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. Read the rest of this entry »