Risk Mitigation for Diagnostic Manufacturers

Invest in your product security and proactively mitigate risk

Risk mitigation is a core focus for IVD manufacturers, driven by commercial best practices and regulatory requirements. Assessment of critical raw material performance, supply and quality is important to minimize risk. Risk must be assessed and mitigated throughout the entire IVD commercialization process.

Our experts can come to you to help you evaluate your risk mitigation needs through our Risk Mitigation Roadshow and Workshop.

Your critical raw materials require active risk mitigation to ensure:

  • Manufacturing continuity
  • Lot-to-lot consistency
  • Regulatory compliance
  • Clinical test reliability

The pillars of risk mitigation are:

  • Supply chain
  • Quality
  • Risk assessment
  • Contract manufacturing

Below are examples of risks coming from raw material supply and in-house manufacturing capabilities that have been identified by IVD manufacturers and where we have programs in place to support you.

  Our Solutions
IVD Manufacturer Risks Supply Chain Quality
Risk Assessment Contract Manufacturing
Supply chain disruptions & delays  
Product or manufacturing changes  
Lack of manufacturing & packaging expertise  
Supplier inability to support current or future demand    
IVD assay variability  
Incomplete documentation  
Specification changes  
Regulatory non-compliance

Supply Chain

Manage your risk of supply chain disruptions with a partner who understands the manufacturing and regulatory requirements for IVD commercialization.

We keep your needs at the center of our supply chain through:

  • Continuous communication and collaboration
  • Understanding the IVD market’s needs and expectations
  • Making our supply chain work for you

We understand the importance of your materials being delivered on time, in full and at the required quality level. By leveraging our global distribution network, you’ll receive accurate and compliant delivery from a valued partner.

Integrated  Supply Chain, Distribution, and Manufacturing

Best Practices for Mitigating Risk in Your Supply Chain

Risk mitigation strategies include selecting fit-for-use products and a variety of commercial arrangements depending on whether your IVD assay is at the R&D, pilot, or manufacturing stage.

A strategic partnership with us involves continuous communication and collaboration and will assure supply at all stages of your IVD process.

Strategic Partnerships for R&D, Pilot, and Manufacturing

Quality

Our Enhanced Quality Program can be used by IVD manufacturers to assist in their own risk assessment for the products they use, and to guide the process of choosing new raw materials. These defined quality levels allow for comparison of quality support and documentation available for raw materials.

The Elite Quality Grade

We have developed the Elite quality grade to offer nearly all GMP quality attributes without the associated cost burden. IVD market feedback indicates that the Elite grade is a good fit for critical raw material usage, balancing price against the need for consistency, transparency and control.

Diagnostic Elite provides enhanced quality attributes that allow our customers to further mitigate risk by supplying raw materials that provide:

  • Quality and regulatory compliance
  • Assay consistency
  • Robust and transparent supply chain
  • Quality materials at a competitive price
  • Enhanced change control notification
  • Change avoidance or reduction

 

ISO 9001, Elite grade, and GMP - Criticality vs. Quality requirements

Risk Assessment

Development and manufacture of IVD products is a complex process involving multiple suppliers and raw materials. Minimizing disruptions of any kind is vital to supply chain management.

Proprietary assessment of our current supply chain is carried out at the product level within the 5 parameters below. The risk assessment is targeted at general disruption of supply of the current product, ideally a product in development.

Product level proprietary supply chain assessment

Our Supply Chain Risk Assessment Program

This proprietary program helps you to clearly understand these potential risks for critical raw materials and
provides recommendations to proactively take the necessary steps to mitigate risk.

How the program works:

  • IDENTIFY: You compile a list of highly critical materials that we supply to you.
  • MANAGE: We analyze supply chain risk potential for each material along the 5 key risk categories (above).
  • MITIGATE: We provide a composite supply chain risk score report accompanied by customized risk mitigation recommendations.

This comprehensive tool is a powerful means to achieve greater insight into the supply chain of your critical raw materials, the associated potential risks, and recommended proactive risk mitigation solutions.
This provides value for all steps of IVD development, from R&D through commercialization.

Contact us to schedule a Risk Assessment.

Supply chain assessment program process

Bulk, Custom and Contract Manufacturing

Our quality systems and regulatory expertise combined with a full range of custom and contract manufacturing services provide global solutions for IVD manufacturers.

These capabilities help reduce your risk and accelerate your commercialization by providing a viable alternative to costly capital expenditure and facility expansion. Let us partner with you from the development of the initial concept, through scale up and final manufacturing; ensuring that you have quality products, at the optimal scale and format, at the right time, to aid your rapid commercialization.

  • Streamline your IVD production by leveraging our global manufacturing expertise
  • Unrivalled flexibility with customized filling and packaging

Visit our Contract Manufacturing Resource Page to see example case studies and further explore how we can support your needs.

Capabilities to Support Risk Mitigation

Capabilities to Support Risk Mitigation