Design for Manufacturing: The Most Expensive Medical Device Decisions Are Made Before Production

Key Takeaways

• Around 70 to 80% of a product's manufacturing cost is determined during the design phase. Design decisions have a far greater impact on cost than later production optimizations.
• A manufacturing feasibility review reduces risk before tooling begins. Checking geometry, materials and tolerances early helps avoid expensive mold modifications and production delays.
• The right manufacturing partner should be consulted before the design is frozen — not just brought in to execute it.

Developing a medical device is rarely limited by a good idea. More often, success depends on how well that idea can be manufactured consistently, validated efficiently and scaled economically.

Many development teams invest months optimizing clinical performance, only to discover during industrialization that the product is difficult to inject, assemble or validate. By then, every design modification becomes significantly more expensive.

The earlier manufacturing is consulted, the lower the overall risk

Multiple engineering studies have shown that the majority of a product's lifecycle cost is committed during the design phase, long before the first production batch begins.

At this stage, decisions such as material selection, wall thickness, draft angles, tolerance strategy, assembly methodology and component count will ultimately determine manufacturing yield, tooling complexity, validation effort and production cost. Changing any of these parameters once tooling has been manufactured can multiply both costs and project timelines.

Common manufacturability issues we flag before tooling

When reviewing customer designs ahead of mold construction, the same challenges frequently appear:

• Wall thickness variations that generate sink marks or warpage.
• Geometries that complicate mold filling.
• Tolerances tighter than the clinical function actually requires.

None of these issues necessarily prevent manufacturing. However, flagging them before mold construction can save months of redevelopment and avoid substantial non-recurring engineering costs.

A manufacturing feasibility review is not redesigning the product

A common misconception is that a manufacturability review means changing the customer's product. In reality, the objective is the opposite: maintain the intended clinical function while confirming the product can be manufactured reliably, robustly and economically — and flagging where it can't.

In many projects, small adjustments suggested at this stage, such as a draft angle, a gate position or a tolerance band, can be evaluated against manufacturability before any commitment is made, without touching device performance. The design decision always remains with the OEM's engineering team; our role is to surface the trade-offs early enough that they're cheap to act on.

Manufacturing should be consulted during development, not just at the final step

Historically, manufacturers entered projects once the design had already been completed. Today, the most successful medical device programs bring manufacturing partners into the conversation much earlier — even if just for a feasibility opinion, not a redesign.

This earlier dialogue reduces technical risk, shortens industrialization timelines and minimizes the number of engineering iterations required before validation. For OEMs, it also means reaching the market faster while maintaining compliance with quality and regulatory requirements.

Building products that are designed to scale

At Innovamed, we believe manufacturing expertise creates the greatest value before production even begins. By supporting customers with injection molding feasibility reviews, cleanroom assembly planning and industrial validation (IQ/OQ/PQ), we help transform promising concepts into products that can be manufactured reliably, efficiently and at scale.

Because a medical device should not only work in the laboratory. It should also be designed to succeed on the production floor.

Gerard Ortiz — Commercial Director | Innovamed Spain