PILOTING A PATH FOR DIGITAL INNOVATION
“ Software has shown itself to be capable of looking at a medical image and providing a diagnosis that matches or exceeds what experts could achieve ”
– Timon LeDain , Internet of Things ( IoT ) Director , Macadamian
expert in public policy with experience working with the Department of Health . “ Lengthy regulatory procedures feed significantly into this delay , generating substantial hurdles for adoption and diffusion of innovation ,” she explains . “ These hurdles are more significant in the context of digital health innovation
( versus pharmaceutical ) because , with rare exceptions , there are currently no established system level pathways and processes to adopt and embed at scale these innovations in practice . This discourages innovation in general , but evermore in areas such as digital health in which product life-cycle tends to be increasingly shorter when compared to therapeutic innovation ,” she explains .
Dr Miraldo believes , from the regulator perspective , the commitment to post-market data collection shared by the innovator can potentially allow real time monitoring of the safety and even value added by these innovations , which is key for streamlining regulatory processes while safeguarding the public interest .
While the healthcare industry appears to be embracing the pathway to market opportunities the Pre-Cert programme could offer , there are institutions keen to offer words of advice and caution . In its open letter to the FDA , the Medical Imaging and Technology Alliance ( MITA ) – the leading organisation and collective voice of medical imaging equipment , radiopharmaceutical manufacturers , innovators and
23