Historically, the value of design control has been to meet regulatory requirements. Both domestic and international regulatory authorities expect design control to be part of a device master record. But by not developing a comprehensive design control file, a company has under utilized a significant asset and has slowed the company’s growth.
The design control file has become a primary indicator as to how fast a company can grow and to a potential investor it is tangible, objective evidence of a company’s worth. Regardless of how wonderful a single product is, for a device company to be of value, it must be able to grow its revenue stream.
Design control not only controls the time it takes for a product to be released to market, it also is the bases for line extensions AND in mergers and acquisitions (M&A) the design control file, is one of the most valuable assets a company has.
From this case study, you will gain greater insight into how to maximize your company’s design control efforts and files.
Learning Objectives:
Determine if your design control procedure has been developed to expedite line extensions.
Develop bench, animal, and clinical data to be leveraged to support future line extensions or other products.
Determine if the technology can be applied to other disease states for additional “indication for use” applications.
Design control is the PRIMARY gate keeper for determining when a device will be released to market AND how fast a line extension can be added.
