What Life Science Outsourcing does

Life Science Outsourcing (LSO) is a Brea, California-based medical device contract manufacturer founded in 1997 that provides integrated, single-source end-of-line services to medical device OEMs and early-stage MedTech companies. Its core service portfolio spans cleanroom device assembly and kitting, in-house EtO/steam/gamma/e-beam sterilization with full validation to ISO 11135 and ISO 11137, ISO 11607-compliant medical package testing, cleaning and decontamination, packaging development (including thermoforming and pre-validated packaging), and GMP-compliant fulfillment and distribution with lot-level ERP traceability. Operations are supported by 12 cleanrooms (Class 5 through 8, including a Class 7 dry room), 30,000+ sq ft of warehouse at each site, and a 125,000+ sq ft footprint across California, New Hampshire, Costa Rica, and a Tijuana, Mexico offshore partner.

The company serves more than 1,400 medical device companies across 20+ device categories including orthopedic, cardiovascular, cardiac rhythm management, neuromodulation, in-vitro diagnostics, minimally invasive, dental, drug delivery, ophthalmic, and wound care. A dedicated Medical Device Incubator offering extends services upstream to startups via cleanroom rental, QMS support, DHF development, and UDI compliance. Pricing is quote-based with no minimum order quantities, supporting a long-tail customer mix from early-stage startups through enterprise OEMs.

LSO is privately held under PPC Enterprises ownership following its January 2023 acquisition of J-Pac Medical (which added biomaterials, diagnostics, and Costa Rica capacity) and a subsequent microfluidics asset acquisition. Doug Constable was appointed CEO in October 2025 to lead the next phase of growth. The company holds FDA CDRH registration, ISO 13485, ISO 11135, ISO 11137, ISO 11607, ISO 17665, and ISTA certifications, as well as Japan MOH and California state manufacturing licenses.

Name

Life Science Outsourcing

Legal name

Life Science Outsourcing, Inc.

Website

https://live-life-science-outsourcing.pantheonsite.io

Company type

Private

Founded year

1997

Operating status

Operating

Headcount range

51–100 employees

Short description

Life Science Outsourcing is a Brea, California-based, PE-backed medical device contract manufacturer founded in 1997, providing integrated assembly, sterilization, packaging, testing, and fulfillment services from facilities in California, New Hampshire, and Costa Rica to medical device OEMs and startups.

Ownership category

akta.pro rank

Product category

Medical Device Contract Manufacturing

NAICS

Testing Laboratories and Services (541380)

SIC

Services-Testing Laboratories (8734)

akta.pro primary industry

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

akta.pro secondary industry

Quality Engineering & Risk Management (ICH Q9/Q10, validation, change control) (HLAGAKAL)

Keywords

• Medical device manufacturing
• Contract sterilization services
• Medical packaging testing
• Medical device assembly
• Cleanroom manufacturing

Headquarters

HQ city

Brea

HQ country

United States

HQ region

North America

Offices4 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

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

Revenue model

1. Contract Manufacturing Services: Assembly, kitting, and manufacturing services for medical devices billed on a project or per-unit basis. Services include manual, semi-automated, and fully automated assembly; catheter assembly; electromechanical assembly; and combination products.
2. Sterilization Services: EtO, steam, gamma, and e-beam sterilization services with full validation to ISO 11135 and ISO 11137. Includes quick-turn single lot release EtO sterilization for faster turnaround.
3. Medical Package Testing: ISO 11607 packaging validation testing services including accelerated aging, seal integrity, distribution simulation, and regulatory compliance testing.
4. Fulfillment & Distribution: Warehousing, inventory management, and global shipping services for finished medical devices with full traceability and GMP-compliant handling.

Pricing tiers

Go-to-market motion2 records

Distribution channels3 records

Marketing channels8 records

Core offering

Life Science Outsourcing (LSO) is a full-service medical device contract manufacturer providing single-source end-of-line solutions that integrate cleanroom assembly, packaging and kitting, sterilization validation (EtO, steam, gamma, e-beam), ISO 11607 package testing, cleaning and decontamination, fulfillment and distribution, and medical device incubator services for OEMs and early-stage MedTech companies. Operations run from FDA-registered, ISO 13485-certified facilities in California, New Hampshire, and Costa Rica, with no minimum order quantities.

Product overview

Life Science Outsourcing (LSO) is a full-service medical device contract manufacturing organization offering a comprehensive, single-source portfolio of integrated services. The core offering includes Medical Device Assembly & Kitting, In-House Sterilization Services (EtO, steam, gamma, ebeam), Medical Device Package Testing, Point of Care Diagnostics manufacturing, Cleaning & Decontamination Services, Fulfillment & Distribution, and Medical Device Incubator Support. These services are designed to work as an end-to-end solution under one roof, with facilities in California, New Hampshire, and Costa Rica. LSO also provides specialized sub-products including Precision Reagent Packaging for diagnostics, Quality Management System Coverage, Device DHF Development, and UDI System Implementation to support startups and OEMs through the complete product lifecycle from prototyping to commercialization.

Differentiator

Problem solved

Functional benefit

Brands

• Medical Package Testing (MPT): A division of Life Science Outsourcing devoted to validation, testing and design of packaging for medical device manufacturers, pharmaceutical companies, biotech companies, and the diagnostic industry. ISTA-certified packaging test lab (ID Number ST-2339).

Products and services

• Medical Device Assembly & Kitting Cleanroom device assembly and custom medical kits with full traceability and documentation, supporting manual, semi-automated, and fully automated assembly including catheter, electromechanical, and combination products for medical device OEMs and startups.
• In-House and Managed Sterilization Services EtO, steam, gamma, and e-beam sterilization with full validation to ISO 11135 and ISO 11137 standards, including quick-turn single lot release EtO sterilization for medical device customers.
• Medical Device Package Testing ISO 11607 packaging validation, accelerated aging, seal integrity, and distribution simulation testing services, operated as the Medical Package Testing (MPT) division and ISTA-certified test lab (ID ST-2339).
• Point of Care Diagnostics Manufacturing End-to-end manufacturing for diagnostic devices, reagents, and consumables with FDA-registered, ISO 13485-certified cleanroom services, including cartridge and consumable assembly and reagent packaging.
• Cleaning & Decontamination Services Validated cleaning, decontamination, and inspection services for reusable and single-use medical devices in FDA-registered, ISO-certified facilities, including field return cleaning, reusable device processing, and loaner kit processing.
• Medical Device Incubator Support

Quantifiable outcome

• Serves over 1,400 medical device companies in nearly 25 years of operation
• +3 more outcomes

Named customers3 records

Segments8 records

Ideal customer profiles3 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature5 records

Partnerships

One partnership is on record.

• J-Pac MedicalcoreStrategic or Co-development Partner · 5 January 2023LSO completed the acquisition of J-Pac Medical, a manufacturer specializing in medical device and diagnostic packaging and sterilization. The deal expands LSO's capabilities in biomaterials and diagnostics end-markets and enhances its production footprint in the US and Costa Rica. J-Pac Medical brought expertise in reagent blister packaging, thermoforming, and sterilization for molecular diagnostics and point-of-care applications.

Scale indicators6 records

Recent moves5 records

Expansion highlights7 records

Direct peers

• Integer Holdings: Large public medical device contract manufacturer and OEM serving cardio, vascular, neuromodulation, and orthopedics markets. Comparable as a medical device CMO with vertically integrated assembly, sterilization, and packaging capabilities serving similar OEM customers.
• STERIS: Global sterilization and infection prevention leader that provides contract EtO and gamma sterilization services to medical device manufacturers. Directly overlaps with LSO's sterilization and laboratory testing service lines.
• Confluent Medical Technologies: Private medical device contract manufacturer specializing in nitinol components, balloon catheters, and finished device assembly. Highly comparable to LSO's catheter, neuromodulation, and complex assembly offerings for OEM customers.
• Phillips-Medisize (Molex): Medical device contract manufacturer and drug delivery developer with global manufacturing footprint. Directly comparable in offering drug delivery device assembly, diagnostics packaging, and integrated OEM manufacturing services.
• Resonetics: Medical device contract manufacturer specializing in nitinol processing, laser micromachining, and catheter components. Comparable as a specialized CMO serving cardiovascular and neurovascular OEMs with precision assembly capabilities.
• SMC Ltd. Private medical device contract manufacturer offering design, tooling, molding, assembly, and packaging. Comparable as a single-source medical device CMO serving startups through large OEMs across multiple therapeutic areas.
• Teleflex Medical OEM: Contract manufacturing division offering extrusions, catheters, and finished device assembly for OEMs. Comparable to LSO's catheter assembly, packaging, and sterilization offerings.
• Trelleborg Healthcare & Medical: Contract manufacturer of polymer-based medical device components and assemblies, including silicone and thermoplastic solutions. Comparable in providing specialty manufacturing services for medical device OEMs.
• Nelson Labs (Steris): Part of STERIS, provides medical device and pharmaceutical testing services including package validation, sterilization validation, and biocompatibility. Directly overlaps with LSO's Medical Package Testing division.

Broad incumbents

• Nipro Corporation: Large Japanese global medical device, pharmaceutical, and glass packaging manufacturer with significant contract manufacturing capabilities. Comparable as a diversified medical device manufacturer with sterilization and packaging services.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

• YouTubeyoutube.com/user/LSOcorporation
• Facebookfacebook.com/lifescienceoutsourcing
• LinkedInlinkedin.com/company/lso-inc
• Xx.com/lso_inc

Compliance9 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles1 record

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 Life Science Outsourcing