Chicago,IL USA – October, 2017
You can always feel when someone is truly frustrated.
Ed, my Father, was sitting across from me at dinner on a warm summer evening. And the stress was dripping off of his face. This was a few years back, but I can still feel it.
The topic of discussion tonight? Work, like usual. Ed had spent weeks reading the latest reg, EU MDR and preparing a presentation for the higher-ups that detailed his multi-year plan for compliance.
At the time, he worked for a massive manufacturer that had a portfolio of hundreds of SKUs, and was notorious for cutting corners. The day of regulatory reckoning was fast approaching, and Ed was adamant about revamping the CER team, the literature review process (that didn’t even exist for 90% of their tech files), and the plan for how to get these things written on time.
He laid it all out for his bosses, a full plan of attack complete with processes, hiring lists, and budgets. All in meticulous, yet easy to digest detail.
Can you guess what happened next?
They completely ignored him. Yep, that’s right. The ultimate decision was ‘let’s punt on this and see how strict they end up being with MDR’. Thanks for the PowerPoint, Ed. Back to work.
There are two types of approaches to regulatory affairs and device compliance. The first approach is what was causing Ed so much stress. Where device compliance is an afterthought, a series of bureaucratic hoops to jump through, an anchor wrapped around the budget of big companies who need to ‘cut costs this quarter’.
The second approach is one of thought and precision. It takes a special kind of person to see the true art and benefits to medical writing. A dedication to getting the details right is vital, but above all else one must actually care.
We started as a family business (father-son) in 2017 and remain family owned to this day.
Our team is global, we are a US Corporation with folks scattered throughout the Americas, Europe, and Asia. We gave up our Chicago office during the Covid years, and have never looked back.
We are a mix of technologists (hardcore software engineers that work on our platform), and seasoned medical writers and regulatory pros (who help out clients that need some extra capacity with their reviews and docs).
We don’t answer to anyone except our customers. Never have taken investments, and are not seeking acquirers no matter how good our platform gets. That means we’re here to stay, and you can count on access and support for years to come.
We’re just getting started.
We make the easiest to use systematic literature review software out there. We serve primarily medtech and pharma, and we’ve got the track record of years of use and successful submissions to stand behind our approach.
We never intended to make this available to the public, at first.
So why didn’t we sell this before? In my opinion it just wasn’t good enough. For our own staff that had already spent months playing with and learning the idiosyncrasies it still worked like a charm and saved a ton of money.
But for a new user who wasn’t familiar with our ‘style’ there still left a lot to be desired in the interface. So we kept working, and made updates every single week without fail based on our teams’ feedback. After 7 years in the business, this ends up being a lot of great feedback translated into new features.
For the past year and a half we’ve been quietly testing the platform with outside users and companies to see how it worked for them. The results have all been positive, and the feedback (not all positive) has fueled a new generation of our software and our philosophy on evidence review.
If you want to learn more about us, the best way is to connect with our co-founders on linkedin. If you want to learn more about our platform, the best way is to get your hands on it and let us walk you through your first project (your own account and data) free of charge. Set up a time to introduce yourself here.
Hope to hear from you soon,
Ethan & Team CiteMed
