For all medical device companies, managing a project can be a nightmare. Proper planning and managing of a project can make the difference between a successful product and a financial disaster. Most projects start out with good intentions. However, with improper planning up front, the project can quickly fall behind and run over budget for a number of reasons: poor or lack of requirements document; scope creep; long or missed timelines; employee commitment; change control; and tracking the project are among some of the most common I've experienced. Let's look at each one of these examples to see the effects they can have on a project.
A good set of requirements is needed for any project to be successful and this is especially true for medical device products. This is where many projects fall short and fail, in that they do not correctly specify what the device should do. A project may be given a deadline for delivery, a budget to spend, and a vague notion of what it should do but will still be doomed because it lacks a comprehensive description of the deliverable. A successful project will have a clear requirements document that states what is expected of the product as well as who is using it. The requirements document will have been collaborated on and approved by all groups inside and outside the company.
Many project managers are well aware of the need for fast delivery to market, leading to the other problems of unrealistic timelines. These are set without considering the volume of work that needs to be done to ensure delivery. As a result, products are either delivered late or only have a fraction of the functionality that was originally requested. A skilled project manager will review all project plans to see if they are realistic and challenge the participants to express reservations or risks they may have in order to ensure that the project will go off as planned.
When preparing your timeline you must, and I repeat "MUST", get an accurate assessment from the employee as to how much time they are willing to devote to your project. For instance, let's say you're planning the initial research phase of your project and you need to get a commitment from your research and development engineer Dilbert. So you sit down with him and say, "So Dilbert, how much time can you devote to me per week on this project? Dilbert being an enthusiastic engineer, eternal optimist, always willing to roll up his sleeves and give 110% kind of guy says, "I can dedicate my entire 40 hours per week to work exclusively on your project."As a project manager the first thing that should pop into your head is: liar! What Dilbert fails to realize (and you better) is that every day he drinks 8 cups of coffee, reads and responds to 30 emails, uses the restroom a couple of times, and attends a few meetings each week. That being said, you now realize no matter how dedicated Dilbert might be, there is no way he is able to provide you 40 "true" hours a week working on your project. Mix in a sick day or two and multiply by all the people working on your project and guess what? Your schedule is toast!
A project manager who is aware of all these obstacles will be better prepared to assess and estimate a more accurate timeline and is more apt to meet the target delivery date and stay on budget.
This emphasizes the advantages of shorter timelines and a phased approach to developing products, so that change has less chance to affect product delivery. When change occurs, it must be managed like any other factor in the project. The project manager must evaluate the change requirement and do a risk assessment to ensure minimum impact on the timeline, resources and budget. Change Management and its sister discipline of Configuration Management are skills that can be taught and in some cases are learned the hard way.
William Wollenchuk , MasterControl Customer Relationship Manager and Medical Device Expert, is an electro mechanical designer with almost a decade of experience in the medical device industry. Prior to joining MasterControl in 2008, he was with Endologix Inc., where he was instrumental in guiding the R&D and Manufacturing Engineering departments in the development of an AAA device, then obtaining FDA approval for the device. Mr. Wolenchuk was also the Document Control Manager, responsible for the compliance, control and distribution of all documentation, including the review of engineering documentation for manufacturability. Prior to joining Endologix in 1999, he was an Engineering Services Manager for Optical Disc Corp. a world leader in the development of compact disc and DVD mastering equipment. As a design consultant for 20-plus years in the commercial and aero-space industries, he worked on such projects as the B2 Stealth Bomber, DIVAD tank, AAH attack helicopter and commercial and military communication satellites.