Category Archives: Strategy vs. Tactics

The Importance of Executive Responsibility for a Medical Device Company

I heard a story from a colleague the other day about a recent experience with a large medical device company. Apparently, the company was under investigation by FDA for some reason. During one of the meetings with FDA, the investigator asked the president of the company about executive management and his responsibilities as president. He answered something along the lines that he delegated the executive responsibilities to his management team. I guess the FDA inspector took exception to this and asked everyone but the president to exit the room. We can all imagine and speculate what was said. Let's just say I'm quite sure FDA expects the president of a medical device company to take executive responsibility seriously and to not delegate this to someone else in the company. I wish I could...

Medical Device Design – Get to Minimum Viable Product

Ah, yes! The often talked about yet seldom implemented "design freeze". If you have ever worked on a medical device product development project, chances are you have had to deal with this issue. What do I mean by design freeze? In theory, a design freeze is a milestone where all the requirements are defined, components and bill of material is established, shape / size / color are set. Typically, design freeze happens prior to design verification and should be set prior to any regulatory submission, such as a 510(k). The design freeze is a very important time for a medical device project. In my opinion, this milestone initiates the transition from design to development. What do I mean by this? At design freeze, the medical device design is moving closer and closer to...

Should I Be Pushing My Client’s Buttons?

Let me set the stage a little bit first. The medical device client relies on a third party vendor to manufacture their device. The product is a reusable electronic device. If the device has issues at the end customer, the customer might contact the medical device company to troubleshoot and possibly send the product in for repairs. In recent months, the medical device company has been receiving about 5 devices per week in for repairs. The contract manufacturer went through some internal process changes and quickly got behind on the repairs. The medical device company began experiencing a great deal of frustration and angst while the backlog of repairs got bigger. Eventually, the contract manufacturer began to get back on top of the situation, reducing the backlog of repairs to almost zero. Now, there is...

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...