As the diagnostic industry evolves under new regulations and advancing technologies, outsourcing production has become vital to maintain innovation and speed. Yet, identifying the right manufacturing partner remains a challenge, with risks tied to compliance, scalability and supply chain reliability.
Effective collaboration is essential to ensure product quality and regulatory alignment.
This whitepaper explores best practices for selecting and managing contract manufacturing organization (CMO) partnerships, focusing on in vitro diagnostics (IVD) development and critical raw materials. It highlights strategies to streamline approval processes, strengthen supply chains and achieve compliance with evolving global standards.
Download this whitepaper to discover:
- How strategic CMO partnerships can drive faster, compliant IVD commercialization
- Key factors to evaluate when outsourcing
- Practical insights on navigating regulatory transitions and mitigating supply risks
White Paper Navigating CMO Partnerships in IVD and Regulated Industries The diagnostic industry is undergoing rapid transformation driven by technological advancements, regulatory changes, and evolving market needs. As companies strive to develop innovative In Vitro Diagnostics (IVDs), the choice of Contract Manufacturing Organizations (CMOs) has become a critical business decision. This white paper explores the key considerations in navigating the complex landscape of contract manufacturing for diagnostic development and critical raw materials, focusing on outsourcing strategies, supply chain management and regulatory navigation. Selecting a trustworthy CMO is crucial. Companies should consider factors such as: • Quality Management Systems: Ensure the CMO meets the QMS requirements for the type of device or a component being manufactured for example: ISO 13485, ISO 9001, FDA CFR 600 and FDA 21 CFR 820 compliant environments. Meeting QMS requirements is a key part of gaining regulatory approval and critical for IVD production as well as other regulated industry components. The demand for rapid and accurate diagnostic solutions has never been higher. With the rise of personalized medicine and the need for early disease detection, companies are increasingly turning to CMOs to leverage their expertise, capabilities and expanded manufacturing resources. This paper discusses the multifaceted aspects of partnering with CMOs, emphasizing the strategic importance and advantages of these relationships in the successful commercialization of diagnostic products and critical raw materials for further manufacturing use. Outsourcing production to a CMO can provide several advantages, including: • Access to Expertise: CMOs often possess specialized knowledge and experience that smaller organizations may lack. They can offer unique process capabilities, capital equipment for efficient production and quality control procedures that are expensive for companies to implement on their own. • Cost Efficiency: Outsourcing can reduce capital expenditure related to in-house manufacturing facilities and equipment expansion. This can allow companies to allocate resources to product development, marketing and other strategic business initiatives. • Expertise in Technology Transfer: CMOs can offer expertise in scaling up production and ensuring successful technology transfer into manufacturing processes, all while maintaining compliance with regulatory standards. • Scalability: CMOs can adjust production volumes based on demand, enabling companies to respond swiftly to market changes without the burden of maintaining excess capacity. • Communication and Project Management: A CMO with a dedicated project management team can facilitate timely updates and address potential issues proactively. This should be a strategic partnership for long-term success for both parties. Importance of Robust Supply Chains The COVID-19 pandemic highlighted vulnerabilities in global supply chains, underscoring the need for companies to develop resilient strategies. A robust supply chain is essential for: • Ensuring Material Availability: CMOs that also manufacture raw materials can provide a more stable supply chain. A diverse manufacturing footprint can better navigate regional disruptions and ensure consistent supply. • Mitigating Risks: Companies should assess potential supply chain disruptions and partner with CMOs that have contingency plans in place with a network of suppliers to ensure reliability and quality of raw materials. Understanding Regulatory Changes The transition from the In Vitro Diagnostic Directive (IVDD) to the In Vitro Diagnostic Regulation (IVDR) in Europe has introduced new challenges for diagnostic manufacturers. Companies must adapt to stricter regulatory requirements that ensure product safety and efficacy. Understanding and navigating these complex changes can be daunting for small inexperienced companies. The Life Science business of Merck operates asMilliporeSigma in the U.S. and Canada.References Partnering with an experienced CMO can help companies: • Navigate Regulatory Complexities: CMO can develop validated manufacturing processes that facilitate a quick and compliant path to market. They offer guidance on regulatory requirements and help prepare the necessary documentation to ensure compliance and a successful commercialization launch. • Streamline Approval Processes: Anticipating important factors related to design and quality, the right CMO partner can alleviate challenges, address regulatory hurdles, and speed up the time to market. Conclusion The landscape of diagnostic development is increasingly complex, with numerous factors influencing the success of new products. The development, scale to production, and commercialization process is a lengthy and expensive investment. Whether you are producing bottles of reagents or complex multi-component kits, we are an experienced and trusted partner for companies planning to outsource their manufacturing projects. We provide contract manufacturing services across a broad spectrum of client needs with proven processes and systems that ensure technical support and reliability at all stages of development. Request a consultation or visit our manufacturing facilities to learn more about our contract manufacturing capabilities. To place an order or receive technical assistance: 1. Merck KGaA, Darmstadt, Germany. Various internal white papers and case studies on contract manufacturing and diagnostic development. This white paper serves as a comprehensive guide for organizations aiming to navigate the complexities of contract manufacturing in the diagnostics field, providing insights into best practices, strategic considerations, and the evolving landscape of technology and regulation. For local contact information: SigmaAldrich.com/offices SigmaAldrich.com/support Merck KGaA Frankfurter Strasse 250 64293 Darmstadt, Germany SigmaAldrich.com © 2025 Merck KGaA, Darmstadt, Germany and/or its affiliates. All Rights Reserved. Merck, the vibrant M, BioReliance, Millipore, Milli-Q, SAFC, Sigma-Aldrich and Supelco are trademarks of Merck KGaA, Darmstadt, Germany or its affiliates. All other trademarks are the property of their respective owners. Detailed information on trademarks is available via publicly accessible resources. MK_WP14499EN Ver. 1.0 62911 05/2025
