Implementing a Hybrid Agile Approach in Pharmaceutical and Medical Device Development

In pharmaceutical and medical device development, traditional project management methodologies such as waterfall have long been the standard. Highly regulated industries benefit from a structured approach and compliance-driven processes. However, Agile methods have proven to be effective for managing complex, iterative research where you don’t know the final solution at the outset.

A hybrid approach combining Agile and waterfall draws on the best of both worlds. It balances the need to adapt with the rigor of regulatory demands.

This article discusses how drug and medtech companies can effectively implement hybrid Agile models by using Agile for early-stage product development and waterfall for later stages. And it explores when to run Agile and waterfall in serial versus parallel formats.

The Right Methodology for Each Phase

A successful hybrid Agile strategy begins with understanding the strengths of each approach. Then you can apply them where they bring the most value.

Agile for Early Development and Iterative Research

Agile thrives in conditions where the path and the destination are unclear. Pharma and medtech research, especially in early development phases, benefits from Agile’s flexibility. Frequent iterations are an asset when testing hypotheses, identifying lead molecules, and refining prototypes.

Waterfall for Qualification and Validation

To meet regulations, teams need to follow clear steps, document everything, and get formal signoffs. Waterfall ensures systematic execution of these actions.

In Line or Side by Side

Companies can use Agile and waterfall models either in a serial or parallel fashion, depending on how complex the project is.

Agile First, Then Waterfall

• Conduct research and early development using Agile, leveraging iterative cycles to refine and optimize.
• Once a lead candidate molecule or design concept is selected, transition into waterfall to test, evaluate, and prepare regulatory submissions.

This approach allows you to be flexible in research while maintaining the rigor needed for compliance steps.

Parallel Agile-Waterfall Execution

Projects with a tight timeline, complex nature, or multiple teams and dependencies mean Agile and waterfall activities are happening at the same time.

• Use planning intervals (PI) from the Scaled Agile Framework (SAFe). In this model, there is a planning session every five or six sprints to set clear objectives for the project.
• Include project managers and other key stakeholders of waterfall teams in planning sessions at the start of each interval. Align on goals, roles, needs, and handoffs.
• Involve waterfall teams in system demos at the end of each PI to share progress across all teams.
• Ensure Agile and waterfall teams understand what they need to accomplish, especially things that may affect deliverables.

This approach enhances collaboration and visibility while allowing progressive adjustments during development.

Best Practices for a Hybrid Agile Program

Fostering cross-functional teamwork is the best way to maximize the value of a hybrid Agile approach. Encourage Agile and waterfall teams to regularly interact through shared planning and review sessions. Avoid an “us-them” situation. Ensure all teams know that neither model is “better” than the other.

Another best practice is to embed quality, systems engineering, and compliance into Agile teams. That way, documentation and regulatory readiness will develop alongside the product. You’ll stay fast and flexible while also staying compliant.

Finally, emphasize incremental value. Agile teams should provide iterative outputs that feed into waterfall milestones. This approach supports steady progress and makes it easier to track results throughout the project.

Conclusion

A hybrid framework enables pharma and medical device organizations to benefit from Agile’s flexibility for early development and waterfall’s structure for compliance. Those that embrace hybrid approaches can be more adaptable, efficient, and collaborative, enhancing their development pipelines.