I’ve talked a little bit about project planning, including the upside and downside of multi-tasking in previous posts. The month of September has proven to be a trying time for product development efforts of a start-up client. One root cause is the extreme amount of parallelism implemented in the project schedule.
The product we are developing consists of a custom electronic device, embedded software, a mechanical enclosure, and a disposable component that includes electronics. Development partners were engaged to develop each of these components. However, the development efforts of each were taking place concurrently. We were agressively pursuing a 510(k) submission to FDA at the end of September. The events of recent weeks compromised this date.
We all knew that something close to a miracle had to happen for us to meet this agressive timeline. The schedule lost any buffer several months ago. But we were able to develop contingencies for all issues to maintain a September filing–that is until issue after issue compromised the entire system. Literally every component mentioned above has encountered very significant problems during the month of September.
So we put on the brakes briefly to evaluate the next steps. A new schedule is being developed with less parallelism and multi-tasking. We are removing quite a bit of project risk from the schedule and have pushed out the 510(k) by several months. This is only possible, though, because of some recent good news about additional project funding coming our way.
Was the high-risk product development approach wrong? The answer is a definite “no”. We had a very legitimate chance to meet project milestones, including the 510(k) submission. We also did not anticipate getting a cushion with project funding and were planning to use the milestone events to help fundraise. The team worked hard and put forth a valiant effort.
But now the real test is ahead of us. The CEO said it best. To paraphrase: “You learn something about people when things are going well. You learn a heck of lot more about the resolve and make up of people when problems arise.” How will this start-up product development team respond? My confidence is extremely high. Stay tuned . . .