Case Study 01 · Orthopedic Implantables

Robotic Assembly Line for Spinal Implant Components

A leading Northeast orthopedic OEM needed a fully automated assembly and inspection line for titanium spinal cage components. Eighteen months. Seven stakeholders. One contract closer.

$4.2M
Program Value
16 mo
Sales Cycle
7
Buying Influences
Won
Outcome
Orthopedic implant components
Background

The Opportunity

A mid-size orthopedic device manufacturer producing titanium spinal cages and interbody fusion devices was operating manual benchtop assembly for final component joining and visual inspection. With FDA 21 CFR Part 820 compliance requirements tightening and throughput targets doubling for a new surgeon distribution agreement, the VP of Operations initiated a capital project to automate the process.

The integrator was brought in on a contract basis at the RFQ stage to develop the technical and commercial strategy, navigate the buying committee, and carry the engagement through to contract signature.

  • Validated 100% budget authority with CFO — $5M cap confirmed
  • Confirmed active project timeline: line qualification required within 20 months
  • Identified internal champion: Director of Manufacturing Engineering
  • Validated 3 competing integrators were at RFQ stage — no incumbent
  • Confirmed FDA traceability and cleanroom classification as mandatory requirements
  • Verified no internal automation team — full outsource model preferred
Stakeholder Map

Buying Influences

RoleName / TitleInfluenceModeKey Concern
Economic Buyer
CFO / VP FinanceFinal budget approval, ROI signoffOverconfidentCapital payback period under 36 months
Technical Buyer
VP OperationsSpecification approval, vendor selectionGrowthFDA validation package completeness
Technical Buyer
Dir. Manufacturing EngineeringTechnical evaluation leadSupportCycle time, cleanroom compliance, vision spec
User Buyer
Production ManagerDay-to-day operations impactEven KeelEase of changeover, uptime SLA
User Buyer
Quality ManagerIQ/OQ/PQ protocol approvalOverconfidentVision system false-positive rate
Coach
Dir. Manufacturing EngineeringInternal advocate, intel sourceSupportWants project success tied to his roadmap
Coach
External Process ConsultantThird-party validation credibilityGrowthIndependent technical assessment
Sales Process

Engagement Flow

Qualification Budget · Timeline Champion · Fit Discovery Site Visit · Spec Stakeholder Map Technical Concept · Demo Risk Assessment Proposal Pricing · Value Case · ROI Model Negotiation T&Cs · Scope Close · Signature Months 1–2 Months 2–5 Months 5–10 Months 10–13 Months 13–16
Win Strategy

Win Checklist

#TypeAction ItemOwnerDue DateDone
1 Internal Alignment Engage SME robotics engineer for cleanroom-rated cell design review Jake Malone Month 3 YES
2 Customer Engagement Site visit with President and VP Operations to walk production floor Collin Phelps Month 2 YES
3 Technical Alignment Obtain existing equipment failure data and throughput analytics per station Chris Columbus Month 4 YES
4 Commercial Alignment Identify and onboard local validation/service partner for IQ/OQ/PQ support Anna Watts Month 5 YES
5 Customer Engagement Executive briefing with CFO — ROI model and 30-month payback analysis Collin Phelps Month 9 YES
6 Technical Alignment Present vision system false-positive data from reference site to Quality Manager Chris Columbus Month 10 YES
7 Commercial Alignment Negotiate 5-year preventive maintenance contract alongside capital deal Anna Watts Month 14 YES
8 Internal Alignment Legal review of FDA validation deliverables and acceptance criteria language Jake Malone Month 13 YES
Why We Won

Key Win Factors

🏆

FDA Validation Package

Competitors offered equipment only. We included a complete IQ/OQ/PQ validation package with local partner support — a decisive differentiator for the Quality team.

🎯

Executive ROI Alignment

Presented a 30-month capital payback model tied directly to the surgeon distribution agreement revenue uplift — won the CFO's approval early.

🔬

Reference Site Visit

Arranged a reference site tour at a comparable orthopedic OEM — reduced perceived risk and neutralized competitor claims about our vision system performance.

🤝

Champion Development

Director of Manufacturing Engineering became an internal advocate. His endorsement of the technical approach was the tipping point in the final vendor review.