For Medical Device

Deadlines or Dead Projects
by William Wolenchuk, Jr., Customer Relations Manager/Medical Device Industry, MasterControl, Inc.

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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.

Lacking or Poor Requirements Document

Many projects are written at a high level, and have a vague description of the functionality and sometimes unhelpful or unclear requirements. This has led to cases where research and development, having no input from the customer/users, build what they believe is needed without having any real knowledge of their business and the product's intended use. Inevitably, when the product is delivered, the end users usually say "It does not do what we intended it to do," or "It's too difficult to use." Either way, the project is a failure. This is closely linked to lack of user involvement but goes beyond it. Users must know what it is they want and be able to specify it precisely.

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.

Scope Creep

Scope is the overall view of what a project will deliver. Scope Creep is the insidious growth in the scale of a project during the development stage that can become a detriment to the success of the project. As an example: a catheter device is conceived which will deploy a medical device (let's say a stent). At some point, someone decides it will also be used to suture an internal wound. If this new use is added to the project, what will happen? Well, you're probably going to need more resources, cost will increase, you will surely miss the target due date and it might not even work as expected because it was not part of the originally approved requirements document--all because of one change to the original project. To run a successful project, the project manager must find the strength to resist scope creep and at best manage it when avoidance is not possible.

Long Timelines

Long timelines for a project can--and have--led to being beaten to market by a competitor or even worse, making a product that is obsolete by the time it gets to market. The key recommendation is that project timelines should be short, which means that larger projects should be split into separate projects and run in parallel or in what's called a phased approach. There are always risks associated with this type of project but the benefits of doing so are considerable and usually outweigh a flat line approach.

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.

Employee Commitment

Employee commitment is arguably the biggest project killer on a number of levels. First, during the initial planning phase, one of the biggest challenges is determining how many employees and what areas of expertise are going to be required. Second, once those requirements have been established, you need to get the commitment from the departments that will be supplying you with these resources. And finally, at the employee level, you need to know how much time per week they will commit to working on your project. This is an extremely important part of managing a project because this affects your timeline, budget and your ability to deliver the product to market as promised.

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.

Change Control

Despite everything, requirements change and change is happening at a faster rate than ever before. So it is not realistic to expect that no change in requirements will happen while products are being developed. However, uncontrolled changes can play havoc with a product under development and have caused many project failures.

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.

Tracking the Project

Tracking a project is a daunting task and is a key aspect to project success. When projects managers fail to keep on top of a project and assume that everything is going as planned, they are doomed to be unsuccessful. There is no such thing as a project that goes as planned! Projects are dynamic and the project manager needs to stay abreast of all aspects in order to meet the expectations of the executive staff. As a project manager, one should never take the word that things are fine, we have everything we need, we are on time, or we are under budget (right). It's the responsibility of the project manager to hold weekly meetings and report the status of the project to the executive staff. While the project manager is holding status meetings and gathering information as to the completion of the task within the project, do not be naive and believe what everyone tells you. Demand documented evidence as proof that what people are telling you is true and accurate. By staying on top of all aspects of a project, you'll be better equipped to have a project that will be on time, on budget and successful.

In Conclusion

These six factors are not the only ones that affect the success or failure of a project but in many studies and reports, they appear near or at the top of the list. They are interlinked and as one can see they are not all technical issues. This supports the idea that projects should be treated as strategic business plans and that everyone involved plays a role in the success or failure of a project.

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.

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