as blockchain, Internet of Things (IoT) and artificial intelligence (AI) enable better data sharing, analysis and monitoring across the ecosystem. By using these technologies, healthcare supply chain stakeholders can identify and address potential issues more efficiently and effectively, ultimately improving patient outcomes.
What steps are there to address transparency concerns?
To use our examples above, in order to comply with the Drug Supply Chain Security Act (DSCSA) and the EU Medical Device Regulation (MDR), several key steps must be implemented. First, companies must fully understand the regulations and their implications. This also includes familiarizing yourself with the most important technical terms and the specific requirements for traceability and transparency.
Next, investing in appropriate technology is critical. This may include updating existing systems or implementing new systems that enable serialization and traceability of products across the entire supply chain, including how inventory moves within the hospital. The SOx platform can help with this. For DSCSA compliance, companies must be able to track each package of prescription drugs as it moves through the supply chain. A higher level of traceability is required to comply with the MDR. Medical devices must be tracked from production to end user with a unique device identifier (UDI) for each product.
Another necessary step is to train staff in these new procedures and technologies. Employees across the organization, from operations to IT to regulatory affairs, need to understand how to comply with these regulations. This may require extensive training and possibly the hiring of new staff with specific expertise in these areas.
Finally, companies must establish processes to regularly monitor compliance and make adjustments as necessary. This also includes staying abreast of regulatory changes, as both DSCSA and MDR are subject to ongoing updates and revisions. This also includes regular audits and inspections to ensure ongoing compliance.
Compliance with DSCSA and MDR requires a multi-faceted approach that includes understanding the regulations, investing in technology, training staff, and establishing processes for ongoing compliance monitoring and adjustment. By implementing these steps, companies can not only comply with these regulations, but also improve the overall transparency and resilience of their supply chains.
Diploma
Transparency concerns are a critical issue for today’s healthcare supply chains. The challenges are real, but the potential benefits of improving quality and resilience and reducing costs can be immense. By building a culture of transparency throughout the supply chain, adhering to changing regulatory requirements, and leveraging the latest technologies, healthcare companies and managers can improve their supply chains and create a safer, more sustainable healthcare system for all. Let’s work together to make our healthcare supply chains more transparent, reliable and people-centered.
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