Helps Ensure Medical Device Design Control Compliance

You might have read about some of our adventures with Today, I’d like to share another chapter in this startup journey.

We had a call with a potential investor / resource. The guy had 20+ years experience in the medical device industry. The purpose of the call was to share a little more about and do a brief product walk through. As we did so, the guy had strong energy about him. Every time we would offer an opinion, comment, or share details about the software, it felt as though he was bringing bad juju and negativity.

Going into the call, I had good energy and an open mind. Right after the call, I felt like someone ran over my dog and slashed my tires.

Now that there has been some time since the call, though, I have had an opportunity to let some of the comments from this guy sink in, trying very hard to scrape away the toxic affects before they sink into my brain.

“Venture backed startups implement enterprise software solutions based on what their investors recommend.”

Maybe in this guy’s experience. This just hasn’t been the case in mine. In fact, of the dozen or so venture backed medical device startups we have worked with over the years, I don’t recall a single one of these companies having any enterprise software in place. Further, the only medical device companies I have worked with throughout my career (which probably totals 4o or more) using enterprise software have been VERY large companies.

“You just have a process flow / spreadsheet that uses FDA Design Control terminology.” (he said in a snarky tone)


I walked this guy through how simple it is to use to input User Needs, Design Inputs, Design Outputs, Design Verification, and Design Validation content. And how the tool automatically builds the traceability matrix for your Design Controls as you go. Yes, I’m biased, but damn, our software development team created a wicked good, simple, easy to use, intuitive way for medical device companies to manage Design Controls.

You see, I’ve sat directly across from ISO and FDA auditors who had technical files and Design History Files in front of them, picking them apart limb from limb. Most of the ripping apart pertained to our inability to clearly and accurately show complete Design Control traceability from User Needs through Design Validation. Of course we had the home grown Excel spreadsheets printed on 28 pages in size 8 font. Cells merged and linked to attempt to demonstrate traceability. Sometimes, I had an hand in creating these wonderfully, painful spreadsheets. Other times, I was there to defend spreadsheets I had no hand in creating. In every case, the audit was painful. In some cases, we survived, relatively unscathed. Other times, findings.

I know our “spreadsheet” is good. I know it will help every one of our customers ensure compliance with FDA Design Control regulations and ensure compliance with Design & Development requirements of ISO 13485. I know that when our customers have up during either a FDA / ISO audit, that they will be able to quickly and easily show complete Design Control traceability.

While we only have a process flow and spreadsheet, it’s a pretty damn important process flow and spreadsheet.


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