Combination Product Industry News & Guidance

The Myth of Fast-Track Device Readiness: Unpacking Real-World Timelines for Autoinjector Development 

At Suttons Creek, our experience supporting pharmaceutical sponsors from early strategy through launch has taught us one truth repeatedly: timelines for autoinjector development are rarely as fast—or as simple—as they seem on paper. 

When timelines are compressed and expectations misaligned, the consequence is not just rework—it’s revenue lost, stakeholder trust eroded, and regulatory review timelines delayed. During a recent internal team discussion preparing for a presentation at the SAE conference, our experts revisited one of the most persistent myths in combination product development: that autoinjector devices can be developed, validated, and commercialized in 12 to 18 months. 

Let’s unpack the realities behind that belief—and where the actual timeline diverges. 

Best-Case Scenarios: When Everything Is in Place 

In the most optimistic scenario, a pharmaceutical company already has: 

• A finalized drug formulation 

• A fully established manufacturing infrastructure (including filling and secondary packaging) 

• A selected and qualified autoinjector platform 

• An internal combination product team with device expertise 

In this narrow case, reaching the clinic in 18–24 months may be feasible. Commercialization may follow in another 6–12 months, assuming smooth regulatory interactions and high executional efficiency. 

But this timeline assumes that foundational decisions are already made, contracts are in place, and no unexpected technical or organizational challenges arise. It’s the exception, not the rule. 

The Realities: Why Most Programs Take Longer 

Most pharma sponsors aren’t starting with all of the above in place. In fact, many begin with little more than a target patient population and a preference for subcutaneous delivery. And when that’s the case, the development journey is much longer—and more complex. 

1. Contracting Alone Can Take Six Months

We’ve observed that even reaching a signed contract with a device vendor can take six months or more. This delay often occurs before any design or engineering work has begun. 

2. Strategic and Regulatory Alignment Is a Heavy Lift

Establishing device strategy, developing a Design History File (DHF), implementing a device-appropriate Quality Management System (QMS), and initiating combination product regulatory pathway planning adds another layer of time and complexity—especially when sponsors do not have device experience in-house. 

3. Vendor Readiness Varies

Not all device platforms are “off the shelf” in the way pharma expects. Even when a platform is available, vendors often must customize molds or develop specific assets for a new client. Even leading platform vendors often do not have commercial-ready assets waiting on the shelf. 

4. Clinical and Drug Product Readiness Is a Parallel Challenge

Clinical teams are not always prepared to align with device timelines. Many projects are delayed because the clinical development team hasn’t finalized protocols, or the drug product itself isn’t available in the necessary configuration. 

Avoiding the Pitfalls: What Makes a Timeline Realistic? 

To help pharma sponsors understand what a truly realistic autoinjector development timeline looks like, the Suttons Creek team advocates for a range-based model: 

With optimal execution, timelines can compress. But projects rarely progress without friction—especially when device, drug, clinical, and regulatory teams are working asynchronously. 

The Cost of Poor Planning: Opportunity Loss 

What’s often lost in this discussion is the opportunity cost of setting unrealistic expectations. Sponsors may: 

• Miss clinical milestones due to device unavailability 

• Delay regulatory submissions due to incomplete design files 

• Lose a year or more of commercial revenue 

And the intangible costs—loss of investor confidence, stress on internal teams, and decreased vendor trust—are just as damaging. 

Suttons Creek’s Take: Plan Early, Align Often 

At Suttons Creek, we’ve supported combination product programs from early strategy through launch. The programs that succeed—on time and on budget—are those that: 

• Engage cross-functional stakeholders from the beginning 

• Incorporate device-specific timelines into their broader development plans 

• Treat the device component with the same rigor as the drug component 

As Jonathan Amaya-Hodges, Suttons Creek Director, Technical Services, notes, “Some sponsors engage extremely early, which gives the best chance to plan. Others come in at the 11th hour—and we know how that goes…” 

We’ve seen both, and we know which path leads to fewer surprises, disappointments and losses. 

Final Thoughts: Communicating Timelines with Confidence 

For those preparing internal strategies or external stakeholder presentations, we recommend replacing specific timepoints with ranges, along with commentary about the critical variables that influence them. 

These variables include: 

• Clinical strategy and protocol readiness 

• Drug product availability 

• Device platform maturity and customization needs 

• Vendor prioritization and contractual delays 

• Manufacturing infrastructure and fill/finish planning 

Communicating a generalized range of 18–48 months from concept to commercial readiness—tailored by these variables—sets more accurate expectations and lays the foundation for trust and alignment. 

At Suttons Creek, we help clients not only build combination product timelines—but beat them. 

Ready to plan your program with realistic expectations and strategic foresight? Reach out to our team at discuss@suttonscreek.com to learn how we can help guide your combination product journey. 

AUTHOR

Bryan Bobo, Associate Technical Director, Suttons Creek – With over 9 years of experience in the pharmaceutical industry, Bryan has extensive knowledge of combination product development and what it takes to launch products on the market. He has practical and hands-on experience in various types of drug delivery systems from his years as both a Device Development Engineer as well as project and program management positions. In addition to his direct product development experience, Bryan engages with the global combination product community through his participation on various international standards committees as well as other various industry forums.