Medical Device Concepting

The Sanner IDP Process®, begins with understanding the user needs and requirements. As a medical device CDMO, our device concepts allow customers to easily visualize their manufacturable and reliable medical device.

Sanner Envelope

Medical Device CDMO Concept - IDP Process® Phase One

  • User requirement specification
  • Apply DfMA
  • IP & regulatory assessment
  • Functional & Manufacturability Assessments
  • Risk Assessment
  • Concept drawings

Medical Device User Requirement Specification

Designing a new medical or medtech device for a CDMO customer starts with understanding the customer requirement specification. We dive into the device’s required functional parameters and work through additional concept considerations such as user comfort, cost-efficiency, and manufacturability. As a medical device CDMO, device concepting is a critical step that carries through the entire design, development, and product stages and clarifies the user requirement specification.

Device Concept Stage Assessments

Once Sanner has a clear definition of the user requirement specification for the medtech device, our experienced device concept teams perform a series of assessments that direct the concept towards a practical, manufacturable design. Our CDMO experts start applying Design for Manufacturing and Assembly (DfMA) considerations at the earliest stages of the process. Sanner performs patent checks and provides regulatory advice that help guide device concept direction with the customer.  We rationalize standardization of materials, human factors, and sustainability at the concept stage as they can impact the product as it advances to design.

Device CDMO Concept Feasibility 

Sanner CDMO engineers look at the feasibility of the device concept from a practical scientific point of view.  Can the medical device concept incorporate all of the required functionality, and still be technically feasible to make? We understand the entire medical device development pathway and therefore build in device manufacturability and automation options for future production and assembly processes. Most importantly we set-up a comprehensive risk assessment to determine potential challenges that the medical concept could pose in future development and manufacturing phases and try to eliminate them at the device concept phase.

Concept Device Sketches

Once we’ve reviewed the user requirement specification and performed our comprehensive series of device concept checks and assessments, we start to bring the concepts to life through drawings. We complete hand sketches of the device, that allow our CDMO customers to visualize their device concept in a tangible integrated way. We can also build a digital device concept drawings using simplified CAD that can serve as the foundation for fully detailed CAD drawings in the next design stages.