Medical device manufacturer for infusion therapy: infusion pumps, IV consumables, closed system transfer devices and sterile injection solutions
ICU Medical, Inc.
San Clemente, CA · Lake Forest, IL · Austin, TX · Salt Lake City, UT · Plymouth, MN · Ensenada (MX) · Tijuana (MX) · San Jose (CR) · Ashford (GB)New on Amplifa
About ICU Medical
ICU Medical is a medical device company specialized in infusion therapy that develops, manufactures and distributes infusion pumps, IV consumables, needlefree valves, closed system transfer devices (CSTD), airway management, hemodynamic, temperature management and renal care products. Manufacturing is vertically integrated, in particular through plastic injection molding (molding), extrusion, automated assembly of infusion pumps and consumables, and sterile pharmaceutical production of flexible primary containers and injectable drug solutions in Austin, Texas. Core product manufacturing, R&D, sterilization and distribution are not outsourced. A joint venture with Otsuka Pharmaceutical Factory produces approximately 1.4 billion IV solution units per year. Production sites are located, among others, in Tijuana and Ensenada (Mexico) as well as San Jose (Costa Rica); the corporate headquarters is in San Clemente, California. Customers include hospitals, oncology, intensive care, home care and veterinary medicine worldwide.
- Site
- San Clemente, CA, USA
- Processes
- Injection molding (molding), Extrusion, Automated manufacturing (automation), Assembly of infusion pumps and consumables, Sterile pharmaceutical manufacturing (flexible primary containers and injectable drug solutions), IV solutions manufacturing (joint venture with Otsuka, approx. 1.4 billion units/year), In-house R&D and core product manufacturing (not outsourced), including sterilization and, Implementation services for infusion systems
- Materials
- Plastic injection molding (molding), Extrusion, Automated assembly, Sterile pharmaceutical manufacturing
- Certificates
- Declaration of Conformity (Plum 360, EU), NABP Drug Distributor Accreditation, Declaration of Conformity Plum 360 (EU), ISO 9001
- Founded
- 1984
- Industries
- Healthcare, Hospitals, Oncology, Intensive care/Infusion therapy, Veterinary medicine, Home care/Alternate Site Care
- 01
In-house R&D (product concept, design, development, testing)
- 02
Plastic injection molding (molding)
- 03
Extrusion
- 04
Sterile pharmaceutical manufacturing (flexible primary containers, injectable
- 05
Automated production
- 06
Assembly of infusion pumps and consumables
- 07
Sterilization
- 08
Distribution (central logistics warehouse in the Netherlands)
- 09
Implementation and technical 24/7 support
Materials and Processes
Plastic injection molding (molding)
Process for manufacturing IV consumables, valves and pump components from medical-grade plastic.
Extrusion
Verified process at the Ensenada site for producing medical plastic profiles.
Automated assembly
Automated production and assembly of infusion pumps and consumables, among others in Costa Rica.
Sterile pharmaceutical manufacturing
In Austin, flexible primary containers and finished injectable drug solutions are manufactured.
Locations
San Clemente, CA
USCorporate headquarters (Marketing, R&D, IT, Finance, HR)
Lake Forest, IL
USR&D, Engineering, Marketing, Quality, Regulatory Affairs, Customer Service
Austin, TX
USSterile pharmaceutical manufacturing (injectable solutions, flexible primary containers)
- Materials
- Plastics
Salt Lake City, UT
USManufacturing and assembly (Production, Molding, Automation, Service Center, QC)
- Materials
- Plastics
Ensenada, MX
MXManufacturing for oncology, intensive care, infusion therapy (280,000 sq ft)
- Lot size
- High-volume
- Materials
- Plastics
- Extrusion
Tijuana, MX
MXLargest manufacturing plant (~2,500 employees, Operations, Manufacturing, Engineering)
- Lot size
- High-volume
- Materials
- Plastics
San Jose, CR
CRVertically integrated manufacturing: molding, automation, assembly of infusion pumps and consumables (650,000 sq ft)
- Lot size
- High-volume
- Materials
- Plastics
Plymouth, MN
USCommercial, R&D laboratory, Engineering, Quality, Regulatory Affairs
Ashford, GB
GBCommercial (R&D, Quality, Marketing, HR)
Products and Components
Inside the production
Industries
Processes & technical limits
| Processes | Tolerance | Max. part | Weight | Lot size | Materials |
|---|---|---|---|---|---|
| Injection molding (molding)Plastics | – | – | – | – | Plastics (medical devices/infusion consumables) |
| ExtrusionPlastics | – | – | – | – | – |
| Automated manufacturing (automation)Assembly | – | – | – | – | – |
| Assembly of infusion pumps and consumablesAssembly | – | – | – | – | – |
| Sterile pharmaceutical manufacturing (flexible primary containers and injectable drug solutions)Joining | – | – | – | – | – |
| IV solutions manufacturing (joint venture with Otsuka, approx. 1.4 billion units/year)Other | – | – | – | – | – |
| In-house R&D and core product manufacturing (not outsourced), including sterilization andEngineering | – | – | – | – | – |
Additional services
Quality and Certificates
ICU Medical controls quality from product concept through design, development and testing to manufacturing, sterilization and distribution. Published documents include Declarations of Conformity for Plum 360 (EU) and the NABP Drug Distributor Accreditation.
| Evidence | San Clemente, CA |
|---|---|
| Declaration of Conformity Plum 360 (EU) | |
| NABP Drug Distributor Accreditation | |
| ISO 9001 |
Company History
- 1984
Founded by George 'Doc' Lopez, MD; first product ClickLock for IV line securement
- 2006
Introduction of first oncology products (ChemoClave CSTD)
- 2009
Acquisition of the Critical Care business of Abbott Laboratories/Hospira
- 2012
Introduction of the Diana Hazardous Drug Compounding System
- 2015
Acquisition of Excelsior Medical Corporation (~59.5 million USD)
- 2017
Acquisition of Hospira Infusion Systems from Pfizer
- 2022
Acquisition of Smiths Medical