Kicking Open the Door for Electronic FDA Submissions

Guidant is the direct answer to today's trivia Tuesday question, "What medical device company helped revolutionize the FDA submission process in 1994?"

But the better (albeit tougher-to-answer) question might have been, "How did Guidant kick open the door for electronic FDA submissions?"

Or, even "Why did Guidant invest in helping to advance the industry on a larger scale than itself? What was the genesis behind the pilot program from Guidant's POV? What about FDA's POV? What did each party have to gain and what did each bring to the table that few, if any, medtech companies could have contributed at that time? What larger industry problem was solved by these two unlikely partners? What value did that particular regulatory and quality pilot program have for the "future" of medtech that got us to where we are today?

The answer depends on who you ask and how long they have had ties to the industry.

Here's a story I stumbled across in our archives recently that addresses all of the above, but perhaps in a different way, depending on how old you are in "medtech years."

Electronic Submissions Aim at Faster FDA Product Reviews?

What I found interesting about the story is that it was published in 1996, in a completely different phase of the healthcare industry's overall reform story, going back to the Clinton-Gore administration.

A 1981 baby, I am limited by my life's experiences. That resume is 43 years old. But my medtech self is only 17. I am limited in my answer based on that length of time.

Someone who worked in the medtech industry at that time regardless of job function (from a janitor to a line worker to the C-suite and everywhere in between) of job function) would likely have a different visceral response to that archived MD+DI story than yours truly because they are old than I am in "medtech years," even though my real age is 43 as of Friday.

When I think about Gore, I think about 2006. You might think of 1996. Your colleague in a different department probably thinks of some year in between.

So this Trivia Tuesday is different from weeks past in that I am going to answer the question from my perspective in "medtech years" but first I have a special request. Tell me YOUR answer in "medtech years."

Email your answer to [email protected] using the subject line "Guidant in medtech years."