Field Service & Operations Consulting

BUILT TO PERFORM.

Senior-level field service leadership for medical device and biomedical companies — from pre-launch startups to established global organizations. Based in Milford, CT. Available nationwide and remote.

35+
Years Experience
30+
Countries Served
FDA
Drug-Device Audits
35+
Years of
Expertise
Field Service Operations FDA 21 CFR Part 820 ISO 13485 Compliance Drug-Device Combination Audits Global Service Leadership Fractional Head of Service Startup Launch Services Depot Repair & Escalation Management Field Service Operations FDA 21 CFR Part 820 ISO 13485 Compliance Drug-Device Combination Audits Global Service Leadership Fractional Head of Service Startup Launch Services Depot Repair & Escalation Management

EXPERT SERVICES.
REAL RESULTS.

01
⚙️

Field Service Operations

End-to-end design and optimization of field service organizations — processes, SLAs, escalation workflows, depot repair, and CRM implementation.

02
📋

Regulatory Compliance

FDA inspection readiness including drug-device combination audits, ISO 13485 gap assessments, CAPA development, and complaint handling systems.

03
🚀

Startup Service Buildout

Complete service infrastructure for first commercial launch — FDA-ready from day one. Policies, depot repair, field engineer programs, and customer support models.

Startup Focused
04
👤

Fractional Head of Service

Ongoing Director-level leadership on a contract basis — ideal for post-launch startups not ready for a full-time hire, or companies navigating leadership transitions.

Startup Focused
05
🌐

Global Service Programs

International distributor and service partner networks, cross-border logistics strategy, and global training programs across 30+ countries.

06
🎓

Technical Training

Field engineer onboarding, distributor training, and customer support program design tailored to complex medical and biomedical equipment.

Who We Serve

TWO MARKETS.
ONE EXPERT.

Mid-Size Companies

Established & Growing Organizations

Medical device and biomedical companies with 50–500 employees facing operational challenges, compliance pressure, or leadership gaps in their service organization.

  • Preparing for an FDA or ISO 13485 audit with compliance gaps
  • High equipment downtime or unresolved field service inefficiencies
  • Expanding internationally without global service infrastructure
  • Between senior service hires and need interim leadership
  • CRM or service management system needs an overhaul
Discuss Your Needs →
Startups — Any Stage

Pre-Launch to Early Commercial

Early-stage medical device companies approaching or post-FDA clearance that need to build a service organization from scratch — without the cost of a full-time executive.

  • Approaching first commercial launch with no service org in place
  • Need service infrastructure that's FDA-compliant from day one
  • Want a fractional Head of Service until ready to hire full-time
  • Series A–C funded and scaling from pilot to full deployment
  • Facing first field complaints with no escalation process
Build Your Service Org →
The Consultant

EXPERIENCE THAT
MOVES THE NEEDLE.

PATRICK
BAXTER
Principal Consultant
35+ years in field service & operations
Global teams across 30+ countries
Medical Device, Biomedical & Semiconductor
ISO 13485 | FDA 21 CFR Part 820
Milford, CT — Northeast U.S. & Remote
⭐ Key Differentiator
Successfully guided a company through an FDA drug-device combination audit — one of the most complex inspection types in the industry, requiring simultaneous compliance with 21 CFR Part 820 and drug GMP standards.

I'm a field service and operations leader with over 35 years of experience building, scaling, and optimizing service organizations across the medical device, biomedical, and semiconductor industries. My career spans both hands-on technical work and executive leadership — giving me the rare ability to engage at the strategic level and the shop floor simultaneously.

I've managed service teams across 30+ countries, implemented CRM systems from the ground up, guided companies through successful FDA inspections, and built service organizations that reduce downtime, improve compliance, and deliver measurable customer satisfaction. Every client I work with gets direct access to me — not junior staff.

2024 – Present
Independent Consultant
Baxter Field Solutions — Milford, CT
2021 – 2023
Director of Service Operations
Defibtech, LLC — Branford, CT
2020 – 2021
National Service Manager
Yushin America — Cranston, RI
2016 – 2020
Director, ATF Service
Repligen Corporation — Waltham, MA
2014 – 2016
Global Technical Service Manager
Avedro, Inc. — Waltham, MA
2013 – 2014
Field Service Manager
NinePoint Medical — Greater Boston
1988 – 2005
Applications Engineer
Helix Technologies — Asia-Pacific

LET'S TALK ABOUT YOUR SERVICE CHALLENGES.

Whether you're a startup building from scratch or an established company looking to improve operations, I'd love to hear what you're working on. Most engagements start with a straightforward conversation.

📍
Milford, Connecticut — Northeast U.S. & Remote
🔗
linkedin.com/in/patrick-baxter-8567861
Available for immediate engagement

I typically respond within one business day.