Medical device original equipment manufacturers (OEMs) are at a critical juncture when it comes to managing a successful supply chain. New challenges have transformed how priorities and efficiencies were addressed and continue to evolve even today. How can OEMs keep up with these shifting changes to ensure a reliable outcome? Three components are key to navigating and maintaining a strong supply chain well into 2025 – those include adapting to sterilization methodology shifts, supply chain model advances, and the all-important factor of time efficiency.
Sterilization methodologies
As sterilization methodologies experienced new, evolving demands throughout 2023, medical device supply chains bore the eventual brunt and fell into delays.
Longer wait times: For smaller OEMs, 2023 ushered in an era of increasingly unstable time delays created by large volume sterilization projects dominating sterilization processes at many contract sterilization providers.
Ethylene oxide (EO) regulatory shifts: EO sterilization also underwent its own evolution, undergoing new regulatory shifts that drove delays and problematic financial impacts. While new technologies such as chlorine dioxide, supercharged carbon dioxide, and nitrous oxide appear to be potential future solutions, they require further research and development to truly understand their impacts to medical device materials and what a revalidation process would look like.
Small batch EO sterilization has risen to the forefront as a solution to these issues going into 2024. Small-batch EO sterilization offers multiple benefits to all OEMs, including:
- Reduced regulatory compliance burden
- Expedited processing with multiple daily cycles
- Ability to pair with ancillary services
- Streamlined operational workflow
Supply chain model shifts
Supply chain managers have experienced entirely new levels of logistical hurdles in recent years, thanks to lingering pandemic-related difficulties and varied supply stream complexities. OEMs can hit the ground running in 2024 and solve their supply chain woes by migrating to a centralized outsourcing model with a reliable partner capable of diversified services.
Consolidating services under one umbrella with a reliable outsourced partner who specializes in manufacturing, sterilization, packaging, and distribution simplifies supply chain management with the added benefit of quality assurance. Life Science Outsourcing is one example of such a partner with demonstrated market resilience and comprehensive services under one roof:
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- Complex medical device assembly capabilities
- Cleanroom facilities and warehouse space
- Integrated, on-site sterilization, validation, and microbiology staff
- Full-service packaging, kitting, and labeling
- Package design and development
- Dedicated procurement teams for material sourcing
- Streamlined fulfillment and distribution
A centralized outsourcing model can enhance operational efficiency with increased reliability – a necessity given that supply chain challenges that will continue to arise.
Industry-driven time delays
Market entry timelines experienced a host of challenges in recent years, including regulatory and compliance delays and validation processes. Adding to those considerable timing setbacks were materials shortages and the sterilization wait times mentioned above.
A few standout approaches can set OEMs up for success going into 2024 with increased time efficiency outcomes:
Pre-validated packaging: Pre-validated packaging solutions significantly reduce package development time and were designed to withstand most sterilization processes. It’s estimated that they can provide market readiness within six months, a significant time reduction that can have measurable impact to an OEM’s bottom line.
Cleaning and decontamination scheduling: Maintaining a strict, routine cleaning and decontamination schedule for reusable medical devices can maximize return on investment by reducing their redeployment time to market.
A successful supply chain begins now
Strategic OEMs and their supply chain managers are anticipating and addressing the many ways they can improve supply chain going into and throughout 2024. Adjusting to sterilization methodologies with small batch EO sterilization, having an agile approach to a supply chain model with consolidated services, and proactively addressing industry-driven time delays can ensure success throughout the year and beyond.
Contact us today to get started!
Looking for more information on this topic? Read Medical Device Drop Shipping: An Answer to Your Distribution Woes.
Start up. Speed up. Scale up. Founded in 1997, Life Sciences Outsourcing is an FDA-registered and ISO 13485-certified organization with services and capabilities spanning the entire medical device product life-cycle – from turnkey manufacturing, testing, validation, and sterilization to precision packaging, fulfillment, and distribution. Email us at info@lso-inc.com or call (714) 672-1090 today to get started.
