Contract Manufacturing

Customization of Complex Diagnostic Instruments

Customization of Complex Diagnostic Instruments

13 May 2010

Precision instruments such as diagnostic instruments and medical devices are built to a very specific set of requirements. However, new requirements may emerge over time, meaning that changes must be made to the instrument.

Customization can vary from simple cosmetic alterations – such as new branding for different markets – to new software, or new mechanical, fluidics or electrical systems to improve performance or extend functionality.

Key Points:

  1. Customizing existing products can be an inexpensive way to satisfy existing customers and reach new markets.
  2. Complex customizations involve considerable design and engineering.
  3. CAD and FEA modeling reduces the time, cost, and risk inherent in the customization process.
  4. Engaging contract suppliers can reduce the level of development risk, but the contractor must possess strong development skills.
  5. Creating fully integrated systems can negate the need for customization kits.

Customization Needs

An instrument designed to load slides for a specific microscope would require customization to enable it to be used with other makes and models. A customization kit would provide functional alignments between the slide loader and the new microscope. This kit would include microscope stages, modified precision-engineered microscope alignment plates and mounting feet, and new installation instructions.

Another potential customization for a slide-loading instrument that would provide additional slide data is the integration of a two-dimensional barcode reader to replace the standard one-dimensional barcode. To interface effectively with the new barcode reader, the customization would involve both hardware and software integration.

In-house vs Outsourcing

Product companies have two main options when it comes to customization: they can either use in-house resources or engage an external supplier. While a program to implement a simple set of branding badges may be easily accommodated in-house, complex customizations pose greater challenges and, consequently, greater risks.

Customizing products internally can provide cost and control benefits over outsourcing. However, finding suitably experienced internal resources is a challenge for most companies, particularly if their core focus is in other areas. Using a contract service provider with a strong engineering capability can not only alleviate this resourcing issue, but it also transfers responsibility for the development challenge, along with its inherent risks.

Reducing the Time, Cost and Risk of Customizations

Before engineering custom parts, advanced modeling techniques such as Computer Aided Design (CAD) or Fine Element Analysis (FEA) can be used to test and refine the new design. In the example of the slide-loading instrument, CAD models could be used to simulate the integration of the instrument with the new microscope, including the design of a precision XY stage and customized mounting components. The customized mounting plates and feet are only engineered once the design has been perfected on computer. Using a CAD model to verify the integration can significantly reduce the time and cost of the design iteration.

To reduce the integration risk associated with developing customization components, a company can engage a contract supplier to develop an end-to-end system already integrated with the new hardware and software. For example, if a contract manufacturer was customizing a slide loader to integrate with a new microscope as well as a two-dimensional barcode reader, they would not only take responsibility for the design, development and testing of the customization components, they would also ship the entire system already integrated and tested. Depending on the nature of the instrument, the supplier may also be responsible for running chemistry or protocol testing on the instrument to verify system operation.

Engaging the supplier to ship the entire system — rather than just a customization kit — provides the simplest solution to the instrument company.

Benefits of Customizations

Customizing existing instruments can be a relatively inexpensive way of increasing sales by adapting an instrument for new markets. Customizations can also add considerable value to existing markets by enabling the original design to be adapted quickly in response to the changing needs of users.