Bringing a medical device to market is rarely straightforward. In this MedTech Makers Q&A with MPO Magazine, LSO CEO John Nino discusses how early regulatory alignment, integrated packaging and sterilization solutions, and a single-source manufacturing model help medtech innovators overcome roadblocks and accelerate commercialization.

Orthopedic OEMs don’t always have the luxury of “just adding another supplier.” When implants require porous coatings, titanium alloys, or specialized finishing, there may be only a handful of vendors worldwide qualified to deliver. Swapping one for another often triggers costly re-validation — and sometimes, new FDA or ISO 13485 submissions.

Orthopedic device supply chains are like puzzles: implants, plates, screws, and instruments all need to come together at the same time. If even one piece is missing, a product launch stalls or a hospital delivery gets delayed. That’s why diversification is a hot topic — but is it really necessary to diversify suppliers for every component?

When the phrase “resilient supply chain” comes up, most people think about having a backup supplier or a secondary logistics partner on call. But in orthopedics, resilience runs deeper. It’s not just about building redundancies — it’s about ensuring that every implant, instrument, and kit makes it to market with compliance, repeatability, and reliability intact, no matter what disruption comes next.

Orthopedic OEMs are under growing pressure to move faster without compromising compliance. At OMTEC 2025, LSO will showcase how consolidating packaging, sterilization, and cleanroom assembly under one roof helps eliminate delays and accelerate commercialization. Visit us at Booth 350—or schedule time with our team whether you’re attending or not.

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.