New product development processes need to be compliant to regulatory requirements, and this chapter highlights the salient processes and quality systems to put into place to achieve success. Project management is made simple with specific tools provided here. Customer feedback is channeled into specific product characteristics, and the right tools are shown in this chapter. The biopharma industry has statistics showing less than 10% of starting compounds succeed in reaching market approval, and this chapter explains what causes these failures. The key issues that have repeatedly caused failure during device and diagnostic product development are also pointed out. Ethical decisions have to be made during product development as shown in this chapter. Outsourcing is a real option due to the availability of many contract research and manufacturing organizations, and judicious use of this option is discussed in this chapter. Key milestones that reduce risk and show transition from early stage to preclinical prototype stages are reviewed here. Does the popular concept of minimum viable product in software development apply in biomedicine prototyping? Other similar questions that help the reader understand pitfalls and best practices are answered here.

In this chapter, we return to linear programming. We begin by covering Phase I pivoting, so that now readers can solve any linear programming problem, whether it is a standard form problem or not. Then we return to sensitivity analysis, but now with the benefit of the simplex algortihm, we show how it becomes much easier to calculate revised optimal solutions and stable ranges of parameters by using some simple matrix algebra.Finally, we consider integer programming, where we require that the solution values of some or all of the decision variables to be integers. While there are several possible approaches, we stick to the branch and bound method in this text. We also observe that integer constraints can be easily handled when solving integer programming problems using Microsoft Excel.