Medical Device Link.

IP AND TECHNOLOGY DEVELOPMENT

Return to Article: Panel Discussion: Defining the Product Development Process

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.