In Vitro Diagnostic Material Development: A Comprehensive Guide
In Vitro Diagnostic Material Development is a process that can be used to create In Vitro Diagnostics (IVD) for medical purposes. In In-Vitro Diagnostics are lab-developed tests that help diagnose and manage diseases, such as cancer or diabetes.
The planning phase includes determining what type of diagnostic test should be developed and which materials need to be created for it, like reagents or substrates. This phase also involves establishing production capabilities and assessing regulatory requirements concerning testing practices. In In Vitro Diagnostic Material Development, a project manager should ensure the planning phase is carried out successfully.
It can take months or years of research and development before it’s ready for market. To speed up this process, laboratories may choose contract manufacturing organizations (CMO) to manufacture In Vitro Diagnostic materials for clinical trials. CMOs have been contracted by over 30% of biotechnology and pharmaceutical companies in the United States alone.
To ensure In Vitro diagnostic material is manufactured correctly, a good quality management system must be in place with testing throughout production at each stage to avoid errors. At the end of In Vitro diagnostic material development, there is typically a period known as validation which means that tests need to be validated to ensure they are accurate and reliable for use in clinical trials or with patients.