By Sean Fenske, Editor-in-Chief

There are a number of reasons orthopedic device manufacturers choose to work with certain suppliers. The right partner can server as a virtual seamless extension of the firm’s manufacturing capabilities. The supplier organization can provide skills and capabilities not native to the orthopedic device OEM. Having such a partner aligned with the needs of the OEM can enable several benefits.

Among those benefits is a quicker time to market. As the adage dictates, time is money, and this is certainly true in terms of bringing product to market for the healthcare space. Device manufacturers facing any delays in launching or supplying a product to the healthcare market ensure increased costs and/or delays in revenue. It’s critical to leverage best practices to avoid such situations.

To help explain how the right supplier can help companies avoid such delays, John Nino, CEO of Life Science Outsourcing, addressed a number of questions on this topic. In the following Q&A, he explains the common causes of delays in getting a product to market, how a vertically integrated partner can help avoid them, and what a company should look for when trying to identify the best supplier for their needs.

Sean Fenske: From your viewpoint, what universal challenges create the biggest delays in getting an orthopedic device to market?

John Nino: The biggest delays in bringing an orthopedic device to market often stem from four key areas: iterative product development, regulatory compliance, supply chain inefficiencies, and validation processes.

• Iterative Product Development: The development of orthopedic devices often involves iterative cycles of design, testing, and validation, which require close coordination between product development, contract services, and validation teams. Each iteration can introduce new delays, especially when adjustments need to be made based on testing feedback, leading to a longer sequential chain of lead times.
• Regulatory Complexity: Orthopedic devices face stringent FDA and ISO requirements, where delays in biocompatibility testing, sterilization validation, or documentation can derail progress.
• Supply Chain Bottlenecks: Many manufacturers rely on multiple suppliers for different stages of production, which introduces inefficiencies and extends lead times.
• Sterilization & Packaging Validation: Final validation for sterilization and packaging integrity is a frequent bottleneck, particularly if manufacturers lack the right expertise or must coordinate across multiple vendors.

Overcoming these challenges requires a contract manufacturing partner with expertise in the orthopedic space to anticipate and resolve issues proactively.

Fenske: In what ways can a supplier help streamline the pathway to market?

Nino: A vertically integrated supplier with end-to-end solutions can dramatically accelerate the commercialization process. Key contributions include:

• Regulatory Support: A supplier with in-depth regulatory expertise can help manufacturers navigate FDA and ISO 13485 requirements efficiently.
• Consolidated Manufacturing & Assembly: Reducing the number of suppliers involved in production minimizes risk and accelerates timelines.
• Sterilization & Validation Expertise: By offering end-to-end, in-house sterilization and validation capabilities, suppliers can prevent delays associated with third-party coordination, helping manufacturers maintain momentum by planning these steps earlier in the product development process.
• Supply Chain Agility: A reliable partner will have sourcing flexibility, mitigating the risk of material shortages that can halt production.

Fenske: Can you speak more to the benefits that can be realized in terms of time to market with a vertically integrated supply/manufacturing partner?

Nino: We recommend initiating packaging design, medical package testing, and sterilization validation as early in the development process as possible and, where feasible, running these activities concurrently. This proactive approach minimizes bottlenecks, reduces the overall timeline, and allows for quicker adjustments in response to testing outcomes.

A single-source contract manufacturing partner can reduce time-to-market by as much as 30% to 50% compared to a fragmented supply chain model. With LSO, for example, customers benefit from:

• Seamless End-to-End Coordination between Device Assembly, Sterilization, and Validation: From design verification to final packaging, an integrated partner eliminates the inefficiencies of dealing with multiple vendors.
• Faster Validation & Regulatory Approvals: Internal expertise in sterilization and packaging validation streamlines compliance efforts.
• On-Site Cleanroom Facilities: Assembly, packaging, and sterilization are conducted in-house to avoid logistical delays.

By managing all critical steps under one roof, we help orthopedic device manufacturers move swiftly from prototype to market-ready products.

Fenske: If you’re launching a new product vs. scaling a commercialized product, what capabilities are most important to identify the “right” partner?

Nino: The most important factor in selecting a supply/manufacturing partner is finding the right size, shape, and scale that aligns with your organization’s specific needs.

For commercialized OEMs:

• Regulatory & Quality Expertise: Proven expertise in navigating FDA regulations and ISO 13485 compliance with a consistent track record of successful regulatory audits.
• Vertically Integrated Capabilities: Look for in-house assembly, packaging, sterilization, and validation to minimize hand-offs.
• Scalability & Flexibility: The partner should support both small pilot runs and full-scale production.
• Speed & Responsiveness: Agility in project execution, combined with a customer-centric approach, can make or break commercialization timelines.

For startups introducing a new product:

• Guidance & Mentorship: Startups benefit from partners who offer strategic guidance through the regulatory and product development process, ensuring a smooth transition from concept to commercialization.
• Flexibility & Customization: The ability to accommodate small, iterative production runs and adapt quickly to design changes is crucial for startups.
• Cost-Effective Solutions: Budget constraints are common in startups, so finding a partner that can deliver high-quality results without excessive costs is vital.
• Rapid Prototyping & Development Support: A partner with rapid prototyping capabilities and hands-on development support helps accelerate the early stages of product development.

Fenske: Do you have real-world examples that help illustrate time-to-market savings?

Nino: Absolutely. One example is a mid-sized orthopedic implant company that partnered with LSO to reduce its sterilization validation timeline by 12 weeks. By leveraging our in-house expertise in steam and ethylene oxide sterilization, we eliminated the need for multiple vendors and streamlined processes, accelerating FDA submission.

Another case involved a startup developing a novel orthopedic fixation device. Initially working with fragmented suppliers, the company faced significant delays. By transitioning to LSO’s integrated model, they cut their total manufacturing lead time from nine months to five months, ultimately getting their product to market ahead of schedule.

A third example is a Utah-based manufacturer of hip and knee replacement implants with over $17 million in annual revenue. During COVID, their supply chain was severely disrupted, preventing them from putting sterile products into the market. LSO provided a pre-validated packaging solution that fit their device, saving significant time and money by leveraging our vast ecosystem of services. As a result, the client was able to get sterile products back into the field quickly and continues to rely on LSO for cleaning, packaging, labeling, and sterilization services. Our partnership has since expanded to include additional product families.

Fenske: Where are the pain points in the OEM/supplier relationship most evident? What trouble spots should companies be aware of and looking to resolve before they become a bigger issue?

Nino: The most common pain points include:

• Lack of Transparency: Misalignment on timelines and deliverables can create costly delays. A strong partnership requires open communication and real-time tracking of milestones.
• Regulatory Missteps: Failure to anticipate compliance requirements early in development can lead to last-minute redesigns and setbacks.
• Siloed Supply Chains: Relying on multiple vendors for sterilization, packaging, and validation increases the risk of logistical issues. OEMs should seek a partner that can consolidate these critical functions and avoid unnecessary risks.

By proactively addressing these pain points, companies can avoid disruptions and maintain momentum in product commercialization.

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 orthopedic device manufacturers?

Nino: Orthopedic device manufacturers face mounting pressure to accelerate innovation while meeting increasingly stringent regulatory requirements. The key to success hinges on forming strategic partnerships with contract manufacturing organizations that go beyond offering services to actively enhance efficiency and mitigate risks.

At Life Science Outsourcing, we’ve built our business around helping orthopedic innovators launch products with confidence and speed. Whether it’s early-stage prototyping, full-scale production, or navigating the final steps of sterilization and validation, we are committed to being the most responsive, experienced, and reliable partner in the industry.

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