Agile in an FDA Regulated Environment - Pathfinder White Paper

Software has become a key differentiating success factor in the industry, helping companies drive more rapid innovation and creating opportunity due to the increased flexibility and agility of software-based products. The importance of software as a driver of value creation is likely to be magnified by a series of interrelated, mutually amplifying trends:

• Reimbursement Model Changes

• Interoperability

• Wearable Sensors

• Mobile

• Consumerization

• Big Data/Healthcare Analytics

Read an Excerpt: 

Medical Device and Diagnostics have typically had long product development cycles, often 3 to 5 years, and Pharma cycles have been even longer, 5 to 10 years. Software development cycles tend to be much shorter, and have been accelerating in many industries. The Software development strategy for medical devices has traditionally been a “Waterfall” model. The Waterfall development model originates in the manufacturing andconstruction industries both highly structured physical environments and where after-the-fact changes are prohibitively costly, if not impossible. In this strategy, each activity, from requirements analysis through systems testing is performed and completed before the next activity begins.


Agile development, Waterfall development, Pathfinder