The Early Bird Gets The Worm Project

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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When All Else Fails, Listen To Your Customer

At Diba, we strive to be close enough to customers that they will share their fluid handling challenges with us. Here is one such case below.

The Need:
The R&D Engineers at a Diba customer in the business of manufacturing diagnostic test kits for clinical labs asked us to investigate possible improvements in probe manufacturing on their flagship HPLC instrument.

The Customer Challenge:
During periodic instrument refining, this global customer uncovered a potential problem with the piercing probe at the point of sample aspiration on their HPLC instrument. Although the instrument’s probe functioned as required, coring occurred as it pierced the caps of sample test tubes.

The Solution:
Our engineered solution improved the probe by smoothing the finish to the side-hole port without changing the basic design. As a result, this customer was able to reduce coring by more than 50%, reducing the risk of unwarranted service calls or premature probe replacement.

Have you had experiences in your career where listening to customer needs improved a design and added value? How about where you partnered with a customer to create an innovative solution within design fluidics?

Leave a comment and share your thoughts and experiences.

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Diba … Fluid Intelligence!