The complexities of developing A high tech medical device are so daunting to the inexperienced it might seem fortune has to do with success than anything else. Yet there are always some managers and businesses that are always more effective than others at finishing projects and introducing new products that are successful. . The performance differences are so consistent that it indicates luck has little to do with it. Successful managers and companies embrace disciplined engineering and project-management procedures, and always try to improve them. The keys to creating such procedures effective in creating a successful medical device are found in three areas speed, quality, and cost efficiency. Quality, speed, and cost efficiency are the measures of success for any engineering endeavor. But maximizing all three qualities at the exact same time is near impossible.
Conversely, maximizing cost efficiency i.e. reducing price usually is accomplished at the cost of either speed or quality, or both. The successful project manager must establish the perfect balance of those attributes and communicate those priorities to the project staff. Nevertheless, in the regulated medical device sector, another step, regulatory compliance, trumps everything else. If the regulatory body does not accept the item or the procedures used to develop the product, then speed, quality, and price efficacy go for naught. Every project engineer wants to design and produce a high-quality item, but quality means different things to different individuals. The regulatory agencies judge quality concerning demonstrable proof that a device is safe and effective. The medical device testing focus on if it meets their requirements. The sales and support departments each have their own viewpoints, whilst technology thinks of a high quality product as one that is easily maintainable.
The project manager must consider all these dimensions of quality and arbitrate the hard trade-offs when different quality measures are in battle. The notion of speed looks self-evident in a project schedule. A shorter development program is far better than a longer one if all other things are equal. To be certain, development rate could be improved in a nonlinear manner with the addition of resources. The very best and most consistent long-term way to shorten a program is to enhance processes and enhance communications among project team members. Time is a project engineer’s biggest enemy. Each medical device has a finite salable life in the market. Every day that a product is in development and research shortens selling time by one day. Changing requirements contributes to longer development times. Project delays invite demands changes. Such unstable situations can finally cause the failure of a job once it runs out of budget or time, or when the item is indeed patched with changes it will become unreliable. Standard time management is most likely the most obvious, most frequently overlooked, and many resisted method of keeping a project on schedule.