Outsourcing production to a diagnostic manufacturing partner can be highly beneficial for diagnostic developers who lack in-house production facilities or expertise. However, choosing the right partner for people’s device’s production is essential. Fortunately, people can take several steps to ensure that people’s outsourced diagnostic device is successful.
Here are five tips to consider when outsourcing the production of diagnostic devices:
1. Assess a Manufacturer’s Credentials
Before signing any contracts or agreements with potential manufacturing partners, it’s vital to ensure that it has the necessary experience, qualifications, certifications, and quality performance.
Initially, people’s assessment should focus on the provider’s experience—have they done this particular job before? How much, and how well? Be sure to confirm that the manufacturer serves people’s industry and can produce the right components. Request a portfolio of case studies to discuss the manufacturer’s work and the overall experience of the partnership. And definitely ask for references (and check them).
When assessing quality, look into the provider’s quality standards, practices, and track record. How does it perform quality checks? What standards does it conform with to ensure consistency and quality? Which regulatory certifications does it hold?
2. Formulate an RFP and Provide Clear Documentation
When entering into an outsourced production partnership, it’s vital for diagnostic developers to provide manufacturing partners with accurate and well-detailed instructions, materials, and documentation. Each objective and concern should be carefully laid out and easily understandable for the manufacturer. Although each manufacturer will have a different preference for documentation, the process will generally start with a request for proposal (RFP) from the diagnostic developer.
Creating a quality RFP is crucial—this is where people define people’s objectives and outline people’s manufacturer’s requirements. The RFP should:
Define the project objectives and outline the manufacturer requirements (with precise descriptions of what, when, where, and how).Provide comprehensive background information about the project.Explain what people need from the manufacturer for the partnership proposal.Clarify people’s objectives in detail and the scope of the services required.Describe how the manufacturer presents its capabilities, costs, and expectations.Express the project’s timeline.Once people’ve partnered with the manufacturer, organize the exchange of additional essential documentation and specifications, including manufacturing drawings, bills of materials, work instructions, and test protocols.
The developer and manufacturer should carry out a joint review of all documentation before commencing production efforts. Such a review should uncover any missing information, redlines, undocumented knowledge, and critical processes.
3. Use a Manufacturer with a Vertical Supply Chain
Vertical integration can streamline communication and project priorities, especially in supply chain management. A manufacturer with a vertical supply chain can provide improved quality due to the widespread monitoring of manufacturing, quality management, and logistic processes. In essence, more materials are kept under one roof. What’s more, manufacturers with vertical supply chains have more control over the supply, ensuring reliable, steady access to raw materials (even during high demand). This careful supply chain management is essential in the medical and diagnostic device industry as shortages of raw and processed materials can lead to adverse public health outcomes. Ensuring that people’s manufacturing partner operates a vertical supply can save potential supply and logistics problems before they arise.
4. Minimize Communication Gaps
Consistent and clear communication between diagnostic developers and manufacturers is critical to successful device outsourcing. Early in the partnership, people should establish how often communications will be made between both parties and who the delegated contact officers will be. This can include order status, production and shipping timelines, payment due dates, and other steps. In addition, a diagnostic manufacturer should provide direct communications access to several staff members, including a technical sales representative, customer service representative, and engineer, so people know who to go to directly with specific questions or concerns.
Establishing these clear contact guidelines is key to reducing communication gaps and ensuring that people stay up to date with project updates. After all, being aware of the status of people’s production allows people and the diagnostic manufacturer to optimize production and troubleshoot potential issues before they arise.
5. Determine if People Need R&D in Addition to Production
Many diagnostic device manufacturers offer research and development in addition to manufacturing services. This can be vital for last-minute design changes, troubleshooting, or transferring a prototype to production. This process can also provide value in functionality or aesthetics to inspire better sales.
For example, suppose a component was found to deteriorate earlier than expected. In that case, a manufacturer with R&D capabilities could quickly redesign the part with minimal time spent on re-development (which holds up commercialization).
However, people should also consider the following questions before establishing a partnership:
Does the manufacturer have the right skill set and internal expertise to provide R&D for people’s device if needed?Will people employ its R&D services during development, during production, or following the product launch?The ideal manufacturing partner should complement people’s business and provide services that complement people’s own. Utilizing such R&D services is an example of how a successful partnership can save people time on development and troubleshooting.
From its headquarters in Atlanta, Ga., CorDx is transforming the global diagnostics industry with innovative R&D solutions, a vertically integrated supply chain, and manufacturing footprints in the United States and around the world. Through its product realization partnerships with leading pharmaceutical companies, CorDx develops, manufactures, and distributes diagnostics and related tools that empower users to monitor and improve their health. Its proprietary line of diagnostics solutions is recognized by families and medical professionals for reliability, affordability, and rapid results.
CorDx is a member of the CorDx Union, a biotechnology organization that delivers medical device solutions to healthcare industries and over a billion users in more than 170 countries.
To learn more, visit CorDx.com