Platform vs Bespoke Drug Delivery Development: Strategic Choices for Effective Combination Products

Choosing the right drug delivery device development platform is one of the first—and most important—steps in creating a combination product.

This single decision influences everything from engineering complexity and launch timelines to regulatory hurdles, intellectual property, and the product’s commercial success.

Broadly, companies face two options:

• Bespoke drug delivery device development – creating a device from the ground up or adapting an existing device with owned intellectual property.
• Off-the-shelf platform – adopting a proven technology already in production with a contract device manufacturing organisation (CDMO).
Both options offer advantages. The optimal choice depends on balancing speed, flexibility, and competitive strategy.

When Bespoke Devices Deliver More Value

While bespoke drug delivery devices demand greater upfront investment and longer development timelines, they offer strategic advantages that can prove decisive:

• Full IP ownership – Protects your market position, raises barriers to entry, and strengthens valuation in licensing or acquisition scenarios.
• Greater design flexibility – Enables optimisation for drug characteristics, patient ergonomics, and brand aesthetics.
• Long-term adaptability – Gives control to evolve the platform in line with new formulations, markets, or regulatory changes.

For therapies where differentiation, lifecycle planning, or competitive defence are critical, bespoke devices often deliver stronger returns across the product’s lifetime.

Beyond the Device: System-Level Considerations

Whether platform or bespoke, drug delivery device development is only part of the equation. Companies must also prepare for:

• Manufacturing infrastructure – New assembly lines, tooling, and quality systems.
• Regulatory scrutiny – Proving substantial equivalence to existing devices or demonstrating new performance standards.
• Human factors – Designing for patients with varying dexterity, cognition, and confidence, ensuring safe and complete dose delivery.

In practice, the device is a small component within a much larger ecosystem of formulation, manufacturing, and patient use. Successful strategies consider all these elements holistically.

Making the Strategic Choice

The decision between platform and bespoke drug delivery device development is not just technical — it is a boardroom-level trade-off between:
• Speed vs defensibility
• Lower upfront cost vs lifecycle value
• Convenience vs flexibility

In fast-moving markets, an off-the-shelf solution may enable a timely launch, but at the cost of long-term differentiation. Conversely, a bespoke device may delay entry but create enduring competitive advantage.

Conclusion

Choosing between a platform and bespoke drug delivery device is a defining moment in combination product development. It shapes not only the engineering pathway but also regulatory outcomes, IP strategy, and commercial success.

At Haughton Design, we help pharmaceutical and medical device companies navigate this decision with clarity — combining technical expertise, human-centred design, and strategic insight to ensure the right choice for each therapy and market.

If you are weighing up your options, our team can support you in evaluating time, cost, and competitive implications — and guide you to the strategy that delivers the greatest long-term value.

Whether you have a clear vision of how you want your bespoke device designed or, you’re unsure whether to use an off-the-shelf platform as part of your development strategy, please get in touch for more advice or to discuss your project.