Case Study 04 · Drug Delivery Devices

Auto-Injector Assembly & 100% Vision Inspection Platform

A specialty pharma device company scaling commercial production of a prefilled auto-injector pen needed a turnkey assembly, fill verification, and 100% camera inspection system validated to FDA 21 CFR Part 211 standards.

$6.4M

Program Value

18 mo

Sales Cycle

Buying Influences

Won

Outcome

Background

The Opportunity

Following FDA approval of a biologic formulation, a specialty pharma-device company needed to rapidly scale commercial manufacturing of its signature auto-injector pen. The capital project required a fully automated assembly line — spring insertion, plunger rod joining, needle guard assembly, label application, and tamper-evident cap sealing — combined with a 100% automated optical inspection station to meet cGMP requirements under 21 CFR Part 211.

The integrator was engaged as both technical consultant and prime integrator, responsible for developing the URS, selecting component vendors, managing system integration, and delivering the IQ/OQ/PQ validation package for regulatory submission.

Confirmed $7M capital envelope approved by Executive VP of Operations
Verified FDA 21 CFR Part 211 cGMP compliance as non-negotiable requirement
Identified R&D champion: VP of Device Engineering, who authored original concept
Confirmed 4 competing integrators at expression-of-interest stage
Validated that previous integrator relationship failed at prototype stage — trust gap
Confirmed commercial launch timeline required production qualification within 20 months

Stakeholder Map

Buying Influences

Role	Name / Title	Influence	Mode	Key Concern
Economic Buyer	EVP Operations	Executive sponsor, board presenter	Growth	Regulatory approval timeline risk
Economic Buyer	CFO	Capital approval, ROI review	Overconfident	Cost overrun exposure from prior failed project
Technical Buyer	VP Device Engineering	URS author, technical champion	Support	Spring force repeatability ±2%
Technical Buyer	VP Quality & Regulatory Affairs	cGMP compliance gatekeeper	Overconfident	21 CFR 211 inspection AQL and false reject rate
Technical Buyer	Dir. Manufacturing Engineering	Line layout and changeover spec	Even Keel	SMED-based format changeover under 45 min
User Buyer	Production Manager	Operational impact, throughput	Even Keel	OEE targets, downtime penalties
User Buyer	Validation Manager	IQ/OQ/PQ protocol ownership	Overconfident	Protocol pre-approval from FDA consultant
Coach	VP Device Engineering	Internal advocate, decision influencer	Support	Restore confidence after prior integrator failure
Coach	External CMO Partner	Third-party technical credibility	Growth	Validation completeness for submission dossier

Sales Process

Engagement Flow

Win Strategy

Win Checklist

#TypeAction ItemOwnerDue DateDone

1 Internal Alignment Conduct internal project risk review of prior failed integrator case — identify root causes and mitigations Jake Malone Month 2 YES

2 Customer Engagement Present prior auto-injector project portfolio to EVP Operations and VP Device Engineering Collin Phelps Month 2 YES

3 Technical Alignment Perform spring force repeatability study using customer device components — target ±1.8% Chris Columbus Month 5 YES

4 Customer Engagement Arrange reference call between VP Quality and reference customer Quality Director on inspection AQL Collin Phelps Month 8 YES

5 Commercial Alignment Engage CMO partner to co-author validation master plan with pre-submission FDA alignment memo Anna Watts Month 10 YES

6 Technical Alignment Demonstrate 100% vision inspection false-reject rate below 0.3% in FAT simulation Chris Columbus Month 12 YES

7 Commercial Alignment Structure contract with shared-risk milestone payments tied to OQ and PQ acceptance criteria Anna Watts Month 15 YES

8 Internal Alignment Assign dedicated program manager to single-point accountability for all customer communications Jake Malone Month 1 YES

Why We Won

Key Win Factors

🔬

Rebuilt Trust After Prior Failure

Rather than ignoring the failed integrator history, we addressed it directly in the first executive meeting — presenting a formal risk register and mitigation plan that no competitor matched.

📉

Lowest False-Reject Rate

Our FAT simulation demonstrated a 0.24% false-reject rate against the 0.3% spec — the best of any vendor reviewed, directly closing the VP Quality's primary technical concern.

📄

FDA-Aligned Validation Package

Delivering a validation master plan with a pre-submission alignment memo — written with the CMO partner — gave the regulatory team an asset they could use for their 510(k) submission, not just our FAT.

🤝

Shared-Risk Contract Structure

Milestone payments tied to OQ/PQ acceptance gave the CFO protection against cost exposure — directly responding to their concern about the previous integrator's cost overrun.