About two years ago, we were asked to write a chapter for a book on project management for in vitro diagnostics (IVD) product development. No problem, we thought. After all, between the two of us we have more than 40 years of experience in developing IVD products. We both managed projects and had been members of core teams. We had experience in putting design and development processes in place. So this should be a snap, right? Turns out even writing about project management can be a good lesson in the subject matter.
Our first challenge was the requirement of fitting all our experience into about 30 pages, including tables and diagrams. Seriously, 40 years of experience into 30 pages? That's less than a page per year, this was going to be real work! Like most projects, we were going to have to focus our goals and scope down to a fine point in order to meet the requirement. Which of course, in retrospect, we didn’t do.
The first draft was, to say the least, rough. We had decided to divide up the subject matter into discrete pieces. You write this, I’ll write that, and we’ll match it up in the end. Needless to say it read like two people had written separate sections and slammed them together. No flow, no context, just words on a page. Clearly, we were still in feasibility.
Enter the most patient man in the world, our editor, Scott Babler. Throughout the process Scott kept moving us forward with a combination of gentle prodding, facilitation, and humor. Scott suggested that our chapter might be 1) too long and 2) too disjointed. Upon a second read it seemed he was right.
We then set upon the idea to re-format the document so that it flowed more like an IVD project. Concept first, then feasibility, development, validation, and finally launch. We began the re-write over the holidays, and ran into our next challenge: which development method is best?
We had very different experiences, especially early in our careers. One of us had spent their formative years working for large, established diagnostics companies. The other had worked for a start-up company moving from research to IVD. One had learned development through best practices, the other through trial and error.
This is a challenge that every project manager faces, how to bring people with different perspectives, bias, and agendas together to build consensus and move forward. In some areas of society, consensus building has become a lost art. Take Washington, D.C. for example, or closer to home, Sacramento. But Scott did what every good project manager should do: listen to both sides, negotiate them to the middle, and make a decision when the team can’t get there (although, thank goodness, we didn’t have any of these). The final product was a blend of the best of our experiences, and in the end was something we were proud of.
The process was over for us, but poor Scott had to repeat it 16 more times for the other chapters in the book. Two years and countless hours later, the book was published, and is now available. The final title is: “Pharmaceutical and Biomedical Project Management in a Changing Global Environment”, edited by Scott Babler, and published by John Wiley & Sons. The final product is a great overview of managing all aspects of a pharmaceutical or medical device project.
So what lessons did we learn? Not sure if it was anything we didn’t already know. It was after all a project, so it needed scope, requirements, good communications, team building and last but not least, a quality product. But if we took anything away from the project, it was reinforcement of the idea that you can bring people together with different viewpoints and experiences and still create a quality product if you apply the tools of project management well. Nice job, Scott.
EDITOR'S NOTE: Scott's not the only one who did a great job. Dave and Diane's efforts to distill 40 years into 30 pages are well worth a read. You can order a copy of their book if you'd like to see for yourself.