Navigating Regulatory Complexities in Cardiovascular Device Logistics

Navigating Regulatory Complexities in Cardiovascular Device Logistics     Key Takeaways: Learn how global regulatory challenges can impact cardiovascular device logistics and impact time-to-market. Discover how precise documentation, real-time tracking, and compliance integration streamline distribution processes. Explore how Millstone’s logistics expertise ensures smooth delivery while meeting strict global standards. The Risks of Regulatory Complexities in…

Simplifying the Complexities of Cardiovascular Device Packaging

Simplifying the Complexities of Cardiovascular Device Packaging   Key Takeaways Cardiovascular devices require customized assembly and packaging solutions due to their varying shapes, sizes, and delicate components. Integrating assembly and packaging design early in product development helps ensure regulatory compliance, reduces costs, and minimizes risks. Complex assembly and packaging strategies streamline operations, reduce delays, and…

Navigating Speed-to-Market Risks in Cardiovascular Logistics

Navigating Speed-to-Market Risks in Cardiovascular Logistics     Key Takeaways Fragmented logistics create inefficiencies, leading to delays, miscommunication, and increased costs. Supply chain disruptions, from material shortages to regulatory challenges, threaten operational continuity. Limited distribution capacity restricts market access, delays launches, and drives up costs. Integrated logistics strategies can mitigate risks and ensure faster time-to-market…

Determining Ethylene Oxide Sterilization Allowable Limits

Determining Ethylene Oxide Sterilization Allowable Limits     What is Sterilization using Ethylene Oxide? The gas ethylene oxide, sometimes referred to as EO or EtO, is frequently used to chemically sterilize medical equipment and supplies. Ethylene oxide is a powerful and deeply penetrating alkylating agent. It is a very effective sterilizing agent because of these…

The Power of An Expert Partnership in Devices for Robotic-Assisted Surgeries

The Power of An Expert Partnership in Devices for Robotic-Assisted Surgeries     Key Takeaways:   Ensure device integrity with a packaging partner specializing in sterility, integrity, and rigorous testing to meet regulatory compliance standards. A partner for in-process testing can improve cost efficiency and reduce lead times, enabling quicker turnaround and faster time-to-market. Expanded…

Understanding Reverse Logistics as a Key to Business Success

Understanding Reverse Logistics as a Key to Business Success     Key Takeaways Implementing reverse logistics helps OEMs reclaim and redistribute inventory, reducing manufacturing costs and maximizing the value of existing products. Reverse logistics strengthens supply chain resilience by redeploying reclaimed inventory to meet market demands, mitigating disruptions. Adopting reverse logistics practices supports recycling and…

Industry Q&A: Six Questions on Supply Chain & Tier 1 Service

Industry Q&A: Six Questions on Supply Chain & Tier 1 Service     More than 18 months into the post-COVID era, medtech OEMs continue to face new challenges of complexity, especially in the orthopedic market. With changes to elective surgery delivery models, persistent supply chain disruptions, labor shortages, and more, the nature of the market…

Leveraging Expertise In Steam Sterilization Validation for Reusable Orthopedic Devices

Leveraging Expertise In Steam Sterilization Validation for Reusable Orthopedic Devices     These days, the business of orthopedics requires some gymnastics. Balancing ever-evolving regulatory compliance needs with continuity concerns can challenge even the world’s biggest, most successful firms. As technologies and markets diverge and diversify, staying ahead of competitors and on top of lead times…

How Comprehensive Product Testing Expertise Reduces Risk for Medtech Manufacturers

How Comprehensive Product Testing Expertise Reduces Risk for Medtech Manufacturers     When the lifesaving and lifechanging products you make are going into patients’ bodies, there is no room for error. Every medical device manufacturer knows this truth. So do regulatory bodies. Taken together, the focus on patient safety and compliance are the driving forces…

Five Reasons Why Supply Chain Visibility Matters in Medical Device Manufacturing

Five Reasons Why Supply Chain Visibility Matters in Medical Device Manufacturing     You’ve heard the saying “what you don’t know can’t hurt you.” While it might be the case for feelings, what you don’t know or don’t see will definitely hurt your supply chain—and, by extension, everything about your business. Without good visibility into…