Bringing a medical device to market is a complicated process. It requires a lot of coordination and planning, not to mention extreme precision and appropriate documentation. Failing to hit the right benchmarks and achieve the necessary approvals and validations at the right times can lead to significant costs or delays. Or worse, they could lead to a product not earning upfront approval or even a costly recall down the road.
Medical device sterilization is an essential step in the process of bringing a medical device to market. It requires deep industry know-how as well as specialized sterilizing equipment and protocols. Given this complexity, it’s often beneficial to work with a sterilization partner that can provide that expertise while also considering sterilization needs in the broader context of bringing an innovative medical device to market. Here’s a closer look at three benefits of partnering with a turnkey device manufacturing partner for medical device sterilization needs.
1. Streamlined timing
While products typically only spend a few hours in the sterilization chamber, the full sterilization and validation process typically takes about 10 weeks (though this timeline can sometimes be expedited). Understanding where the validation process fits into the larger go-to-market efforts can help demystify the process. What’s more, it helps ensure the sterilization occurs at a strategic time in the process and other activities can be completed while the validation is underway.
2. Better coordination with cleaning and packaging
Partners that can provide turnkey solutions around cleaning, packaging, and sterilization are few and far between – especially when it comes to specialized services including steam and Ethylene Oxide (EO) sterilization. These partners will also have a more in-depth understanding of which sterilization processes should be used with different types of packaging, depending on the type of barriers being used and other considerations.
Often, even companies with in-house sterilization capabilities will have those operations spread out across multiple sites in multiple geographies, which can create complications and delays. What’s more, when the sterilization itself is outsourced, it can lead to less control over the process, mistakes, longer lead times, communication gaps, and other challenges.
3. More targeted sterilization efforts
Within the sterilization process itself, working with a partner who understands all manufacturing stages and sterilization objectives can be highly beneficial. That partner will understand what type of validation is required based on the needs of the product, from validation heading into clinical trials, or Premarket Approval to full 510(k) validation, or obtaining a CE mark for European distribution.
Turnkey solutions elevate providers into true partners
For medical device manufacturers, particularly start-ups and innovative early-stage companies, navigating the complexities of the manufacturing and approval process can be daunting. Pulling together one-off providers and services creates inefficiencies and risks in the overall process. Life Science Outsourcing has decades of experience helping start-ups and OEMs see around corners and anticipate challenges and opportunities in the process of bringing innovative new products to market.
