Medical Device Design and Development

Medical Device Industry Solutions

With more than three decades of experience in electronic product development, Tri-Star Design has successfully launched a wide range of healthcare products. Our team consistently delivers solutions that not only meet but exceed our clients’ quality expectations and cost objectives.

Tri-Star Design has medical device product development experience across a variety of technologies, including: motor drive and control system applications, bio sensors, bioimpedance, biopotential, optical technologies, and more. We develop medical device products utilizing our ISO 13485 design process and have experience with a majority of the medical device standards including: IEC 60601-1, ISO 62304, and ISO 14971. Tri-Star Design works closely with your team throughout all phases of the development cycle to ensure your product is ready for proof-of-concept, prototyping or clinical trials.

The Tri-Star engineering team includes experts in precision measurement and control, thermal analysis, embedded processor design, wireless design, power supply development, motor drives, FPGA development, communications protocols, device drivers, plastic and sheet metal design, board cost reduction, reliability and more. Such a broad range of technology expertise permits our team the ability to take on any project within a variety of medical device products. In addition, Tri-Star Design is partnered with industry leading semiconductor suppliers, exclusively trained and design experts on their latest healthcare targeted products.

Applications in Medical Device Design

Medical Device Design Project Examples

Self-injecting EpiPen

Ambulatory Infusion Pump

Ventricular Monitoring

Medication Adherence

Pill Station

Biosensor Product Development

Tri-Star Design biosensor development provides the technology needed to collect, manage, and process data samples. Our low-power electronic designs utilize advanced wireless communication technology, enabling seamless data analysis on smartphones and tablets for both home and clinical applications.

Electrochemical and Bio-Impedance Platform

By leveraging the latest technologies, Tri-Star Design has developed a biosensor platform that supports high-precision measurement and control, low-power high-performance digital signal processing, and industry-standard wireless connectivity.

ISO 13485:2016 Certified

Companies that achieve the ISO 13485:2016 certification must meet the stringent product safety, reliability, and quality requirements of the International Organization of Standardization (ISO). ISO 13485:2016 certification involves demonstrating best practices throughout all stages of a medical product’s design and development cycle.

ISO 13485:2016 certification is recognized throughout the international medical device industry. The QMS under this certification defines audit, management review and continuous improvement processes focusing on solving customer needs thereby providing more expedient medical product design execution with increased satisfaction.

As a best-in-class product design company, Tri-Star Design is committed to supporting customers in the Medical Device sector.

Healthcare Development Partner

Working in partnership, PDD and Tri-Star Design offer healthcare clients an opportunity to get ahead, with products and services that work for people, make the most of emerging digital technologies, and address complex challenges in the highly regulated medical industry.

Learn more about our partnership with PDD