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Medical Product Design and Manufacturing

Your Trusted Expert for Connected Care

Work with us to design and build reliable, secure, high-performing connected devices unique to your medical needs. Ensure your next product is a success while adhering to strict medical requirements.

For over a decade, global leaders in cardiac rhythm monitoring, respiratory therapy, sleep apnea, diabetes, and medication adherence have turned to TxWireless™ for help designing and delivering connected health devices that provide:

  • Wireless connectivity using cellular, Wi-Fi, BLE, and satellite
  • Ultra-secure protection for data at rest, in-motion, and in use
  • Industry-leading battery life from extreme low-power designs
  • Timely data for preventative intervention

Our multidisciplinary team includes:

  • Industrial and antenna designers
  • Electrical and mechanical engineers
  • Safety and security engineers
  • Compliance and regulatory experts
  • Device software specialists
a person working on computer on connected health software
a IoT device being used for tests and analysis
a medical device on a table to monitor patients health
a TxWireless engineer working on computers at his station

Safe and Secure Device Management

At TxWireless, we recognize that Zero Trust is an essential component to any organization’s security plan. Particularly in the health care environment, when you work with multiple personas and multiple levels of access to the same data. That’s why we offer our customers a safe and secure device lifecycle management strategy with longevity in mind. Our technology is designed to last, and our customers can trust us to deliver secure devices from the first use to the end of their life. 

Get To Market Faster

How We Get You There

Our comprehensive portfolio of hardware, software, engineering services, supply chain management, and support services enables our customers to get innovative connected health products to market faster and with lower development costs. Drawing upon years of expertise, our team adheres to a well-defined process to ensure a streamlined and efficient integration process. We can provide end-to-end turnkey solutions for customers that consist of multi-radio systems with backhaul through Wi-Fi, cellular, and satellite radios with difficult certification requirements that we know well. This is a comprehensive suite of options for customers that want to develop internally.

Our professional services span:

Connected Device Design
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Connected Device Design

Engage with our experts to minimize design risk throughout the product development journey and augment your team with multi-disciplinary seasoned professionals.

Test & Validation
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Test & Validation

We test and validate at each stage of development to ensure the successful delivery of our customers solutions on time, the first time, and in mass production.

Connected Device Security
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Connected Device Security

We provide comprehensive security solutions, safeguarding products from end-to-end. Securing data in motion, data in use, and data at rest ensures a trusted connectivity solution.

RF & Cellular Certification
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RF & Cellular Certification

Our team possesses the knowledge and resources to navigate the complex regulatory landscape for both government and industry-specific wireless certifications and medical regulatory compliance.

Connected Device Manufacturing
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Connected Device Manufacturing

We deliver high-quality, connected devices at scale using multiple contract manufacturers and EMS companies around the globe.

Product Lifecycle Management
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Product Lifecycle Management

We help your product evolve and adapt, ensuring it stays reliable, secure, and effective, by designing for flexibility, including remote firmware updates for all systems.

Trusted Worldwide

Enabling Efficient Care Delivery

We build the bridge between patient and caregiver by developing custom-to-application remote monitoring solutions. These devices are multi-radio gateways communicating to wearables and implantable with backhaul through Wi-Fi and cellular radios. The software stacks are ISO62304 compliant and built as a Zero Trust architecture.

Our approach prioritizes rigorous verification and validation activities early in the product lifecycle, bolstering the likelihood of deploying and securely managing your connected product at scale. This commitment to quality, security, and data compliance is why we are trusted by the world’s leading medical device companies. We have extensive experience in:

We have designed and produced Bluetooth-to-cellular gateways used to communicate with implantable cardiac monitors (ICM) and implantable cardiac defibrillators (ICD). These securely transport patient data to cloud-based dashboards for cardiac consultants, doctors, and physicians.

Our technology allows for remotely monitoring sleep apnea and ventilation equipment such as CPAP machines using low-power Bluetooth radios with backhaul over cellular networks.

We develop small-form-factor cellular radio technology to allow for continuous glucose monitoring and general diabetes disease management through connected home gateways and wearable devices.

We integrate BLE, Wi-Fi, and cellular connectivity into devices including connected inhalers and portable and static oxygen concentrators for remote medical device monitoring and predictive maintenance.

We design connected devices to remotely monitor and manage diseases such as COPD and inflammatory autoimmune conditions using unique sensing and edge intelligence algorithms to minimize cellular data usage.

Patient compliance with prescribed medication therapies can be remotely monitored using products we design and manufacture for our clients. Optical sensors detect the presence of spent insulin pens and relay that information over cellular to the cloud to deliver adherence reports to the care providers.

Cardiac Monitoring
Sleep Monitoring
Glucose Monitoring
Respiratory Monitoring
Chronic Disease Management
Medication Adherence
connected health cardiac

We have designed and produced Bluetooth-to-cellular gateways used to communicate with implantable cardiac monitors (ICM) and implantable cardiac defibrillators (ICD). These securely transport patient data to cloud-based dashboards for cardiac consultants, doctors, and physicians.

connected health sleep

Our technology allows for remotely monitoring sleep apnea and ventilation equipment such as CPAP machines using low-power Bluetooth radios with backhaul over cellular networks.

connected health glucose

We develop small-form-factor cellular radio technology to allow for continuous glucose monitoring and general diabetes disease management through connected home gateways and wearable devices.

connected health respitory

We integrate BLE, Wi-Fi, and cellular connectivity into devices including connected inhalers and portable and static oxygen concentrators for remote medical device monitoring and predictive maintenance.

connected health chronoic disease

We design connected devices to remotely monitor and manage diseases such as COPD and inflammatory autoimmune conditions using unique sensing and edge intelligence algorithms to minimize cellular data usage.

edge connect devices

Patient compliance with prescribed medication therapies can be remotely monitored using products we design and manufacture for our clients. Optical sensors detect the presence of spent insulin pens and relay that information over cellular to the cloud to deliver adherence reports to the care providers.

Connectivity Solutions

Bringing Care To Where It's Needed

Our expert team guides our customers toward the ideal connected health devices in patient homes to ensure caregivers can identify and treat emerging problems before they escalate. Our connectivity options include:

Defining the Future of Connected Health

4G and 5G create new opportunities to connect patients and their caregivers no matter where they are. This enables new care paradigms that benefit both patients and caregiver organizations such as hospitals and physician groups. TxWireless provides medical device manufacturers and other health care companies with cellular solutions that enable these and other applications.
smartwatch1 Wearables
sensor Sensor
device 1 Personal Connected Health Devices
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Nurturing Health through Wi-Fi Connectivity

Wi-Fi is a ubiquitous wireless technology that offers high-performance connectivity, government-grade WPA3™ security, and support for legacy devices, making it ideal for a wide variety of health care applications in homes, senior living communities, hospitals, and other care settings. Typical applications include:
cardiac High-speed capture-and-send devices (diagnostic equipment or cardiac monitoring)
wifi connection1 In-home gateways converting BLE/ISM to Wi-Fi or Wi-Fi to cellular backhaul
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Smart Healing, Harnessing BLE for Health

BLE is ideal for wearables and other short-range health care applications where extended battery life is a top priority. It supports lower bandwidth rates, ranging from 125 Kb/s up to 2 Mb/s, including a connectionless-mode and the connection-oriented mode of Classic. BLE has become the de facto communication protocol for intelligent wearable devices due to its ultra-low energy consumption, ease of development, good enough network coverage, and data transfer speed. Typical applications that connect to a home gateway or mobile phone include:
smartwatch1 Body worn peripherals like pulse oximeters, blood pressure cuffs, and fitness bands
blood bag Implanted therapy, drug delivery, diagnostic, and monitoring devices
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Machine Vision AI and Cloud Services

In addition to wireless connectivity, TxWireless has the proven expertise in on-board imaging sensors and cloud services that enables our customers to seamlessly integrate machine vision and data management into their solution — quickly, reliably, and cost effectively.

a circular device that showcases futuristic design

Machine Vision

Machine vision uses artificial intelligence (AI) to enable health care devices to see and analyze patient conditions. It provides another set of expert eyes to extend care into new locations and applications, such as patient homes and remote clinics. TxWireless has proven expertise with imaging sensors and vision processing units (VPU) that enables our customers to seamlessly integrate machine vision into their product portfolios — quickly, reliably, and cost effectively.

Our solutions and services let customers use machine vision to:

  • Measure container capacity/utilization
  • Grade quality of product and identify defects
  • Identify, sort, and count objects

Cloud Services

Cloud services play a central role in connected health applications, offering data ingestion, security, and storage resources that are essential for managing the raw data created by each device. These services enable real-time and post-process data analysis in a highly scalable, cost-effective manner while providing global accessibility. TxWireless EDGE IoT hardware and software platforms enable our customers to create custom solutions that allow for:

  • Automatically monitor and manage patient medication adherence and compliance
  • Seamlessly transmit data between medical devices and health care systems
  • Enable personalized health care for precision medicine and digital therapeutics

Discover our full range of

Connected Smart Devices

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Success Stories

Bluedrop Medical Ltd.

Strong partnerships are the foundation of growth. Our success is determined by the accomplishments of our customer. But, we don't expect you to take our word for it! We'll let our customers speak for themselves.

"Collaborating with TxWireless was excellent. It was clear from the start they had experience in designing and manufacturing medical devices for premium health care OEM brands. Their multi-disciplinary team included experts in wireless, computer vision/ML/AI, and security/safety. They work with Bluedrop right through from hardware to device software all the way into product manufacturing. Their global connectivity and medical device domain expertise was clear — from project management to engineering to customer service teams — and they are a great co-pilot for our state-of-the-art remote patient monitoring technology for diabetic foot disease patients"

Gavin Corley , Ph.D
Chief Technology Officer,
Bluedrop Medical Ltd.
a person using a premium healthcare device
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EDGE Connect... Instant IoT
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EDGE Connect

Portable cellular and telematics gateway enables real-time insights and intelligence to help you reduce costs, increase revenue, and enhance compliance.

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EDGE Locate... Instant IoT
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EDGE Locate

High Precision GNSS Solution IoT hardware platform providing high precision GNSS for high volume navigation and autonomous applications in an off-the-shelf, compact form factor.

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EDGE Vision... Instant IoT
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EDGE Vision

Vision platform offers a versatile solution for automated imaging applications, including measurement, tracking, and other event detection tasks.

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Industrial Gateaway... Instant IoT
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Industrial Gateway

Industrial Monitoring Cellular and Telematics gateway with GNSS. Monitor, manage and track the usage of your assets remotely from anywhere in the world.

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EDGE RTK... Instant IoT
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EDGE RTK Starter Kit

Portable cellular and telematics gateway with High precision GNSS Cellular, Bluetooth, onboard sensors, multi-band GNSS and RTK, and cloud-based management platform.

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EDGE Insights... Instant IoT
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EDGE Insights

Cloud-based software platform. Flexible, reliable and efficient gathering of data and life-cycle management of EDGE devices.

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Explore our Solutions

Accelerate Time To Market

TxWireless offers a comprehensive suite of product building blocks, ranging from component-level solutions to complete devices, enabling our customers to deliver their own product portfolio on time and within budget. Our experienced engineering team offers rapid prototyping and product design to aid a seamless integration into your product. This alleviates the need for costly and time-consuming engineering, freeing our customers to focus on developing market-differentiating capabilities.

Accelerator Platforms
Products

Explore our Solutions

Accelerate Time to Market

TxWireless offers a comprehensive suite of product building blocks, ranging from component-level solutions to complete devices, enabling our customers to deliver their own product portfolio on time and within budget. Our experienced engineering team offers rapid prototyping and product design to aid a seamless integration into your product. This alleviates the need for costly and time-consuming engineering, freeing our customers to focus on developing market-differentiating capabilities.

Accelerator Platforms

High Precision GNSS Solution IoT hardware platform providing high precision GNSS for high volume navigation and autonomous applications in an off-the-shelf, compact form factor.

read more

Vision platform offers a versatile solution for automated imaging applications, including measurement, tracking, and other event detection tasks.

read more

Portable cellular and telematics gateway with High precision GNSS Cellular, Bluetooth, onboard sensors, multi-band GNSS and RTK, and cloud-based management platform.

read more

Products

Portable cellular and telematics gateway Enables real-time insights and intelligence to help you reduce costs, increase revenue, and enhance compliance.

read more

Industrial Monitoring Cellular and Telematics gateway with GNSS. Monitor, manage and track the usage of your assets remotely from anywhere in the world.

read more

Cloud-based software platform. Flexible, reliable and efficient gathering of data and life-cycle management of EDGE devices.

read more

TAKE A DEEP DIVE

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