Design Solutions


Design Solutions Inc. is a medical device design and product engineering company established in 1998, with locations in Minnesota and Colorado. The company specializes in comprehensive and cost-effective engineering services including electrical, software, firmware, mechanical, verification, manufacturing setup, and regulatory testing. They are ISO 13485:2016 certified and have a strong focus on collaborative team partnerships, innovation, and industry expertise. Their mission is to assist clients in developing medical products from concept to manufacturing, ensuring quality, safety, and regulatory compliance.

Industries

medical
medical-device
product-design
software

Nr. of Employees

small (1-50)

Design Solutions

Chanhassen, Minnesota, United States, North America


Products

Wireless event recorder device (case study)

Next-generation ambulatory cardiac event recorder using a cellular modem platform; single-enclosure design replacing older two-box architectures.

Oximetry analysis software system (case study)

Windows application that transfers oximeter data, performs advanced analysis, generates reports, archives data to a database, and supports multiple languages.

Intra-compartmental pressure monitoring device (case study)

Integrated instrument for measuring and recording compartment pressure with touchscreen display, data logging, USB data export, and design for military airworthiness.

Peripheral artery disease measurement system (case study)

Redesigned single-enclosure peripheral artery disease detector that supports two-channel measurement and porting of legacy software code base.

First responder vital signs monitor (case study)

Ambulatory monitor that interfaces with garment-integrated sensors and wirelessly transmits heart rate, respiration, activity, position and temperature to a base-station GUI with alerting.

Contrast injector system redesign (case study)

Electrical redesign to replace obsolete components while minimizing software changes to reduce verification and validation effort and restore product shipment capability.


Services

Concept generation, specification development, proof-of-concept prototypes, and end-to-end design through manufacturing transfer.

Embedded real-time and user-interface development, desktop analysis applications, data transfer, and verification-ready software delivery.

Analog/digital circuit design, microcontroller/FPGA/DSP systems, motor control, telemetry design, PCB layout, and electrical test development.

Industrial design, enclosure and housing design, electromechanical integration, prototype fabrication, and material selection/testing.

Creation and execution of verification test plans and protocols to ensure devices meet product requirements and applicable safety/environmental standards.

Assistance with regulatory approvals, safety certifications, and alignment to medical device regulatory requirements.

Expertise Areas

  • Medical device product development
  • Embedded systems and firmware
  • Electronic circuit and signal processing design
  • Mechanical and industrial design for medical devices
  • Show More (4)

Key Technologies

  • Embedded systems (microcontrollers)
  • FPGA and DSP signal processing
  • Analog front-end for medical sensors
  • Wireless telemetry and cellular integration
  • Show More (8)

News & Updates

Design Solutions, member of MDRG, invite you to this exclusive webinar featuring former US Congressman Erik Paulsen.

DSI has been awarded ISO 13485:2016 certification, an international standard for quality management systems specific to the medical devices industry.

Jim Smith, President of Design Solutions, was recognized at the Medical Alley Association annual meeting for his efforts in developing R&D educational programs.

Design Solutions has been awarded ISO 13485:2016 certification, validating their ability to design, develop, and test medical devices that meet customer and regulatory requirements.


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