Hartman Medical Group

Name

Hartman Medical Group

Legal name

Hartman Medical Group

Website

https://hartman-med.com

Company type

Private

Founded year

2019

Operating status

Operating

Headcount range

1–10 employees

Ownership category

akta.pro rank

Product category

Medical Device 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), Wholesale-Medical, Dental & Hospital Equipment & Supplies (5047)

akta.pro primary industry

Manufacturing Quality Assurance & GMP Compliance (batch release, deviation/CAPA, tech transfer QA) (HLAGAKAJ)

akta.pro secondary industries

Quality Engineering & Risk Management (ICH Q9/Q10, validation, change control) (HLAGAKAL), GMP Quality, Validation & Regulatory Support (GMP/CSV/Qualification) (HLAGAGAL)

Keywords

• Medical device manufacturing
• IV administration sets
• Blood collection devices
• FDA regulatory consulting
• OEM medical products

Headquarters

HQ city

Birmingham

HQ country

United States

HQ region

North America

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. Medical Device Sales: Sale of IV extension sets, IV administration sets, IV flow controlled sets, infiltration tubing, and Monarch blood collection sets to hospitals and health systems
2. Quality & Regulatory Services: Regulatory consulting services including GMP readiness, FDA registration and listing, 510K and Pre-Market Approvals, DeNovo submissions, and QMS build, launch, and maintenance

Go-to-market motion1 record

Distribution channels1 record

Marketing channels2 records

Core offering

Hartman Medical Group (HMG) designs, manufactures, and distributes medical devices and supplies for hospitals and health systems, including IV extension sets, IV administration sets, IV flow controlled sets, and infiltration tubing under private label/OEM arrangements, along with the Monarch brand of single-hand-activated blood collection sets. The company also provides quality and regulatory services covering GMP readiness, FDA registration and listing, 510K and Pre-Market Approvals, DeNovo submissions, and quality management system build, launch, and maintenance.

Product overview

Hartman Medical Group operates as a medical device company offering a portfolio of products and services organized around three main pillars: Quality & Regulatory Services (providing GMP readiness, FDA registration, 510K/DeNovo submissions, and QMS support), Private Label/OEM manufacturing of IV medical devices (extension sets, administration sets, flow controlled sets, and infiltration tubing), and the Monarch brand of blood collection sets featuring single-hand activation technology. The company positions itself as a partner to healthcare facilities, offering product conversion support with inventory management through their HMG True Partnership program.

Differentiator

Problem solved

Functional benefit

Brands

• Monarch: Blood collection sets featuring single-hand activation, self-activating door, reduced needle exposure, and reduced bloodborne pathogen exposure. Website at monarchsafe.org.

Products and services

• Quality & Regulatory Services Comprehensive regulatory support services including GMP readiness, FDA registration and listing, 510K and Pre-Market Approvals, DeNovo submissions, and Quality Management System (QMS) build, launch, and maintenance. Targeted at medical device companies and healthcare organizations needing regulatory compliance support.
• Private Label / OEM Products Contract manufacturing of IV medical devices including IV Extension Sets, IV Administration Sets, IV Flow Controlled Sets, and Infiltration Tubing under private label and OEM partnerships. Designed for healthcare distributors and brands seeking an ISO 13485-certified manufacturing partner.
• Monarch Blood Collection Sets Single-hand activated blood collection devices featuring self-activating door technology designed to reduce needle exposure and bloodborne pathogen exposure for healthcare worker safety. Targeted at hospitals, health systems, and clinical laboratories performing blood draws.

Quantifiable outcome

• 2 months' worth of inventory maintained on hand for converted hospital or health system customers
• +1 more outcomes

Named customers2 records

Segments1 record

Ideal customer profiles2 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature1 record

Partnerships

One partnership is on record.

• MonarchcoreOthersMonarch is a product line under Hartman Medical Group focused on blood collection sets. The Monarch brand features single-hand activation technology and self-activating door mechanisms designed to reduce needle exposure and bloodborne pathogen exposure. Available at monarchsafe.org.

Scale indicators1 record

Recent moves5 records

Expansion highlights4 records

Direct peers

• ICU Medical: Pure-play IV therapy company manufacturing IV administration sets, extension sets, and infusion safety devices. Closely comparable to HMG's IV Extension Sets, IV Administration Sets, and IV Flow Controlled Sets product lines for hospital customers.
• Vygon USA: Specialty manufacturer of single-use medical devices including IV therapy, neonatal, and vascular access products. Highly comparable to HMG's IV-focused product portfolio and similar niche positioning within the hospital market.

Broad incumbents

• Cardinal Health: Major medical products distributor and manufacturer serving U.S. hospital systems. HMG explicitly positions against the 'primary distributor' model that Cardinal Health (and peers like McKesson) typically occupy, making it both a competitor and the incumbent HMG displaces in accounts.
• Medline Industries: Large privately held manufacturer and distributor of medical supplies, including IV products and general hospital consumables. Comparable in being a broad-line medical supply alternative to primary distributors, though at substantially larger scale than HMG.
• Teleflex Incorporated: Medical device manufacturer with significant presence in blood collection, safety needles, and IV access products. Competes with HMG's Monarch blood collection line and broader infusion portfolio, with established hospital sales coverage.
• B. Braun Medical: Large medical device manufacturer with deep IV therapy, infusion, and safety-engineered product lines sold to hospitals. Overlaps directly with HMG's IV sets and tubing products and competes for the same hospital procurement contracts.
• Henry Schein: Major distributor of medical and dental supplies serving healthcare providers. Comparable distribution model to the primary distributors HMG competes against, with established hospital and health system relationships.
• McKesson Corporation: One of the largest pharmaceutical and medical supply distributors in the U.S., serving hospitals and health systems. Represents the type of primary distributor HMG positions itself as a nimble alternative to during supply constraint periods.
• Becton, Dickinson and Company (BD): Global medical device manufacturer with leading positions in IV therapy, infusion sets, and blood collection (including Vacutainer and safety-engineered needles). Directly competes with HMG across both IV sets and Monarch's safety blood collection space, but at vastly greater scale and with broader product portfolios.
• Smiths Medical (ICU Medical / ICU Medical acquisition pending): Manufacturer of specialty medical devices including IV infusion, safety devices, and vascular access products. Direct product overlap with HMG's IV and safety-engineered device portfolio in hospital channels.

Market position

Strengths4 records

Weaknesses5 records

Competitive moat3 records

Key risks6 records

Key highlights5 records

Customer concentration

• LinkedInlinkedin.com/company/hartmanmedicalgroup

Compliance1 record

Revenue estimate

Valuation estimate

Number of profiles

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 Hartman Medical Group