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Assistive Percutaneous Pinning Device

Problem Background:

Every year there are approximately 6.3 million bone fractures, of which 1.25% of them are centralized in the upper extremities of the hand. If the hospital determines that a realignment is necessary, then the patient is scheduled for a percutaneous pinning procedure on the finger. This surgical process installs metal pins into the patient’s finger to prevent rotation and ensure correct healing of the bone. 26% of the patients who have this realignment surgery are required to come in for a secondary corrective surgery due to the fracture’s malunion or nonunion. The original surgery uses a trial-and-error system of taking x-ray images of the patient’s hand and incrementally guiding the pins into their finger. If done poorly, the surgeon will back out the pin and try again, causing stress on the patient’s hand tissue as well as additional time for the surgeon. This current solution costs the hospitals, patients, and insurance companies for unnecessary procedures that should have been correctly achieved during the first surgery. Existing devices on the market are too bulky for accurate pinning to be performed on the patient. Additionally, there is no method to check the correct pinning of finger without the use of many x-ray scans on said finger.

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Business Proposal:

Over the course of a six-year development plan, the product will initially undergo R&D to ensure x-ray analysis software hurdles are bypassed. Following this crucial step, benchtop MVPs can be built up for early stage validation and verification. Once a functional prototype can be built, animal and clinical testing will commence followed by regulatory and compliance filing through the FDA. Marketing will be performed in accordance with the team’s business model canvas and value proposition map, showcasing the key pathways to maximizing revenue within the first few years. Overall, if funding does not become an issue and development goes according to plan, this innovative product could be released in the year 2026 while expecting a breakeven point of just under two years later.

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Project Tasks:

Tasks included needs assessment, stage-gate processes, stakeholder analysis/competitor analysis, risk management, project management, marketing strategies, financial forecasting, product life cycle management, product launch strategies, idea pitching.
 

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Figure 1: Visual representation of current process

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