Medical Device Startup CEO Disconnect Syndrome

I'd like to take a few minutes to share with you a story. One where a CEO of a medical device startup does not feel or seem to appreciate the time, effort, and energy his team is about to spend documenting Design Controls, Risk Management, and a Quality Management System. While the names have been changed, these events are true . . .

Medical device startup - a journey

My story begins a couple months ago. I was contacted by a medical device startup engineer, Phil. You see, Phil had read The Ultimate Guide to Design Controls and was intrigued by software solution. Why? Phil had worked for big companies before. He witnessed the ridiculousness firsthand. Standard, legacy software "solutions" attempting to solve issues they were...

Why I am passionate about Design Controls

If you've met me or have read blog posts and articles I've written, you have probably figured out that I have a strong passion for Design Controls. Earlier today, I had a chance to provide some training to a company venturing into the regulated medical device world. Can you guess the training topic? Yep. Design Controls. It's a topic I've been passionate about for quite some time. Which is one reason I authored The Ultimate Guide to Design Controls a few weeks ago. Hell, Design Controls is why I co-founded After the training earlier today, I was giddy. Like a kid. I can feel my eyes twinkling a bit. And I know why. I don't believe I've ever shared with you why I enjoy Design Controls so much. So let me tell you a...

A peek into my Design Controls philosophy

Defining when Design Controls begin is up to you. Okay, to a point. Let me state this another way. You get to establish your company procedures for Design Controls, including what the "trigger" is to move you out of research (or feasibility or whatever you call pre-development) and into official product development.

Design Controls Philosophy

To illustrate part of what has formed my personal Design Controls philosophy, I need to go back in time about 12 years. I had the title of Design Control Engineer for Cook Medical. When put into this role, I was given two broad objectives.
  1. Improve the consistency and practices for product development and Design Controls at Cook, Inc. (the flagship company).
  2. Establish a consistent framework for product development and Design Controls across Cook Medical (consisting of 11 companies spread over 4 states...

Complaints Mean You Get Better

During the past few years, there is one topic that sticks out more than anything else: medical device complaints. It seems to be that complaints is controversial and definitely misunderstood. Complaints are viewed as negative. [caption id="attachment_6694" align="alignnone" width="300"]Embrace complaints to improve Embrace complaints to improve[/caption]   Medical device companies seem to want to avoid complaints because of the negative stigma. Yet I think "avoid" is the wrong verb in this case. I think actually companies may want to ignore them. You know as well as I that ignoring something does not mean it will go away. And ignoring medical device complaints is not a good idea. Instead, you need to figure out two things:
  1. What can you do to reduce the number of complaints?
  2. What can you do to manage and...