Device Development

Many cell and gene therapy products require highly specialized devices for manufacturing, storage, transportation, and/or delivery. Our device engineers design a customized device solution that meets the unique needs of your product.  We assist you with manufacturing and regulatory support for implementation of your device solution.

URS development

Working with your team, we define the specific user requirement specification (URS) for your required device solution.


Landscape scan and gap analysis

Once a URS is defined, we evaluate the landscape of available devices to determine if an existing solution can meet your needs.


Custom device design

If an existing device does not exist that can meet your requirements, our device engineers design one for you.


Contract manufacturing management

Once a concept design is developed, our team leads Request For Quotation (RFQ) authorship, engineering firm selection, and project management oversight of prototype and final device manufacturing.


Regulatory documentation

We assist you in authorship of Design History File(s) (DHFs), Device Master Files (DMFs), and any other required documentation for your device.

Other Core Capabilities

DHC Experts in

Device Development

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