June 2026 | Jack Overell – Head of Production, SAE Media Group

Earlier this month, SAE Media Group’s 10th annual Pre-Filled Syringes & Injectable Drug Devices West Coast conference convened in San Diego and brought together leaders across pharma, device engineering, and delivery systems to address one central reality: drug delivery is becoming the bottleneck – and the opportunity – within modern therapeutics.

Across three days of discussions, several consistent themes emerged around human-centric design, rising biologics complexity, integration challenges, and the need for new delivery paradigms.

1. The Shift to Patient-Centric, Home-Based Care

A dominant theme throughout the conference was the continued migration from clinic-based to at-home drug administration, driven by both patient expectations and system-level cost pressures.

• There is clear acceleration toward self-administration of therapies previously delivered intravenously, enabled by subcutaneous formulations.
• This shift supports reduced burden on healthcare systems and improved patient convenience and adherence.

However, this transition is placing unprecedented pressure on device design:

• Devices must now be more intuitive, reliable, and tolerant of real-world variability.
• Human factors are no longer a compliance exercise, but a core strategic differentiator.

Critically, discussions emphasized that usability must be embedded across the entire product lifecycle – not just validated at the end.

2. Human Factors as a Strategic Capability

A major theme was the elevation of human factors from “study requirement” to organizational capability.

Key insights included:

• Effective human factors work must begin at early discovery stages, including user research, ethnographic studies, and interface design.
• Continuous engagement with real users – across development, validation, and post-market phases – is essential.

Organizations highlighted the need to:

• Build dedicated, integrated human factors teams.
• Maintain continuous feedback loops between patients, engineers, and commercial teams.
• Ensure cross-functional alignment, especially with regulatory, clinical, and safety functions.

A recurring challenge is that human factors are still often treated as a parallel process, rather than embedded within design control – limiting its impact.

3. Rapid Growth of Biologics Driving Delivery Innovation

The rise of biologics remains one of the most transformative drivers in the injectable delivery space.

Key data shared during the conference indicated:

• Biologics now represent a growing proportion of approvals.
• The majority of development pipelines are early-stage injectable biologics, with a strong move toward subcutaneous delivery.

This is fundamentally reshaping delivery requirements:

• Higher doses and viscosities are becoming standard.
• Increasing demand for large-volume (2–10 mL and beyond) delivery systems.
• Growth in on-body injectors, wearable devices, and advanced auto-injectors.

The industry consensus is clear: traditional device formats were not designed for the next generation of biologic therapies.

4. The Challenge of Large Volume & High-Viscosity Delivery

One of the most widely discussed technical challenges was enabling safe, effective delivery of large-volume, high-viscosity drugs.

Key issues include:

• Patient ability to tolerate faster injections at higher volumes.
• Need to balance injection time vs. user comfort and tissue response.
• Increased complexity in ensuring complete dose delivery and preventing leakage or device removal too early.

From a device design perspective:

• Engineering challenges are solvable – but patient usability and physiology are limiting factors.
• The solution space is expanding toward:
• Wearable injectors
• Slower, controlled delivery systems
• Hybrid device models

A critical takeaway: “More force” is not the answer – understanding patient interaction and tissue response is.

5. Increasing Complexity in Combination Product Development

Combination product development is becoming more interconnected, slower, and risk-prone.

Challenges discussed include:

• Integration of drug, device, manufacturing, and supply chain decisions.
• Increased need for early alignment across multiple stakeholders.
• Risk introduced by complex vendor networks and fragmented supply chains.

Lifecycle management is particularly challenging:

• Device changes, formulation changes, or manufacturing updates can trigger regulatory rework.
• Post-market feedback (e.g., user errors or complaints) often drives redesigns.

Speakers highlighted that delays are often caused not by innovation failure, but by late-stage integration issues and rework.

6. Regulatory Evolution and Quality Expectations

Regulatory expectations continue to evolve rapidly, particularly in the US.

Key developments discussed:

• The transition to QMSR (Quality Management System Regulation) requires deeper alignment between drug and device quality systems.
• Regulators expect:
• Transparent documentation
• End-to-end lifecycle traceability
• Explicit risk-based decision-making frameworks

Additionally:

• Inspections are shifting toward risk-based approaches, rather than checklist compliance.
• Greater emphasis on demonstrating a “culture of quality” across the organization.

This represents a shift from procedural compliance to organizational accountability.

7. Manufacturing, Sterilization, and Scalability Challenges

Scaling novel delivery systems introduces operational challenges:

• FDA expectations increasingly favor terminal sterilization over aseptic processing where feasible, for improved safety and scalability.
• Trade-offs between sterility, material compatibility, and cost remain significant.
• Manufacturing complexity increases with:
• Novel materials
• Multi-component devices
• Combination product workflows

Supply chain fragmentation was highlighted as a major risk driver, with calls for:

• Greater integration across value chains.
• More end-to-end ownership of development and manufacturing processes.

8. Emerging Technologies and Future Direction

Several forward-looking areas gained significant attention:

a) Connected Devices and Digital Health

• Despite strong theoretical benefits, adoption of connected drug delivery remains limited.
• Barriers include:
• Cost of digital infrastructure
• Fragmented data ecosystems
• Lack of payer support

Consensus: standardization and ecosystem integration are critical for success

b) Device–Drug Co-Design

• Increasing need to design devices around drug properties, not retrofit later.
• Early-stage testing and feasibility studies are becoming essential.

c) Advanced Delivery Modalities

• Lyophilized drugs and dual-chamber systems enabling at-home reconstitution.
• Micro-needle systems and novel injection approaches.
• Gas-powered or alternative actuation technologies for extreme delivery requirements.

9. Core Industry Priorities Going Forward

Across all sessions, several clear priorities emerged:

1. Design Around the Patient
     a. Usability, accessibility, and real-world use must guide development.
2. Integrate Earlier Across Functions
     a. Drug, device, and manufacturing teams must collaborate from the outset.
3. Enable Large-Volume Delivery Safely
     a. New device architectures are required for next-generation biologics.
4. De-Risk Development Early
     a. Early testing and feasibility studies reduce costly late-stage failures.
5. Simplify the Ecosystem
     a. Standardization and integration – especially in digital – are essential.

Conclusion

The PFS West Coast conference reinforced a critical industry shift:

Drug innovation is no longer limited by biology – it is increasingly defined by delivery.

As biologics become more complex and patient expectations rise, success will depend on:

• Human-centered design.
• Integrated development strategies.
• Scalable, flexible delivery systems.

The organizations that can align these elements effectively will define the next generation of injectable therapeutics.