A large-sized, medical device company that produces medical imaging software is seeing tough market conditions and stiff competition. While the cost for creating the software is steadily rising, its client's expectations are also rising because there are new, nimble players in the market who offer similar software at competitive prices.

Being in the healthcare industry, the medical device company operates within a regulated environment and, therefore, is routinely audited. Regulators have imposed a mandatory requirement to produce specifications and documentation in each phase without which the company cannot release products in the market. These documents go through a rigorous and version-controlled review process by departmental representatives. The documents are ink signed for approvals, printed, and saved in a document repository. Signed hard copies are then printed and stored in locked cabinets under video surveillance. Any changes require the specification to go through another review process which adds further complexity, is extremely slow and cumbersome. The company's focus has been to comply with regulatory and patient safety policies so that it may continue to operate in the market. As such, the user interface and software features are designed in a way to prevent the company from entering lawsuits and to avoid regulators from revoking its license to operate. While the company is excelling in protecting its reputation and conforming to regulations, its customers are complaining that they are not receiving value for their investments. Version upgrades are too few and far in between. Due to heavy and sequential business processes and lengthy release cycles, a critical patch can take anywhere between 6 months to a year. Minor product enhancements take years to be released into the market. Due to delays, product enhancements often lose their value by the time they are released. For these reasons, the company is receiving flak in the market and is unable to attract new markets and retain existing ones. The company's bottom line profit margins are steadily declining. To survive and keep themselves afloat during this challenging time, the company has explored several avenues yet failed including rebranding and revamping their product. Currently, they have a multi-million dollar 5-year phased project in the pipeline that will add new features, workflows, and design elements to the product.

The medical device company follows a traditional waterfall software development life cycle. In all, 25-35 documents are generated prior to project closure, depending on the size of the initiative within the project. Reviews are performed formally through email and long bureaucratic processes. The organization uses a heavy-weight content versioning system and requirements management tool that stores the page's long requirement specifications.

The project team comprises of co-located team members: a Project Manager, Product Manager, Business Analyst, Developers, Tester, and Regulatory officer. Currently, the software development life cycle looks like this:

question 1 A brief summary of the challenges that exist within the current waterfall model of the case

question 2 Application of agile principles and concepts required for the transformation

question 3 A redesign of the project team and a brief explanation of the roles of each team member.

question 4 Illustration of how the software development life cycle has to change.

question 5 What tools you would recommend to help with requirements management.

question 6 Document the assumptions you have made that support your recommendations.