Insights for FDA Regulated and HIPAA Compliant Organizations
The Best Path to Commercialize a Diagnostic Test Kit
Finding the Right Partners is the Key
Inherent with the goal of commercialization lies the problems of production and distribution methods and costs, which must be worked out before manufacturing begins.
FDA regulated companies are looking for a shorter and less costly pathway to commercialism, especially for smaller diagnostic testing companies.
The rise of biotech capabilities, specifically of genetic testing companies, has created a great deal of urgency to launch new specimen collection kits on a regular basis. But speed-to-market is often hampered by a supply-chain that includes too many vendors and/or not enough specialization.
As the science of genomics increases and more and more tests become available, DNA testing companies must outsource their kit development, production and distribution to trusted expert partners. Labs must be concerned with the quality of their own internal processes and not worry about the logistics of specimen collection.
These complex core activities can pose financial, operational and technological challenges during rapid growth and commercialization. By incorporating state of the art technology with a team of dedicated experts, every life sciences company can get any product to market faster and more accurately.
If you can remain focused on mission-critical internal processes and outsource non-core competencies such as kitting, warehousing and outbound and inbound shipping of diagnostic kits, this can be a tipping point toward greater commercialization success.