Category Archives: Strategy vs. Tactics

Medical Device CEOs Should Stay Out of Limbo

A medical device CEO should establish a sound business strategy and communicate the vision for their organization (yes, this is true of any CEO). Being strategic, establishing a clear vision, and communicating throughout the organization is tough. And from my experience, very few medical device CEOs have this ability. Most medical device CEOs operate in a state of limbo. We have experienced this first hand with a couple of clients. In one particular case, the CEO was highly critical of third party vendors on meeting timeline, deliverables, and expectations. However, he did not provide the same sort of vigor with internal resources and employees. The CEO was being very wishy washy. Saying one thing, yet often doing another. This sent mixed messages. The employees seemed to have a free ride and were seldom held...

Tips for Preparing a 510(k) Submission

The past few weeks have been super hectic and crazy busy. I've been up to my eyeballs preparing a 510(k) submission for a startup. Good news is that it is sitting on my desk right now and is ready to ship to FDA. The device is relatively simple and straightforward. The submission is too, yet still comes in at ~200 pages. As I look at the stack of paper sitting on the desk, I begin to wonder if this is how a novelist feels right before sending a manuscript off to be edited. I'm anxious, excited, and a little bit nervous. Regardless, the submission will be boxed up and shipped this week. And in about 2 - 3 weeks from now, we should get work from FDA whether the 510(k) has been...

Why Ignore FDA?

A couple weeks ago, I shared a story about a medical device company seeming to not take FDA 483 observations very seriously. I learned recently, they have done little in the past month to address the identified shortcomings. At first this really bothered me. How could a medical device company be some nonchalant and complacent regarding FDA observations? Seems like you would want to fix the issues as quickly as possible. This medical device company has a different philosophy though. And I really saw this come to light a few weeks back. When they basically ignored the commitment they made to follow-up with FDA by May 1, the signs were apparent. I was given the responses ". . . I've been too busy to deal with FDA stuff ....

I’m Just Too Busy. I Don’t Have Time.

Yeah, I've said this before. And this response is so generic and meaningless. Of course we're all busy. Yes, there never seems to be enough time. As a consultant working with medical device companies to implement solutions, from time to time, I need the company's resources to participate in the activity. I need the resources to review the procedures, forms, etc. I am proposing. I even sometimes need their assistance implementing. I realize that sometimes I am suggesting a change to their comfortable, busy life. However, when we are brought in to identify opportunities for improvement and implement, I need you to find some time to be part of the solution.  ...