Medical Device News
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Expertise in the specialization of idea development, improving implants and external devices
Human Physiology and Biomechanics
Extensive knowledge of anatomy and biomechanics for specialized implant location analysis. Specializing in :
- Spinal motion (cervical, thoracic, lumbar, and lumbosacral)
- Shoulder motion (rotator cuff, clavicle, scapula, and humerus)
- Head and neck injury biomechanics
- Gait (motion, accelerations, and linkage system)
- Vascular motion within the musculoskeletal system
- Cardiac and respiratory motion
All pertinent structures and motions in the implant location are identified and evaluated for relevance. Analysis provides parameters for device/implant design and function. Implant stress and fatigue motion are also identified for life cycle testing. Documentation (i.e. white papers, engineering test reports, etc) of analysis and resulting test methods are provided for FDA justifications.
This process, completed at the beginning of the initial desing phase, provides parameters for materials, geometry, and performance. It can also prove to be useful to current designs to ensure in vivo integrity. Becoming knowledgeable on the motion and surrounding structures of your device location, whether it is stabilizing a knee or pacing a heart, allows better designs to progress.
Mechanical Design Assurance
Test Methodology and Experimental Testing
Mechanical characterization tests of materials and subassemblies are developed to provide a baseline of their performance. Combining this with test methods and protocols developed from biomechanical analysis and existing standards (i.e., ISO, EN, etc), will ensure mechanical integrity in vivo. Recommendations on testing design and parameters are tailored to the specific anatomic location and physiological motion around the implant or device.
The design and development of these tests can be provided with the extensive knowledge of implant testing in cadavers, that include spinal motion segments (base of skull to sacrum), shoulders, knees, hips, hands, rotator cuffs, and vascular sections.
Laboratory Assistance
In addition to testing design and parameters, laboratory review and set up can be provided whether it is expanding an existing lab or starting in a new space. Recommendations on testing systems based on individual/company need and budget. Will provide guidance through purchasing, setup, and training.
Optimization of device design
In vivo analysis in animal models, aid in the preclinical development of the design. Optimizing these studies increases the understanding of in vivo performance, as well as decreases the number of studies needed to be done.
Developing realistic bench models that mimic conditions of implant delivery and explant can prove to be extremely useful identifying challenges in tools and implant interactions. Bench models also provide a place for the clinical team to practice with new designs and provide feedback to the design engineers. Systems can be tailored to specific implant locations from insertion to delivery site.
Communicating with the clinical team and applying in vivo results to evolving engineering designs help develop clinical protocols designs and determine best possible implant configuration for success. Services include explant analysis, writing protocols and designing experiments to solve challenges.
Cine and x-ray analysis can also be provided. Cadaver and animal model (canine, porcine) analysis experience.