We’ve Helped Build the Prototype. We’re Ready for the Next Phase.
Stryker’s commitment to innovation has created one of the most impressive product portfolios in medical technology.
Fathom has had the opportunity to support portions of that effort already. As new products continue to move through development and commercialization, we’d welcome the chance to support more of the work behind them.
It’s a Good Problem to Have, but it’s Still a Problem.
Stryker is expanding across multiple fronts at once. Mako SmartRobotics continues to grow, Inari is bringing new capabilities into the portfolio, and technologies like the 1788 imaging platform are gaining traction across healthcare systems.
Success at that scale creates additional demands on engineering, sourcing, and operations teams. New products require prototypes. Existing products generate revisions. Acquisitions create integration work. Validation activities multiply.
Most of that effort happens behind the scenes.
That’s where Fathom fits. We help support the hardware, tooling, fixtures, and manufacturing requirements that keep programs moving while internal teams stay focused on the products themselves.
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Keep Mako 4 ramps on schedule – Fathom qualifies secondary manufacturing routes for robotic interfaces, linkages and mounts so a single-supplier hiccup doesn’t pause your platform launch.
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Compress endoscopy and OR integration hardware iteration cycles – Camera housings, cable brackets, thermal features and fixtures built and revised at prototype speed, with production documentation discipline from the start.
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Support Inari and vascular portfolio integration – Handle components, tray fixtures, test blocks and process aids across a controlled, traceable supply path as new platforms absorb into Stryker’s quality model.
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Offload the surrounding instrument hardware so internal capacity stays on core product – Trays, kits, guide handles and validation fixtures delivered through one partner instead of four.
Fathom is Already Your Partner for the Great Toes Implants Program.
10+
Stryker locations Fathom has worked with
224
Contacts the Fathom team has worked with
7
Programs Fathom is working with
ISO 13485
Maintaining medical-grade quality for 20+ years.
Meet Your White Glove Team
Healthcare Manufacturing Program Expertise
Pamela Melton-Arroyo
Medical Device Manufacturing Partner
During the last three decades, Pam has made contributions to innovation, integration and scalable growth across clinical systems, biotech partnerships, and advanced medical manufacturing. As Co-Founder of ProForma Technologies for 27 years, she built a trusted reputation in the medical device and biotech sectors. She partnered with global leaders like J&J, Medtronic, Baxter, and numerous startups to deliver high-performance mechanical parts, cable assemblies and PCBAs into FDA-regulated environments. Her career has bridged the gap between technology, operations, and innovation, enabling healthcare organizations and OEMs to bring safer, smarter and more reliable products to market.
Speed Without Fragmentation. Quality Without Chaos.
Quick-turn shops move fast and break compliance. Full-program suppliers protect the paperwork and move slowly. Stryker needs both at the same time: The responsiveness to absorb ECN-driven design changes and launch ramps, and the discipline to deliver FAI-ready, traceable, controlled-revision hardware on time and on spec.
Most suppliers handle one piece of that equation. When demand surges, fragmented supplier networks create a coordination problem that program and procurement managers must absorb personally.
Fathom is engineered for that intersection. We handle the paperwork and reporting so you can focus on providing exceptional patient care.
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DFM, DFQ and DFE engagement before the quote, with engineers reviewing prints for tolerance feasibility, finish compatibility, inspection approach and production scalability.
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Controlled revision management, FAI documentation and traceable inspection packages built into every program from the first prototype run to production.
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Multi-process execution under one roof: CNC machining, sheet metal, photochemical machining, additive manufacturing, injection molding, finishing, light assembly and inspection. It’s all coordinated within one integrated operating model.
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ISO 13485-capable facilities with the documentation discipline medical device programs require, so qualification doesn’t restart every time scope expands or a new platform comes online.
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White-glove service is standard, whether your project is a 25-piece prototype CT component set or a production-scale instrument tray run.
Mako SmartRobotics: Validated Overflow When the Platform Roadmap Can’t Slow Down.
Mako 4 is expanding from hip and knee into spine and shoulder, including new procedure-specific interfaces, new validation requirements and new fixture builds, all without pausing the existing installed base.
Fathom is the qualified overflow path for robotic interface machining, subassembly fixtures and limited-market release hardware, so your internal capacity stays focused on the production platform, not managing the ramp of mechanical components.
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Minneapolis, MN / Elk Grove, IL / Round Rock, TX – Precision CNC machined mounts, linkages, tool-interface details, actuator-adjacent hardware and tight-tolerance machined metal and plastic robotic subcomponents.
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Hartland, WI – Additive prototype iterations, polymer bridge housings, injection-mold tooling paths and fixture builds for design verification and limited-market release.
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Denver, CO / Ithaca, NY – Internal sheet-metal brackets, covers, cable-routing shields and assembly aids for robotic cart and navigation accessories.
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Newark, NY – Photochemical precision flat parts including shims, thin stainless reference features and burr-free shields for compact instrument or navigation assemblies.
Endoscopy & OR Integration: Iterate the Hardware Without Resetting the Supplier.
The 1788 4K camera platform rollout and OR integration portfolio expansion mean that small mechanical changes, such as cable routing updates, enclosure revisions and thermal management tweaks, trigger repeated fit checks and new component builds. Fathom compresses those iteration cycles by running prototype, bridge and production hardware in the same documented operating model, so the design team stops waiting on parts.
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Hartland, WI – Additive prototype camera housings, operator-touch surfaces, cable clips and injection-mold bridge parts for early clinical and demo configurations.
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Denver, CO – Fabricated internal chassis panels, brackets, laser-cut retainers, ventilation features and finished enclosures for carts, hubs and OR integration accessories.
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Newark, NY / Ithaca, NY – Precision flat retainers, shims, shields, tags and thin stainless components where burr-free edges and repeatability are required.
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Minneapolis, MN / Elk Grove, IL – CNC overflow for machined aluminum and stainless enclosure and bracket hardware on camera platform production runs.
Peripheral Vascular & Inari Integration: A Bridge Path That Moves as Fast as the Acquisition.
The Inari acquisition brings fast-growing VTE devices into the Stryker quality and supply chain model at exactly the moment demand is accelerating. Fathom provides the second-source and bridge-production path for handle components, packaging fixtures, test blocks and process aids. That means integration into Stryker’s manufacturing standards happens on schedule, not on the supplier’s timeline.
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Hartland, WI / Global Network – Molded handle, grip, cap, tray and packaging fixture prototypes, then tooling paths as volumes stabilize and transfer workstreams progress.
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Minneapolis, MN / Round Rock, TX – CNC machined actuator-adjacent parts, test blocks, catheter-handle components, gage hardware and metal fixture details.
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Newark, NY / Ithaca, NY – Precision flat shields, stainless shims, thin plates and burr-free process aids for inspection and assembly qualification.
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Controlled documentation and change traceability to support supplier-quality evaluation and alternate-path qualification for post-acquisition program transfer.
Orthopaedic Instruments, Kits & Launch-Set Hardware: Keep the Surrounding Supply Chain From Pacing the Implant.
Orthopaedic and spine instrument sets refresh constantly based on surgeon feedback, robotics workflow updates and evolving hospital preferences. The implants themselves are rarely the bottleneck. Rather, the surrounding tray hardware, launch fixtures and procedure-specific instruments tend to slow down rollouts. Fathom helps you offload that layer, so your internal machining capacity stays on implants and core production, not the support hardware.
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Elk Grove, IL / Minneapolis, MN / Round Rock, TX – High-precision CNC machined stainless, titanium, aluminum and plastic instrument components, trial hardware, handles and adapter features.
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Denver, CO – Fabricated trays, brackets, guards, laser-cut panels and finished sheet-metal components for instrument kits, carts and production support hardware.
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Hartland, WI – Additive prototype handles, surgeon-evaluation models, drill-guide iterations, moldable ergonomic parts and validation fixtures for new set launches.
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Full FAI-style inspection packages with serialized lot control, dimensional reports and controlled revision handoff. Documentation discipline is built in, not added at the end.
One Partner. Every Platform. Every Ramp.
Stryker’s growth is accelerating in multiple directions at once. What that means for engineering and procurement is that you need a supplier network that can expand, qualify and document faster than most contract manufacturers can manage.
Fathom is built for that pace. Not as a transactional machine shop, but as an integrated manufacturing partner that simplifies your supply chain during surge conditions.
The same network that supports Mako robotic interface machining supports endoscopy platform iteration, vascular device fixture builds and orthopaedic instrument overflows. One accountable operating model. One project manager coordinating documentation, scheduling, quality and ECN flow across every program. Fewer vendors to manage, fewer qualification cycles, fewer gaps between prototype and production.
That is what it means to work with Fathom:
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Domestic multi-site manufacturing footprint: Seven U.S. locations, built for the geographic coverage Stryker’s facilities require. Much more efficient managing a dozen separate suppliers.
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Multi-process capability under one roof: CNC machining, sheet metal, photochemical machining, additive manufacturing including DMLS, injection molding, finishing, light assembly and inspection, all coordinated as one accountable partner.
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ISO 13485 plus quality systems built for medical device documentation requirements: FAI packages, traceability, controlled revision management and inspection discipline engineered in from day one.
Case Studies
How Medical Device Programs Stay on Schedule With Fathom:
Engineering Isn’t a Transaction. Neither Is This Partnership.
Fathom isn’t a transactional machine shop. Every Stryker program runs through DFM, DFQ and design-for-excellence engagement before a quote is submitted. Real engineers review prints for tolerance feasibility, finish compatibility, inspection approach and production scalability. We surface manufacturability risks at the print review, not at first-article rejection.
That posture is built into how we work, not bolted on as a service tier.
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We’ll assign an engineer to your project from our first conversation, not a ticketing queue or a rotating quoting team. You need answers, not algorithm-generated, superficial advice.
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We provide you with continuity from prototype to production. The same Fathom team, the same documentation thread, the same operating model. No requalification, no supplier reset, no relationship restart every time the design evolves.
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That is what white-glove service means in a regulated manufacturing environment: Engineering care and program accountability from the first prototype to the final production run.
What Every Stryker Program Manager, Manufacturing Engineer & Supplier Quality Lead Gets With Fathom
ISO 13485 Quality System
Medical device quality management built for Stryker’s needs: FAI packages, traceability, controlled revision management and CMM-backed inspection.
Domestic Multi-Site Network
Manufacturing facilities across Hartland, Minneapolis, Elk Grove, Round Rock, Denver, Ithaca and Newark. Our geographic coverage aligned to Stryker’s principal US facilities, with dual-source and surge capacity inside the same operating model.
FAI & Inspection Discipline
First-article inspection reports, dimensional and finish verification, material certifications and serialized lot control. These are built into the program from the first prototype run, not added as a late-stage deliverable.
DFM Before Quote
You get a single program contact and the same engineering team from prototype to production. No requalification cycle, no supplier swap, no documentation restart. The program moves continuously, and so does Fathom.
White-Glove Continuity
You get a single program contact and the same engineering team from prototype to production. No requalification cycle, no supplier swap, no documentation restart. The program moves continuously, and so does Fathom.