What is the quintessential nature of a “perfect” medical device?

 

Answer:  A device where the effectiveness, versatility, and problem solving ability of the medical device far out weighs the cost of the device.

 

 

Why do we refer to Ex-Press-Fix as "The Problem Solver?

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Answer:  The beauty of Ex-Press-Fix lies within its lack of complexity while simultaneously solving many problems with regards to surgical pin fixation. By innovative evolution and simplicity we were able to transform the problems of today’s generation of medical devices into the future generation of medical devices.

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What are some causes of surgical pin site infections?

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Answer:  Surgical pin infections can be caused by a variety of reasons such as: a compromised intra-operative sterility process and pin site drainage laden with skin flora seeping into the surgical pin site. In addition, patient co-morbidities (Diabetes, Peripheral Vascular Disease, Immune Compromised Patients) can facilitate a surgical pin site infection.

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What are the causes of surgical pin loosening?

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Answer:  Surgical pin loosening is the decreased contact continuity between the surgical pin and surrounding bone at the bone-pin interface. Factors that can affect surgical pin loosening are: infection, surgical pin type (un-coated pins. versus bio-ceramic  coated pins), pin insertion technique (pre-load, pin orientation), pin site thermal osteo-necrosis and frame stiffness (frame/ skin distance, pin to pin distance).

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What is the correlation between surgical pin loosening and surgical pin site infections? 

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Answer:  Surgical pin site infections can cause osteolysis at the surgical pin site. Subsequently this can lead to surgical pin micro-motion and loosening.

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With the advent of bio-ceramic coated pins (HA) how can Ex-Press-Fix increase pin stability?

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Answer:  Ex-Press-Fix acts as a variable compression closed wound dressing housing. This design was purposeful in that it will decrease pin site drainage and ultimately decrease surgical pin infections (one cause of surgical pin loosening). In addition bio-ceramic pins provide pin stability at the bone-pin interface while Ex-Press-Fix stabilizes the pin at the skin-pin interface. Therefore, Ex-Press-Fix would potentiate the overall beneficial effects of bio-ceramic pins by providing a secondary mode of pin stabilization at the skin-pin interface.

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How Cost Effective is Ex-Press-Fix?

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Answer:  

Through precision and problem solving we were able to design a device that would eradicate the high costs associated with the post operative care of patients with external surgical pin fixation devices. 

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In Hospital Costs

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• Shorter Hospital Admissions

• Better Staff Utilization (less staff needed)

• Decrease in medical supplies

• Decrease in medical waste

• Decrease in surgical pin infection after care

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Outpatient Costs

• Decrease need for wound expensive wound dressing materials

• Less need for home health care

 

 

What is the device itself composed of?

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Answer:  The device would be composed of a high grade medical plastic. This material would be capable of withstanding both compressive and shear forces associated with the use and repeated application of the device.

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What is the wound dressing itself composed of?

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Answer:  The wound dressing could be made from various pre FDA approved wound dressing materials. The type of material would depend on the intended use of the device and the clinical circumstances in question.

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What is the process of developing Ex-Press-Fix?

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Answer: Through the use of 3-D printing, a fully functional prototype was created. The medical device is manufactured utilizing an injection molding process.

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