New Product Design and Development Services

Duke Empirical designs and develops market leading products for use in global interventional and diagnostic medical device markets. Our in-depth expertise is specialized in the design of catheter based minimally invasive surgical and medical tubing products across a wide range of clinical market segments. Our experienced team of product development engineers utilize the latest material technology and processing equipment to produce the highest performing catheter and medical tubing products which are specifically designed to enable new medical procedures.

Product Design Verification

Duke Empirical provides design verification for new products according to EN 13485:2016 compliant design control standards to confirm that the design meets all of the defined requirements for the intended use. The design verification process confirms that the design input, which are provided by the client, meet the design output which is confirmed by empirical methods.  The process follows a phased approach.  In phase I, a preliminary design specification is developed from the client’s requirements as they are known at the time. This may be in the form of the client’s marketing requirements or may be a complete design specification or engineering drawing for a new product design which has not been built previously.
Duke Empirical assists clients with the preliminary design specification and provides guidance for informed specification development based on our substantial product development and manufacturing experience both at the concept phase and also the design screening phase. The main advantage our experience provides is efficiency in establishing an optimized design solution. Design screening begins with the design concept phase, followed by the design selection process with the client whereby we enumerate multiple design options each having the potential to meet the intended design goals. A matrix of considerations is used to weigh each design option in terms of priority, difficulty/complexity, cost, and the time to demonstrate design feasibility. 
Based on the selection criteria our clients often choose to pursue multiple design paths in parallel for development of functional prototype samples to demonstrate concept feasibility. In the design screening phase multiple design concepts are evaluated using testing methods that provide variable and attribute data to quantify and qualify a design in terms of the ability to meet the design requirements. Design screening may include engineering bench tests, preclinical experiments, physician preference evaluations and specific tests are used to investigate particular aspects of a design such as simulated use, force analysis, dimensional, fatigue, thrombogenicity, or other tests.  
During the design screening phase a series of tests are defined and conducted on samples to generate objective data for the narrowing of the designs to a selected design.  Upon design selection the milestone of Prototype Design Freeze is reached and the project moves to the design characterization phase where multiple copies of the selected design are built according to standard manufacturing processes for further characterization of the design specification for the product.
Depending on the client’s needs, Duke Empirical will lead the process and deliver a complete design solution, that is qualified, tested, manufactured and certified to meet all defined specifications including functional and dimensional requirements. Other client engagements are customized whereby Duke Empirical will perform a limited subset of activities to support our client’s design control process. This may include providing data for compiling design history records (DHR) and regulatory filings. Some examples of select design verification services are listed below:
  • Design Documentation
  • CAD Modeling
  • Functional performance evaluation – kink resistance, burst pressure, column strength, axial stiffness, elongation & tensile testing
  • Characterizing Design Performance – simulated use
  • Benchmarking comparable devices
  • Design of Experiments
  • Design for Manufacturability

Design Validation

Design Validation is, “establishing by objective evidence that device specifications conform with user needs and intended use(s)” (21 CFR 820.3).

Upon completing design verification, design validation activities are performed to ensure the design meets the user needs and intended use of the product. These activities require the design be manufactured according to manufacturing controls. Some of the activities in the verification phase are also activities in the design validation phase.  These include:
  • Bench Tests
  • In Vivo Testing
  • Physician Preference Testing – bench testing, cadeaver, preclinical, and clinical evaluation
Design verification confirms that the design output meets the design input requirements, while design validation ensures that the “right” product is made.
The distinction between V&V is made more clear in the following chart:
FDA CDRH 1997 Design Control Guidance for Medical Device Manufacturers

Development Services

Our development service options include:
  • FMEA (failure mode effects analysis)
  • Risk Assessment
  • Functional Test Plan creation
  • Testing Protocol Development
  • Design, fabrication, and implementation of testing fixtures
  • Test Method Validation
  • Supporting Regulatory Filings with Design History File Records
Our product development services are provided in conformance to Duke Empirical’s EN 13485:2016 certified quality management system ensuring that our development processes and manufactured products meet the latest federal requirements and international standards throughout the lifespan of your product from conception through commercialization.

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