Several weeks ago, we established that December 31, 2013 would be a good deadline for submitting a 510(k) for a startup client we are working with. As we entered December, this target date seemed very feasible. Each of the team members had their assignments and due dates. I worked on the back end, pulling content and documentation together to build the FDA 510(k) submission packet. All was going pretty smoothly. Maybe too smoothly.
A big part of the plan involved working with the local copy / print shop to print, tab, and organize the documentation for the 510(k). Based on a few recent experiences with this resource, I had developed a good working relationship with one employee in particular. With a couple weeks left in the deadline, I decided to call the copy / print shop to coordinate schedules with this particular person–especially considering the holidays coming up. I found out that the person was out of the office from 12/23 through 12/30 but would be opening the shop up at 7:00am on 12/31. Okay, I didn’t like waiting until then but also didn’t want to waste time training a new person to put together submissions either.
I decided to take the risk and wait for my guy on 12/31.
In the few days before, I went through the submission several times, making a few minor tweaks and edits. The night before, I made sure all the documents were numbered, organized, etc. and put on a USB drive. I also drafted a few simple instructions for the copy / print shop. Although, I knew if my person was there, it should go smoothly. I arrived at the print shop a little after 7:00am. My guy was there and no one else, including customers. I took 15 minutes or so to walk through everything. Seeing confidence on my assistant for the day, I asked when he thought it would be ready for pick up. Response: noon.
I left and headed back to the office to get a little more work done for the next few hours. Sometime around 11:00am, I got a call from the print shop. He was the only employee there for most of the morning and not making as much progress as he had hoped. He pushed it back to 3:00pm. No problem. 12/31/2013 deadline still in good shape.
I checked in a couple hours later. Progress continued to be slow. My guy had to leave at 3:00pm but started training a fellow employee to assist. It should be ready around 5:00pm–just in time for the FedEx pick up.
I called around 4:00pm to talk to the new person working on the 510(k). He had just a few more sections to go. Great. I hopped in the car and made the 30 minute drive. When I walked in a little after 4:30pm, the other employees said there was no way the job would be ready to ship today. They assured me, though, that it would be ready to ship on Thursday (1/2). I stated this was not an option; the 510(k) had to be shipped TODAY. I checked in with the new guy to see where he was in the process. Still quite a bit to go. I let him be and tried to keep calm.
At 4:55pm, I asked how things were going. I was told he was preparing to print and finalize the submission. It might be a little after 5:00pm. Hopefully the FedEx driver could wait a couple minutes. 5:10pm and the printing was happening. The FedEx driver was not there yet. Yeah! There was hope. Within 5 minutes, the driver arrived. He said he had some time to spare and didn’t mind waiting a few extra minutes.
I began reviewing the printed documents. They still needed to be put in order with tabs. I volunteered to go through each of the 762 pages of the submission (I was going to review it anyway). After getting about 50% through the organization, I knew it would be a few more minutes and didn’t want to hold up the FedEx driver any longer, knowing he had additional stops. I asked him if there were other pick-up locations and when he would be at each. I jotted down the next several, including the times he would be at each. This was a little more assuring. There were several options available during the next couple hours. Surely, we would be finished in time.
By a little after 6:00pm, I had finished review and organization of the printed documents. I handed to the print shop guy to punch holes in the paper and box it up. He also had to finish burning a CD with all the documents too. By 6:30pm, the contents were boxed and ready to go. By 6:45pm, I had paid the bill and was out the door. My new destination for FedEx pickup was open until 7:00pm and across town. By 6:59pm, I arrived and handed the box off to ship.
And I also learned a few lessons:
- I put off writing the submission a few days based on when my print shop resource was available. I should have had it all ready to go several days ahead of time.
- I relied too heavily on a single resource at the last minute to pull the entire submission together. My rationale was this would be better than training someone new. In hindsight, had I gotten the print job in a week or so earlier, I would have had plenty of time to work with and train a new person to do the job.
- Having a second resource trained to assist with FDA submissions will be beneficial for future projects.
- Don’t wait until the last minute.