Harmac Medical Products, Inc.

Name

Harmac Medical Products, Inc.

Legal name

Harmac Medical Products, Inc.

Website

https://harmac.com

Company type

Private

Founded year

1968

Operating status

Operating

Headcount range

1,001–5,000 employees

Ownership category

akta.pro rank

Headquarters

HQ city

Buffalo

HQ country

United States

HQ region

North America

Offices5 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. Contract Manufacturing Services: Full-service CDMO providing design, development, manufacturing, assembly, tooling, automation, process validation, packaging, and sterilization services for single-use medical devices. Revenue is generated through long-term supply agreements and project-based engagements across the product lifecycle, from initial concept through commercial-scale production. Vertical integration (raw resin to finished packaged device) allows single-partner accountability.
2. Value Engineering and Process Optimization: Ongoing value engineering services embedded within manufacturing partnerships, including supply chain optimization, cost reduction initiatives, and process improvement. These services are bundled within long-term contractual relationships and contribute to recurring revenue through continuous improvement projects and expanded scope with existing customers.

Pricing tiers

Go-to-market motion2 records

Distribution channels2 records

Marketing channels6 records

Core offering

Harmac Medical Products is a full-service contract development and manufacturing organization (CDMO) for single-use medical devices. It offers vertically integrated capabilities spanning design and development, injection molding and assembly, custom tooling and proprietary automation, value engineering, process and product validation, sterile barrier packaging, and sterilization services across facilities in the United States, Ireland, and Mexico. The company serves medical device OEMs from early-stage startups to Fortune 500 firms, manufacturing products across fluid management, wound care, oncology, ophthalmic, diagnostic, respiratory, and extracorporeal therapy categories.

Product overview

Harmac Medical Products operates as a full-service Contract Development and Manufacturing Organization (CDMO) for single-use medical devices. The company offers an integrated portfolio of services spanning Design & Development, Manufacturing & Assembly, Tooling & Automation, Value Engineering, Process & Product Validation, and Packaging & Sterilization. These core services are organized to support medical device companies from initial concept through volume production and market delivery. The company manufactures products across seven therapeutic categories: Fluid Management, Wound Care (NPWT), Oncology, Ophthalmic, Diagnostic (POC/IVD), Respiratory, and Extracorporeal therapies. With facilities in the USA (Buffalo, NY), Ireland (Castlerea), and Mexico (Tijuana), Harmac provides global manufacturing capacity with vertically integrated operations.

Differentiator

Problem solved

Functional benefit

Brands

• H3: Brand name used for the Tijuana, Mexico facilities (H3 de Tijuana). The H3 facilities represent Harmac's wholly owned manufacturing operations in Mexico.

Products and services

• Design & Development Comprehensive medical device design and development services supporting all stages of the product lifecycle, from concept feasibility through volume manufacturing, with dedicated engineering teams and prototype development capabilities including 3D printing and in-house machining. Targeted at medical device OEMs requiring DFM and DFA expertise.
• Manufacturing & Assembly Full-scale manufacturing and assembly of single-use medical devices in ISO 14644 cleanroom environments, featuring injection molding, RF welding, ultrasonic welding, induction forming, laser cutting and marking, insert molding, two-shot molding, impulse sealing, solvent bonding, and heat sealing processes. Targeted at medical device OEMs scaling Class I, II, and III devices.
• Tooling & Automation Custom tooling design and proprietary automation systems for medical device manufacturing, including in-house production and fabrication centers, injection mold optimization, and assembly automation with robotic systems and vision inspection. Targeted at OEMs needing compressed time-to-market through dedicated automation assets.
• Value Engineering Strategic cost optimization and supply chain management services through vertical integration, process development, and continual improvement to lower costs, enhance performance, and speed time-to-market while maintaining quality. Targeted at OEMs seeking long-term TCO reduction.
• Process & Product Validation Comprehensive validation services including Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), Process Performance Qualification (PPQ), Test Method Validation (TMV), and Measurement System Analysis (MSA), following FMECA risk analysis approach. Targeted at OEMs preparing for FDA, CE Mark, and ISO 13485 submissions.
• Packaging & Sterilization End-to-end packaging and sterilization solutions including sterile barrier packaging, automated pouch/seal/tray sealing, form-fill-seal, bulk packaging, labeling services, and sterilization methods (ETO, Gamma Radiation, E-Beam) with full testing and validation including tensile strength, burst, seal integrity, transportation simulation, and aging studies. Targeted at OEMs needing market-ready sterile packaged devices.
• Single-Use Medical Device Manufacturing (across Therapeutic Categories) Manufacture of single-use medical devices across seven therapeutic categories: Fluid Management (chest drainage, blood collection bags, IV catheters, administration sets, infusion pump accessories, apheresis sets), Wound Care (NPWT devices with canisters, dressings, tubing, connectors, hydrophilic filters), Oncology (chemo infusion sets, port access needles, ostomy bags, biopsy devices, cryogenic storage bags), Ophthalmic (phaco and vitrectomy cassettes), Diagnostic (POC/IVD cartridges with microfluidic components), Respiratory (endotracheal tubes, ventilator circuits, HME/bacterial-viral filters), and Extracorporeal (hemodialysis sets, apheresis kits, cell separation kits).

Quantifiable outcome

• 100% commercial batch pass rate achieved for 2025 across all lots
• +5 more outcomes

Named customers7 records

Segments9 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature7 records

Partnerships

20 partnerships are on record, tiered core and minor.

• Endeavor IrelandcoreStrategic or Co-development Partner · 1 January 2025John Somers serves as Endeavor Western New York Chair. Harmac took part in an Endeavor Ireland event celebrating Ireland's MedTech and Life Sciences talent. Event held in association with Enterprise Ireland, focused on helping Irish entrepreneurs scale internationally.
• Enterprise IrelandcoreStrategic or Co-development Partner · 1 January 2025Joint event partner with Endeavor Ireland for a MedTech and Life Sciences evening. Enterprise Ireland's shared mission with Harmac includes helping Irish entrepreneurs scale faster and create meaningful impact through peer-to-peer connections.
• TUS (Technological University of the Shannon)coreStrategic or Co-development Partner · 1 January 2025Strong partnership with TUS supporting the West of Ireland as a centre of excellence in advanced manufacturing. Harmac introduced Penn State representatives to TUS during GPSIS 2025, creating a direct link between US and Irish institutions for potential research collaboration, student engagement, and knowledge exchange.
• GPSIS (Global Polymer Sustainability and Innovation Summit)coreGTM or Marketing Partner · 1 January 2025Platinum Sponsor of GPSIS 2025. The summit brought together industry leaders, researchers, and policymakers on polymer sustainability, AI-driven manufacturing, composites, and advanced processing. Sponsorship strengthens ties between education and advanced manufacturing.
• BUMBLEance (Child-Designed Ambulance Service)minorOthers · 1 January 2023Harmac Ireland's Charity of the Year, raising €17,000 for the world's first ambulance service designed specifically for children (receives no government funding). Raised through payroll deductions, a Spin-a-thon, and fundraising events.
• IDA Ireland (Industrial Development Agency)coreStrategic or Co-development Partner · 1 January 2022IDA Ireland partnered with Harmac in a major investment and recruitment campaign for the Castlerea facility in County Roscommon. An Tánaiste Leo Varadkar visited the facility in August 2022 to acknowledge the continued investment in Castlerea.
• Mayo Roscommon Hospice FoundationminorOthers · 1 January 2022Harmac Ireland's Charity of the Year for 2021. €12,000 raised through payroll deductions and fundraising events throughout 2021.
• The Alzheimer Society of Ireland (Castlerea Day Care Centre)minorOthers · 1 January 2020Harmac Ireland's Charity of the Year in 2020. €16,000 raised for the Castlerea Day Care Centre.
• Penn State BehrendcoreStrategic or Co-development Partner · 1 January 2011Longstanding partnership dating back to 2011, centered on plastics engineering and polymer science expertise. Includes thriving internship program, investments in educational technology, student visits to Buffalo and Ireland facilities, and real-world learning experiences. John Somers served as keynote at inaugural Corporate Engagement Luncheon in 2024.
• Habitat for Humanity (Buffalo)coreOthers · 1 January 2008Long-term community partnership forming the backbone of the Bailey Green Initiative. Since 2008, 21 new single-family homes have been built in partnership. Erie BOCES students participate in construction as part of hands-on curriculum. Funding partners include Bauer Foundation and Univera Healthcare.
• University at Buffalo School of Architecture and PlanningcoreStrategic or Co-development PartnerLong-standing academic partnership with Professor Hiroaki Hata leading master planning for Bailey Green Initiative. Graduate students participate in community design sessions and architectural planning for Bailey Green Commons. Featured in The Buffalo News.
• GroundWorks Market GardenminorOthersBailey Green Partners member organization. Transformed 2.5 acres of abandoned land into a market garden supplying local restaurants and a CSA program. Hosts annual Garden Kickoff & Plant Giveaway events.
• The Buffalo PeacemakersminorOthersBailey Green Partners member organization focused on community safety and trust building. Works collaboratively with Harmac on neighborhood revitalization efforts.
• WEDI (Westminster Economic Development Initiative)minorOthersBailey Green Partners member organization providing micro-financing and business development support for local entrepreneurs in the East Buffalo neighborhood.
• University at Buffalo (General)coreStrategic or Co-development PartnerOngoing collaboration with UB on architecture and planning for Bailey Green Initiative. Students participate in design planning and community engagement exercises. UB's Innovation Commons, faculty-led service-learning projects, and student volunteer work are areas of active collaboration.
• STEAM Education Ltd.minorStrategic or Co-development PartnerIreland team partnered with STEAM Education Ltd. for a 10-week school program where Harmac engineers (Gary Dolan, Carl McEnroe) mentor students on STEAM disciplines including engineering, renewable energy, and bioengineering. ~25 students from Tamron NS participated.
• Northland Workforce Training CenterminorStrategic or Co-development PartnerHarmac is a continuing supporter of Northland Workforce Training Center, an organization dedicated to educating and training Western New Yorkers for good-paying jobs. Harmac has hired employees from this organization.
• Catholic Charities Workforce & Education Services ProgramminorStrategic or Co-development PartnerHarmac supports Catholic Charities Workforce & Education Services Program which provides college and vocational training placement assistance. Has hired employees from this program.
• Say Yes to Education — BuffalominorStrategic or Co-development PartnerHarmac collaborates with Say Yes Buffalo on diversity and equity programs. CEO John Somers participated in a joint initiative with Say Yes Buffalo Executive Director David Rust. Has hired interns and employees from the program.
• Medical Product Outsourcing (MPO) MagazineminorGTM or Marketing PartnerVP of Business Development Jim LaVersa contributed thought leadership articles to MPO Magazine on CDMO partnerships and medtech supply chain resilience. Company sponsored a Networking Break at MPO Summit 2021.

Scale indicators24 records

Recent moves14 records

Expansion highlights5 records

Direct peers

• Viant Medical: Full-service medical device contract manufacturer offering design, tooling, injection molding, assembly, packaging, and sterilization. Closest direct peer to Harmac in scale and vertically integrated single-use device focus.
• Spectrum Plastics Group: Specialty medical plastics CDMO with capabilities in extrusion, injection molding, and assembly of single-use medical devices. Highly comparable in therapeutic focus and customer profile to Harmac.
• Nordson Medical: Division of Nordson Corporation focused on medical device component manufacturing including fluid management and assembly. Directly competes in single-use device components and OEM contract manufacturing.
• Tecomet: Privately held contract manufacturer of complex precision medical devices and implants with vertically integrated manufacturing and tooling capabilities. Comparable in vertical integration and OEM customer base.
• Confluent Medical Technologies: Specialty medical device contract manufacturer focused on nitinol, polymer, and textile-based components for minimally invasive devices. Comparable scale and therapeutic customer overlap with Harmac's fluid management and surgical device segments.

Broad incumbents

• Integer Holdings: Largest publicly traded medical device outsource manufacturer with broad capabilities across cardio, vascular, and advanced surgical devices. Operates at materially larger scale than Harmac but in directly overlapping end markets.
• Phillips-Medisize: Molex-owned medical device contract manufacturer offering design, tooling, and high-volume manufacturing of drug delivery and diagnostic devices. Larger scale peer with directly overlapping single-use device capabilities.
• Jabil Healthcare: Healthcare-focused division of Jabil providing large-scale medical device manufacturing, packaging, and sterilization. Competes for the same Fortune 500 medtech outsourcing contracts, though at significantly larger scale.
• Flex (Flextronics): Global contract manufacturer with a dedicated health solutions business serving medtech OEMs with design, manufacturing, and supply chain services. Larger scale peer competing for enterprise medtech contracts.
• West Pharmaceutical Services: Publicly traded manufacturer of primary packaging, delivery systems, and contract manufacturing services for pharma and medical devices. Comparable in elastomer/single-use device manufacturing and regulated production.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat6 records

Key risks6 records

Key highlights6 records

Customer concentration

• LinkedInlinkedin.com/company/harmac-medical-products

Compliance6 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles11 records

Funding overview

Funding rounds

Investors

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

M&A

Investments

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

Frequently asked questions about Harmac Medical Products, Inc.