Pro-Tech Design & Manufacturing, Inc.

What Pro-Tech Design & Manufacturing, Inc. does

Pro-Tech Design & Manufacturing, Inc. is a privately held, third-generation family-owned medical device contract manufacturer founded in 1980 by Pamela McMaster and headquartered in Santa Fe Springs, California. The company provides full-service FDA-registered and ISO 13485-certified contract packaging, contract assembly, and outsourcing services to medical device original equipment manufacturers, ranging from Fortune 500 companies to boutique startups. Service offerings span medical device packaging design, pre-validated packaging, kitting and sub-assembly, sewn medical products, in-house laboratory services (ISO 17025 accredited), sterilization management, labeling with proprietary Label Control Software, cleaning and passivation, and FDA-registered warehousing and distribution. Customer use cases include orthopedic implants, catheters, cardiovascular devices, neurostimulation products, combination drug-device products, and clinical trial device builds.

The company operates three ISO 13485-certified manufacturing facilities across the United States, in Santa Fe Springs, California; Arlington, Texas; and St. Paul, Minnesota (acquired in 2022 via the Surgical Technologies, Inc. acquisition), with 100,000 sq. ft. of combined manufacturing and warehouse space. Its technical infrastructure includes Class 10,000/ISO 7-rated cleanrooms (capacity doubled at headquarters in 2024), automated cleaning systems with custom fixturing built in an on-site machine shop, barcode scanners and vision systems for label verification, and custom web portals for real-time inventory and purchase order tracking.

Pro-Tech generates revenue through project-based B2B contracts with medical device OEMs under a quote-based pricing model determined by project requirements, volume, and complexity. The go-to-market is direct enterprise field sales supported by active participation in major industry trade shows (MD&M West, MD&M Minneapolis, OMTEC, Florida Medical Device Symposium, BIOMEDevice Boston), content marketing through articles and educational tools such as the Accelerated Aging Calculator, and customer case studies. The company has remained entirely family-controlled since founding, with no disclosed private equity or institutional investment, and is led day-to-day by founder Pamela McMaster's sons Aaron Swanson (President) and Jeff Swanson (Vice President of Sales).

Name

Pro-Tech Design & Manufacturing, Inc.

Legal name

PRO-TECH Design & Manufacturing, Inc.

Website

https://protechdesign.com

Company type

Private

Founded year

1980

Operating status

Operating

Headcount range

251–500 employees

Short description

Pro-Tech Design & Manufacturing is a third-generation, family-owned medical device contract manufacturer founded in 1980, providing FDA-registered, ISO 13485-certified packaging, assembly, and outsourcing services from three US facilities to medical device OEMs ranging from Fortune 500 companies to startups.

Ownership category

akta.pro rank

Product category

Medical Device Contract Manufacturing

NAICS

Surgical and Medical Instrument Manufacturing (339112), Surgical Appliance and Supplies Manufacturing (339113), Medical Equipment and Supplies Manufacturing (3391)

SIC

Surgical & Medical Instruments & Apparatus (3841), Orthopedic, Prosthetic & Surgical Appliances & Supplies (3842), Wholesale-Medical, Dental & Hospital Equipment & Supplies (5047)

akta.pro primary industry

Pharmaceutical & Medical Plastic Packaging Manufacturing (IMANAEAK)

akta.pro secondary industries

Anti-Counterfeit & Track-and-Trace Packaging (Serialization, Security Features) (IMALAIAJ), Pharmaceutical Labels & Patient Information Packaging (Labels, IFUs, Booklets) (IMALAIAK), Quality Engineering & Risk Management (ICH Q9/Q10, validation, change control) (HLAGAKAL)

Keywords

• Medical device packaging
• Contract manufacturing services
• Sterile barrier packaging
• Cleanroom assembly services
• Medical device outsourcing

Headquarters

HQ city

Santa Fe Springs

HQ country

United States

HQ region

North America

Offices3 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Personnel, Operations, Infrastructure, Supply Chain, Technology or R&D

Revenue model

1. Medical Device Contract Packaging: Full-service contract packaging for medical devices including custom packaging design, pre-validated packaging, trays, pouches, form-fill-seal, and liquid filling. Services include packaging validation, labeling, cleaning and passivation, supply chain management, and warehouse/distribution. Revenue generated through project-based contracts with medical device manufacturers.
2. Medical Device Contract Assembly: Contract assembly services for medical devices including kitting, sub-assembly, and final product assembly performed in ISO 7 cleanrooms. Supports complex multi-component products with full traceability.
3. Laboratory Services: In-house laboratory services including cleaning validations, TOC testing, packaging validation, and stability studies. ISO 17025 accredited facility.
4. Sterilization Services: Sterilization management services including coordination of EO (ethylene oxide), gamma radiation, and other sterilization methods for medical devices and packaging.
5. Sewn Medical Products: Custom sewn solutions for medical products including product design, prototyping, manual and automated sewing for wearable medical devices and sewn medical components.

Go-to-market motion2 records

Distribution channels2 records

Marketing channels6 records

Core offering

Pro-Tech Design & Manufacturing is a full-service, FDA- and ISO 13485-registered medical device contract manufacturer and packager providing end-to-end services spanning contract packaging, contract assembly, sterilization coordination, ISO 17025 accredited laboratory validation, sewn medical products, labeling, supply chain management, and FDA-registered distribution from three US facilities equipped with Class 10,000/ISO 7-rated cleanrooms. The company manufactures and packages finished medical products for OEMs on a project-based, quote-driven basis, supported by proprietary tools such as Label Control Software and custom web inventory portals.

Product overview

Pro-Tech Design & Manufacturing is a full-service medical device contract manufacturing organization offering a unified portfolio of integrated services centered on contract packaging, assembly, and outsourcing. The core offering consists of Medical Device Contract Packaging and Medical Device Contract Assembly, supported by specialized modules including Pre-Validated Medical Packaging, Medical Device Packaging Design, Medical Device Labeling, Cleaning and Passivation, Supply Chain Management, and Warehouse and Distribution. Supporting services include Laboratory Services, Sterilization Services, and Sewn Medical Products. A proprietary Accelerated Aging Calculator tool is also provided. The company operates three manufacturing facilities in California, Texas, and Minnesota with Class 10,000/ISO 7-rated cleanrooms, all under ISO 13485 and FDA registrations.

Differentiator

Problem solved

Functional benefit

Products and services

• Medical Device Contract Packaging Full-service FDA and ISO 13485 registered contract packaging for medical devices, including pre-validated packaging, custom packaging design, trays, pouches, form-fill-seal, liquid filling, labeling, and packaging validation testing conducted in ISO 17025 accredited labs. Intended for medical device OEMs needing compliant sterile barrier solutions.
• Medical Device Contract Assembly End-to-end assembly services for medical devices performed in Class 10,000/ISO 7-rated cleanrooms, supporting both manual and automated assembly processes for kitting, sub-assembly, and final product assembly with full traceability. Intended for medical device OEMs requiring sterile, traceable assembly of complex multi-component products.
• Medical Device Outsourcing Comprehensive outsourcing solutions that combine assembly, packaging, sterilization coordination, and distribution services under a single point of contact for finished medical products, allowing OEMs to consolidate multiple manufacturing functions with one FDA-registered supplier.
• Laboratory Services In-house ISO 17025 accredited laboratory services including cleaning validations, Total Organic Carbon (TOC) testing, and packaging validation testing to support medical device manufacturing quality requirements. Available to OEMs requiring accredited validation data for regulatory submissions.
• Sterilization Services Medical device sterilization management services including coordination with third-party sterilization providers and validation of EtO, gamma radiation, and other sterilization methods for medical devices and packaging.
• Sewn Medical Products Custom sewn solutions for medical devices and components including product design, prototyping, and both manual and automated sewing capabilities for wearable medical devices and sewn medical textile products.
• Medical Device Packaging Design Engineering-driven packaging design services including rigid and flexible packaging design, packaging consultation, test runs, and validation testing to bring medical devices to market. Intended for OEMs needing expert packaging engineering prior to production.
• Pre-Validated Medical Packaging Stock pre-validated pouches and trays tested with aging studies for up to 5 years, enabling faster market entry with reduced validation costs for single and dual sterile barriers. Available to OEMs seeking accelerated timelines without full custom validation programs.
• Medical Device Labeling In-house label design, proofing, and printing with full UDI/GS1/HIBC compliance, using proprietary Label Control Software (LCS) for serialized product tracking and 100% digital verification of label content at each assembly stage.
• Cleaning and Passivation Medical device cleaning services including IPA dip/wipe, ultrasonic cleaning, detergent cleaning, and citric/nitric acid passivation, performed in certified Class 10,000/ISO 7 cleanrooms with in-house TOC testing for quality verification.
• Supply Chain Management Comprehensive supply chain services including purchasing management, material storage and inspection, custom web portals for real-time inventory tracking, and supplier scorecards for performance metrics.
• Warehouse and Distribution Managed 100,000 sq. ft. of warehouse and manufacturing space with dedicated FDA-registered distribution facilities, proprietary inventory and delivery systems, and HIPAA-compliant shipment capabilities to end users.
• Accelerated Aging Calculator Online tool for medical device manufacturers to calculate accelerated shelf-life testing parameters, estimating product aging based on temperature differentials, Q10 values, and real-time aging targets. Available publicly as a lead-generation and educational resource.

Quantifiable outcome

• 100% label traceability and accuracy achieved for complex multi-component product assembly
• +3 more outcomes

Named customers5 records

Segments3 records

Ideal customer profiles3 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature7 records

Scale indicators5 records

Recent moves8 records

Expansion highlights5 records

Broad incumbents

• Integer Holdings Corporation: Integer Holdings is one of the largest medical device outsource manufacturers globally, offering contract manufacturing and design services for medical device OEMs across cardiovascular, neuromodulation, and orthopedic segments. Comparable to Pro-Tech in serving medical device OEMs with assembly and packaging services, but at materially greater scale, with a public listing and global footprint.
• Phillips Medisize: Phillips Medisize is a global medical device and pharmaceutical contract manufacturer owned by Molex, offering design, development, manufacturing, and packaging services. Comparable in providing integrated contract manufacturing for medical devices, but at larger scale and with broader pharmaceutical exposure.
• Jabil Healthcare: Jabil Healthcare is the medical division of Jabil, one of the largest global contract manufacturers, providing design, manufacturing, packaging, and supply chain services to medical device OEMs. Comparable end-to-end services but at vastly greater scale and global reach than Pro-Tech.
• Flex Ltd (Flextronics): Flex is a global contract manufacturer with a sizable medical device segment providing design, manufacturing, sterilization, and packaging services. Comparable in offering vertically integrated medical device outsourcing but at hyperscale relative to Pro-Tech.
• Sanmina Corporation: Sanmina is a global EMS provider with a medical segment offering design, manufacturing, packaging, and sterilization services for medical device OEMs. Comparable in medical device contract services but with much broader electronics manufacturing exposure and global footprint.

Direct peers

• Tecomet Inc. Tecomet is a medical device contract manufacturer specializing in precision components, assemblies, and packaging for orthopedic implants, surgical instruments, and cardiac devices. Directly comparable to Pro-Tech in serving orthopedic and cardiovascular OEMs with sterile packaging and assembly capabilities.
• Vesta Industries: Vesta is a privately held medical device and medical textiles contract manufacturer offering sewing, assembly, and packaging services with multiple US facilities. Directly comparable to Pro-Tech in sewn medical products, assembly, and packaging services for medical device OEMs.
• Sparton Corporation: Sparton (now operating as part of a broader medical device services platform) provides medical device contract manufacturing and packaging services including assembly, sterilization management, and supply chain services. Comparable to Pro-Tech in serving medical device OEMs with vertically integrated contract services.
• Natech Plastics: Natech Plastics is a US-based medical device contract manufacturer specializing in plastic injection molding, assembly, and packaging for medical device OEMs. Comparable to Pro-Tech as a mid-sized US medical device contract manufacturer focused on plastics-based assemblies and sterile packaging.
• MicroSpec Corporation: MicroSpec is a medical device contract manufacturer specializing in extrusions, catheter components, and assembly services for medical OEMs. Comparable to Pro-Tech as a mid-sized specialized medical device CMO serving OEMs with components and finished device assembly.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat6 records

Key risks6 records

Key highlights7 records

Customer concentration

• YouTubeyoutube.com/channel/PRO-TECHDesign%26Mfg

Compliance5 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles4 records

Subsidiaries1 record

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A1 record

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Pro-Tech Design & Manufacturing, Inc.