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Applying Agile in U.S. Food and Drug Administration (FDA) Regulated Industries Disclosure Number: IPCOM000246006D
Publication Date: 2016-Apr-26
Document File: 4 page(s) / 325K

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Disclosed is a prototype to address barriers to Agile adoption in U.S. Food and Drug Administration (FDA) regulated organizations. The prototype solution addresses issues of scalability and the need to focus on human factors engineering and documentation.

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Applying Agile in U.S. Food and Drug Administration (FDA) Regulated Industries

Software development teams in enterprises that follow industry regulations set forth by the U.S. Food and Drug Administration (FDA) tend to stray away from the Agile* development methodology. Businesses often cite the lack of upfront planning, design, architecture, and documentation associated with Agile to be hindrances in adopting the methodology. However, the current approach that many organizations follow is linked to a high percentage of project failures and the inability to meet the actual needs of the business/customer.

Extended models of XP, extreme programming, have been designed to address FDA regulations, but the models are seriously limited in that they only apply to organizations that use just a few people to complete software development; they cannot be easily scaled. One extended model of Scrum also has also been adopted by an organization, and while it may work for that single company, it is not suitable for FDA applications more broadly because it lacks a focus on human factors engineering and the necessary documentation required by FDA regulations. The proposed model, contrastingly, focuses on both of these key areas and enables organizations to overcome the barriers to Agile adoption in regulated industries.

The proposed solution is a prototype to address barriers to Agile adoption, enabling organizations to reap the benefits of Agile in a regulated environment. The novel prototype system applies Agile in FDA regulated industries, which typically employ traditional software development methodologies. The model provides FDA-regulated organizations with the benefit of regular releases, speed-to-market, iterative development, early revenues realized, etc. The following description outlines how Agile can effectively include and accomplish many of the necessary regulatory practices.

Pre-Sprint, which typically involves stakeholders from both the business and development teams, tackles many of the planning and design related issues cited by critics of Agile. Driven by empathy-based research and customer-driven requirements, stakeholders can effectively determine how to divide a project into different minimally marketable features (MMFs). This high-level project planning should be coupled with business requirements document sign-o...