ABSTRACT
One of the most positive developments for the medical device industry in Singapore has been, in recent years, the recognition by innovators, clinicians, engineers, and economic planners of the regulatory approval process’ centrality in bringing innovation to the benefit of patients. The recognition that medical technology innovation cannot exist without the regulatory approval process is, in the first instance, founded on ethical and medical grounds, but it also drives economic considerations as embodied by the following questions: “How do we maximize the effect of R&D investments?,” and “how do we reduce the attrition rate in medical device development?” This recognition has spurred into action the panoply of programs now available in Singapore that raises awareness of, and builds capabilities in, the regulatory approval process. We believe that there is heuristic value in the Singapore experience, and this chapter will outline these programs, highlighting for illustrative purposes the Singapore-Stanford Biodesign Program [1].
