|
|
|
|
|
|
|
and accuracy or special features result in a substantial product development program linked to the drug development program. |
|
|
|
|
|
|
|
|
The consequence of the closer meshing between the development of drug substance and the device to deliver it is that the same pressures on time to market and regulatory compliance apply equally to drug and device. In spite of all this, device development is still frequently perceived within the pharmaceutical industry as easier than drug development and as somewhat peripheral to the core business. |
|
|
|
|
|
|
|
|
It is natural for the head of pharmaceutical development to underestimate the difficulty (if not the importance) of developing an excellent drug delivery device. It is extremely hard to imagine, without painful experience, what pitfalls lie in disciplines other than one's own, and no head of pharmaceutical development is likely to be a mechanical engineer, a physicist, or a designer. |
|
|
|
|
|
|
|
|
Underestimating the difficulty or size of the device development project can lead to several undesirable consequences: |
|
|
|
|
|
|
|
|
selection of an inappropriate organization to conduct the development, either under-qualified or under-resourced |
|
|
|
|
|
|
|
|
inadequate or nonexistent management of the project |
|
|
|
|
|
|
|
|
poor integration of the many functions required to launch a successful device |
|
|
|
|
|
|
|
|
separation of the drug development from the device development program. |
|
|
|
|
|
|
|
|
The result of falling into these traps is often disaster with, at best, substantial delays to the launch of the product and, at worst, cancellation of the development. If we have stressed the risks associated with treating device development too lightly, it is because experience shows that it is the underlying cause for many severe development problems. So, what can be done in project management to maximize the chance of success? |
|
|
|
|
|
|
|
|
III.
Selecting a Development Resource. |
|
|
|
|
|
|
|
|
Selecting the right team to undertake development of the device is the critical first step in the process. Recognizing the full range of skills needed often comes as a shock. Skills needed in many projects include mechanical engineering and design; electronics; software; ergonomics and industrial design; analytical chemistry; materials science; production engineering; tool |
|
|
|
|
|