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.

 

Keywords: 
Agile development, Waterfall development, Pathfinder