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 greenlight.guru.

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 short story. I’m going to go back in time about 17 years.

The start of a medical device career

I was finishing my senior year of college at Rose-Hulman Institute of Technology. My degree path was chemical engineering, yet in my junior year, I had discovered this thing called biomedical engineering. I took a course that was actually taught by the school president, Dr. Sam Hulbert.

The class was intriguing. I had never really spent any time even thinking about medical devices until that time. Enrolling in the course was a bit of a whim. I needed to take an engineering elective, and it happened to fit into my schedule.

Dr. Hulbert had a way. He brought his experience as a practicing biomedical engineer who had designed artificial knees and implants to share with his students. Sam exuded passion about being a biomedical engineer.

But I was pursuing chemical engineering.

As the latter part of my senior year rolled around, I had the opportunity to take another Sam Hulbert course. My fascination continued.

And the chemical engineering job opportunities were sparse. I had a few mechanical engineering friends landing jobs with medical device companies. One suggested I submit my resume to a company in Bloomington, IN called Cook Medical.

I grew up about 30 minutes or so from Bloomington yet had never heard of this company. Probably because I paid no attention to medical devices until late in my college career.

No matter. I submitted my resume. I needed a job.

And a job I got. As a medical device engineer.

I remember the first day of orientation at Cook. I remember being told that nearly all Cook products were hand-crafted. As an new engineer right out of school, I thought this meant that a person pushed buttons on a piece of automated equipment to spit out whatever medical devices Cook manufactured.

But, not the case. Cook’s medical devices were (and still are) hand-crafted. The people who make the needles, guidewires, catheters, and other products at Cook are passionate about what they do.

Medical device manufacturers I worked with are passionate

Medical device manufacturers I worked with are passionate

Every new employee at Cook watches an orientation video. In this piece, numerous employees talk about how the medical products designed and manufactured at the company could be used on your mother or your sister or brother, etc.

My Design Controls passion

The magnitude of what I was now employed to do began to take root.

Before long I started working on product development projects. I had the privilege of working side by side with physician inventors like George Arndt, Dietmar Enk, and Richard Melker. Brilliant, wicked smart men! All passionate about what they do.

Doctors I worked with are passionate

Doctors I worked with are passionate

And I started to grasp my role. My purpose. Many engineers grumbled and complained about Design Controls. Yet, for me, I had a different point of view and perspective.

I quickly grasped what Design Controls are and why they matter to medical device product developers.

I began to form opinions, points of view, opinions, and philosophy regarding Design Controls.

Where others viewed roadblocks and obstacles, I saw Design Controls as a path forward.

I began to see how Design Controls formed my purpose as a medical device engineer. Design Controls were a means to capture the essence of the products I was fortunate to help design–with guys like Drs. Arndt, Enk, and Melker.

Design Controls were the supporting evidence to prove and demonstrate that the medical devices I helped develop were safe enough to use on my mother, my sister.

I started to really grasp that my profession has a positive impact on the quality of human lives. The products I have been part of bringing to the market help improve and save lives.

And this is a HUGE part of why I am passionate about Design Controls.

Design Controls - a passion of mine

Design Controls – a passion of mine



Jon Speer has been in the medical device industry for over 16 years. In 2007, Jon started Creo Quality to help medical device companies with project management, quality systems, and regulatory submissions. As a result of his experience in the medical device industry, Jon had an idea to develop a software solution to improve how companies handle Design Controls. Because of this greenlight.guru was born. You can find him on Google+Twitter, and LinkedIn


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