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Experienced Medical Device Experts can assist with a case in many different ways. First, they have industry knowledge of the medical device industry and can assist with prior art in patent litigation cases for example. They understand the technology and how claim terms are understood for one skilled in the art of medical device design, testing, and manufacturing. This firsthand information can then assist with proper claim construction and infringement analysis. Experience with medical devices product development can also assist in determining what is obvious in the field and what is not as it pertains to patent validation.

Medical device experts with access to their own laboratory and test equipment can test medical devices and report personal experience on the results. Addition of photographs and video of macroscopic and microscopic views create powerful demonstratives that are worth more than a 1000 words, especially when the expert has access to Scanning Electron Microscopes (SEM) and small bore scopes to look inside devices to see and create videos on how they operate. This in addition to making cross-sectional cuts of small parts encased in epoxy allows a full analysis of a device so that both parties in a case, including a judge and jury, can understand the operation and parts of a device. The picture below is an example of a Needle-Free IV Valve that was encased in epoxy and cut in half. The red epoxy shows the blood fluid path and the yellow shows a separate volume of space in the valve. The clear or blue tint portions are the walls of the plastic valve. This valve is being activated by a male Luer lock fitting.

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Tests done using calibrated equipment can help both plaintiffs and defendants for medical device liability cases. Devices can be tested to see if they caused the injury and analysis can often lead to the root cause of the failure and/or injury. The results are then backed up by data, pictures, and/or video to support how the tests were performed and under what conditions.

Another more recent area where a medical device expert can assist with a case is in depositions of the other parties' experts or fact witnesses. An expert can assist with forming good technical questions and can help an attorney understand the answers that are given by the witness. Many times a properly asked and answered question during a deposition can make or break a case and having experienced technical support can be a great asset.

In conclusion; a medical device expert is a valuable asset to both patent litigation and liability cases and can assist in all parts of your case from initial document or patent review, to testing and analysis, pictures and video for demonstratives, assistance with depositions, and finally confidence and knowledge for a thorough and easy to understand testimony with clear articulated answers under cross examination.

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Karl Leinsing, MS, PE, is the President of ATech Designs, Inc. and focuses on medical device product development from concept to production. His medical device experience includes, but is not limited to, intravenous (IV) systems and pumps, needle-free IV valves, catheters, syringes, hernia repair, laparoscopic instruments and staplers, endometrial ablation, cardiovascular systems, mitral valve repair, abdominal aortic aneurysm (AAA) repair, spinal plates and screws, sleep apnea devices, and peritoneal dialysis machines. Mr. Leinsing has been granted many patents, is the winner of five medical device design awards, and is recognized as one of the top 100 medical device professionals in the country by MD&DI Magazine.

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