Life Science Outsourcing, Inc.

The EU MDR transition was extended—not relaxed. Our new Industry Standards guide explains what the 2027/2028 timelines mean for packaging, testing, and sterilization—plus a fillable MDR Readiness Checklist to accelerate your plan. Read the guide: https://hubs.la/Q03PJq7C0 Download the checklist: https://hubs.la/Q03PJq_L0 Highlights: • Deadlines by class (Regulation (EU) 2023/607) • Legacy device criteria & “significant change” risk • ISO-aligned packaging & sterilization requirements (11607/11135/11137/17665) • A 6-step readiness roadmap for 2025–2026 #EUMDR #MedicalDevices #PackagingValidation #SterilizationValidation #ISO11607 #Regulation2023607 #QA #RA #MedTech

We’re live at MD&M Midwest! The BYOD booth is open — stop by Booth #2607 and tell us about your device, challenge, or idea. Whether you’re refining your packaging design, preparing for sterilization validation, or scaling up manufacturing, our team is here to help you find the fastest, most compliant path to market.

Life Science Outsourcing (LSO) has appointed Doug Constable as Chief Executive Officer, leading our next phase of growth. Doug brings 30+ years of MedTech leadership, most recently as CEO of Clayens North America, where he guided U.S. and Mexico expansion. If you’re attending MD&M Midwest, stop by Booth 2607 to meet Doug and the LSO team. Read the full announcement: https://hubs.ly/Q03Pmk4j0 #MedTech #Leadership #MedicalDevices #LifeScienceOutsourcing #ContractManufacturing #Growth #MDMMidwest

BYOD: Bring Your Own Device (or just your idea) We’re heading to MD&M Midwest – Oct 21-22 in Minneapolis. Drop by Booth #2607 and tell us about your project or challenge. Our LSO experts will help you map a path to faster validation, packaging, and launch.

Orthopedic OEMs don’t always have the luxury of “just adding another supplier.” When implants require porous coatings, titanium alloys, or specialized finishes, there may only be a handful of qualified vendors in the world. Switching them out often means costly re-validation — and sometimes, new FDA or ISO 13485 submissions. That dependency makes supply chain risk a daily reality. The fix isn’t always adding more suppliers. In fact, that can create more handoffs, audits, and compliance friction. The smarter strategy? Consolidate packaging, sterilization, and kitting under one FDA-registered partner. Reduce vendor dependencies you can control. Protect compliance without slowing production. 👉 Read the full post: “When Second-Sourcing Isn’t an Option: Reducing Dependency in Orthopedic Supply Chains.” 👉 Download our Vendor Dependency Risk Worksheet to assess your risk profile. https://hubs.la/Q03MSD2b0

Diversify or Consolidate? Rethinking Supplier Strategy in Orthopedics In orthopedics, a single delayed screw, plate, or instrument can stall an entire kit — and with it, a hospital delivery or product launch. But is diversifying every supplier really the answer? Spreading out vendors can add cost, slow down regulatory approvals, and introduce more risk. On the other hand, too much consolidation leaves OEMs vulnerable when disruption hits. The smarter path? Diversify where raw material risks are high (titanium, packaging substrates). Consolidate where regulatory continuity matters most — like assembly, packaging, and sterilization. That balance keeps orthopedic supply chains audit-ready, compliant, and reliably moving forward. 👉 Read our latest blog: “Diversify or Consolidate? Rethinking Supplier Strategy in Orthopedics” 👉 Download our Strategic Supplier Matrix to see where diversification or consolidation makes the most impact. https://hubs.la/Q03M9tZ80

ASTM D4332 is essential for packaging validation — but stopping there leaves gaps that can delay approvals. In this short video, see why D4332 is just the beginning, and how LSO helps manufacturers build smarter, faster, and stronger audit-ready packaging programs. Ready to get started? Tell us about your project info@lso-inc.com #ASTMD4322

Resilience in orthopedics isn’t about backups. It’s about compliance under pressure. When COVID exposed titanium shortages and sterilization bottlenecks, orthopedic OEMs learned a hard truth: more suppliers don’t equal more resilience. True resilience means integration — aligning quality, logistics, and sterilization readiness to prevent disruption before it happens. At LSO, that’s exactly how we help orthopedic OEMs stay compliant, repeatable, and audit-ready — even under pressure. 👉 Read our latest blog: Beyond Backups: Redefining Supply Chain Resilience for Orthopedic OEMs 👉 Plus: Download our Supply Chain Resilience Checklist to benchmark your own readiness.

At today’s MPO Summit, our CEO John Nino joined industry leaders for a candid discussion on the forces reshaping medtech. The panel explored how the FDA is embracing innovation, the role of AI in medical technology, and the impact of tariffs and nearshoring on global strategies. They also examined how companies can mitigate supply chain risks, turn setbacks into opportunities for change, and adapt to new care modalities. Drawing on decades of experience, John emphasized how integrated partnerships enable OEMs to stay resilient, reduce risk, and accelerate speed to market in the face of these challenges. At LSO, we believe complexity is best met with collaboration, and we are proud to contribute to conversations that drive the industry forward. Special thanks to Medical Product Outsourcing for organizing this great event. #MPOSummit #MedTech #Leadership #Innovation #SupplyChain

We are proud to have John Nino, CEO of LSO, join the MPO Summit panel addressing the most pressing issues in MedTech. John brings decades of leadership experience guiding medical device companies through complex challenges in supply chain, labor, regulatory, and cost controls. His perspective reflects LSO’s broader expertise in helping innovators accelerate commercialization with integrated services that reduce risk and speed time to market. We look forward to the dialogue this panel will spark and to sharing how LSO’s experience continues to support the evolving needs of the MedTech industry. #MPOSummit