Category Archives: Strategy vs. Tactics

Building A Culture of Continuous Improvement

Sometimes we work with companies who are pretty set in their ways. And unfortunately, many times these ways are not 100% up to regulatory expectations. Usually, though, when a client hires us, they realize there are things they need to improve. Things they need to do differently. This is why they hire Creo Quality. We've probably all gone through the "5 stages of grief" at some point in our personal life:
  1. Denial
  2. Anger
  3. Bargaining
  4. Depression
  5. Acceptance
Interestingly, it seems as though many of our client engagements also go through these 5 stages too. Our objective is to get to acceptance as quickly as possible. However, I think it is very important to give each of the other stages their time too. Let me explain a little more. Client calls CQ and says they need help ensuring their quality system meets...

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...