Case Study

Life sciences company develops a flexible methodology framework

Abstract

A leading life sciences firm struggled with technology production deployments which did not meet performance criteria, had insufficient attention to interdependencies on other applications and processes, and which ultimately did not meet user requirements and objectives. Mastodon developed a comprehensive and flexible System Development Life Cycle framework that factored risk, criticality and team size into project rigor.

The Challenge

Most technology organizations address methodology in one of two ways. At one end of the spectrum, they have no formal processes, but instead rely upon hiring lots of smart people and letting them do what they do. This may make sense for a start-up, but it is not a sustainable or repeatable practice. At the other end of the spectrum, the organization follows an incredibly rigid development process. But in reality, no real project follows any one process, so methodologies are never fully adopted.

This biotechnology firm was no different. The company had tried several times to implement a methodology that would work for all technology projects, and had been unable to find a solution that was appropriately flexible — light for small software releases, and heavy for FDA-regulated, critical systems.

Contributing to the difficulty was the fact that the culture of the organization was extremely resistant to change, as change meant potential failure. It was considered better to add bureaucracy on top of bureaucracy, creating huge inefficiency, than to streamline processes, as refining process offers the risk of failure. The new framework created by Mastodon offered consistent processes while allowing for sufficient flexibility — fitting small software updates as well as huge initiatives where an error could cost a human life.

How We Helped

Mastodon Consulting created a flexible methodology framework, which allowed the company to adjust methodology weight based on a risk-based analysis that focused on each individual project's size, complexity, criticality and risk factors. With a blend of methodological expertise, an understanding of agile and iterative approaches, and a deep knowledge of risk and engineering practices, Mastodon facilitated the process, cultural and organizational change necessary for success.

Mastodon's services included:

• Business process engineering
• Regulatory compliance oversight
• Change and communication management
• Technology integration services
• Methodology development
• Project and portfolio management
• Complete integration with change and project management processes
• Facilitation of workshop sessions for sharing of best practices
• Risk management
• Organizational design

Lessons Learned

With the new methodology framework, every initiative within the company, from a small technology enhancement to rollout of critical systems, follows a predictable and repeatable process. Projects under lower regulatory structure can follow an iterative approach, with the flexibility to accommodate new requirements or tactical changes as needed, while projects requiring greater regulatory oversight are not compromised. With this new methodological framework, the company is able to meet performance criteria and customer needs in an ongoing, sustainable manner, while appropriately managing risk.

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