Auto-Injector Readiness:

Why Most Teams Start Too Late 

Pharma and biotech teams often feel prepared when they begin thinking about integrating an auto-injector (AI) into their program. 

1. They have a QMS. 
2. They have SOPs. 
3. They understand their clinical milestones. 

But readiness for an auto-injector development program is much more than internal infrastructure. It requires the right timing, the right strategy, and the right cross-functional alignment — and this is where most teams fall short. 

Problems don’t arise because teams lack capability — they arise because device strategy starts too late.

At Suttons Creek, we see the same patterns across the industry. Below we will walk you through the most damaging patterns and how to get off on the right foot. 

“We have a QMS, so we’re ready.” Not Quite.

Most organizations equate operational readiness with program readiness. But these are not quite the same.  

True auto-injector development requires: 

• A device strategy aligned with your molecule and use-case 
• Integrated CMC and device timelines – not parallel, disconnected plans 
• Early human factors inputs that inform decisions – use population, use environment, critical tasks, and potential use errors – before the design is locked 
• Regulatory evidence planning from the start, not retroactive justification 
• A clear rationale for device – container compatibility, grounded in feasibility, not assumption 
• Cross-functional alignment on requirements, risks, and decision ownership.  

It is imperative to establish program readiness at the strategy stage – when risks are still manageable, decisions are still flexible, and the program can be set-up correctly the first time – not after issues have surfaced and remediation becomes unavoidable.  

Timing: the #1 readiness issue we see across clients

Most teams do not start thinking about the auto-injector until after the formulation is defined or Phase 2 planning is underway.  

By then, critical decisions are already set: 

• Syringe or container selection 
• Viscosity limits 
• User population and environment assumptions 
• Stability and stress profiles 
• Clinical and manufacturing timelines 
• Regulatory expectations 

At this stage, device development becomes reactive, constrained by earlier choices rather than guided by strategy. Suttons Creek is often brought in to clean up issues that could have been avoided in the strategic phases of product development.  

Clients who engage in early device strategy move confidently and efficiently. Clients who wait end up needing remediation.  

Case Study: “We thought we were ready – until the program slipped.” 

A fast-growing biotech planned to transition a monthly clinical therapy to an auto-injector. From the leadership perspective, the program appeared ready: 

• Mature QMS 
• Aligned SOPs 
• Preferred device vendor 
• Defined clinical timeline 

What was missing was a clear assessment of device integration. When they started feasibility testing, several unexamined assumptions surfaced: 

• Cold-temperature viscosity exceeded the device’s delivery capability 
• Syringe tolerances conflicted with the platform’s mechanical interference 
• Early human factors work exposed high orientation use error rate 
• Regulatory lacked a defensible rationale for platform selection 
• Device development lagged CMC by nearly a year 

This triggered: 

• Device customization and re-design 
• Additional compatibility studies 
• New usability studies and risk management updates 
• Rewriting regulatory strategy 
• Revising development timelines  

Total impact: 9 months of delay. 

Suttons Creek was brought in for the remediation – aligning stakeholders, resetting expectations, updating strategy, and rebuilding the plan. The broad takeaway was straightforward: the delay was not caused by execution failure or lack of process. It stemmed from unexamined assumptions made early, before the device workstream was fully understood.  

For leadership teams, readiness is ultimately about knowing which questions need to be answered early – and making space to answer them before momentum takes over.  

What ‘ready’ looks like for an auto-injector program

From a leadership perspective, readiness is not about having the right tools or teams in place. It’s about whether the organization has clarity, alignment, and foresight before committing to irreversible decisions.  

At Suttons Creek, we see true readiness emerge when five areas are addressed together – not sequentially or in siloes.  

1. Technical readiness means the organization understands whether the molecule can be delivered reliably under real-world conditions and where the true boundaries are, before timelines and platforms are locked.  
2. Human factors readiness means user assumptions, use environments, and critical tasks have been identified to inform design and platform decisions, as opposed to surfacing late as validation findings. 
3. Regulatory readiness means the program has coherent evidence and a justification narrative from the outset – not a collection of post-hoc rationales assembled under submission pressure. 
4. CMC and device timeline readiness means the drug and device system are progressing on a single, integrated plan with manufacturing and supplier considerations factored in from the start.  
5. Cross-functional readiness means decisions are made as a team with shared understanding across Technical, CMC, Quality, Regulatory, Clinical, Manufacturing, Supply Chain – eliminating gaps where expectations may diverge.  

In our experience, readiness is achieved by asking the right questions, at the right time, across the right functions. This alignment determines whether an auto-injector program advances smoothly or becomes reactive.  

When to engage combination product expertise:

The most effective time to bring in experts is earlier than most programs expect; specifically, before: 

• Committing to a device delivery approach 
• Selecting a syringe or platform 
• Finalizing human factors, CMC, or regulatory strategies 
• Locking product requirements and development timelines 

Engaging at this stage allows leadership teams to pressure-test assumptions, understand true constraints, and align decisions across functions while flexibility still exists.  

When expertise is introduced later, the role often shifts from guiding strategy to managing consequences – addressing misalignment, rework, or unanticipated risks.  

In practice, Suttons Creek supports organizations at both points. Some engagements begin with an early strategic assessment. Others begin when a program has already encountered challenges and needs to recover. The former offers more options, while the latter requires specific corrections and unbudgeted time and money.  

Final thought: readiness is a strategy, not a checkbox.

Auto-injector development is not simply a procurement decision. It’s a cross-functional strategy that touches every part of product development. While most teams believe they are ready, without combination product expertise, few truly are.  

If your organization is beginning to explore an auto-injector (or any drug delivery system) or if you’re already seeing friction, remember that readiness is not only about having the right processes but also having the right strategy at the right time. To that end, Suttons Creek has created a tool to help you assess your readiness for a combination product. 

Simply register for access to our online tool below and you will be emailed with a link and password.  

Parth Kothari, Senior Principal Consultant, Suttons Creek –Parth is a results-driven leader with over 13 years of experience in the regulated healthcare industry, specializing in the development and commercialization of complex medical devices and combination products. He has successfully led programs from concept through launch at global pharmaceutical and medical device organizations. Link to bio.

Michael Koucky, Principal Consultant, Suttons Creek – Michael is an engineer with more than 10 years of experience providing technical and design control expertise to the drug-device/biologic-device combination product and medical device industries. He has provided successful support to clients through all phases of the product life-cycle, from new product development through design transfer, life-cycle management, and end-of-life. Link to bio.