In this edition of Three Questions, health care & life sciences partner Nate Brown spoke with Jeremy Schutz, director of business development, recall & remediation at Sedgwick, to explore key strategies that pharmaceutical companies and medical device manufacturers can adopt to mitigate risks related to supply chain disruptions, cybersecurity threats and increased FDA enforcement of quality control and compliance.
Sedgwick is the world’s leading expert in product recall and remediation spanning over 7,000 recalls, in 100 countries, and 50 languages.
What operational strategies can pharmaceutical companies adopt to mitigate the risks of supply chain disruptions?
In 2024, supply chain disruptions continue to be a significant risk for pharmaceutical companies, especially in the context of global component and ingredient shortages and transportation challenges. Companies should adopt a risk-based approach by diversifying their supplier base, investing in domestic production and building stronger supplier relationships to improve resilience. Real-time supply chain monitoring through digital tools like blockchain can help companies track and predict potential bottlenecks. For 2025, stakeholders should watch for increased regulatory pressure from the FDA to ensure supply chain transparency and resilience, particularly for essential drugs and devices critical to patient health.
How can medical device manufacturers minimize the risk of cybersecurity threats?
With the FDA’s new and stricter cybersecurity regulations, medical device manufacturers face increased risks. Manufacturers must integrate cybersecurity protocols early in the product development process, ensuring compliance with FDA guidelines for cybersecurity risk management. This includes secure software development, regular updates, vulnerability monitoring and patch management. Manufacturers should also establish post-market cybersecurity monitoring programs. Looking ahead to 2025, the FDA is expected to intensify its focus on artificial intelligence (AI)-driven medical devices and cybersecurity for wearables, which will require manufacturers to maintain a proactive cybersecurity strategy to prevent costly disruptions and recalls.
How can life sciences companies mitigate the risks associated with increased FDA enforcement of quality control and compliance?
In 2024, the FDA has ramped up inspections and enforcement actions, especially related to quality control in manufacturing processes for both pharmaceuticals and medical devices. To mitigate risks, companies should implement continuous quality improvement (CQI) processes, ensuring that manufacturing standards meet Good Manufacturing Practices (GMP) and FDA regulations. This includes regular internal audits, employee training on compliance and investing in digital quality management systems (QMS) that provide real-time monitoring and documentation of production processes. As we approach 2025, companies should anticipate more FDA scrutiny on data integrity and digital record-keeping, making it essential to maintain robust data security and transparency throughout the product lifecycle.