I agree with f-dot, I think there is a good purpose for this book to open people’s eyes to the medical industry. If a company fails a clinical trial, the results still become public which can hurt trust and confidence in the company brand name. And if that failed product moves forward, the failed clinical trial can be used by competition to show it’s unreliability. I think companies take several precautions to ensure they pass a clinical trial. From what I have seen in the industry, several reliability tests are completed when the product is being developed and then thorough preclinical and formative (usability) studies are conducted right before the scheduled clinical trial. The internal preclinical and formative studies provides results that will be expected to be seen in the clinical trial because they use the same procedures and materials that will be used in the external clinical study. I honestly believe if companies didn’t have the freedom in selecting the parameters that go into clinical trials (such as the staff, equipment – especially, and location of the site), and these were determined by the FDA limited variability in testing procedures, many medical devices would be in question about passing or not.

I found a New England Journal of Medicine blog that provides some examples (in Tables 1 and 2) of alternative ways that companies can use to collect data for a medical device compared to conducting clinical trials, demonstrating some of the FDA’s flexibility.

http://www.nejm.org/doi/full/10.1056/NEJMra1512592?rss=searchAndBrowse&