De-Risking Auto-Injector Development with Manufacturing-Driven Design

Auto-injector development carries a unique level of risk. Not because of any single challenge, but because product performance, manufacturability and scalability must all be achieved simultaneously. These requirements are often evaluated under different conditions and at different stages of development, limiting visibility into how design decisions will perform in high-volume manufacturing and automated assembly and in the hands of the end user.

When designs are translated into high-volume manufacturing and assembly, these gaps in visibility and alignment become operational constraints. Component design influences not only how parts are molded, including material selection, tolerances and dimensional stability, but also how they are handled and assembled.

Constraints such as molding limitations, component handling requirements and assembly sequence complexity should be defined early in development. Decisions made in early-stage design and development ultimately determine how efficiently a device can be brought into production, automated and scaled.

This is where de-risking begins. When design and manufacturing decisions are informed by real production experience, teams can identify constraints sooner, reduce costly redesigns and move into scale with greater confidence.

Integrating Manufacturing and Assembly

Building on this foundation, development must be structured to incorporate manufacturing and assembly inputs into decision making while key design choices are still being defined. Design for Manufacturability (DFM) becomes critical at this stage, guiding design specifications using manufacturing, automation and assembly inputs, rather than validating them later.

This involves evaluating component design, material selection and molding constraints, along with part count and assembly strategy. The goal is to determine how these decisions influence handling stability and consistent performance across manufacturing and assembly. It also requires understanding how variation during molding carries through to assembly. This ultimately affects how consistently parts fit together and how reliably the device can be produced.

Rather than relying on sequential handoffs, Design & Development, Tooling, Automation and Manufacturing functions should collaborate continuously, using real production insights to assess trade-offs, identify constraints and guide decisions as the process evolves. Concepts are assessed not only for performance, but for manufacturability, assembly feasibility, automation readiness and scalability, leading to more efficient and repeatable production outcomes.

Understanding Manufacturing and Assembly Constraints

Assembly is where real-world manufacturing conditions converge to determine whether a device can be consistently produced at scale. It is also where the impact of design decisions and upstream manufacturing variation becomes fully visible.

Many challenges only emerge when a design is translated into an automated assembly sequence. Components that appear straightforward in isolation can behave differently when they must be fed, positioned and integrated repeatedly at speed.

Evaluating manufacturing and assembly early in development requires more than assessing individual components. Teams must consider how the full system behaves, including how components can be fed and positioned, and how sensitive the assembly sequence is to process variation.

These issues often originate from variation in molding conditions, which can affect part fit and alignment, leading to incomplete engagement, higher insertion forces or misalignment, which in turn can create assembly constraints such as handling instability and inconsistency in cycle time.

During development, a practical way to approach this is to assess assembly as an integrated system rather than a series of discrete steps. This includes identifying where components require reorientation, where motion changes introduce timing sensitivity and where part-to-part variation may disrupt sequencing or create force consistency issues.

Designing for Scale

Design decisions that seem acceptable early in development can fail as devices are scaled to higher volumes, where variability in manufacturing and the demands of automated assembly expose constraints not previously apparent.

Designing for scale requires making deliberate trade-offs during device development to simplify manufacturing and assembly processes. This approach should include minimizing part count, selecting materials and geometries that support consistent manufacturing performance, and structuring components into defined sub-assemblies that can be built and integrated in a controlled, repeatable way.

Increased assembly complexity introduces more opportunities for variability, while difficult-to-handle components can disrupt automated systems. Multi-directional assembly sequences further increase equipment requirements and cost while reducing overall line efficiency.

Consistent part presentation is also critical, ensuring components can be reliably fed and handled within automated systems while minimizing additional manipulation to reduce cycle time and overall complexity.

Supporting linear, single-axis assembly further reduces the need for rotations and additional handling, simplifying automation and improving repeatability. Addressing these elements early in development enables more predictable manufacturing and assembly, avoiding costly rework and minimizing disruption.

Applying Manufacturing-Driven Design Through the A.i.r. Platform™

The A.i.r. Platform™, developed by MGS, was designed with the end state in mind, where manufacturability and assembly considerations shaped key decisions from the beginning. Its core technology was developed by working backward from how the device would be manufactured and assembled at scale, aligning component geometry, material selection and assembly strategy with production requirements.

This manufacturing-driven approach is reflected in how the platform simplifies both assembly and automation. The components are designed for consistent feeding and orientation, minimizing rehandling or repositioning during assembly. The platform design supports a linear assembly flow, reducing multi-directional movements and enabling a more predictable and efficient automated assembly sequence.

This is further supported by a streamlined component set, with just seven plastic parts and two springs, organized into two primary sub-assemblies. This structure enables controlled, repeatable integration, simplifying handling and supporting more efficient automation. The simplicity of the assembly process also facilitates quality control, as process completeness is inherently easy to verify and critical engagements are clearly identifiable and reliably confirmed.

A key contributor to this simplified design is the spring system, which is engineered to manage energy transfer within the device while minimizing mechanical complexity. The power spring is a DFA-optimized extension spring designed for orientation-independent bulk-feed assembly. No detanglers, trays or other separation methods are required during storage or prior to assembly.

Enabling Faster, More Predictable Device Development

Building on this manufacturing-driven design approach, the A.i.r. Platform™ is based on a modular, core technology that enables flexibility across drug, device and patient needs. Injection time, activation profile and delivery force can be adapted to accommodate a range of formulations, including higher-viscosity biologics, while supporting fill volumes from 0.3 mL to 2.25 mL and compatibility across pre-filled syringe (PFS) configurations.

A key advantage of this platform approach is that customization is achieved without changing established assembly processes or manufacturing setups. By developing design specifications to align with real manufacturing and assembly conditions, the platform maintains a consistent foundation while enabling variation where needed. This avoids the need to develop new manufacturing processes from scratch with each variation of your auto-injector. Using a platform, the manufacturing principle remains consistent, even as customization within the platform can make variants look and perform to different specifications.

MGS’ integrated capabilities across Design & Development, Tooling, Automation and Manufacturing enable earlier decision-making, accelerating development timelines by up to three years compared to bespoke devices developed from scratch.

Leveraging this combined expertise, feasibility assessments can be conducted using functional, molded prototypes delivered within approximately 12 weeks. These devices enable Pharma teams to evaluate product performance and user interaction in real-world scenarios.

From Manufacturing Strategy to Competitive Advantage

The ability to translate design intent into scalable production is increasingly defining success in device development.

For Pharmaceutical and Biotechnology companies, developing a new drug delivery device inherently carries risk. When manufacturing, automation and assembly considerations are addressed only after design decisions are made, risks often emerge as delays, redesigns and production challenges. By bringing these considerations into the design phase, teams can identify and resolve constraints earlier, reducing uncertainty and establishing a more predictable path to scale-up.

Partnering with a Contract Development and Manufacturing Organization (CDMO) with integrated capabilities enables production considerations to be validated early by bringing Design & Development, Tooling, Automation and Manufacturing together while designs evolve.

This approach shifts development from reacting to issues to preventing them. Programs move forward with fewer redesign cycles and more predictable timelines, while devices are designed to perform consistently in high-volume production.

As demonstrated through the A.i.r. Platform™, aligning design with manufacturing and assembly conditions enables more efficient, scalable auto-injector devices without introducing unnecessary complexity. The result is a more controlled path to commercialization and greater confidence in how the device will perform in the hands of patients.

In this model, manufacturing-driven design becomes a competitive advantage, allowing teams to reduce risk, accelerate development and bring devices to market with greater predictability and control.