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Medical Device Manufacturing

White Glove Service – For Your Most Challenging Applications
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Our Medical Customers
Philips
Smith & Nephew
Stryker
Medtronic
GE Healthcare

We Build Parts as if Lives Depend on It. Because They Do.

We know you’re under a lot of pressure today. You need to innovate and bring new products to market faster, while ensuring the highest quality and maintaining strict regulatory compliance. This balancing act is hard enough without having to worry about your contract manufacturer:

  • You’re committed to innovation in medical device design – but your vendor is lagging behind.
  • Your vendor seems to have forgotten the word “rapid” in rapid prototyping. Iteration cycles are taking too long.
  • Delivery timelines are slipping. If they don’t solve their problems soon, your latest product launch will be in critical condition.
  • Problems with part quality are getting worse. The thought of hospital system audit is giving you a migraine.

Across our network of U.S. locations, we have decades of medical manufacturing experience, backed by white glove, hands-on service. We’ve helped manufacturers like you engineer and produce everything from medical device enclosures and surgical tools to orthopedic implants and spinal screws.

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Human-First Manufacturing

With so much at stake, it’s comforting to know that you’ll have access to a team of experienced professionals. We’ll help you through every step of the product lifecycle, from part design and prototyping to scaling up production. It’s all part of our white glove approach to meeting your needs.

Account Manager

Your strategic partner who understands the unique pressures of medical NPI, where biocompatibility, regulatory readiness, and risk management matter. They help align your project with manufacturing options that support verification builds, clinical timelines, and production reliability.

Applications Engineer

A DFM expert experienced with tight-tolerance plastic and metal components used in surgical equipment, diagnostic devices, and life-science tools. They advise on materials, manufacturability, regulatory considerations, and assembly challenges.

Project Coordinator

Your operational anchor who manages detailed schedules, documentation, and revision control, essential for medical programs preparing for validation, sterilization testing, or regulatory submissions. They help keep your program audit-ready.

Customer Success Representative

Your trusted support partner who keeps communication open, addresses questions quickly, and helps ensure your experience stays positive as your medical device moves through development.

Our Expertise – By the Numbers

3500+

Medical device components, making the lives of patients better.

25+

Manufacturing processes used on medical components.

100+

Medical device manufacturers we’ve worked with

ISO13485

Maintaining medical-grade quality for 20+ years.

How Do Medical Device OEMs Use Fathom?

Unmatched Breadth of Technologies

We offer more manufacturing technologies than any other contract manufacturer. Get more of your needs met with one supplier and one set of quality standards.

Rapid Prototyping

We’re set up to manage your rapid prototyping needs for your time-critical projects. Our expert engineers can help you quickly test, iterate and finalize your part designs for production.

Product Lifecycle Support

We can support your needs throughout the product development lifecycle – from early prototypes for design validation and late-stage prototypes as well as bridge production and full production. We specialize in low-volume/high-mix projects. Your new product is in good hands with us.

Engineering & Design Support

We take a hands-on, white glove approach to DFMs to ensure thatanypotential part design issues are identified and solved early in the design process. We can help you optimize your part designs, production processes and material selections for the best results, at the best price.

Quality Assurance

At Fathom, our commitment to in-house inspections enables us to turn around parts quickly, including CMM validation, surface inspections and tensile strength testing. In addition, we have a proven ability to comply with any medical OEM’s process, material and workmanship standards.

“Working with Fathom has made our purchasing process for 3D-printed components much easier. Their team is consistently fast, clear, and reliable — which matters a lot in medical, where timelines and documentation can get complicated. They turn around quotes quickly, communicate openly about lead times, and deliver parts that meet the exact specifications our engineering team requires. Fathom has saved us countless hours coordinating between suppliers, and they’ve become our go-to partner for rapid prototypes and low-volume builds.”
Senior Buyer
Medical Device Manufacturer
“Fathom’s engineering support has been invaluable for our medical device programs. Their team worked closely with us during the design phase to improve manufacturability and helped us streamline a few critical features that were causing issues in early prototypes. They’re quick to flag potential challenges, offer alternatives, and explain the trade-offs clearly. It’s rare to find a manufacturing partner that brings this level of design insight while still moving fast. Fathom has become one of the teams we rely on the most.”
Senior R&D Engineer
Top US Medical Device OEM
“Our SteriPen product must meet the quality standards of a medical device — if it ever malfunctions, people will get sick. Yet it must be economical enough to permit many people to own one. And we need the design flexibility to keep pace with rapidly changing technology. Our production at ICO meets all three challenges.”
Don Snoke / VP of Operations
Hydro-Photon, Inc.
“With their response time, quotes and communications, Fathom is highly regarded because they are always upfront. They say what they do and do what they say.”
John Doe
Consumer Technology Company
“No matter how complex or how new issues are with product design, we can always count on Fathom. Their team provides an unbiased, ‘out-of-the-box’ professional opinion that is always forward-thinking, interesting and helpful. We value their exemplary commitment to providing superb engineering.”
Rich Rayhill
Crown
“It is a pleasure to work with a company whose personnel are willing and able to think out of their box. With your commitment to staying on the cutting edge of technology, you supply tooling to us that is right on time and works first shot.”
Norman R. Akens
Medical Murray
“We choose Fathom because of their reputation as a great company to do business with. We have stayed with them for over 5 years because they consistently deliver to meet our needs.”
Barbara Gramenz
3M
“When I need reliable, accurate flat parts, Newcut is my first choice of suppliers. Their commitment to quality is top notch. With fast turnaround times on parts and even faster times on quotes, my projects are never behind. I can spend the time saved by Newcut’s quick response on developing and delivering the best product to our customers.”
Derek H. / New Product Development Manager
Leading international contract manufacturer
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Comprehensive Capabilities for Medical Device Manufacturing

With a portfolio of 25+ advanced manufacturing technologies, we’re able to provide you with blended solutions that meet your exact requirements. It’s all backed by our white-glove, hands-on service. From the doctor’s office to the emergency room, we’ve got you covered.

Precision Machined Parts

We have decades of expertise machining tight-tolerance parts for critical medical components including implants (knee, hip, shoulder, toe, ankle, femoral and tibial), surgical instruments (drill guides, reamers, inserters, extractors, retractors, slap hammers, saw guides and broaches) and cutting tools.

Complex Metal Forming & Turning

Our sheet metal experts can help you optimize your designs for production, from monitoring and diagnostic equipment to brackets, springs and connectors used in hospital and home care environments. Our machined parts are also widely used in CT scanners, X-ray and MRI machines.

Additive Expertise

We’ve been building parts using additive technologies for over 40 years. During that time, we’ve manufactured components for everything from medical imaging and orthopedics to patient monitoring, rehabilitation and in-home care. We’ve seen a lot and can help you avoid common design problems for your projects.

Materials Expertise

Today, medical devices are used far and wide, well beyond the doctor’s office or hospital environments. Mobile monitoring and in-home care devices must be designed for ruggedness and reliability. Leverage our process and materials expertise to help you select the right options for your unique needs.

Common Medical Applications

We have years of experience meeting the world’s most demanding medical device applications, including

  • Surgical instruments
  • Implants
  • Prosthetics
  • Medical device housings
  • Wearable monitoring devices
  • Medication delivery systems
  • Components for imaging equipment
  • Catheter system parts
  • IV connectors
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Why Choose Fathom for Your Medical Device Parts?

No matter which segment of the medical industry you serve, we have the capacity and expertise to help you achieve your objectives.

  • Application Expertise

    We understand the environments that your parts are exposed to, from in-body applications to the operating room. We’ll recommend materials, processes and finishing options to ensure your parts will meet your performance, cost and timing targets.

  • Your Lifecycle Partner

    We can support your needs throughout the product development lifecycle – from early prototypes for design validation and late-stage prototypes to verify fit, finish and functionality to bridge and full production.

  • Unmatched Breadth of Manufacturing Technologies

    We offer more advanced manufacturing technologies than any other contract manufacturer, plus a wide variety of in-house finishing services. This combination enables you to simplify your supply chain and your supplier base.

  • Track Record of Success

    We have a long track record of success delivering high-quality parts to a variety of medical OEMs. From diagnostic and surgical tools to prosthetics and implants, we’re a trusted partner of manufacturing solutions to leading companies in your industry.

  • Relevant Certifications

    Our certifications include:

    • ISO 13485:2016
    • ISO 9001:2015

    In addition, we have a proven ability to comply with customer-specific process, material and workmanship standards.

Get a Quote
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