Informing New Product Development: Investigation of Drivers of Perceived Value in New Urogynaecological Devices by Urogynaecological Surgeons

Abstract

Urogynaecological medical devices are used to provide support to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI). Devices known as meshes and minisling, used to treat POP and SUI respectively, are considered unreliable and many have been removed from the market in light of an FDA warning in 2011. This has resulted in considerable surgeon and patient concern regarding the use of all urogynaecological devices. However, urogynaecological disorders are increasing in frequency with the aging population and left untreated would create a considerable loss in quality of life and economic burden for managing these conditions. For this reason surgeons have expressed interest in a next generation device which could address issues of the last generation. In the face of reductions in healthcare costs, an urogynaecological device developer will need to identify the requirements of a next generation of products to efficiently focus product development on key value drivers in order to deliver superior value to stakeholders while minimising costs. To identify the requirements for a next generation of urogynaecological devices and to identify a strategy to deliver value to urogynaecological surgeons, a qualitative investigation was conducted. This investigation was conducted using hour long interviews of six senior urogynaecological surgeons who used a combination of synthetic and biological devices for both indications. Data was analysed with an approach utilising aspects of grounded theory. Overall this investigation was effective at identifying drivers of value. Long term clinical data was identified as the primary driver of value for surgeons considering a new urogynaecological device. Surgeons suggested biomechanical, biochemical and design strategies in order to develop a product which would have the greatest chance of having strong clinical outcomes. Cost was identified as a substantial barrier to product adoption; gatekeepers to adoption such as hospital managers and insurance managers were perceived to have a maximum price they were willing to fund for urogynaecological devices, restricting devices which surgeons could use. Training and ease of use were identified as strong drivers of value; however their impact on driving adoption were perceived to be limited while surgeons remain discontent with the outcomes of current devices.