Full citation

Norlin-Weissenrieder, A. & Board, S. (2007). The Importance of Advanced Material Selection and Testing Strategies. Medical Device Technology, 18(5), 22-27.

Format: Peer-reviewed article

Type: Experience

Experience level of reader: Fundamental

Annotation: The success of NPD can be increased by employing a strategic and integrated approach to material selection and testing. The value of this approach is described in case examples.

Setting(s) to which the reported activities/findings are relevant: Federal lab, Government, Large business, Small business (less than 500 employees), University

Knowledge user(s) to whom the piece of literature may be relevant: Manufacturers, Researchers

Knowledge user level addressed by the literature: Organization

This article uses the Commercial Devices and Services version of the NtK Model

Primary Findings

Barriers:

  • Material-related failures are multi-faceted and include mechanical failure, corrosion, material interaction, material chemistry and bio-compatibility. While the mechanical aspects are considered, issues related to fundamental material properties are often neglected. Even simply failure modes can cause major disruptions to a project if left unaddressed or discovered too late.
    Case studies and author experience.
    Occurrence of finding within the model: Stage 2, Stage 4
  • Medical Device NPD — Biological testing is very expensive and consumes a good deal of elapsed time. For example, biocompatibility testing can cost tens of thousands of dollars and take months to complete.
    Case studies and author experience.
    Occurrence of finding within the model: Stage 5, Stage 6

Carriers:

  • Medical Device NPD — Chemical characterization (ISO 10993-18) of materials, can substitute for biological testing, to establish equivalence of new devices to predicate devices.
    Case studies and author experience.
    Occurrence of finding within the model: Stage 5, Stage 6
  • Subject experts, such as material scientists, can screen different material technologies and select the best solution for the intended device. Interactive and parallel material-device design strategies are advantageous in the Concept Phase.
    Case studies and author experience.
    Occurrence of finding within the model: Stage 2, Stage 4

Measure: The execution of various test protocols is of great important during the early stages. These tests are necessary to evaluate novel technologies, make appropriate design decisions, and gather data to support submissions to regulatory bodies. It is necessary to involved subject experts to define test strategies. Poorly designed test strategies can obstruct the NPD process.
Case studies and author experience.
Occurrence of finding within the model: Stage 2, Stage 4, Stage 5, Stage 6

Model: Most medical device companies utilize some sort of NPD process to ensure their devices are developed in a cost effective, controlled and quantifiable environment. Stage-Gate Models divide the process into successive stages such as Concept, Plan, Design, Verification and Release.
Case studies and author experience.

Methods:

  • Bench tests generate useful data for regulatory reviews, for creating discussion points with the regulators, and for designing the laboratory and field testing by users.
    Case studies and author experience.
    Occurrence of finding within the model: Step 5.3
  • Knowledge gaps in the NPD project team directly influence the quality and efficiency of its deliverables. Even small changes in the design can introduce weaknesses or failure points, even when all materials are kept the same. It is critical to ensure that the team is comprised of people with the appropriate variety of skills and experiences.
    Case studies and author experience.
    Occurrence of finding within the model: Stage 4, Stage 5, Stage 6
  • Regulatory bodies in different nations have different requirements and different approaches to specific tests. It is possible and helpful to identify a global submission strategy that can, at least partially, be used for several nations or global regions. It is particularly important to interact with regulatory personnel to stay up to date on current regulatory requirements.
    Case studies and author experience.
    Occurrence of finding within the model: Step 4.5, Step 7.8
  • To obtain clearance or approval to market and sell a medical device, the manufacturer must provide the Notified Body with all information necessary for proper assessment of the device's conformity to specified requirements.
    Case studies and author experience.
    Occurrence of finding within the model: Step 4.5
  • Testing in the Medical Device Industry: Medical devices are classified according to the level of control that is necessary to ensure the safety and effectiveness of the device during its intended use. The U.S. FDA and the European Medical Device Directive identify three classes, with Class III requiring the greatest control.
    Case studies and author experience.
    Occurrence of finding within the model: Step 4.5