End-to-end development of ophthalmic subsystems

Why the decisions with the greatest impact are made before design freeze

A typical case: An ophthalmic OEM is developing a patient-contacting subsystem for a laser-based treatment. Its function has been defined. The material, geometry and manufacturing process have not yet been finalized, nor have the requirements for cleanliness, ergonomics and validation readiness.

At this stage, it may seem natural to finalize the design internally first and approach a manufacturing partner only once the specification is complete. This approach follows an understandable logic: first finalize the drawing, then award the contract.

However, this sequence pushes unresolved questions into a phase in which answering them becomes expensive. Late design changes, revision cycles after the initial prototypes, additional validation steps and regulatory rework consume development time that was still available at the start of the project.

Developing an ophthalmic subsystem is therefore not so much a manufacturing challenge as a development challenge. It follows a different logic, one that starts much earlier.

More procedures, higher requirements, more complex subsystems

The pressure to reconsider this sequence is increasing as the market and procedure volumes grow. 

The regulatory framework is also becoming more demanding. Both the European Medical Device Regulation (EU) 2017/745 (MDR) and FDA requirements call for validation, documentation and traceability to be considered consistently from the development stage onward. Meeting these requirements is heavily influenced by material selection, connection design and the configuration of manufacturing processes. They must therefore be integrated into design and development decisions at an early stage.

The market shows how OEMs are responding. Manufacturers are specifically seeking development partners with single-use expertise who combine engineering expertise, materials expertise, and quality and regulatory capabilities.

Where the Engineering Gap arises

What OEMs are looking for here is not a given in established supplier structures. In practice, the development and manufacturing of complex subsystems are often distributed among several specialist suppliers. One partner extrudes the tubing, another handles injection molding, while others manufacture optical components or assemble the unit. Each of these services may be technically well controlled in its own right, but the critical questions arise at the interfaces.

Each party initially optimizes only its own manufacturing step, not the entire pathway. As a result, the development process becomes fragmented. Interfaces multiply, coordination takes place bilaterally rather than across the entire process, and iteration loops emerge wherever requirements come together only at a late stage. This gap between the individual process step and the overall system is also referred to as the Engineering Gap.

This becomes particularly critical at the transition from concept to volume production. Decisions made early in the design process do not reveal their impact until later: from a technical perspective, when it becomes clear whether the assembly can be manufactured and joined reproducibly; and from a regulatory perspective, during validation and documentation. Those who make these decisions without considering both aspects often recognize the consequences only once corrections have become costly.

The consequences are particularly serious in ophthalmic applications. Requirements for material compatibility, precision and particulate control are extremely high. A functional component on its own is therefore not enough. What matters is whether all components work together reliably as an assembly under real manufacturing and use conditions.

End-to-end as a development principle

This is precisely where end-to-end development comes in: a seamless approach in which functional requirements, material selection, design, manufacturing processes, assembly, and quality and regulatory requirements are aligned from the early concept phase through validated volume production.

The key is not the breadth of the service portfolio. An end-to-end partnership does not mean offering as many services as possible; it means viewing the development steps as an interconnected system. The choice of material affects the tendency to generate particles and sterilizability, geometry affects ease of assembly, and the choice of process determines how readily it can be validated. Optimization within a single manufacturing step may therefore create new requirements elsewhere.

A subsystem partner therefore looks beyond its own manufacturing step to the OEM's entire value chain. It must understand the role the assembly will play in the final system, how it will be handled in the clinical environment, what evidence the OEM requires and how manufacturing can be scaled throughout the product life cycle.

This approach comes into play not during manufacturing, but in the early development phase.

Design flexibility before design freeze

In practice, this means evaluating material, design and manufacturing process together while all three can still be changed. For patient-contacting components, this may involve choosing between silicone and thermoplastic elastomers. The decisive factor is not a material preference, but the balance between function, biocompatibility, processability, cost and regulatory suitability.

At the same time, Design for Manufacturing and Design for Assembly are incorporated early in the design process. The aim is a design that enables safe, reproducible and cost-effective manufacturing before the drawing is finalized. For patient-contacting components, this also includes ergonomics: geometry and tactile properties influence handling and thus clinical use.

Cleanliness requirements likewise need to be built into the design from the outset, rather than addressed only during assembly planning. Particulate contamination is a highly sensitive issue in ophthalmic applications.

The appropriate manufacturing and integration processes depend on the specific project. Depending on the requirements, separately manufactured and assembled components or more highly integrated multi-component solutions may be appropriate. An early development partnership makes it possible to compare these options based on functional, manufacturing and regulatory criteria before design freeze limits the solution space.

Quality and regulatory affairs as integral components

Product development and regulatory requirements cannot be considered separately. Whether a product and its manufacturing process meet the applicable requirements and can subsequently be successfully qualified and validated depends largely on decisions made during product design concerning material selection, component design and process configuration.

The development partner thus becomes part of the OEM's regulatory evidence chain. In addition to controlled manufacturing processes, it supplies documented material evidence, process data and validation support. The IQ/OQ/PQ approach guides development through to validated volume production. The overview below summarizes the standards and systems that form this framework. 

Early decisions shape the entire product life cycle

Manufacturability, cleanliness, regulatory assurance and scalability do not emerge in isolation. They are the result of the same early decisions regarding material, design and process configuration.

Making these decisions jointly reduces risk throughout the entire product life cycle. It also avoids the very revision cycles that most often prolong the path to market readiness.

The distinction between a component supplier and a subsystem partner therefore lies not in the service portfolio, but in the development process. In ophthalmology, where precision is non-negotiable, this decision is made early. Ideally, before the drawing is finalized.

Are you working on an ophthalmic subsystem for which the material, process or manufacturability has yet to be defined? Let's talk.