CRA Insights

Unique barriers in development & launch of Disruptive Healthcare Products

August 23, 2022
Hospital, Surgical light, on

We define Disruptive Products (DPs) as healthcare offerings highly differentiated from existing products with the potential to fundamentally alter the standard of care in their target markets – eg, microbiome therapeutics, organ-on-a-chip systems, or digital health platforms. As illustrated in Figure 1, some DPs – such as gene therapies and mRNA vaccines – are already playing a major role, while others are still moving toward market readiness.

Figure 1: Illustrative Disruptive Products

Makers of DPs face unique challenges throughout development and commercialization, which are different than the challenges faced by manufacturers of traditional healthcare products. These barriers, illustrated in Figure 2, must be systematically identified and overcome by developers to ensure launch success.

Figure 2: Barriers to developing & launching Disruptive Products

Developers advancing DPs are frequently faced with these barriers. Below, we provide five recent illustrative examples of DPs that CRA supported to overcome the barriers above.

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