Why Addressing Transparency Concerns in Healthcare Supply Chains is More Urgent Than Ever
The COVID-19 pandemic has highlighted the importance of healthcare supply chains like never before. From personal protective equipment (PPE) to ventilators, the pandemic brutally exposed critical weaknesses in many healthcare supply chains, stretching them to breaking point and leaving hospitals and healthcare facilities scrambling for vital equipment and supplies.
Alongside these challenges, however, another problem has increasingly entered the spotlight: transparency concerns. Recent scandals and failures related to quality and safety are further emphasizing the need for more visibility and accountability across healthcare supply chains.
A complex and global World
One of the biggest challenges of addressing transparency concerns in healthcare supply chains is the complexity and global nature of these chains. Healthcare supply chains encompass a wide range of parties, from equipment suppliers and manufacturers, to distributors and shippers, to medical professionals and patients. Supply chains may span different countries, regulatory environments, and legal frameworks, making it challenging to gain visibility and hold all parties accountable. Additionally, the lack of standardization and harmonization in supplier evaluation, procurement, and reporting processes further exacerbates the problem. Collecting, managing and sharing data is another challenge that is often faced particularly by smaller companies that cannot afford to invest in complex technology or process management systems.
However, despite these challenges, there are tangible rewards to be gained from addressing transparency concerns in healthcare supply chains. Doing so can greatly improve the quality, safety and reliability of the equipment and products that patients depend on for their healthcare needs. 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 stockouts.
What do managers need to keep in mind as they consider ways to address transparency concerns in their healthcare supply chains? One key consideration is building a culture of transparency across the entire supply chain — from suppliers to customers — to seek greater 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 evaluate and manage risk in the supply chain. Additionally, managers must ensure that transparency initiatives are integrated into their corporate strategies and regularly monitored to assess their effectiveness.
Another important consideration is keeping pace with the regulatory environment. Increasingly, government agencies are focusing on supply chain transparency, with initiatives such as the US Food and Drug Administration’s Drug Supply Chain Security Act (DSCSA) and the EU Medical Device Regulation (MDR) that require companies to track and trace their products through the supply chain. Complying with these regulations requires a considerable investment in technology, personnel, and processes to meet traceability and transparency requirements. However, this investment can ultimately lead to a more efficient and resilient supply chain.
Another critical element managers must consider is the increasing role of technology in healthcare supply chain transparency. Advanced technologies such as blockchain, Internet of Things (IoT), and artificial intelligence (AI) are enabling greater data sharing, analysis and monitoring across the entire ecosystem. By leveraging these technologies, healthcare supply chain stakeholders can identify and address potential problems more efficiently and effectively, ultimately improving patient outcomes.
What are the steps to address transparency concerns?
To use our examples above, to comply with the Drug Supply Chain Security Act (DSCSA) and the EU Medical Device Regulation (MDR), several key steps need to be implemented. First, companies must have a complete understanding of the regulations and their implications. This includes getting familiar with the key terminology and the specific requirements for traceability and transparency.
Next, investing in appropriate technology is crucial. This might involve upgrading existing systems or implementing new ones that can handle product serialization and traceability across the supply chain, including how stock moves within the Hospital, which is something the SOx platform can assist with. For DSCSA compliance, companies need to be able to track and trace each package of prescription drugs as it moves through the supply chain. For MDR compliance, a higher level of traceability is needed. Medical devices must be tracked from production to the final user, with a unique device identifier (UDI) for each product.
Another necessary step is training personnel on these new procedures and technologies. Employees throughout the organization, from operations to IT to regulatory affairs, need to understand how to comply with these regulations. This might involve extensive training and possibly hiring new personnel with specific expertise in these areas.
Finally, companies must establish processes to regularly monitor compliance and make adjustments as necessary. This includes keeping up with changes to the regulations, as both DSCSA and MDR are subject to ongoing updates and revisions. It also entails regular audits and inspections to ensure ongoing compliance.
DSCSA and MDR compliance requires a multi-faceted approach involving understanding the regulations, investing in technology, training personnel, and establishing processes for ongoing compliance monitoring and adjustments. By implementing these steps, companies can not only comply with these regulations but also enhance the overall transparency and resilience of their supply chains.
Conclusion
Transparency concerns are a critical issue for today’s healthcare supply chains. The challenges are real, but the potential rewards for improving quality and resilience and reducing costs can be immense. By building a culture of transparency across the supply chain, keeping pace with evolving regulatory requirements, and leveraging the latest technology, 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 human-centered.
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