MEDICAL AND ASSISTIVE
TECHNOLOGY

Designs for real-time data acquisition, communication
and advanced data analytics that conforms to 21CFR11

MEDICAL AND ASSISTIVE TECHNOLOGY

Medical device design and development is a highly regulated and intricate process that demands meticulous attention to detail and adherence to strict quality standards. It begins with identifying a clinical need or problem, followed by conceptualization, feasibility studies, and detailed design. Engineers and medical professionals collaborate closely to ensure that the device meets clinical requirements, safety standards, and regulatory guidelines. The advent of IoT in Medical and Assistive Electronics has made healthcare more participatory, personalized, predictive and preventive. Medical Electronics Product Development and Assistive Technology Products come with advanced connectivity and high data rates that enable continuous transmission of real-time patient data to a physician. This data keeps the physician updated on the health condition of the patient, provides insight into any potential risk, and enables him to initiate any preventive measures if required. Assistive Electronics ease connectivity and communication for individuals with sensory, physical or cognitive difficulties and enable them to fully participate in society. medical device design and development, medical device product development companies, Assistive Electronic Devices, Medical Device Software Development, Medical Electronics Product Development, Assistive Technology, Non-invasive medical devices and Non-invasive medical electronics, Assistive Electronics and Assistive Electronic DevicesOver recent years, there has been an increasing need for access to high-quality, affordable, and accessible healthcare. With the convergence of IoT, M2M Communication and several scientific and technological breakthroughs, Medical device product development companies are leading innovations that have made possible solutions like medical device design and development, telemedicine, and continuous patient monitoring.

Medical Electronics Product Development

Mistral works with leading medical device product development companies helping them realize real-time, robust Non-invasive medical devices and Assistive Technology devices, enabling bi-directional communication between individuals and healthcare providers. The recent technological developments have greatly influenced Medical Device Software Development and Medical Electronics Product Development. Now, Medical Electronics and Assistive Electronic Devices are more accessible and are available at low cost, maintenance-free, and lightweight. The Medical and Assistive Technology device developers strive to adopt latest technologies and trends like miniaturization, portability, enhanced connectivity and reliability among others.

Medical Electronics Product Development and Medical Device Software Development necessitates a proven process to ensure design control, verification and validation of each phase of development and seamless software-hardware integration. The process must cover the entire product development cycle, from medical device design and development and Medical Device Software Development to clinical trials, risk management and manufacturing ensuring the product is both effective and safe for use.

Mistral’s embedded product design services offer Medical Electronics Product Development and Assistive Technology design services which include hardware development, sensor integration, OS porting, middleware and application development, testing and system validation. Some of the non-invasive Medical Electronics Product Development by Mistral include fetal heart rate monitoring, high-end camera solutions, ultrasound equipment, BP infusion pumps, etc. Also, Mistral has the requisite skills to design and develop connected assistive electronics devices, specifically to help people with vision loss, Hearing, Augmentative and Alternative Communication (AAC) or other disabilities.

Some of the Assistive Electronics devices designed by us include portable scanners for the visually impaired,  low-vision aids, braille tablets, and audio aids among others. We help medical device product development companies with Medical Electronics Product Development and robust Medical Device Software Development services, leading all the way up to the FDA certification. By offering a broad platform support, Mistral brings invaluable processor/operating system/testing/system validation expertise to the medical device design and development process.

Medical Device Software Development

medical device design and development, medical device product development companies, Assistive Electronic Devices, Medical Device Software Development, Medical Electronics Product Development, Assistive Technology, Non-invasive medical devices and Non-invasive medical electronics, Assistive Electronics and Assistive Electronic DevicesMistral has extensive expertise in medical device software development and application development for Assistive Technology Products and non-invasive medical devices. Our designs support and aid medical professionals in real-time data acquisition, communication and advanced data analytics for informed decision making. Mistral’s Medical Electronics Product Development process adheres to various global regulations and standards to ensure safety and commercial deployability.

Our medical device design and development and / or medical device software development team incorporates the latest techniques in sensor integration, software development, and GUI design to facilitate Medical Electronics Product Development through all phases. Mistral also offers a range of advanced Patient Monitoring solutions based on mmWave Technology. These modules can be integrated into our medical device design and development  or assistive electronics designs to provide patient monitoring and elderly care solutions. Click here to read a blog on Assistive Technology and a Case study on Assistive Electronics Product Design – Braille tablet for Visually impaired and Portable Barcode scanner.

Also read a blog on “An Overview of Medical Electronics” and “Current trends in Medical Electronics“.

EXPERTISE

With more than 25 years of experience in embedded product design and sensor-based data acquisition, Mistral has unparalleled expertise offering Medical Electronics and Assistive Technology design services for cutting edge healthcare solutions that conform to 21CFR11 and meet the criteria for FCC, CE, UL certifications.

Medical Electronics Product Development

  • Feasibility Study
  • Design, Development and Integration
  • Prototyping and Industrial Design (ID)
  • Power Management
  • FCC, CE, UL certification and 21CFR11 Support
  • Production support with test jigs and suites
  • Product Lifecycle Support

Hardware Design

  • Small-footprint, power optimized Flex and HDI PCB designs
  • Analog front-end for high precision data capture
  • Hardware-Software Co-design
  • System partitioning between Hardware, Software and FPGA
  • Multiple RF and Wireless integration
  • Secure boot, encrypted storage with on-the-fly decryption
  • Safety critical & fail safe system design

Software Development

  • System Software - Android/Linux BSP, Firmware, Driver
  • Integration of medical sensors like Heart rate, ECG, SPo2 etc.
  • Integration of ECG calculation/Analysis algorithms
  • Custom DSP libraries integration for data analysis
  • BSP, firmware porting, Middleware and Embedded applications
  • GUI and application development using QT/QML, AWS, GCP, Azure
  • Secure boot, encrypted storage with on-the-fly decryption

Sensor and Wireless Integration

  • Wi-Fi, Bluetooth, GPS, GSM/GPRS, 9-axis IMU
  • Blood pressure, SpO2, ECG/EEG, Temperature
  • mmWave RADAR
  • Gyro, Camera, Accelerometer
  • Voice recognition, Gesture recognition, OCR, TTS etc.
  • Third-party Library Integration

Embedded / Web Apps

  • Custom iOS and Android Apps
  • End-use case development and Framework customization
  • Headless Android/Linux App and Interactive voice-based menu and
  • Low latency graph plotting for vital signs and data exchange with PC devices
  • Generation and storage of vital signs output
  • Web Applications and Real-Time applications using RTOS/Bare Metal
  • Integration of AI/ML Algorithms

Cloud/Web Services Integration


  • Currency/object recognition
  • Barcode scan and online Product search
  • Video Analytics
  • VoIP/Skype/Google Meet integration
  • Integration of custom DSP libraries

APPLICATIONS

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Blood Pressure Monitors

Desktop, handheld and wearable blood pressure monitor designs, integrating multiple connectivity features and an intuitive User Interface, ideal for individuals and healthcare practitioners.

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Temperature Monitors

Compact, robust and highly accurate temperature monitor designs integrating advanced MCUs, sensors and user-friendly HMI, ideal for home and clinical use.

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ECG and EEG

Reliable and trustworthy hardware, software and user interface (Web and PC Applications) for high efficiency ECG Machines that provide multi-protocol connectivity, noise-free ECG Signals and conform to Code of Federal Regulations.

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Pulse Oximetry

High performance, low power Oximeter designs using latest MCUs and Optical Analog Front Ends (AFEs) that reduce design complexity and enhance product accuracy.

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Glucometer

Handheld and pocket-friendly blood Glucometer designs using latest MCUs, sensors and user-friendly HMI, ideal for home and clinical use.

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Patient Monitoring and Tracking

Design for advanced Patient Monitoring and Tracking systems that incorporates mmWave Radars, Advanced SOCs, Graphics processors and runs advanced AI-based vision analytics.

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AAC Devices

AAC Device designs that incorporate the latest communication technologies, text-to-speech, gesture recognition, special keyboards, pointing devices, screen readers, and head trackers to facilitate differently abled.

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Hearing Aids

Analog and digital hearing aid designs (behind the ear, in the ear, in the canal) that integrate volume control, remote control, Bluetooth, directional microphone, wind-noise management and data logging among others.

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Vision Aids

Designs for vision aids such Desktop Magnifiers, Text-to-Speech Devices, Barcode Scanners, Electronic Notetaker, etc. that integrate latest communication technologies, connectivity and remote assistance.

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