Fast and Furious Medical Device Product Development

Do you remember when ketchup came in a glass bottle and seemed to take forever to trickle out–especially when it was a new bottle? I think it was Heinz who had a brilliant ad campaign to emphasize the time it took for ketchup to come out of the bottle. Their slogan was “. . . The best things come to those who wait . . .” Now finding ketchup in a glass bottle is a little more challenging. Most of the time ketchup comes in a container that allows you to squeeze in order to get your ketchup delivered to your fries as fast as possible.

Ketchup is just one example of course. Pick anything else. We can’t get our coffee fast enough. Our internet speed is too slow. Speed limits on the highway should be faster. Faster, faster, faster! I’m surprised that no one has thought of super fast food. Go with me for a second on this one. Imagine that I place my order and pay for it via text or a smartphone app before I get to my favorite fast food place so that when I arrive, the food is ready for pick up. Yeah, it will happen.

Is faster better? What happens to the quality when the speed increases? Logic suggests that the factor of time does have an influence on the overall quality. What’s that you say? Excess time could also have a diminishing return. Continual increases in time does not translate into continual improvements in quality. True. And that’s kind of the mystery to solve.

Which for ketchup and fast food, for now the quality is good enough at the current rate of speed.

But what about medical device product development? Is fast and furious a good thing? Should we push for faster and faster and faster? Do we realize that the speed factor can have a negative impact on our product development efforts? And are these risks you are willing to take? Or do you need twice as much time? If so, will your quality really be that much better? Will your product development efforts go that much smoother?

To me, this is a very interesting conundrum.

It’s now October. Ten months ago, I started a medical device product development project with an entrepreneur / CEO. The goal he made very clear was that before the end of 2013, he wanted to have the device on the market. The device is semi-complicated. It’s an electronic gadget driven by custom firmware. Plus, there are plastic parts and pieces, disposable components, and so on. Before kicking off the project, I had a few conversations with the CEO about project timeline. He reiterated time and again one year, one year, one year. I told him that while theoretically this schedule was possible, 18 months was more realistic–mostly because of FDA wildcard. So we talked about FDA and 510(k) process. After hearing about all of this, the CEO said he thought FDA would only take 90 days to provide clearance and that we should plan accordingly. He saw no reason why one year was not feasible. I tried to explain all the ups and downs that are likely to happen during medical device product development. That if I could plan for it, then it would be avoided. But it’s the things we won’t think of that will be challenging. After discussion, I did feel it was realistic to get to a point when a 510(k) submission could be submitted before the last 90 days of 2013. And since he believed 90 days with FDA would suffice, then this goal of getting to market before 2014 was in fact doable.

Yes, as of this post, there are less than 90 days left in 2013 and a submission has not gone it yet. However, we did have a period of over a month where we had to regroup and find a new design and development team. Despite this, the 2013 goal has still been in place. And we are so close. We are finishing up IEC electrical safety testing and should conduct head to head performance testing within a week or so. I anticipate being 510(k) ready within a couple weeks.

We have been fast and furious with the medical device product development. Some days things have gone smoothly. Others, not so much. From my perspective the fast has created some of the furious. I realize the importance of urgency and being driven toward an aggressive goal. When everything feels like an emergency, though, the sense of urgency loses its meaning and gets washed out. Of course every project manager would prefer a longer schedule–I’m no exception. I guess what I’m trying to say is that we have been running through this thing pretty quickly, sometimes taking business risks that if only we had waited another day or two might have resolved themselves. It feels furious almost every day. And lately, because of all the moving parts and pieces that must come in sync all together now, the fast suddenly feels slow–almost backward.

Fast and furious and medical device product development? Yeah, I think that’s fine. The challenge, in my opinion, is knowing when to slam the acclerator to the floor, when to ease off a bit, and when to apply the brakes.

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