Category Archives: Planning

Lack Of Planning On Your Part

Should not constitute an emergency on my part. I'm guessing you have heard this saying a time or two as well. But based on the actions of a couple of our clients, I'm guessing this saying has little meaning. Let me share a brief example. A medical device company has several products on the market in the U.S. and many other parts of the world. They are actively pursuing getting their products cleared all across the world. The company relies on distributors in the specific countries to take care of getting products registered. The company has no in-house regulatory or quality resources and has relied on us to serve in this capacity as a very part-time basis. And when I say very part-time basis, I mean that we help with regulatory issues somewhat after the fact. Let...

Contingency Planning for Medical Device Product Development

Never underestimate the importance of a solid medical device product development project plan. But even the best of plans should be revisited throughout the product development process and adjusted according to the ever changing project landscape. Sometimes, though, we are very good about planning early on in the efforts but forget about the need to update. I'm up to my eye balls in one of these medical device projects right now. Every minute of every working day, and even several minutes of non-working days, can easily be consumed with going from one fire to the next to try and address product development issues and concerns. Lately, I do feel very much like the good ol' project manager firefighter. Grab a hose and spray towards the latest and greatest fire. Trouble is, I don't...

There Is A Plan. I Promise.

The last few weeks have been a little stressful and hectic. Yes, I've felt the pressure as a project manager for a medical device startup. Our efforts had been stalled for too long yet started to make some real progress a couple weeks ago. Right now, it feels like chaos. Organized chaos, maybe. There are quite a few components, resources, etc. involved in bringing this medical device closer and closer to market. Each day for the past week or so has been spent identifying the critical pieces--those items which either gate future development and/or are stalled for some reason. And through all the chaos there is a plan. I'm approaching this a little differently than other medical device product development projects. Overall there will be two products--the main device and an accessory kit. Each...

Where Does Your Real Meeting Happen?

How many times have you been in a meeting when there was lots of discussion about the topic of hand only to have the real decisions happen in the hallway by a couple stakeholders minutes after the sit down? We've all been part of this. And it's frustrating. Why assemble all these people to sit in a stuffy conference room for an hour or so if the two people who are going to make the real decisions are going to do so without everyone else? It happens. It sucks. It's the wrong approach too. I didn't realize how frustrating this past experiences were until I was part of the right way to do meetings. I have a startup client that has meetings the right way. Seldom does a meeting go over an hour. And...