The Early Bird Gets The Worm Project

Posted on October 27, 2016

The Importance of Early Involvement in a Project’s Design

When designing an In-Vitro Diagnostics (IVD) system, the level of regulations to which the machines are subject are high (i.e., FDA and/or EU approvals). For this reason, these systems go through extended periods of testing in which the form, fit and function of all components are critical to its overall operation. Having a technology partner that is engaged early in the project’s design is key to its long term success.

Once the machines are tested and released into production, the probability for any changes taking place, such as tubing sizes, type of connectors or material/resin changes is highly unlikely.

Resources + Time = Money … Lots of Money!

Let’s say that your new instrument has the requisite approvals from the regulators and is released into production. In order to perform any changes (as small as they may be), the machine – or at least the module in which the change is taking place – has to be revalidated and tested. The revalidation process is usually quite expensive, and it requires resources to document and test the change as well as time to perform the tests. Depending on their complexity, revalidation may take six months or longer to complete.

As a general rule, an OEM will make a change to a system only if:

  • a recurring quality issue exists,
  • a component becomes obsolete, or
  • cost reduction greater than the cost of validation is possible by making the change.

For these reasons, being in the forefront of the system’s design and development is critical. This will enable the component manufacturer to present the OEM with less expensive, easier to manufacture and better performing solutions.  The OEM’s technical team often has a general view of components, but relies on the supplier’s expertise to provide them with the optimal solution.  This can only be done efficiently if the suppliers have full access and are involved in the design of the system early on.

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Categories: Design

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