Bionix Spinewear Simulator.
Enabling more elegant orthopaedic device developmentAdvanced testing technology allows large medical device manufacturers to better mitigate risk and get new products to market faster.
The medical device industry has expanded rapidly over the past 20 years, driven primarily by entrepreneurial medical professionals conceiving innovative orthopaedic products to improve patient quality of life. Talented surgeons, engineers and scientists have fueled this rapidly growing industry, devoting enormous energy to bringing new designs to market.
But as larger medical device manufacturers acquire products to make them available to more patients, it has become apparent that the entrepreneurial model does not adequately address their product development needs. Specifically, the entrepreneurial model does not address large manufacturer requirements to more efficiently manage risk and get products to market faster.
In response to these pressures, many large manufacturers have followed the example of the aerospace and automotive industries, choosing to augment the entrepreneurial model with a more elegant and structured device development path. This “elegant” path gives manufacturers the engineering wherewithal to conduct meaningful testing earlier and more frequently throughout the development process, helping them to better mitigate risk and integrate advanced modeling techniques to perfect designs more quickly.
The Integration of Testing
The orthopaedic device industry is also seeing an increasing sophistication in patient quality-of-life needs, which is adding complexity to the devices produced to meet them. More engineers are integrating testing throughout development to meet the design challenges of these devices, from initial concept stages to clinical validation. This evolution in testing can be exemplified by the progression in required orthopaedic device testing need for the hip, knee and spine:
• Hip applications require 3 control channels and involve relatively few soft tissue considerations.
• Knee applications require 4 control channels and must account for greater soft tissue influence.
• Spine applications, highly complex in nature, require up to 8 control channels and have a very high soft tissue influence.
This evolution will certainly continue. As device complexity increases, the full integration of testing throughout the development of materials, components and full devices will become the norm.
Many test system suppliers are addressing the increasing sophistication of orthopaedic device designs by applying advanced test technologies originally pioneered for the aerospace and automotive industries. Multiple degree-of-freedom (DOF) control technology, increased processor speeds and more sophisticated test algorithms provide designers with precisely the multi-channel control and compensation they need to test today’s complex orthopaedic devices.
Integrating testing at all stages of development allows medical device manufacturers to perfect their designs more quickly, reducing costs and time to market. Design engineers also are able to develop safer, more reliable products using the data generated from their tests. That is why the U.S. Food and Drug Administration (FDA) now recognizes the link between testing and clinical studies, using test data from development to validate results observed in clinical studies.
The Rise of Virtual Modeling
Virtual modeling also is becoming increasingly commonplace in medical device development. This technique offers several major benefits to design engineers, including faster product development, reduced time to market and improved product quality and safety. Virtual modeling requires considerable resources to achieve critical mass, but it can be leveraged across multiple products once in place in a larger corporation.
The increased use of modeling will only increase demand for device testing. As medical devices become more sophisticated, more complex models will need to be developed. And as these models progress in complexity, they will need to be correlated with data gleaned from frequent physical testing. There will be a need for “discovery” testing in the early development stages, “verification” testing at the end, and for more model validation throughout.
Testing promises to increase in sophistication and frequency as modeling plays a more prominent role in the development of increasingly complex orthopaedic devices. Testing is gaining such a foothold that test engineers are being recruited from other industries to keep pace with the demand. Test equipment manufacturers also are being pulled into the mix at an earlier stage than ever before, helping medical professionals and entrepreneurs add testing equipment needs to their venture capital proposals.
And while the orthopaedic device industry relies on testing and modeling technologies developed originally for automotive and aerospace industries, it has pushed innovation in both of these areas to better meet the unique challenges specific to the industry. For example, the growing familiarity with advanced testing and modeling among clinicians and designers will further push device technology, and aging populations and elevated quality-of-life expectations will make this an extremely lucrative market. And the emergence of biologics for use in applications where soft tissues are a significant factor, such as spine, are opening up an entirely new arena for testing and modeling applications.
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