This guide advises in vitro diagnostics companies on how and when to engage an IVD contract manufacturer.
Topics covered
- Proximity and logistics: choosing a manufacturer near major freight hubs with backup airport access, and the value of current technology such as lyophilization to remove cold-chain complexity
- Timing of engagement: benefits of early manufacturer involvement (uncovering inefficiencies, refining design) versus later engagement (when freeing internal space or ensuring supply redundancy)
- ‘Variabilization’ — converting fixed manufacturing costs into variable costs by outsourcing, freeing capital for commercialization
- Supply chain expertise and regulatory compliance as risk-mitigation factors
- Building trust: quality alignment, transparent pricing with no hidden surprises, and viewing the manufacturer as a strategic partner rather than a vendor
Choosing the right IVD (in vitro diagnostics) manufacturer is a pivotal decision that can significantly impact your organization’s success in the highly competitive molecular in vitro diagnostics industry. With multiple IVD manufacturers to choose from, as well as numerous suppliers for assay materials, you may be considering one manufacturer for initial formulation, another for final formulation, and potentially even a third for assembly and packaging. It’s crucial to choose IVD manufacturers who can provide the necessary capabilities for formulation, filling, testing, and storage/distribution. If your organization has a large commercial footprint, you may also want manufacturing redundancy from a primary and secondary site.
Learn More: Aluris’s IVD Manufacturing Services
Proximity & Technology
Optimize logistics with local IVD manufacturers: Choose IVD manufacturers that are proximal to central logistics hubs. As an example, your IVD manufacturer should not be reliant on one airport- they should be able to drive freight to a second large airport within 2 hours. Manufacturers need quick specialized support for HVAC, water purity, isolators, freezers, or robotics technicians, so the facilities should not be rural.
Select IVD manufacturers that use current technologies, for example lyophilization: Lyophilizing your IVD assay removes cold chain logistics and shipping temperature challenges for both you and your customers.
Early Engagement: Timing Matters in Partnering
Early involvement with IVD manufacturers: Engaging manufacturers early in your development process allows you to uncover inefficiencies and explore cost-saving innovations. Partnering early also helps refine your manufacturing processes before finalizing your design, ensuring a smoother path to production.
Outsourcing manufacturing later in the product life cycle: Late engagement can make sense when you need to free up manufacturing space, divert resources to higher priority projects, to ensure supply chain resilience or redundancy, or when production becomes infrequent.
Variabilization: Turn Fixed Costs into Variable Costs
Strategic Outsourcing: By outsourcing to a dedicated in vitro diagnostic manufacturing organization, you can avoid the significant capital investment required for in-house production facilities. This strategy frees up resources that can be redirected towards commercialization and other critical areas of your business.
Scaling with flexibility: Partnering with IVD manufacturers enables you to scale production up or down based on market demand without tying up your capital. This flexibility allows your business to respond swiftly to market changes, maintaining competitiveness and profitability.
Focus on innovation, not manufacturing: Outsourcing manufacturing tasks lets your team concentrate on core competencies such as research and development. This ensures that your resources are dedicated to advancing your product and staying ahead of the competition.
Learn More: Aluris’s IVD Manufacturing Services
Supply Chain Expertise: A Key Benefit of Working with IVD Manufacturers
Mitigate supply chain risks: Partnering with in vitro diagnostics manufacturers who have robust, mature supply chains helps safeguard your production process against disruptions. This ensures consistent, reliable delivery of your products, even during supply chain disruptions and market instability.
Regulatory compliance: Choosing IVD manufacturers with strong regulatory knowledge and experience ensures your products meet all necessary standards. This reduces the risk of compliance issues that could delay your product launch and helps you navigate complex regulatory landscapes with confidence.
Expertise and Trust: The Foundation of a Successful Partnership
Align on quality: Ensure that your IVD manufacturers meet your stringent quality and regulatory requirements. This alignment is critical for maintaining product integrity from development through to market, protecting your brand’s reputation and ensuring customer satisfaction.
No surprises: Clear pricing models from your IVD manufacturing teams are essential to prevent unexpected budget overruns. Include alternative models that account for changes in volume, use of secondary sources, and higher labor usage.
Build a strategic partnership: Look for IVD manufacturers who offer more than just production—they should be strategic partners who understand your business goals. A strong partnership with the manufacturing organization can transform your supply chain into a competitive advantage, driving success and growth for your company.
Learn More: Aluris’s IVD Manufacturing Services
Choose From a Wide Selection of Aluris’s IVD Manufacturing Services
Full service contract manufacturing for IVD, POCT and RUO
Complete product cycle management
Complete supply chain management for all your assay suppliers and vendors
Product configurations, formulations, assay development, kitting
Ability to fill cartridges, devices, chips, etc.
Controlled temperature storage
Pick-pack-ship, drop-ship, pallet shipping available
Lyophilization services– cake, powder, beads, dots
Why Aluris Meets Your in vitro Diagnostics Manufacturers Requirements
Top IVD Manufacturing Attribute | Why Aluris |
Regulatory Expertise | Aluris is FDA inspected and supports a wide range of products under 21 CFR 820. |
Quality and Documentation | With ISO13485:2016 and cGMP, Aluris adheres to the highest quality standards, ensuring compliance and reliability. |
Technical Expertise | With decades of experience in IVD manufacturing, Aluris’s team of experts offers guidance at every stage of product development and commercialization. |
Lyophilization | Aluris is a recognized leader in lyophilization with a wide service selection including cakes, LyoDose beads, and LyoDots™. |
Scaleable Solutions | From hand-filling for precision needs to robotic systems for large-scale production as demand grows, Aluris provides flexible solutions for a number of formats. |
Risk Mitigation Strategies | Aluris has a robust quality systems and redundancy in supply chains, guaranteeing continuity and reliability even during global disruptions. |
Early and Late Supply Chain Support | From pre-launch engineering builds to flexible on-demand production, Aluris manufacture in all commercial phases. |
Packaging and Shipping | Leveraging advanced logistics solutions, Aluris ensures secure, compliant, and efficient packaging and global shipping for temperature-sensitive IVD products. |
