Product realization (bringing products to market) is the goal of most technically-minded companies, at least the ones who want to make money. However, most companies significantly underestimate how much time and money it will take to do this, which can be a major headache for large companies, and devastating to smaller companies and startups. Even worse, what if we miss something and we get a Warning Letter from the FDA? How can we ensure we have all bases covered and that we’ve budgeted accurately? We will discuss the challenges and solutions here.

Inevitably, whenever a company, whether it be a startup or a major corporation, starts a new product development project the question upper management always asks is “when will it be done?”

Given the massive number of unknowns, how can we answer this question truthfully without making commitments that are unachievable? Do we even know what we need to consider and cover?

On average, bringing a new medical device to the market takes 3.4 – 5.2 years* depending on product type and complexity. 

*Ph1 – 6-9 Months, Ph2 – 9-12 Months, Ph3 – 18-24 Months, Ph4 – 7-10 Months, Ph5 – 6-12 Months 

When this client, let’s call them “MediTech”, approached WDIB, they had difficulty evaluating new projects, consistently planning and executing projects, providing consistent reports to upper management, and a lack of consistency in how they were bringing products to market. This caused major challenges when MediTech wanted to let investors know when things would be done, who was accountable for the work, what project risks were present, and how MediTech could bring new projects into the product realization pipeline. Furthermore, MediTech had no consistent way to manage and store project Gantts or manage the resource pool.