Many of the dominant pharmaceutical companies operate partly, or wholly, in the generic drugs market. In 2016, the generics divisions of Teva, Mylan and Novartis all reported revenues in excess of $9bn with the top ten manufacturers reporting nearly $50bn between them. Whilst generic drugs are long-established, there are fewer players in the generic devices market, especially with high profile submissions from companies such as Hikma and Mylan being rejected by the FDA in recent years.
It is very easy to think of a generic device as being a replica of the original product and that reverse engineering the reference device will automatically be successful. In this whitepaper we show that designing and developing a generic device presents some unique challenges. Understanding where and when innovation is necessary and targeting it at the right device functions to make an impact can help companies capitalise on these specific, generic opportunities.