Over 18 years in Life Sciences and IVD product development, I've noticed an interesting phenomenon that seems to apply broadly across companies. They are all puzzled to some extent by the same question: what exactly do I do with Project Management?
Most - if not all - acknowledge that project management has some intrinsic benefit. Getting a product to market as efficiently as possible is a good thing, particularly if you're not flush with resources.
But what's the best way to accomplish this? Do you create a project management office with highly trained and experienced PMs ready to answer the call? Or is it enough to find a young, energetic manager, equip them with Microsoft Project and some training courses and send them off to battle?
In any organization, the goal of any successful product development initiative is to make the project manager the owner of the development process. And in an IVD firm, this means that the project manager should be the de facto owner of the design control process.
Design control on a large, IVD project is too big a job to drop on either regulatory or QA. There are literally thousands of pages of plans, protocols, raw data and reports. Tracking all these pieces of the design requires someone to monitor each of the tasks and its associated deliverables on a full-time basis.
There is no better person to make sure that all the elements of design control are being adhered to than the project manager, because ultimately design control incorporates the best practices of project management:
- Having clear project goals (design input requirements)
- Creating a detailed plan that includes a risk analysis, resource requirements and communication plan (design & development plan)
- Tracking the deliverables (design outputs) against the project goals (design inputs)
- Tracking changes in deliverables and scope (design change management)
- Reviewing the deliverables with Senior Management (design review)
- Documenting everything in a project binder (design history file)
If an IVD company with a fledging product development process does nothing other than clearly define the role of project managers as the design control process owners, then they are ahead of the curve. Of course, just anointing them the design control gurus is only the first step in the process.
In the next installment, I'll talk about how to make sure that your new project management office is successful.