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Perhaps the angle they are going for is cost effectiveness for the user, but maybe not. A review of the One Touch Select system's 510(k) summary on file with the FDA indicate that the new test strips will feature changes to appearance and layout of electrodes on the strip, but with no changes to the fundamental scientific technology, and no changes to the performance characteristics of the system.

The reality is that this is a continued tactic employed by the home diagnostics industry (and J&J in particular): make marginal changes to the product design to keep the product covered under continued patent protection, while offering patients little (if anything) in terms of advancements in the technology. Remember the One Touch Fast Take? That was an example of how this strategy was implemented, as minor changes were made to the design to extend the patent life of the test system with no fundamental changes to the technology. Anyone care to bet on how long the One Touch Ultra remains around?

The reality is that the introduction of generics would be the only strategy make the system more accessible to patients, but the manufacturers continue this practice, thereby preventing true, cost-based competition from emerging.

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