New ebook from Pathfinder Software addresses how agile development can accelerate medical product development to shorten timelines, reduce risk, and improve quality.
The medical device and diagnostics industries are facing unprecedented challenges: regulatory and reimbursement model changes, dramatic technology changes, increasing technology interdependence, and the rising expectations of physicians and patients. Medical Devices and Diagnostics typically have long development cycles, often 3 to 5 years under the traditional “Waterfall” model, where each activity, from requirements analysis through system testing is performed and completed before the next activity begins. This process can work when requirements are well understood and well-defined, and there are no changes, hidden complexities, undiscovered requirements, or defects. However, current “waterfall” product development methods are ill suited to dealing with the pace of change and uncertainty that product development organizations are facing.
This ebook addresses how:
– the shortcomings of waterfall development specifically in regulatory environments
– agile development meets the safety, reliability and FDA regulatory needs of the medical device and diagnostics industry
– agile development can help ensure delivery of successful software