Succeeding with Scrum in an FDA-regulated Environment

Summary
Medical technology company BD Biosciences had just released the first version of a new product, which included hardware and software, and were preparing for subsequent clinical versions. The program faced significant budget and schedule commitments, along with the pressures of FDA regulations. Construx worked with the company’s R&D software organization to develop a tailored plan that addressed key challenges, helped them successfully implement Agile practices and delivered on the company’s business goals.

The Challenge
Medical technology company BD Biosciences (BDB) provides instruments, reagents, software and a wide range of services to support the work of researchers and clinicians who understand disease and improve care. BDB had just released the first version of a new system, which included hardware, reagents, and software, and were preparing for subsequent clinical versions. The program faced significant budget and schedule commitments, along with the pressures of FDA regulations. BDB’s R&D team realized that their approach to planning, managing, and executing large software programs needed improvement if they were to deliver against business goals. The group had tried implementing some Agile practices, but they needed help to successfully transition to an Agile software development approach. 

BDB's goals included:

  • Creating a clinical version of the product that would be successful in the marketplace
  • Getting the release out on time and within budget

How Construx Helped
Rather than push a one-size-fits-all prescriptive approach, Construx met with the R&D leadership to understand the situation and develop an incremental plan that would quickly address the major pain points, while building capabilities in critical areas. These areas included requirements analysis, project planning, engineering practices, and management and leadership strategies. After an initial Scrum Boot Camp, and ongoing challenges with implementation, BDB brought Construx back for a weeklong training, followed by a six-month consulting and coaching engagement. 

Construx helped the client master critical success components, including:

  • Establishing a simple, practical framework for a scalable multi-team Scrum program
  • Assigning Agile project leadership roles and staffing Scrum teams appropriately
  • Creating effective user stories that were actionable for Scrum teams
  • Creating viable Agile project plans with realistic schedule forecasts
  • Coordinating dependencies effectively across teams
  • Implementing effective program-wide metrics to track progress

End Result
After establishing a baseline for velocity, BDB was able to identify and overcome quality and requirements issues. Quality improved and the project hit every milestone on time. “The transformation we experienced was not only being able to speed up our development but more importantly, we are now able to provide transparency and predictability to the organization that they never had before,” said Neal Herman, Software Development Manager and Chief Scrum Master.
With the ability to report quantifiable, transparent metrics, the R&D team could share their status across the entire organization bi-weekly.

Results included:

  • Productivity has increased more than 60%, as measured by improved velocity
  • Formal validation cycle was reduced by half

These changes have improved the way software is developed at BDB. “This was a big, complicated project, with 60-70 people involved and seven Scrum teams,” said Herman. “Construx gave us a straightforward, simple set of rules to live by that made a big difference. They also helped bring in elements of Kanban and Lean. For example, using pull scheduling, we were able to reduce our formal test cycle for research releases by half. It was a real eye opener.”

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