The Case for Concurrent Development in Modern Medtech

For decades, the medical device industry operated a largely linear, task-based model for development. In this environment, functional disciplines complete specific requirements in isolation before transferring the project to the next department. This sequential approach suffices for simpler devices but a clear sign it doesn’t fit modern medtech’s growing complexity is when a program meets its technical milestones and still fails commercially. Teams can design, verify, and launch exactly what was requested to find too late they’ve solved the wrong problem for users or the market. That risk sits at the heart of a linear model, where critical development-stage decisions are made in siloes without enough input from those who will eventually need to build, use, or scale the product. Passing those decisions downstream makes the risk of failure—or cost of change—far higher. 

In an alternative concurrent model, multi-disciplinary teams work toward shared goals at each stage of development. That makes it easier to identify risk early, test assumptions quickly, and resolve issues in hours or days rather than the months it can take if dealt with later.

Sequential development relies on function-specific disciplines performing isolated tasks rather than multidisciplinary teams achieving shared milestones. In a sequential setup, a mechanical engineer might select a specialized polymer based on performance properties or weight requirements. Without early consultation with supply chain or manufacturing experts, they may not realize the material has a long lead time or requires an injection molding process unavailable in the target production region.

By the time the manufacturing or procurement teams identify these issues, months of subsequent engineering decisions are built on the initial design decision. This creates structural instability in the project. If a foundational technical decision is found unfeasible at a project’s late stages, the entire timeline and budget can be compromised. Correcting these errors late in the cycle often requires months of redesign and significant capital investment.

When teams work sequentially, they’re exposed to several critical points of potential project disruption:

• Selecting assembly approaches or materials without involving manufacturing experts can lead to design for manufacture (DfM) gaps and designs that are difficult to produce at scale or require prohibitively expensive labor.
• Relying on components available in one region but restricted in another can disrupt international launch plans. 
• Identifying a regulatory hurdle during the final verification phase necessitates moving backward through the entire design process, significantly lengthening the commercialization timeline.
• In sequential models, the project risks spending more time in recursive loops than in productive execution, such as redesigning the same components multiple times.

These risks focus on the logistical and technical execution of a linear, task-based project but the true strength of the alternative integrated model lies in its ability to first validate the team is building the right product. This shift is most evident in usability engineering, which transforms from a final regulatory requirement into a foundational tool for early problem discovery.

A common approach in medtech development is treating usability engineering and risk management as downstream checkpoints used to confirm a product is “good enough” and prove to regulators the product is safe. However, undertaking usability work earlier in the process should help define the right problem to solve before the team invests in the wrong solution. Restricting usability testing to a final validation phase limits its impact to confirming basic tolerance rather than establishing the solution’s optimality or fundamental necessity.

When integrated into the earliest development phases, usability engineering is a tool for problem discovery—often combining quantitative and qualitative research methods. It lets teams identify core challenges faced by patients, clinicians, and other device users before extensive development is underway. This is essential to avoid over-engineering, a frequent byproduct of the sequential model. Without early user-focused constraints, technical teams might add features because they’re technically feasible. The result is often a device that’s too expensive, too complex to maintain, and poorly aligned with end-user and market needs.

Early usability engineering is a strategic guide, ensuring development focuses on features that provide genuine value. By combining quantitative market data with qualitative ethnographic research, teams gain deep insights into how users interact with equipment in their natural environments. This integrated approach lets developers align the design with the user’s workflow, uncovering subtle but decisive behaviors (such as whether a task disrupts a routine) that ensure the solution is intuitive and highly adopted.

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In the traditional sequential model, manufacturing and supply chain constraints are often viewed as obstacles that limit the creativity of designers and engineers. In a concurrent model, these constraints can be catalysts for more robust engineering.

When designers work collaboratively with manufacturing and automation specialists during the concept phase, they create more viable options for solving design challenges. Manufacturing experts bring deep knowledge of materials and assembly processes that can enrich the concept generation phase. 

This integration is equally vital for international supply chain resilience. By involving procurement and global quality teams from day one, organizations can avoid selecting components that lack the necessary regulatory documentation for specific international markets. This early de-risking helps secure a smooth transition to production by proactively eliminating the need for additional design-build-test cycles and urgent design pivots.

The most common internal resistance to concurrent development is the difficulty of justifying the higher initial resource requirement of involving a multidisciplinary team of experts at the project’s inception. When implemented strategically, front-loading can be a highly effective and efficient use of capital over the product’s total lifecycle.

A change made during a medtech program’s concept phase is significantly cheaper and quicker than one made during manufacturing. Resolving a complex automation failure during pilot production can take up to a year, whereas addressing the same mechanical risk during early-stage digital simulation takes days. 

High-quality decision-making at the project’s inception secures the foundation for a more predictable and rapid execution phase. Resolving multidisciplinary constraints early eliminates the extensive redesign cycles that typically stall traditional programs, ensuring a continuous and efficient path toward commercial launch.

Transitioning from a sequential to an integrated framework is as much a cultural challenge as an operational one. A mechanical engineer, industrial designer, and manufacturing specialist have different professional rigors and may work in different ways. Over-integrating these disciplines and forcing them to work in the same way is a risk, as it can dilute their specialized strengths. 

The goal should be a culture of mutual respect where teams maintain their disciplinary excellence while collaborating through a shared playbook. That means shared goals, repeatable processes, and enough trust across functions to ensure issues are raised early and solved together, rather than hidden or passed downstream. Many organizations struggle here, especially when development capabilities are added through acquisition without enough attention to how the teams will actually work together. 

An effective collaboration approach is partnering with a specialized contract design and manufacturing organization. This allows companies to benefit from a culture of mutual respect and established disciplinary excellence while avoiding friction associated with internal expansion or bolt-on acquisitions. This model’s success relies on collaboration across core principles:

• Transition from monitoring individual departmental tasks to tracking shared project milestones and stage-gates.
• Ensure all disciplines from quality to engineering have a platform for real-time consultation to reduce the friction of formal documentation hand-offs.
• Implement a consistent product realization process with a Quality Management System (QMS) and standard operating procedures (SOPs) that act as the team’s common operating manual.
• Use continuous feedback loops and comprehensive, regular sessions to review project challenges and feed those lessons back into the development process to prevent recurring errors.

When these elements are established, teams can work in close coordination without losing each discipline’s strengths. In this environment, technical insights from manufacturing experts can be immediately shared with the design team, allowing for immediate collaborative resolution. This cultural resilience enables a project to maintain momentum through the complex technical hurdles inherent in medical device engineering.

As device architectures become more complex, requiring access to multidisciplinary thinking throughout the development lifecycle, the need for concurrent development becomes more critical. Only the largest original equipment manufacturers (OEMs) can sustain the scale of in-house teams needed for major multidisciplinary programs. For others, the challenge isn’t access to expertise alone. It’s how to organize that expertise so design, manufacturing, usability, and risk management collaborate from the start.

Engaging with a specialized design and manufacturing partner provides immediate access to an integrated framework and multidisciplinary team that’s already culturally and operationally synchronized. This collaboration lets medical device leaders bypass the friction of internal restructuring and focus instead on high-level innovation and long-term portfolio growth.

The path to commercial success in modern medtech requires a shift in how the development process is viewed and executed. Move away from seeing usability, manufacturing, and supply chain as downstream hurdles to be cleared at the end of a process. Instead, these disciplines should be the main considerations shaping design from the first day.

By breaking down functional silos and fostering a culture of collaborative problem-solving, medical device leaders can protect their capital, accelerate their time-to-market, and drive successful real-world adoption among users and care teams. The path forward requires a practical shift that involves moving beyond the inefficiencies of the sequential past by getting the right multidisciplinary teams in the same room and aligning them around a shared goal from the beginning of the development program.

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Mike Susi oversees operations and sales for Ensera’s design and product development offering across the U.S. and U.K. He is responsible for making sure design teams continue to be known for their fresh-thinking and agile innovation, while also strengthening integration with manufacturing teams. Susi has over 25 years’ experience in the medical device industry, most notably in leadership roles at Radius/Jabil and Veranex.