We have led the successful commercialization of numerous medical products and have firsthand experience of what does and doesn’t work well. This helps avoid pitfalls, reduce risk and accelerate achieving results. This is particularly impactful in the resource scarce environment in which startups tend to operate.
A concept is commercially valuable only if it addresses a problem in a way that is superior to alternatives and satisfies multiple stakeholders involved in its purchase and use. A value proposition needs early validation as it is critical to attract funding and focusing development activities.
Navigating the regulatory clearance process can be overwhelming. However, the scope of the regulatory challenge needs early determination as it can have a significant impact on the commercialization plan, including the riskiness of the plan, the budget and skill sets required. Clarity in this area if often a prerequisite to attract investment.