PDA Letter

Pushing Combination Product Risk Upstream to Accelerate Time to Market

The PDA Letter features Mark Tunkel’s insights in October issue!

PDA Letter

In an increasingly competitive market fueled by both innovative new therapies and the introduction of high volume generic alternatives, new combination product speed to market is now a leading focus of delivery device developers. The substantial lead time required to meet U.S. FDA approval further intensifies this focus, and makes ensuring that product development cycles are efficient and completed on time critical.

PDACover1015Companies that shortcut their design and development process in an attempt to accelerate their speed to market, however, run the very distinct risk of discovering core device functionality issues at a later stage. This not only adds months to device development cycles but it also causes substantial cost overruns. Fueled by the erroneous assumption that core-to-function design issues can be mitigated as part of a commercialization process, fast-tracking the larger development process proves to be a fatal mistake for most.

Thankfully, by leveraging the appropriate tools at every step of the development effort—from components and subsystems to fully integrated systems design—developers can uncover issues early in the development process well before commercialization, and prove that making a product work correctly in early stage development exponentially increases the likelihood it will work in the field once on the market.

To read the entire article, published in the October 2015 issue of The PDA Letter, click here.