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.


Phil had worked for big companies before. He witnessed the ridiculousness firsthand. Standard, legacy software “solutions” attempting to solve issues they were not designed for. Phil knew these battleship QMS software solutions were expensive to implement and used as a dump station for all sorts of documents and records. With inefficiencies that seemed to be built in by design.

Not too late to do what’s right!

But Phil was now with a medical device startup. And he knew that his new company needed two things:

  1. Design Controls
  2. Quality Management System

Phil shared that his company had already submitted a 510(k) to FDA, in hopes of getting market clearance.

How can a medical device startup submit a 510(k) and ignore Design Controls?

How can a medical device startup submit a 510(k) and ignore Design Controls?

And he confessed that his company had done something no medical device startup should do for: they had ignored Design Controls.

Yep, that’s right. This startup company was on the brink of getting the go ahead from FDA to manufacture and sell medical devices.

And by ignoring Design Controls, this company was willing to start their fragile beginnings in a state of non-compliance.

It took real guts for Phil to share this fact about his medical device startup.

Phil also admitted that the company had done nothing to establish a Quality Management System.

And while his big company experience told him there had to be a better way, Phil knew and understood the necessity for Design Controls and a QMS.

My conversation with him was good. Phil knows his stuff.

It was clear that the pain Phil and his medical device startup were feeling (even if the startup was not entirely aware just yet) aligned very well with Creo Quality and

I provided a demonstration of software. Phil was excited. Excited because he could see how we had designed a REAL solution for his medical device startup. A REAL solution design specifically for the medical device industry.

Easy. Targeted. Simple.

And Phil knew the road ahead would eventually involve the startup CEO, Roger.

I got the feeling as the name “Roger” escaped his lips, that there would be a challenge.

Implement a solution designed for medical device startups

Phil had a simple plan. The plan was this:

  • Connect with his colleague and co-worker, Sam, and provide a software demo.
  • Knowing that Sam would be just as excited, the two of them would present the business case to Roger.

I connected with Sam. Sam got it, within 10 minutes–maybe less. He agreed with Phil. was simple to use and elegantly designed for the medical device startup.

Sam shared that CEO Roger had a way and a few ideas of his own. I started to get the impression that Roger was seldom wrong and maybe difficult to work with.

Sam also shared that the company had three employees: Sam, Phil, and Roger.

Part of me thought this is great! Sam and Phil represent 67% of the medical device startup. And Sam and Phil love our product.

Sometimes, part of me can be naive. Very much an optimist.

CEO Roger had avoided Design Controls and QMS, either willingly or out of ignorance. Why would he change his ways?

When I wrapped up my first conversation with Sam, he mentioned that he and Phil had a meeting with Roger in a couple days. They would present the business case since the medical device startup was not in compliance. Sam and Phil would make the case for implementing’s solution.

Phil & Sam knew what their medical device startup needed

Phil & Sam knew what their medical device startup needed

CEO Disconnect Syndrome – it’s real!

I caught up with Sam a couple days after the meeting with Roger. I couldn’t see Sam’s face. His voice was different. A hint of defeat from his words.

Apparently, CEO Roger had an idea. He agreed that something needed to be done for his medical device startup. Roger instructed Sam to cast a wider net. To evaluate other QMS solutions available.

The news was semi-refreshing to hear. I didn’t share names of the other solutions. Nor did I share my experiences with this solutions. My advice to Sam was tw0-fold:

  • Don’t believe the pricing these companies share on their websites. Dig a bit deeper to understand the true financial commitment required.
  • Get a better understanding of the time it will take a three person medical device startup to implement these other options.

A couples weeks later, Sam and I caught up. He told me that he appreciated the advice. These battleship QMS companies had things to hide. They were not up front about costs. And getting a demonstration scheduled was a nightmare. In fact, he was still waiting to have another software demo.

Apparently Roger inserted his opinion in the mix too. Roger instructed Sam to evaluate Company A. Company A has been around for a long time. Roger felt that was important.

Hearing this made me smile. I knew Company A. I know Company A is not a fit for a medical device startup. Actually not a fit for a medical device company.

Sam and I reconnected after he finally had the demo with Company A.

Sam’s voice was weak. Defeat. He admitted that was the best option he and Phil had seen. BY FAR.

At first, I didn’t understand the defeat.


Sam said Roger preferred Company A because they have been around a long time. And Roger wants to reduce risk for his medical device startup in hopes of being acquired in a few years.


The single BIGGEST risk for Roger and his medical device startup had been thrown out the window when he ignored Design Controls and establishing a Quality System.

Earth to CEO: Your TEAM is your most valuable asset

Keep in mind these facts:

  • Roger had not seen either software demo.
  • Roger won’t be the primary user of the system.
  • Sam and Phil voted for
  • Sam and Phil will be the primary users of the system.
Is your medical device startup CEO disconnected?

Is your medical device startup CEO disconnected?


I kept my cool with Sam. He was just the messenger.

I was not ready to give up.

I asked Sam for one simple request.

I asked Sam if he could schedule a 30-minute conversation between Roger and CEO, David DeRam.

My logic: If Roger truly cares about the future of his medical device startup, he should at least be as informed as possible about the ramifications of the decision he was about to make. Roger should be willing to have ONE 30-minute conversation CEO to CEO.

A few days later, Sam called me. I knew right away.

It was like Sam had come to pay his condolences. I matched his sorrow.

Sam said Roger had his mind made up and was too busy for a 30-minute call. This medical device startup would be moving forward with Company A.

After the call, I was PISSED.

I was baffled.

Ignore your team = you lose credibility

How could CEO Roger completely ignore the advice of his team? Especially when Roger’s team will take care of Design Controls and Quality Management System that he ignored.

I wish the story I just shared about this medical device startup was made up. I wish this was an isolated case.

However, it’s a story that happens all too often.

Don’t be a Roger.



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 was born. You can find him on Google+Twitter, and LinkedIn

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