Designing a Decision-Support Tool for Safe, Consistent TPN Configurations
By Melissa Beaudette
1. Background & Context
Total Parenteral Nutrition (TPN) mixing can be dangerous. TPN ingredients must be added in the right sequence to prevent serious medical consequences. For example, adding calcium-containing ingredients in close sequence with phosphate can cause dangerous precipitates.
TPN compounders depend on a “configuration,” which acts as a map that defines how the compounder is set up and the order in which it pumps the ingredients. Hospitals vary widely in how often they adjust their TPN configurations. Larger facilities with diverse or high-acuity populations tend to update them more frequently, especially during drug shortages or shifts in clinical needs, while smaller hospitals may make changes less often.
2. Problem Definition
While Baxter’s training and operational manuals specified that all configuration changes be reviewed by a Baxter pharmacist, several factors made this process operationally challenging in practice:
Operational Environment Constraints
The review required coordination between pharmacy leadership, Baxter support, and Baxter pharmacists. Clean-room access and segregated networks created a multi-step transfer process, adding friction to handoffs that were already subject to back-and-forth communication.
Cross-domain Expertise Demands
While pharmacists are experts in drug compatibility and preparation standards, configuration updates also require understanding sequencing, flow mechanics, flushing logic, and port placement. These device-specific considerations sit outside typical clinical training, even though they are addressed in Baxter’s training. As a result, configuration updates require more judgment and focused attention than standard clinical workflows.
Constraints on Digital Enforcement
TPN therapy is time-sensitive and often life-sustaining, which means pharmacists must retain the ability to exercise clinical judgment when the formal review cycle cannot be completed in time. Introducing approval gates could have risked treatment delays or driven pharmacies toward manual mixing, neither being acceptable in practice. At the same time, the compounder’s tightly coupled architecture and lack of automated tests made software updates difficult to introduce safely, leaving digital enforcement or other targeted solutions off the table.
3. Insight & Opportunity
As the Senior Software Quality Engineer and responsible for the quality of the compounding software, I routinely monitored complaints, support interactions, and internal product discussions. Over time, a consistent pattern emerged. Questions about configuration sequencing, port assignments, and flushing logic surfaced frequently, sometimes when pharmacists directly requested configuration approvals, and other times indirectly as support teams worked through unrelated issues.
Across these interactions, two themes became clear:
- Certain device-specific compounding rules were difficult for pharmacists to recall or apply consistently, and
- Pharmacists often remained unaware when urgent, clinically appropriate configuration decisions resulted in suboptimal setups that persisted long after the immediate need had passed.
Neither challenge suggested a need for workflow gating or enforcement. Instead, they pointed to an opportunity for a decision-support toolset that supported best-practice configuration decisions without limiting pharmacists’ ability to act quickly when therapy required it.
4. Solution Approach
I proposed developing a standalone, rule-based decision-support tool that would surface sequencing, compatibility, and operational considerations without restricting pharmacist autonomy. By decoupling this functionality from the legacy system, we could provide clearer guidance while maintaining the stability and reliability of the existing system. The initial concept focused on providing:
A simplified, structured editing experience
Providing a clearer, more intuitive path through configuration editing.
Rule-based guidance
Highlighting sequencing, compatibility, and flushing considerations during editing, helping pharmacists apply device-specific compounding principles consistently.
Rule-based guidance
Highlighting sequencing, compatibility, and flushing considerations during editing, helping pharmacists apply device-specific compounding principles consistently.
Contextual annotations
Non-blocking indicators surfacing elements pharmacists might want to review or validate, which would be helpful both during routine updates and when refining configurations created under urgent conditions.
Extensive automated testing
Ensuring tool was reliable, maintainable and safe to deploy without introducing dependencies into the legacy system.
The team immediately recognized the value: it addressed the operational challenges pharmacists faced while remaining feasible and safe within the constraints of the existing system architecture.
5. My Role
I performed the systematic analysis that surfaced the underlying challenges and then led the cross-functional effort to define an appropriate solution. Working closely with our pharmacist, engineers, and product manager, I drove the development of the vision, scope, and MVP feature set while ensuring alignment with 21 CFR Part 820 expectations and our annual release cadence. I also authored the test-case strategy and acceptance criteria to ensure the design was verifiable, compliant, and feasible within the constraints of the existing compounding system.
6. Outcome
We delivered a working early release and were progressing toward full MVP when organizational priorities shifted due to an FDA warning letter for another product. Shortly after, the Baxter location closed, preventing further development.
This experience demonstrated core product-management capabilities, including:
Identifying high-value opportunities in a regulated environment
Synthesizing complex clinical, operational, and technical signals into actionable insights
Leading cross-functional teams toward user-centered, feasible solutions
Although this project predated formal agile adoption, the product behaviors I demonstrated (discovery, synthesis, prioritization, decision-making, and cross-functional alignment) are foundational to agile product management and continue to define how I work today.