The development of the product development plan is an evolutionary effort that continues through the life of the medical device project.
Bill Betten, Betten Systems Solutions, and Tom Waddell, Waddell GroupThis is the second in a series of articles that will discuss the design of innovative products in the highly regulated medical environment. The first article focused on the process framework needed to guide the overall development. If the process serves as the foundation for the development, the “plan” serves as the blueprint for development. Applying these principles to your development process will result in a faster and cheaper path to market.
As a reminder, this series will focus on the definition and execution of product development activities post-funding and includes the following:
- Idea – Without it, nothing to be developed
- Process – The structure for development
- Plan – The blueprint
- Requirements – The details
- Regulatory / Reimbursement – Critical to the medical device space
- Verification/validation – The right product doing the right thing
The development of the product development plan is an evolutionary effort that continues through the life of the project. Field Marshal Helmuth von Moltke famously said, “No battle plan ever survives contact with the enemy.” In much the same way, a development plan is obsolete as soon as it is committed to paper (or computer). However, a plan is essential to gathering and assigning the appropriate resources to the effort, particularly for a startup trying to obtain funding and support for the subsequent development. At Nortech Systems, we often collaborated with a client to develop a detailed plan in the proposal stage, prior to development of the requirements. This enabled the development of a more accurate proposal, as well as helped the client to understand the various elements of a complex dance among cost, schedule, and resources. This initial plan would be continuously refined throughout the project, reacting to the inevitable changes that occur along the way.