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 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 the greenlight.guru 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 not designed for.

Phil knew these battleship EQMS software solutions were expensive to implement and were often used as a dump station for all sorts of documents and records. With inefficiencies that seemed to be built in by design.

Trying To Fix The Problem

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?

And he confessed that his company had done something no medical device startup should ever do: 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.

But 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 than using legacy systems, 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 greenlight.guru's solution.

I provided a demo of our platform. Phil was excited. Excited because he could see how we had designed a real software solution for his medical device startup's design control and QMS needs.

Easy to use. Fast to Implement. Exclusively for medical device companies.

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

greenlight.guru is the only quality management software designed exclusively for medical device companies. You can view our full platform and services here.

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. greenlight.guru 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 company. 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 a 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 greenlight.guru’s solution.

Phil & Sam knew what their medical device startup needed

Phil and 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. But 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.

Fair.

The news was semi-refreshing to hear. I know the other solutions out there. I've had plenty of experience dealing with them over my 16+ year career in the medical device industry. I know they are very difficult to use and not designed for medical device processes.

Not to mention, we go up against them all the time, and win.

My advice to Sam was similar to that I give all medical device startup prospects when evaluating other solutions:

  1. Make sure you dig deeper into the real pricing and understand the full finacial commitment required.
  2. Get a complete understand of the time it would take a three person medical device startup to implement one of these other options.

A couples weeks later, Sam and I caught up. He told me that he appreciated the advice. These legacy EQMS 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.

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

Sam’s voice was weak. Defeated. He admitted that greenlight.guru was the best option he and Phil had seen - by far.

At first, I didn’t understand the defeat. Then... 

Roger.

Sam said Roger preferred Company A because they have been around a long time. That was all that mattered to Roger. Roger wanted to reduce risk for his medical device startup in hopes of being acquired in a few years.

Are you kidding me!?

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.

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 greenlight.guru.
  • 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 greenlight.guru 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, you can imagine I was pretty upset.

Actually, 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 the Quality Management System that he ignored.

I wish the story I just shared about this medical device startup was made up. I wish the problem of some medical device startup CEOs ignoring the importance of Design Controls and QMS wasn't an issue.

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

Don’t be a Roger.


 

Demo greenlight.guru's Quality Management Software

 


Jon Speer, Co-founder greenlight.guru

Written By Jon Speer


Jon is the founder and VP QA/RA of greenlight.guru (quality management software exclusively for medical devices) & a medical device guru with over 18+ years industry experience. Jon knows bringing a device to market is hard, so he built greenlight.guru to make it easier. Click here to get our actionable medical device content delivered right to your inbox 1x per week.


P.S. You can learn more about our eQMS software and services here.