Sigenix Inc

What Sigenix Inc does

Sigenix Inc is a privately-held, Pittsburgh-based (Monroeville, PA) contract electronics engineering services firm founded in 2005. The company delivers end-to-end electronics development for medical device companies and other regulated-industry manufacturers, spanning schematic capture, multi-layer PCB layout (2 to 16+ layers), embedded firmware on STM32 and Infineon PSoC platforms, custom AC/DC and DC/DC power supply design, and in-house EMI/EMC pre-compliance testing. Its core differentiation is the ability to take a Class II medical device from concept through FDA 510(k) submission under IEC 62304, IEC 60601-1, and ISO 14971, with the same engineers handling hardware design, firmware, and regulatory documentation to eliminate handoff gaps.

The firm works with both Fortune 500 manufacturers (Bombardier, Philips, Bosch) and early-stage startups (ALung Technologies, Vixiar, Trice, Circadiance), and has shipped 50+ products to market across respiratory, compression therapy, cardiac, imaging, and wearable categories. Its president holds 14 granted U.S. patents spanning medical device monitoring, therapeutic compression, and patient compliance systems, and the firm has supported multiple FDA 510(k) submissions. SiGenix also collaborated with the University of Pittsburgh on the Sonic Flashlight ultrasound device and developed products such as the LVEDP Estimator, Hemolung ECCO2R system, Camera-Enabled Needle, and a hand hygiene compliance monitor.

Revenue is generated through project-based professional services engagements with quote-based, multi-year contract structures. Pricing is determined through a discovery call and statement of work; no public pricing tiers exist. Customer acquisition is primarily inbound via the company website and organic search driven by a technical engineering blog, supplemented by referrals. The firm operates as a deliberately small team (1–10 employees) and has received no external funding, maintaining a boutique, founder-led operating model with remote collaboration and selective on-site visits.

Name

Sigenix Inc

Legal name

SiGenix

Website

https://sigenix.com

Company type

Private

Founded year

2005

Operating status

Operating

Headcount range

1–10 employees

Short description

Pittsburgh-based (Monroeville, PA) contract electronics engineering firm founded in 2005 that delivers end-to-end hardware, firmware, and FDA 510(k) regulatory support for Class II medical devices and other regulated electronics, serving Fortune 500 manufacturers and early-stage startups.

Ownership category

akta.pro rank

Product category

Electronics Engineering Services

NAICS

Engineering Services (541330)

SIC

Services-Engineering Services (8711)

akta.pro primary industry

Testing, Inspection, Certification & Commissioning (TICx) Technical Services (BPAHAIAL)

akta.pro secondary industry

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

Keywords

• Medical device engineering
• Embedded systems design
• Electronics engineering services
• FDA 510(k) consulting
• PCB layout design

Headquarters

HQ city

Pittsburgh

HQ country

United States

HQ region

North America

Offices2 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

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

Revenue model

1. Contract Engineering Services: Electronic engineering services and electronic product engineering services billed on project basis. Work includes schematic design, PCB layout, embedded firmware development, prototype assembly, EMI/EMC testing, and FDA 510(k) submission support. Engagements structured as standalone development partner or integrated extension of client team.

Pricing tiers

Go-to-market motion1 record

Distribution channels2 records

Marketing channels3 records

Core offering

SiGenix provides contract electronics engineering services covering schematic capture, multi-layer PCB layout, embedded firmware development, custom switching power supply design, EMI/EMC compliance testing, and end-to-end medical device development including FDA 510(k) submission support. The company serves clients from Fortune 500 companies to early-stage startups across medical devices, industrial equipment, consumer electronics, and defense industries, operating as either a standalone development partner or an integrated extension of client engineering teams.

Product overview

SiGenix is a Pittsburgh-based engineering firm offering a portfolio of electronics engineering services for medical devices, embedded systems, and power electronics. Their service offerings include Electronics Design & PCB Layout, Embedded Software Development, Medical Device Development, Switching Power Supply Design, EMI/EMC Compliance Engineering, 510(k) & Regulatory Compliance, and Prototype Assembly & Bring-Up. The company has developed multiple FDA-cleared medical devices including the LVEDP Estimator (handheld cardiac monitor), Hemolung (ECCO2R respiratory system), Camera-Enabled Needle (medical imaging device), and Reliefband Wearable Nausea Relief device. They also developed respiratory devices, portable ultrasound systems, and hospital hand hygiene compliance monitoring systems. SiGenix works with technologies including STM32 microcontrollers, Infineon PSoC devices, and various communication protocols (Bluetooth/BLE, CAN, UART, SPI, I2C, USB). Their president holds 14 U.S. patents spanning medical device monitoring, therapeutic compression, and patient compliance systems.

Differentiator

Problem solved

Functional benefit

Products and services

• Electronics Design & PCB Layout Services Full-cycle PCB design services including schematic capture, component selection, multi-layer PCB layout (2 to 16+ layers), signal integrity analysis, and manufacturing documentation. For medical, industrial, consumer electronics, and defense companies needing concept-to-fabrication electronic design.
• Embedded Software Development Services Firmware development for microcontrollers and processors including STM32 and Infineon PSoC devices, RTOS integration (FreeRTOS, ThreadX), device drivers, and safety-critical software per IEC 62304. For medical device and embedded systems companies requiring low-power, safety-certified firmware.
• Medical Device Development Services End-to-end medical device development including design controls, risk management per ISO 14971, FDA-compliant software per IEC 62304, IEC 60601-1 safety requirements, and 510(k) submission support. For medical device companies developing Class II regulated devices.
• Switching Power Supply Design Services AC/DC and DC/DC converter design with focus on efficiency, thermal management, and EMI compliance, including custom transformer and inductor design per IEC 60601-1 for medical isolation. For medical device and industrial electronics companies needing efficient power conversion designs.
• EMI/EMC Compliance Engineering Services Pre-compliance testing, board redesigns to meet CISPR and FCC requirements, and support through radiated emissions and susceptibility certification testing per IEC 60601-1-2. For electronics manufacturers needing EMC certification support.
• 510(k) & Regulatory Compliance Services Regulatory strategy, design history files, risk analysis, and preparation of FDA 510(k) submissions for Class II medical devices including predicate device strategy and FDA correspondence. For medical device companies seeking FDA regulatory clearance.
• Prototype Assembly & Bring-Up Services In-house prototype PCB assembly and hardware bring-up including SMT and through-hole assembly, fine-pitch BGA and QFN rework, first-article debug, and thermal imaging. For electronics companies needing rapid prototype iteration.

Quantifiable outcome

• 50+ products shipped to market
• +2 more outcomes

Named customers7 records

Segments4 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature6 records

Partnerships

One partnership is on record.

• University of PittsburghminorStrategic or Co-development PartnerSiGenix collaborated on the Sonic Flashlight project, a revolutionary ultrasound device originating from the University of Pittsburgh where the ultrasound image is projected onto a partially reflecting mirror on the probe.

Scale indicators4 records

Recent moves6 records

Expansion highlights5 records

Direct peers

• Boston Engineering: Engineering services firm with a medical device and defense practice covering embedded systems, mechanical design, and product development, comparable to SiGenix in both technical scope and end-market focus.
• Sterling Medical Devices: Medical device design and development firm focused on embedded software, hardware, and FDA/IEC 62304 compliance work for Class II and III devices — directly comparable to SiGenix's regulated development services.
• StarFish Medical: Canadian medical device design and manufacturing services firm that provides end-to-end product development from concept through regulatory submission, directly comparable to SiGenix's medical device development focus.
• Sunrise Labs: Medical device and life sciences product development services firm specializing in embedded software, hardware design, and FDA submission support — a near-direct match to SiGenix's integrated service offering.
• Meddux Development Corporation: Medical device product development firm providing embedded systems, PCB design, and regulatory services for Class II and III devices, directly comparable in technical scope and client profile.
• Product Development Solutions (PDS): Engineering services firm supporting medical device and industrial clients with embedded software, hardware design, and regulatory submission work — overlapping capability set and similar client mix.

Broad incumbents

• Veranex: Larger-scale medical device services platform offering design, regulatory, clinical, and commercialization services; broader in scope than SiGenix but operates in the same medical device development services category.
• Battelle: Large R&D services organization with a medical device and life sciences practice covering electronics, software, and regulatory work; overlaps with SiGenix on contract engineering but at much larger scale.

Others

• Logic PD (now part of CIRCUITECH): Electronics product development services firm serving medical, industrial, and aerospace clients; historically comparable to SiGenix on full-cycle product engineering before its acquisition.

Emerging players

• Integrated Computer Solutions (ICS): Custom software and embedded development firm with medical device and regulated industry practices; partial overlap with SiGenix on embedded firmware for medical devices.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat4 records

Key risks6 records

Key highlights6 records

Customer concentration

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 Sigenix Inc