Learning Points

• Define product characteristics at the beginning of a biomedical product development plan using clinical study endpoints and indications,

• How do drug, device, and diagnostic development processes differ?

• Why do many drugs, devices, and diagnostics fail in development stages?

• How to build a product development plan for drugs, diagnostics, or devices,

• When to kill a project,

• How to prepare for clinical trials what are the specific issues for diagnostics and devices?

• Successfully make a pitch for a project to senior management for funding,

• What ethical issues must be recognized during product development activities?

• When should you outsource?

• Compliance to specific certifications and laboratory regulations when setting up a new laboratory.

Read this chapter going through the book sequentially, and then revisit the exercises in this chapter after reading Chapters 5, 6, and 7. The approach to new product development has to be an integrated, multi-disciplinary approach, taking input from Chapters 1, 2, 3, 5, 6, and 7 into account (see the roadmap in the preface).

This chapter deals with the development of a product that is being developed with some new-to-the-world features, requiring a full review by the FDA before reaching market. Drug or diagnostic products that go through abbreviated product development paths (generic drugs, and diagnostics or devices that are largely equivalent to marketed products) are addressed in greater detail in Chapter 5. However, the principles discussed in this...