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.

Chapter 8 deals with the financial terms of licensing agreements, including fixed/up-front/lump sum payments, running royalties, sublicensing income, milestone payments (Law v. BioHeart), equity compensation, cost reimbursement (including for patent prosecution), most-favored clauses (Kohle v. Hercules) and audit clauses. Special attention is given to the calculation of license royalty rates, including tiered royalties, the royalty base (Allen Archerty v. Precision Shooting), the entire market value rule (EMVR), the smallest-salable patent practicing unit (SSPPU) rule, now-disfavored rules of thumb such as the 25% rule, standard exclusions from royalty calculations, minimum royalties, royalty caps, royalty stacking clauses and escalation clauses (Arbitron v. Tralyn Broadcasting). Special issues such as reach-through royalties and package royalties are also addressed.

Your vision statement for your group, presented both orally and in writing, is one of your most important and memorable acts as a leader. It should be given a great deal of advance thought and planning ahead of time, and you should be sure to vet it with a number of people who will give you good and frank advice. Although they can be intimidating, vision statements are usually full of positivity and forward thinking, are a great source of inspiration to your group, and serve as the ultimate frame of reference. This chapter describes difference between “mission” and “vision,” and how to develop both types of statements. It discusses the three “pillars” of academic medicine – clinical, research, and education – but also additional pillars worth considering as you develop your mission and vision statements. It goes into how to set goals, metrics, and milestones for your vision statement, as well timelines for achieving them. It then describes how to get your group to fully understand your vision and rally behind it, and concludes with a discussion of how to periodically reassess and recalibrate your vision.