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 Cardiovascular Device Logistics In the logistics of cardiovascular devices,…

Tolerable Ethylene Oxide Sterilized Medical Device Exposure Limiters

Ethylene oxide sterilization is what? A commonly used gas for chemical sterilizing medical equipment and products is ethylene oxide, sometimes known as EO or EtO. Ethylene oxide is a strong and quite penetrating alkylating agent. These qualities make it a successful sterilizing tool. At some doses, though, ethylene oxide can potentially induce cancer. Under vacuum…

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 enhance patient safety. The assembly and packaging of…

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 without compromising quality or compliance. In the fast-paced…

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. One powerful and deeply penetrating alkylating agent is ethylene oxide. It is a very effective sterilizing agent because of these qualities. But ethylene oxide can potentially cause cancer…

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

Key Takeaways: Robotic-assisted surgeries are revolutionizing the medical field, offering unprecedented precision and control in various complex procedures. However, the success of these surgeries heavily relies on the quality and reliability of the medical devices used. Navigating the complexities of producing these devices can be overwhelming for original equipment manufacturers (OEMs). Expert partnerships become crucial…

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 reuse, aligning with corporate social responsibility and environmental sustainability goals. Partnering…

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 looks…

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 is hard.…

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 behind comprehensive…