Anatomy Of A Successful Medical Device Development Project
The complexities of developing a high-tech medical device are so daunting to the inexperienced that it may seem luck has more to do with success than anything else. Yet there are always some managers and companies who are consistently more successful than others at completing projects and introducing successful new products.. The performance differences are so consistent that it suggests luck has little to do with it. Successful managers and companies adopt disciplined engineering and project-management processes, and constantly strive to improve them. The keys to making such processes effective in developing a successful medical device are found in three areas: quality, speed, and cost efficiency.
Quality, speed, and cost efficiency are the measures of success for any engineering project. But maximizing all three qualities at the same time is next to impossible. Maximizing speed or quality is often less cost-efficient. Conversely, maximizing cost efficiency (i.e. minimizing cost) usually is accomplished at the expense of either quality or speed, or both. The successful project manager must determine the right balance of these attributes and communicate those priorities to the project team.
However, in the regulated medical device industry, another measure, regulatory compliance, trumps everything else. If the regulatory body doesn’t accept the product or the processes used to develop the product, then speed, quality, and cost efficiency go for naught.
Quality Has Many Dimensions
Every project engineer wants to design and develop a high-quality product, but quality means different things to different people. The regulatory agencies judge quality in terms of demonstrable evidence that a device is safe and effective. The users of the device focus on whether it meets their needs. The sales and service departments each have their own perspectives, while engineering thinks of a high-quality product as one that is easily maintainable. The company’s regulatory affairs staff wants a project to stand up well to an audit or regulatory inspection. The project manager must consider all these dimensions of quality and arbitrate the difficult trade-offs when different quality measures are in conflict.
“Speed Kills”
The concept of speed seems self-evident in a project schedule. But is it? A shorter development schedule is better than a longer one if all other things are equal. To be sure, development speed can be improved in a nonlinear way by adding resources. The best and most consistent long-term way to shorten a schedule is to improve processes and streamline communications among project team members.
Time is a project engineer’s biggest enemy. Every medical device has a finite salable lifetime in the marketplace. Every day that a product is in research and development shortens selling time by one day. Every day a project is in research and development extends by one more day the window of opportunity for requirements to change. Changing requirements leads to longer development times. Project delays invite requirements changes.
Such unstable situations can ultimately lead to the failure of a project when it runs out of time or budget, or when the product is so patched with changes that it becomes unreliable. A delayed market release means new competitors can invade the market, or medical practices and standards can change, making an instrument obsolete even before it’s released. Basic time management is probably the most obvious, most often overlooked, and most resisted way of keeping a project on schedule.
Pay Now or Pay More Later
Cost behaves much like speed in a development project. Often, development projects are squeezed into an existing budget or a budget that was set by someone outside the development group responsible for meeting the budget. The project manager responds by cutting corners where he can.
Unfortunately, theoretical cost reductions are seldom realized. Cutting corners usually results in additional costs to maintain and service the resultant product. This is not really reducing development cost as much as it is shifting development cost into the maintenance phase. If the corner-cutting results in poor quality, product sales and the company’s long-term reputation and profitability can be hurt.
Regulatory Acceptance: the Trump Card
Since all medical devices are subject to regulation by the Food and Drug Administration (FDA), the very presence of a product on the market is dependent on the FDA’s acceptance of the safety and efficacy of the device, and of processes and controls in place when the device was designed and developed. Experienced, successful project managers take regulatory compliance into consideration right from the start of the project and follow the FDA’s design control requirements rather than try to “retro-control” near the project’s end.
The FDA’s design control and validation requirements are nothing more than requirements for a good engineering process. Implementing the controls and processes as recommended by the FDA can actually lead to a better-quality, lower-cost development. Retro-documenting design control is tedious, expensive, and delivers none of the advantages of the controls because the process has not really been followed. If regulatory compliance is missing, the project won’t get off the ground.
Management’s Contribution to Success
Managers should view their role as facilitators and guardians of the development process. Recognizing that manpower is probably the largest development expense, they should evaluate return on investment for providing development and validation engineers with everything they need to save work, and therefore the time and cost invested in a product design. In evaluating cost, managers must also consider the total cost to the organization of a project that’s far behind schedule, not just the cost against his or her own development budget.
Managers can also contribute to cost and schedule overruns. Perhaps the most common managerial flaw is indecision. Managers need to consider the costs they impose on the development organization by slow decision-making or by hasty decisions changed later on.
Projects that are highly process-driven with a disciplined engineering environment are more successful projects by the measures of quality, speed, and cost efficiency, with regulatory compliance looming over all these in importance. By thoughtfully introducing formal processes into a development environment, a manager can optimize these three measures to meet the company’s desires and goals.
David A. Vogel, Ph.D., is president of Intertech Engineering Associates, Inc. in Norwood, Mass. Intertech (www.inea.com) provides hardware and software development, requirements and quality engineering, product validation services, training and consulting for medical device manufacturers. He can be reached at dav@inea.com.
Tags: Medical Devices
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