Running a Medical Device Company Not a Hobby

I would hope that you agree with the title of this blog post. I have a hard time believing that someone would take running a medical device company nonchalantly. I can tell you a few stories about the CEO of a medical device company who handles his business more like a hobby, though. Every time I think about the CEO and the stories, I just shake my head.

The medical device company in question has been struggling for quite some time. To be honest, I don’t know how they continue to be in business. In spite of themselves, they are. Since we have been engaged, we have been trying to get the medical device company to focus on medical device regulations. It’s a constant challenge.

The company, in our opinion, is very exposed for a few reasons:

  • They’ve never had a FDA inspection
  • They do NOT effectively manage complaints
  • They’re products have been part of a few MDRs in recent years
  • They do not follow ANY Quality System procedures

We’ve stressed these points over and over. We have worked with the staff, providing training and guidance. However, the staff is left up to their own wishes and practices when we are not there. The company president allows it too.

Currently, the company is hemorrhaging. Product issues and repairs are at an all time high. Progress is more or less at a standstill. We have tried to jump start this once again to get them back on track. Yet, the company seems to have little concern. Here is a short story to illustrate.

A few weeks ago, we were on site to discuss the current product repair and complaint process. Company management participated in the discussion, expressing their wish list. We went back to the office and spent time mapping out the process and some work instructions and provided these to company management to review and edit. About a week later, we had heard nothing. I contact the president to find out what was going on and if he had a chance to review. He relayed to me that he has been very busy and hasn’t had any time to review. The president further shared that he has been tied up dealing with getting his house ready to put on the market to sell and hasn’t spent much time on medical device company operations.

Are you kidding me? A medical device company is NOT a hobby! It is a business that manufactures and sells MEDICAL DEVICES!

Despite knowing how this client is, I found myself at a loss for words when the president told me this.


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