SigmaPro

What SigmaPro does

SigmaPro Engineering & Manufacturing, LLC is a Fort Worth, Texas-based precision injection molding contract manufacturer founded in 2003, serving medical device OEMs and Tier 1 medical suppliers. The company operates a 12,000 sq. ft. purpose-built facility housing a Class 8 cleanroom (ISO 14644), in-house tool room, and integrated metrology lab, and is ISO 13485:2016-certified (by SGS), ISO 9001:2015-certified, and FDA-registered under 21 CFR Part 820.

SigmaPro's core offering is micro-precision injection molding with dimensional tolerances down to ±4 microns, enabled by in-mold pressure and temperature sensing, shot-to-shot statistical process control, and automated part handling and inspection. Around this core, the company provides vertically integrated services including Design for Manufacturability with Moldflow simulation, prototype and bridge tooling, cleanroom assembly and packaging (ultrasonic welding, insert molding, overmolding), and IQ/OQ/PQ validation with CMM/optical inspection and electronic batch records. Target applications span minimally invasive surgical tools, diagnostic cartridges, drug-delivery device components, and wearable health-device enclosures.

Commercially, SigmaPro generates revenue through per-unit contract manufacturing agreements with medical OEMs, with quote-based pricing tied to part complexity, volume, material, and validation requirements. The company sells exclusively through direct enterprise engagement targeting Class II and III medical device programs, and currently serves customers across North America and Europe from its single Texas facility. Distribution is direct-to-OEM with no disclosed channel partners, and the company is privately held with no reported institutional investment, acquisitions, or ownership changes.

Name

SigmaPro

Legal name

SigmaPro Engineering & Manufacturing, LLC

Website

https://sigmaproeng.com

Company type

Private

Founded year

2003

Operating status

Operating

Headcount range

51–100 employees

Short description

SigmaPro is a Fort Worth, Texas-based precision injection molding contract manufacturer serving medical device OEMs, producing micro-tolerance (±4 micron) plastic components in a Class 8 cleanroom under ISO 13485 certification.

Ownership category

akta.pro rank

Headquarters

HQ city

Fort Worth

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Services

Cost components

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

Revenue model

1. Precision Injection Molding Services: Contract manufacturing services for precision plastic components. Revenue is generated through production contracts with medical device OEMs, typically based on per-unit pricing for manufactured components. Services include design collaboration, tooling, molding, assembly, and validation support.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels3 records

Core offering

SigmaPro is a contract manufacturer providing precision injection molding services for medical and life science OEMs. Its core offering is the production of tight-tolerance plastic components (down to ±4 microns) inside a validated Class 8 cleanroom, supported by Design for Manufacturability engineering, tooling, secondary operations, and ISO 13485-compliant validation. Services span prototype through high-volume manufacturing for Class II and III medical devices, diagnostics, drug delivery, and wearable health applications.

Product overview

SigmaPro is a precision injection molding company offering vertically integrated services for the medical and life science industries. The core offering centers on precision injection molding with tolerances down to ±4 microns, supported by cleanroom manufacturing (Class 8), design for manufacturability (DFM) with Moldflow simulation, and ISO 13485-compliant quality and validation services. These services work together as an end-to-end solution from early design collaboration through validated high-volume production for critical medical components.

Differentiator

Problem solved

Functional benefit

Products and services

• Precision Injection Molding High-precision injection molding services for medical and life science components with dimensional tolerances down to ±4 microns, using advanced process control, in-mold pressure and temperature sensing, multi-cavity molds, and metrology. Designed for medical device OEMs and Tier 1 suppliers requiring validated, tight-tolerance production.
• Cleanroom Molding & Assembly Class 8 cleanroom manufacturing, assembly, and secondary operations (including ultrasonic welding, insert molding, and overmolding) for medical-grade components, validated to ISO 14644 standards. Targeted at medical device, diagnostics, drug delivery, and life science OEMs requiring contamination-free production.
• Engineering & Design for Manufacturability (DFM) Support Design-phase engineering collaboration using Moldflow simulation for part geometry optimization, material selection, and process parameter optimization, including prototype and bridge tooling. Helps medical OEMs reduce risk and accelerate time to production for precision components.
• Quality & Validation Services ISO 13485-compliant quality services including IQ/OQ/PQ validation, CMM and optical inspection, statistical process control (SPC), and full traceability with electronic batch records. Targeted at medical OEMs needing validated production and regulatory documentation.

Quantifiable outcome

• Dimensional tolerances down to ±4 microns
• +2 more outcomes

Segments4 records

Ideal customer profiles4 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature5 records

Scale indicators4 records

Recent moves5 records

Expansion highlights4 records

Direct peers

• SMC Ltd. Medical device contract manufacturer offering precision injection molding, blow molding, and assembly with cleanroom capabilities for diagnostics, drug delivery, and medical device OEMs. Closely comparable in service portfolio and mid-sized CMO positioning.
• Confluent Medical Technologies: Medical contract manufacturer focused on nitinol and polymer components, balloons, and catheters. Comparable medical OEM customer base and Class II/III component focus; differs in nitinol specialization but overlaps in precision molding and cleanroom assembly.
• Integer Holdings: Medical device contract manufacturer specializing in precision components, finished devices, and assembly for cardio, vascular, and neuromodulation markets. Comparable end-markets (Class II/III medical OEMs) and vertically integrated manufacturing model, with deeper capabilities in metals and electronics.
• Phillips Medisize: Global medical contract manufacturer owned by Molex, offering precision injection molding, cleanroom assembly, and full DFM-to-volume services for diagnostics, drug delivery, and medical device OEMs. Most directly comparable to SigmaPro in scope and customer base, but at materially larger scale.
• Spectrum Plastics Group: Specialty medical plastics manufacturer (part of Aptyco/Solesis) offering precision extrusion, injection molding, and cleanroom assembly for medical, diagnostics, and life science customers. Direct overlap with SigmaPro in cleanroom medical molding for diagnostics and drug delivery.
• Viant Medical: Medical device contract manufacturer (part of Solesis) offering precision molding, extrusion, and assembly for implantable and single-use medical devices. Comparable Class II/III OEM customer base and ISO 13485 certified manufacturing footprint.
• West Pharmaceutical Services: Public medical packaging and drug delivery component manufacturer producing elastomeric closures, syringe components, and injection device parts. Comparable to SigmaPro in cleanroom molding for injectable and drug delivery applications, but far larger and publicly traded.
• Tessy Plastics: Custom injection molder with medical, diagnostics, and industrial customers, operating Class 7/8 cleanrooms and offering in-house tooling. Direct comparable in precision molding and medical vertical; broader in non-medical customers.

Broad incumbents

• Gerresheimer AG: European-headquartered primary packaging and specialty products manufacturer for pharma, biotech, and healthcare. Comparable in cleanroom production of glass and plastic drug delivery components, but at substantially larger scale and broader packaging scope.
• Nordson Corporation: Diversified industrial equipment manufacturer with a precision dispensing and fluid management segment serving medical and electronics customers. Broadly incumbent in industrial manufacturing adjacent to medical, rather than a direct specialty competitor in medical molding.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks5 records

Key highlights7 records

Customer concentration

Compliance4 records

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 SigmaPro