We have developed a new cancer screening technology that could save lives – will the clinical community adopt it?

Screening and diagnostic technologies have among the most complex commercialization issues among medical device opportunities. Many of these technology platforms need extensive clinical and regulatory development to establish their utility in screening or providing valuable diagnosis of a clinical condition and in the end, the main benefit to the patients, the overall value proposition, and the economics surrounding the adoption of the new screening or diagnostic modality may lead to modest adoption in the marketplace.

A large multi-national healthcare company approached SI with a novel breast cancer screening technology that would have enabled routine screening of women for evidence of breast pre-cancer, similar to pap-smear screening for evidence of cervical intraepithelial neoplasia. In the absence of any other technique to screen and detect breast pre-cancers, and in the presence of a 7000 patient clinical trial validating the strong correlation between the market used in the proposed assay, and the presence of breast pre-cancerous tissue, the value proposition seemed eminently obvious and intuitive.

SI was asked by the client company to carefully evaluate the current clinical evidence, and the potential commercial viability of such a new screening technology. SI conducted a thorough secondary research reviewing the most current clinical literature on the details of the research conducted to date, and the status of similar screening technologies. Furthermore, SI identified key opinion leaders in oncology and interviewed a significant number of these experts regarding the value proposition of the new technology and the viability of such device to be used in routine screening of women. The results, surprisingly, led to highly counter-intuitive conclusions and ultimately led to a recommendation for SI’s client to pass on the new screening technology.