Medical Devices

Medical Equipment Design & Product Development

Medical Devices and Biomed Development

Boston Engineering solves complex engineering challenges for medical devices clients ranging from Fortune 500 companies to enterprising startups. We help clients through every phase of medical equipment design and product development — from managing the entire innovation process to resolving development hurdles within a product’s lifecycle.

With more than 20 years of successful design experience, Boston Engineering serves as a trusted partner for product development and medical equipment engineering initiatives. Our multidisciplinary teams create devices that help diagnose human illness, improve lifesaving care, and advance the surgical suite. And our ISO 9001:2015 and ISO 13485:2016 certifications underscore our quality management system for product design and development consulting services for the medical devices market.

Boston Engineering’s capabilities and expertise concerning medical equipment design:

  • Developing medical devices optimized for user needs, reliability, and technical performance
  • Designing and engineering technologies and products based on market insights
  • Redesigning mid-life products to improve manufacturability, reduce cost, ensure RoHS compliance, and replace obsolete components
  • Innovating via a phase-gate process that identifies and eliminates potential product development problems early in the development cycle
  • Managing risk throughout the product/device development process
  • Conducting product verification and validation
  • Implementing an ISO 13485:2016 certified quality management system that supports FDA best practices
  • Creating and maintaining design history file (DHF) documentation to fulfill FDA submission requirements

Product Development Experience

Our diverse background in medical devices innovation spans:

  • Automated genomic synthesis system
  • Bio-assay test system
  • Blood filtration process equipment
  • Computed Tomography (CT) power electronics and enclosure
  • CT patient table controls
  • Electrostatic wound healing bandage
  • Endoscopic device control console
  • Intravenous (IV) infusion pump
  • Microtiter dispensing system

Medical Devices Director

Paul has directed product innovation for Smith & Nephew Orthopedics and others.

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Medical Devices Testimonial

“…thanks to Boston Engineering’s fast response and dedication to ensuring that we were successful.”

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Defibrillator Case Study

Defibrillator redesign solves obsolescence and compliance challenges.

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