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jl959 replied to the topic Inputs for Design Input Document in the forum Project Management Process and Medical Device Development 6 years, 2 months ago
The design input should be a collaborative effort between the initiating process team, customer support, and stakeholders. Input from the customer support department is required to state the needs of potential users, in order to fix any shortcomings of the previous products and prevent commercial failure. The stakeholders will set their expectations of the product (such as product boundary and protected revenue), while the initiating process team works on bridging any gaps between the stakeholder’s expectations and the team’s primary objective. The scope, objective, feasibility, customer needs, expected profit, and risks should be discussed between all groups before finishing the design input document. Addressing these needs from the very beginning will minimize delays and failures down the road due to setting unrealistic goals.