Commercializing Successful Biomedical Technologies: Basic Principles for the Development of Drugs, Diagnostics and Devices

There are four main uncertainties in all product development two that management can control are resource uncertainty and organizational uncertainty, and two that management has to adapt and adjust to are technical uncertainty and market uncertainty (Leifer et al., 2000).
Technical uncertainties are addressed by engineers and scientists in product development while market uncertainty in terms of competition and market segmentation, pricing, etc. can be factored into the product development processes and product definition or characteristics. Resource and organizational uncertainty may occur because the project may not have the right amount of funding assigned to it at the right times, the team in charge of the project may get disbanded, a senior manager supporting the project may leave, expertise in that technical area may not exist in the organization, or market channels may be new or unknown to the organization. However, these types of high internal uncertainty projects are also means for the company to renew itself from within as the company growth trajectory is launched into a steeper curve. Examples include the Avastin drug product at Genentech, which made it a world-leading oncology company in a few short years, the digital X-ray project at GE, the first drug-coated stent at Boston Scientific, Viagra at Pfizer, etc.
As the uncertainties in product development rise, so also does the possibility to give the company tremendous advantage and market share or revenues by radically changing the...