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You may think you're saving the company money by using that "free" Excel spreadsheet to track design. Trust a remediation consultant... you're not.
On average, I'm asked to work with some medical device company to remediate a Design History File once a year. These projects generally last anywhere from three months to two years depending on the amount of banker's boxes I have to sift through to determine if the company actually has the documentation they need to satisfy auditors or a submission.
I'm never surprised by the fact the company usually has to call the storage company to haul countless boxes of ancient paperwork initially used to get a product through the FDA's PMA approval or 510(k) clearance process. I'm not even surprised anymore when the company tells me the FDA is now looking at their product and asking for a proper and complete DHF in order to allow the product on the market.
I'm even less surprised to find that my project will be to sort through countless banker's boxes, attempt to find the spurious documentation, perform an assessment of the quality of that documentation, and then draft up a timeline for completing the remediation in a ridiculously short amount of time. After all, this is how I stay in business as a consultant.
What honestly surprises me is the widespread paradigm by practically every company's executive management is the idea that "if we can hurry up and fix this for right now, we'll be good. How long will it take you to do all this?"
To which I reply..."quality, fast, cheap...pick two."
And in my world Quality is always one to choose, so the choice really is: Fast or Cheap? Invariably, executive management has a choice to either bring in a senior-level consultant who has done these types of remediations before, but cost more. Or bring in a junior level person and...well, you get what you pay for. If you think a professional is expensive, wait till you see how much the amateur is gonna cost you in the long run by not doing a thorough job or missing key elements to the remediation.
And that's the point, isn't it? Executive management doesn't plan for the long haul when it comes to systems designed to reduce paperwork, research time, remediation costs. Thoughts of remediation never stray towards "how can we make this a robust system in which we never have to spend this amount of money or lose this much productive time again." It's all about hurry up, get it done so we can get back to making money again.
If hired to perform the remediation, a great deal of my time is spent pulling the subject matter experts away from their current duties to spend time taking the knot out of the past effort (and good luck finding anyone currently working who was a part of the mess that was left behind to remediate!) It ties up everyone's time and grinds productivity to a halt in many cases. So in this case, management is tying up resources for a one-shot fix with no discernible asset for future issues.
Rarely does management think about how to leverage the current remediation to lessen future remediations. Not learning from past mistakes is causing many executive decisions makers to continually throw remediation money (expensive) at problems every time they arise rather than spending proactive money (cheaper) to put a system in place that forces a standard, more organized approach and process that will ultimately reduce the amount of research, investigation, storage costs, and compliance remediation, not to mention drive down the cost of nonproductive hours for next time (oh....and there will be a next time.)
Let's take an example of what I'm saying here and apply it rationally.
Company A has been told that the product they have been selling for 18 years has now been called into question and unless it generates a DHF that will satisfy today's requirements, the FDA will prohibit them from selling the device on the US market (real case, by the way.)
Not having an electronic system (or even having scanned the documents in at least!) the company now must formulate a response, stop all other activities, order back in all the banker's boxes currently holding various and sundry historical documentation, take the time to sift through them, and document a Gap Assessment, attempting to put a timeline (and deadline) on nonproductive hours wasted getting caught up to FDA expectations.
If the company doesn't have the internal experience to do a Gap Assessment, they will need to contract a consultant to perform this service. Invariably, the hiring manager will express that time is of the essence and that this needs to be done yesterday without knowing the depth or breadth of the gaps.
As you can imagine, this project can (and probably will) develop scope creep as all of the details surrounding what wasn't done before - but is expected by today's requirements - is formally announced. Dollars to donuts, executive management was not prepared nor expecting the time or expense it will take to remediate.
Since this project had to be remediated anyway and since internal company employees had no experience remediating a discrepant DHF AND the company had no program to prevent this from happening again, my question is: why not kill two birds with one stone? My experience has taught me to start from scratch and actually build the DHF from the Essential Requirements all the way through Validation.
I was doing this manually from an Excel spreadsheet, but I was missing a lot of the functionality and missed many points of risk that are built into applications designed to connect the two and present in a way that shows compliance. There are, of course, a lot of points that cross reference that are just tough to do on an Excel spreadsheet if you are the average MS Office user.
Enter Greenlight Guru...
I found Greenlight Guru while attempting to research out an application that easily allows companies to build their Design History Files from scratch. I've worked with the big players (we all know who they are) and they all have their good and bad points about them. But with Greenlight Guru, they seemed to me (in my medical device consultant professional estimation) to have the one product that was very easy to organize and develop files using existing staffing and less time learning new software.
And since a large part of the remediation is organizing what exists from what doesn't, it made sense to me to use this program to house all the documents we were pulling from the banker's boxes and learn to build a DHF from scratch in a manner that would lend itself to both future remediations and future new product development.
I can't tell you that you will be able to totally eliminate the decision between Fast and Cheap using Greenlight Guru; however, if you have to do the work anyway, why would you not want to maximize the effort and put a system into place that will allow you to lessen the cost of the next remediation or new product development using lessons from the past?
This to me is like killing two birds with one stone, so to speak, and maximizes the effort to reduce cost and nonproductive hours in future. The more I've worked with Greenlight Guru, the more I am convinced that this is the right program for a small to medium sized companies who need to remediate, organize their design files, and plan to design more medical device products in future.
This solution was developed by a medical device engineer who transferred that knowledge into a software program designed specifically to close the gap between making that decision between Fast and - at least - Less Expensive.
Using Greenlight Guru, in my humble opinion, is the closest solution I've ever seen to allowing my customers to choose Quality, Fast, and Less Expensive.
Full disclosure: I signed a partnership agreement with Greenlight Guru recently specifically because I felt their product does exactly what this article purports: helping inexperienced and startup companies with putting an electronic system in place that caters directly to the Medical Device industry. I am in no way being compensated for this article, merely stating what I feel is a solution to consider if you happen to find yourself in the unenviable position of having to remediate DHFs for whatever reason and have a tight budget.
Mark is an independent consultant and President/Owner of his own Quality and Regulatory company called MLB Marketing, Inc. based out of Florida. He has worked at various levels from small start ups to multibillion dollar, multinational corporations; has multiple college degrees; is a certified Quality Auditor from...