Navigating the complexity of the production and approval process can be challenging for medical device makers, particularly start-ups and innovative early-stage enterprises
FREMONT, CA: The process of bringing a medical product to market is challenging. It entails considerable organization and planning and precise precision, and proper documentation. Failure to meet the appropriate benchmarks and obtain relevant approvals and validations on time might incur considerable expenses or delays. Or, in the worst-case scenario, they could result in a product not receiving initial approval or possibly an expensive recall down the line.
Sterilization of medical devices is a critical stage in bringing a medical product to market. It necessitates extensive industry knowledge in addition to specific sterilization equipment and methods. Given this intricacy, it's frequently advantageous to collaborate with a sterilization partner who can provide that knowledge while also addressing sterilization requirements within the context of bringing innovative medical equipment to market. Three advantages of cooperating with a turnkey device manufacturing partner for medical device sterilization are discussed in greater detail below.
Simplified time: While products spend only a few hours in the sterilization chamber, the complete sterilization and validation procedure takes around ten weeks. Understanding the validation process's relationship to bigger go-to-market initiatives will help demystify it. Additionally, it assists in ensuring sterilization occurs at a critical point in the process and allows for the completion of other tasks while validation occurs.
Improved cohesion between cleaning and packing: Turnkey partners for cleaning, packaging, and sterilization are few—even more so for specialized services such as steam and Ethylene Oxide (EO) treatment. Additionally, these partners will better understand the sterilizing techniques that should be employed with various forms of packaging, depending on the type of barrier used and other factors.
Organizations with in-house sterilizing capabilities frequently have such processes distributed across numerous locations and geographies, resulting in problems and delays. Additionally, outsourcing sterilization might decrease control over the process, errors, longer lead times, communication breakdowns, and other issues.
Increased sterilizing efforts on a more focused basis: Working with a partner who understands all manufacturing phases and sterilization objectives can be quite advantageous throughout the sterilization process itself. That partner will understand the type of validation required according to the product's demands, from pre-clinical validation to full 510(k) validation or getting a CE mark for European distribution.