By Sean Fenske, Editor-in-Chief

While medical device manufacturers are constantly seeking to cut costs and improve time to market, the pandemic and subsequent supply chain challenges that followed opened many eyes to concerns. This period highlighted the critical areas where improvement was needed. As such, there’s been a dedicated effort to make changes to ensure resiliency to avoid future issues, delays, or problems.

One option that companies are interested in exploring is working with a one-stop-shop service provider. While the specifics of the definition of that term may vary, generally speaking, it involves a vertically integrated organization that can provide a breadth of services to help supplement the needs of a medical device OEM. Such a company can aid in cost and time-to-market savings.

Taking time to help illustrate exactly what benefits can be realized from working with such a company is John Nino, CEO of Life Science Outsourcing (LSO). In the following Q&A, he explains what to look for in a supply and manufacturing partner, the benefits that may be realized for different-sized firms, and the capabilities such companies should possess to make them valuable members of the supply chain.

Sean Fenske: What reasons are you seeing for medical device manufacturers reevaluating their supply chains? What’s driving them to make changes?

John Nino: Medical device manufacturers are reevaluating their supply chains due to increasing market pressures, including rising costs, stringent regulatory requirements, and a growing demand for faster time-to-market. Additionally, the COVID-19 pandemic exposed vulnerabilities in global supply chains, prompting companies to prioritize resilience, scalability, and redundancy. Many manufacturers are also seeking partners with end-to-end capabilities to reduce the complexity and risks associated with managing multiple suppliers.

Fenske: What’s the most important factor a company should be seeking in determining the supplier company with which to partner?

Nino: The most important factor is alignment—both in capabilities and values. Companies should seek a supplier that offers deep expertise, a proven track record in regulatory compliance, and the flexibility to scale operations. A true partner not only provides technical solutions but also shares a commitment to quality, innovation, and customer-centric collaboration.

Fenske: “One-stop-shop” is a common phrase, but doesn’t mean the same thing to everyone. What capabilities do true, one-stop-shop supplier companies offer?

Nino: A true one-stop-shop provides a comprehensive suite of services under one roof. At LSO, this includes everything from procurement, kitting, assembly, packaging, and sterilization (steam, EO, and gamma), combined with validation and testing support to ensure regulatory requirements are met. The integration of these capabilities eliminates supplier-to-supplier handoffs, simplifies project coordination, reduces lead times, and enhances quality assurance throughout the process.

Fenske: What unique benefits are realized for companies of varying sizes—startup, small-/mid-sized, and large/leading organizations—with this type of comprehensive approach? Can you speak to the benefits for each level of firm?

Nino: For startup companies, we simplify the path to market by providing expert guidance from concept through to commercialization. This includes guidance to ensure all prototyping and manufacturing activities are performed and documented in accordance with FDA regulations and industry quality requirements. We also provide an FDA-regulated environment and quality management system umbrella to ensure a robust foundation for scaling from prototype through pilot production and into full production with one partner. Our support allows these companies to focus on innovation while we handle operational complexities throughout the product lifecycle.

Small-/mid-sized firms often need scalable, cost-effective solutions. We provide the flexibility to grow alongside them, offering services that meet their current needs and future expansion. This includes leveraging LSO’s state-of-the-art ERP system to migrate growing companies from “consigned to turnkey” materials management, thereby minimizing the OEM’s operational burden. In addition, LSO’s variety of cleanroom manufacturing environments facilitates efficient production in alignment with our customer’s commercial expansion. Further, LSO’s nearshore production capabilities facilitate the transition to a lower-cost region when production volumes and market conditions demand this competitive advantage.

Large OEMs benefit from our ability to handle high volumes, ensure consistency, and maintain strict quality standards. Our comprehensive capabilities help streamline their supply chains, reducing the burden of managing multiple vendors. We also provide additional kitting, assembly, and packaging capacity for the production of mature devices, which enables OEMs to focus their internal production on less mature devices that require more internal product development attention.

Fenske: How does a one-stop-shop supplier save time to market and enhance product quality, while also ensuring regulatory compliance? What capabilities make this possible?

Nino: Integration is the key. By providing multiple in-house services—assembly, packaging, sterilization, validation, and regulatory support—within one organization, we eliminate the inefficiencies associated with coordinating multiple suppliers. Internal coordination from validation through production facilitates more efficient “parallel” operations, which improve delivery times over sequential lead times encountered when dealing with multiple suppliers. Our in-house regulatory expertise ensures compliance while streamlined workflows reduce delays and risk. Additionally, leveraging our robust electronic quality management system ensures every product is produced to the highest standards before it leaves our facility.

Fenske: What value-added capabilities should companies be seeking from a one-stop shop that may be outside the typical list of manufacturing functions/capabilities?

Nino: Beyond core manufacturing capabilities, companies should look for:

• Regulatory consulting: Assistance with FDA submissions, ISO certifications, and other compliance needs
• Supply chain optimization: Insightful strategies for sourcing materials and managing inventory
• Design for manufacturability: Collaboration during the product design phase to optimize production efficiency
• Vertically integrated services that complement production, such as packaging design, development, validation, in-house sterilization validation and production sterilization
• Customized solutions: Tailored services like kitting, labeling, and specialized packaging for unique product requirements
• Nearshore production transfer support and production operations

Fenske: Do you have any additional comments you’d like to share based on any of the topics we discussed or something you’d like to tell medical device manufacturers?

Nino: Life Science Outsourcing is not just a supplier; we’re a strategic partner committed to our customer’s success. Whether you’re bringing a new product to market or looking to scale production, our team is here to provide the expertise, innovation, and flexibility necessary to help small, medium, and large medical device OEMs achieve their goals. Our one-stop-shop approach ensures you’re not just meeting industry standards but exceeding them, with cost-effective solutions tailored to your unique needs. Working in concert with our customers efficiently advances healthcare and improves lives.

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