Manufacturing & Prototyping Partnering with Engineered Medical Systems to Deliver Medtech Innovation


Founded in 1986, Engineered Medical Systems ( is an ISO-13485 Medical Device Manufacturing organization with facilities based in Indianapolis, Penang, Malaysia and Baltimore. They are a privately held company specializing in manufacturing devices to client’s specifications, while developing and manufacturing their own line of proprietary disposable air management and electromechanical products. Manufacturing capabilities and OEM services for clients include:

  • Product design from concept to completion
  • Prototyping with in-house 3D printing
  • Tooling design and build
  • Injection molding with state of the art equipment
  • Complete assembly, gluing, sonic welding, product testing
  • Offshore sourcing with Sourcing Manager stationed in China
  • Management of Third Party Product Testing, including:
    • Bio Compatibility
    • Sterilization Validation
    • Software V&V
  • Assistance with 510k Submissions and Letters to the File
  • Logistics coordination including drop shipping directly to clients customers

They produce private label products for several firms using their proprietary designs and 510k’s and commonly license patents from inventors to use those designs and technology in some of their products.

Pulmodyne® is the brand name for their proprietary portfolio of products. Please see details at

The Pulmodyne distribution channels have over 200+ representatives calling in the US Hospital and Emergency markets. Internationally, Pulmodyne products are CE Marked and distributed in over 60 countries, managed by an Indianapolis-based Vice President of Sales & International Sales managers. Five regional Sales Directors, stationed in Europe, the Middle East, Africa and the Far East manage local distribution channels.

Engineered Medical Systems can help you with your transition from prototype and proof-of-concept to commercial manufacturing. For info:
Contact: Jeff Quinn

Residents can also operate their own manufacturing cells within the regulated device facility. For more information about these LaunchPort services:
Contact: Bob Storey

Get Started

Let’s build something together.

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