Top 3 reasons why your surgical robotics development program is late
It is a reality of Medtech product development that programs often run longer than planned. These products are increasingly complex, and with product complexity comes program uncertainty. Underneath each Medtech program is an intricate mesh of parallel development tracks, gating inter-dependencies, technical risks, and verification challenges, all of which are frequently given insufficient ongoing attention. The key to success is continuously asking yourself the following questions:
What could go wrong with my development program?
What do I absolutely need to do right for my program to be successful?
How will I know when it goes right or wrong?
Successful Medtech organizations recognize their development challenges and then diligently measure and monitor throughout the program, applying sound integration planning, risk management, and verification planning principles.
Integration Planning
Ineffective integration planning is a common reason manufactures experience schedule uncertainty. Too many organizations map out their delivery dates based on their earliest assumptions and then sit by in exasperation as those dates slide by without showing the progress they were meant to represent.
Integrate early, integrate often, and demonstrate incremental progress. System integration points are a great tool for identifying progress as well as potential issues with the system design. A failed early integration point that identifies a flaw in interface design, for example, provides an opportunity to make adjustments and recover the schedule.
Proper integration planning starts with a clear definition of each individual thread of development, be it hardware, software subsystem, third party component, etc. Planning must establish the critical milestones on each development thread, including explicit, measurable criteria for determining when each milestone has been met. Any dependencies between threads must be clearly understood, including a detailed accounting of the potential impacts, i.e. risk, of unmet or delayed dependencies.
Risk Management
When development programs get off track, and the missed dates begin to pile up, the root cause can typically be found in some form of realized risk. ALL development programs have technical risk. Manufacturers encounter solution feasibility challenges, unmet supplier obligations, component shortages, hardware instability, incorrect assumptions, and many more forms of development risk. These types of issues are commonplace and must be planned for explicitly to ensure product success.
Often, when Medtech manufacturers consider risk, they default to focusing solely on patient risk. While patient risk is a non-negotiable consideration for a medical product, the reality is that patient risk doesn’t exist unless and until you can get your product to market. To successfully market a product, an organization must first be successful in overcoming their technical development risks. Doing so begins with identifying risks, but it does not end there.
Effective risk management is a continuous process. Each identified risk must be managed until it can be retired. A sound development plan must consider risk avoidance, realized risk detection, risk mitigation and contingencies, and risk priority.
Start by determining where you have risk, how you will measure it, and how you will manage the impact if your risk is realized. As development proceeds, meet periodically to reassess your risks, characterize any new risks that have arisen, and re-assign risk priority. In your planning, emphasize retiring your highest priority risks as early as possible in your development schedule. Often, the timely retirement of risk will mark a critical milestone in your integration planning.
Verification Planning
Verification planning goes hand-in-hand with proper integration planning and risk management, supporting each. As we stated at the outset, a successful manufacturer will consider how they will know when critical aspects of their development program have gone right or wrong. When done correctly, verification planning establishes key criteria for both determining integration readiness (i.e. something went right) and identifying realized risk (i.e. something went wrong).
In the not-too-distant past of MedTech development, verification was commonly limited mostly to manual testing undertaken only once a full product system was integrated. For some manufacturers this habit has proven difficult to break. This represents a missed opportunity, and commonly leads to the discovery of problems too late in the development cycle, when root causes are more difficult to identify and far more expensive to fix.
The prudent manufacturer will plan for significant component and subsystem level testing, and leverage passing tests as gating criteria in their integration planning. The verification plan should also accommodate any identified risk, specifying additional testing wherever there is high-priority risk.
Lastly, don’t shortchange yourself on automation and simulation. Automation enables more tests to be run more often and, when applied effectively, reducing the chances of undetected regressions. Simulation unlocks a greater depth of testing earlier in the development cycle, before gating dependencies (hardware or other subsystems) are met. Done well, simulation will boost integration readiness confidence. Don’t overlook that automation and simulation can require significant effort to develop. Be sure to account for this in your integration planning as these will ideally represent milestones of their own.
Conclusion
Taken together, integration planning, risk management, and verification planning are powerful tools for effective program management when applied diligently and consistently. By charting an integration path that front loads the most difficult delivery challenges (risk) and explicitly confirms when key milestones have been met (verification), an organization can drive higher predictability in their development schedule much earlier in the cycle.
While these techniques are not a cure-all that guarantees a program will never run long, they will drastically improve the observability of development progress. Organizations that apply due diligence in their integration planning, risk management, and verification planning will find that they are able to identify and react to challenges more quickly, while allowing fewer critical disruptions to slip past critical milestones, culminating in improved product delivery performance.