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Originally Published MX Supplement July/August 2007 IP AND TECHNOLOGY DEVELOPMENT
Cross-Sector Development: Conflict and Confusion
The development and manufacturing of combination products creates a
number of challenges and conflict points caused by the different development
patterns and regulatory requirements of the individual technology
components. Among the differences that need to be considered in this
context are the following.
- Clinical trial requirements for devices and pharmaceuticals vary significantly.
Pharmaceuticals usually require higher patient enrollment,
longer follow-up, and additional trial phases, as well as toxicology and
dosage studies.
- Pharmaceuticals and devices have different requirements for manufacturing
and traditionally have different quality system standards.
- Understanding of the mechanism of action is essential for device testing
and regulation, but is not relevant for pharmaceuticals.
- Device life cycles are typically measured in months and years, whereas
the life cycles of pharmaceuticals are often measured in years and
decades.
- Product iterations are an essential part of device development, but not
of pharma and biotech development.
Copyright ©2007 MX
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