Over the past few years, I’ve watched a major shift take shape in medical device manufacturing. More and more companies are rethinking where and how they produce their products. For a long time, overseas manufacturing was the default. Today, OEMs are increasingly seeking more control, less risk, and faster paths from concept to customer. Near-shoring answers that need.

Renting cleanroom space offers medical device startups and OEMs faster market entry, lower capital risk, and built-in regulatory compliance. This diagnostic helps companies evaluate whether renting or building aligns better with their stage, resources, and long-term plans—while highlighting how LSO supports both models with scalable, validated facilities.

Learn if your medical device issuitable for pre-validated packaging solutions with our free ‘Will It Fit?’ calculator.

The medical device industry is only a few years away from the MDD becoming the MDR for CE mark recertification in Europe. On average, it takes 18 months to recertify medical devices – meaning that slower-to-adopt companies may fall behind and risk losing certification altogether.

Medical device companies have a real challenge when managing diverse supply chain demands, especially if they utilize multiple resources to achieve disparate processes. And it’s no surprise that difficulties will continue to arise as we move into 2024 in the form of new requirements, resource access limitations, a lack of in-house expertise, and disconnected communication channels.

Medical device OEMs must anchor their supply chains with agility and foresight to successfully navigate 2024 challenges. The key? Embrace the trifecta of change: advanced sterilization methods, flexible supply models, and the race for time efficiency. OEMs who master these elements will not only endure but lead the charge in a new era of medical innovation.

Recent data reveals that up to 30% of FDA submissions now focus on combination products. In our latest article, we explore their definition and their diverse categories, including the fusion of drugs, devices, and biological products. The allure of combination products is based in their myriad benefits: From localized treatment and streamlined processes to minimized contamination risks and precise dosage control, they are elevating patient treatment and care.

Rapid growth can strain supply chains, cause production bottlenecks, and increase lead times. That’s why scalability isn’t just about making more units. How can companies ensure they’re ready for future growth scalability? By building a rock-solid infrastructure with a reliable contact manufacturing partner.