TABLE OF CONTENTS It is important to understand that, despite good technical progress and data, projects get killed in development. Usually, many considerations enter into that decision, including market and reimbursement issues, competitive pressures, newly discovered patent issues, lack of patentability, regulatory changes, financial constraints, or simply a change of strategy in company due to a management change or merger or acquisition of the company. However, a counter-intuitive point frequently brought up in biomedical product development is discussed here: Why is early failure sought after (over late failure) in biomedical product development?
A high cost and rapidly rising rate of expenditure in the later stages of medical product development make it attractive to recognize potential product failure points at the earliest possible stage of development. There are always new product ideas that could be tackled by the resources freed up by failed projects. Also, exhaustive and early tests for potential side effects or toxic effects might help prevent the liabilities of legal lawsuits (see Section 7.13) in the future when the product is marketed to a broader population. Examples are given in Box 4.3.
Examples of failures or problems in diagnostics development and diagnostics products
Sensitivity related failure
An IVD test being developed by a large diagnostics company for sepsis was aimed at locating a surrogate marker...
