In July, my book, Innovation Breakdown--How the FDA and Wall Street Cripple Medical Advances, was released. As the author, I am simultaneously anxious and reluctant to read what people have to say about it. This book has an important message, for sure, and it is one of those books that many say "needed to be written." It is a book about the extreme challenges in bringing forth real life-saving and life-enhancing medical innovation. Innovation Breakdown is a series of true stories and anecdotes that dramatize the inter-relationships of science, business, and law/regulation in a startup. It chronicles the long and difficult journey from early development to FDA approval and use by doctors taking care of patients.

I purposely wrote the book in a very personal and revealing manner because when you are the CEO of a medical startup, you identify with the company to such an extent that it literally becomes you. There is a line in the book about how I would introduce myself, even in social settings, by saying, "My name is Joseph Gulfo and my initials are MELA," which was the ticker symbol of the company. On the one hand, that was the reason we were successful, but it was also the reason that I was so psychologically and emotionally depleted in the end. My wife was reluctant to see me go through the writing process, lest I relive the pain and emotional turmoil, and lest she fall prey in the collateral damage, again. Writing it was therapeutic, but that's not why I did it.

The book review written by Alex Tabarrock, Bartley J. Madden Chair in Economics at George Mason University, took me by surprise for several reasons. First, I found out about it while drinking my first cup of coffee (decaf only since making it through the events of the book) on Tuesday morning, two weeks ago. Second, it was one thing for me to write about my ordeal--but to see someone else's take on my personal experiences was unsettling, I felt exposed but in fact, Professor Tabarrock's review was quite favorable.

I wish that my mother were alive to have read his piece; to have someone who doesn't know me make such validating statements about something her son did would have made her smile. My mother died tragically and suddenly of a hemorrhagic stroke in 2006. There are no tests available to screen for the risk of hemorrhagic stroke, and if therapy (craniotomy and vascular repair) is not performed immediately, and even then a lot of luck is needed, it is futile. My family is still reeling from the sudden loss.

And this is why I wrote the book--modern medicine has not yet caught up with the advancements in science, and a huge reason for that is the FDA. I want a screening test for hemorrhagic stroke, as much as I want better therapies for multiple sclerosis, cancer, scleroderma and many other diseases that afflict my loved ones.

My favorite point that Mr. Tabarrok makes is actually in disagreeing with me--"...Yet remarkably, given his experience, Dr. Gulfo writes that he still believes in a strong FDA. He argues in the book that better "leadership" and a few tweaks to existing rules can fix the problem. He's wrong."

He then quotes Sergey Brin, "Google's Sergey Brin recently said that he didn't want to be a health entrepreneur because "It's just a painful business to be in . . . the regulatory burden in the U.S. is so high that I think it would dissuade a lot of entrepreneurs." Mr. Brin won't find anything in Dr. Gulfo's book to persuade him otherwise. Until we get our regulatory system in order, expect a lot more Yo's and not enough life-saving innovations."

I do believe that the system can be fixed and I have proposed specific measures that will help in the last chapter (The Medical Innovation Manifesto) of my book. I also want to create the Medical Innovation Institute to do it.

However, in order to fix this broken system, the public needs to demand it. So, I hope that Mr. Tabarrok's book review, and my efforts, will be able to marshal the forces of the not so silent majority to demand better.

I hope, as well, that future entrepreneurs and managers of startup medical companies will continue the fight. I hope that they will have a better understanding of the risks that threaten the process. I often say that the greatest value of my MBA training was in teaching me to look at everything in business from the perspective of the major risks (financing, competitive, regulatory, management, personnel, execution, technology & development, and natural causes) and devising plans to mitigate issues.

I think that my book paints these risks in spades, and I hope others learn from it.

The lives of our mothers, fathers, sisters, brothers, wives and children depend on it.