Embracing Convergence: A Smarter Path to Medical Device Success
The path to developing a medical device is rarely straightforward. While linear processes are appealing, real-world medical device development is iterative, requiring a strategic approach to manage constant adjustments. Enter the concept of ‘convergence,’ which helps navigate the complex cycles between requirements, design, and testing. Let’s dive into how convergence can help overcome development challenges and bring your device to market more efficiently.
Moving Beyond the Fallacy of Linearity
There’s a prevalent misconception in the world of medical device development – the fallacy of linearity. This is the idea that development should follow a straightforward, linear path of requirements, design candidates, and testing. It is appealing because it offers an illusion of predictability and control. However, this fallacy can lead to frustrations, missed expectations, and costly mistakes. In reality, development is far from linear, and the path to a successful device is an iterative journey that requires embracing the concept of “convergence.”
Convergence acknowledges the constant interaction between three core elements: requirements, design candidates, and testing. Unlike a linear approach, where each phase is neatly defined and sequential, convergence accepts that any of these elements can change at any point in the process, driving iterations that bring the product closer to its final form. In this post, we’ll explore why iterations happen, how to plan for them, and why convergence is key to navigating the complexities of medical device development.
The Fallacy of Linearity
Why do so many people default to thinking that development should be linear? The answer lies in how we naturally perceive processes. Retrospectively, a completed project can be described in neat phases: requirements were defined, a design was created, tests were performed, and adjustments were made. From this vantage point, it appears logical that one should be able to outline a development plan and simply execute it.
Theoretically, CEOs, funders, and even project teams understand that iterations are necessary, but in practice, few anticipate the number of cycles needed or what drives those iterations. It begins to feel like an endless loop, with goals seemingly forever out of reach.
What Drives Iterations?
Iterations are driven by uncertainty—by elements of the design whose success is still in question. When a significant design feature is unproven, it doesn’t make sense to complete other aspects (examples might include enclosures or labeling). A recommended approach is to develop only until you encounter a critical feature whose outcome is uncertain. At that point, determine whether the feature works or fails before moving forward.
Think of it like solving a series of simultaneous equations. Each equation needs to be resolved, and if you could solve them at the same time, it would be ideal, but we know that the solution to one often informs the next. In the same way, medical device development requires tackling uncertain elements sequentially, refining the process at each step. This iterative cycle helps minimize the risk of costly rework, especially when dealing with major design features.
Convergence Explained
Convergence, then, is the process by which requirements, design candidates, and testing come together in an ever-narrowing cycle toward a final, market-ready product. It acknowledges that at any given time, any of these elements can change, based on what is learned through testing and iteration. Here’s how convergence works in practice:
- Requirements Refinement:
Requirements are not set in stone. In the early stages of development, they may be loosely defined, providing room for exploration and adaptation. As development progresses and testing reveals limitations or new possibilities, requirements can evolve. This flexibility can ease the process by allowing the team to adjust goals and reduce the complexity of the project. Even in later stages, roadblocks can be addressed by loosening certain requirements. Of course, late in the process, relaxing a requirement inherently shows that the element was NOT a true requirement, but rather a design target. Using design targets thoughtfully keeps the design space flexible, aspirational, and well-defined. - Dynamic Design Candidates:
The design candidate is not a final product. The goal of “design freeze” is elusive to many projects, but the goal of “design frost” can be well achieved using the concept of convergence through iterations. For a particular design candidate, its features, components, and configurations may be altered based on feedback from testing or changes to the requirements. “Design freeze” is a useful concept, but it should only be applied once there is alignment between requirements, the design, and successful test outcomes sufficient for the whole team to consider releasing the product as-is. - Incremental Testing:
Testing should begin as early as possible to validate design choices and identify risks. Not every test needs to be formal. Here the fallacy is a myopic “get to design freeze so we can enter verification and validation”. Rather than hoping for a one-and-done testing readiness, instead choose to focus on many cheap and easy early-stage engineering confidence tests. These can help the team fail fast and cheaply, addressing the highest-risk items first before moving to more costly, formal testing phases against a production-ready product.
Prototype Scenario: A Real-World Example of Convergence
A common situation we encounter is a client coming to us with a request for a prototype. Typically, we discuss their ideas, define a few basic requirements, and create a prototype that meets their initial expectations. The client is happy because the prototype “works”—but the definition of “works” is critical here.
The prototype meets a very limited set of requirements, typically ones that were loosely defined at the outset. For a regulated medical device, however, requirements are much more extensive. They cover not only the intended function but also safety standards, usability, and regulatory guidelines. This means the initial prototype represents only a fraction of the journey toward an FDA-cleared device.
Imagine a client’s surprise when they learn that, even after developing a successful prototype, the next steps could cost several million dollars. This reaction is reasonable and is often driven by a misunderstanding of the iterative nature of medical device development. The prototype may look like it’s 90% complete, but the remaining 10% can represent 90% of the work. This is known as the “90/10 trap.”
The 90/10 Trap: Why the Last 10% Takes 90% of the Effort
The 90/10 trap is a well-documented phenomenon in project management, especially in industries with stringent regulatory requirements like medical devices. While early development phases may go smoothly, the last stretch involves addressing numerous requirements that were not immediately visible. For instance, while an initial prototype might solve for 6-8 basic requirements, an FDA-cleared product may need to satisfy hundreds of requirements.
As a thought experiment, consider that if each requirement costs roughly $5,000 to resolve—a number chosen simply for illustration—solving 300 requirements would cost $1.5 million. While some requirements are straightforward, others may involve complex testing procedures, expensive materials, or custom manufacturing processes. A single $50,000 test or a $150,000 mold can impact budgets, quickly dwarfing proof-of-concept spending.
Helping Clients Understand the Need for Iterations
Clients often want to rush to formal testing to speed up the process. However, this is usually unwise because discovering a minor error during a $50,000 formal test suite can be extremely costly. Instead, we guide clients toward performing a series of engineering confidence tests first, focusing on areas with the highest risk.
By demonstrating the consequences of skipping iterations, clients can see the value in planning multiple smaller cycles of development. Early-stage testing is a form of risk management, helping to uncover unknowns before they escalate into expensive problems.
Convergence in Startups vs. Established Companies
Convergence manifests differently in startups versus established companies. Startups often face many undefined variables, requiring a more flexible and iterative approach. Established companies, on the other hand, may have more defined constraints, allowing for a relatively linear process. However, the built-in costs of rigid processes in big companies can be immense.
Interestingly, business professionals from large companies may lack familiarity with convergence, leading them to make decisions that don’t account for the need for iteration. Their experience may suggest that a more linear pathway is feasible, but the realities of novel medical device development often contradict this belief.
Is Convergence a Formalized Concept?
While the concept of convergence isn’t itself formally outlined in industry standards, methodologies like lean thinking and agile development touch upon similar principles. These approaches emphasize iterative progress, continuous learning, and adapting to change—key elements in the convergence process.
Detailed project tracking also aligns with the principles of convergence by helping teams identify when and where changes are necessary. While convergence isn’t formally defined as a methodology, it serves as a valuable framework for navigating the complexities of development.
Risk Management and Convergence
Risk management is a core component of the convergence process. Early-stage testing, sometimes referred to as engineering confidence testing, can help identify risks before they escalate. This proactive approach helps to minimize the chances of encountering ‘unknown unknowns’ later in the process, when they can be far more costly to address.
By focusing on high-risk areas first, teams can uncover hidden challenges and make informed decisions about where to allocate resources. This strategy aligns with the goal of convergence: to bring requirements, design, and testing into alignment as smoothly and efficiently as possible.
Practical Tips for Embracing Convergence
- Plan for Iterations:
Accept that multiple iterations are not a sign of failure but a necessary step toward refinement. Allocate time and resources for early-stage testing and rapid prototyping. - Prioritize High-Risk Elements:
Identify the features with the greatest uncertainty and tackle them first. This approach helps you “fail fast” and adjust plans before investing heavily in elements that may need to be revised. - Remain Flexible with Requirements:
Allow for adjustments to requirements as new information is gathered. This flexibility can prevent scope creep and keep the project aligned with regulatory and market needs. - Use Prototypes as Learning Tools:
Don’t expect a prototype to be the final design. View it as a tool for gathering data and refining the product, rather than as an endpoint. - Align the Team Around the Concept of Convergence:
Make sure everyone involved, from funders to technicians, understands the iterative nature of development. Clearly communicate that the process involves cycles of refinement, not a straight path to completion.
Conclusion: Moving Beyond Linearity
Medical device development is an intricate dance between requirements, design candidates, and testing. Embracing convergence allows teams to navigate this complexity by treating these elements as fluid, rather than fixed, fostering a more adaptable and risk-aware approach.
Convergence isn’t about cutting corners or compromising on quality; it’s about strategic, iterative decision-making based on real-time feedback – refining the product step by step. When done right, it leads to more efficient development, better alignment with regulatory requirements, and ultimately, a higher-quality medical device.
If you have any questions, please feel free to reach out for more insights!