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Technology commercialization assessment: near infrared wound healing monitor
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|Title: ||Technology commercialization assessment: near infrared wound healing monitor|
|Authors: ||Greenspan, Adam J.|
|Keywords: ||Biomedical engineering|
Near infrared spectroscopy
|Issue Date: ||30-Sep-2010 |
|Abstract: ||The following report is intended to examine the commercial viability of the Diabetic wound monitor using near infrared (NIR) spectroscopy, which is currently under development at Drexel University. The market conditions shall favor the introduction of this technology, as it not only addresses a currently unmet need, but also is expected to appeal to multiple and distinct groups of end users. The overall wound care management market exceeds $20 billion in the U.S., and the global wound care therapies market is growing at an 8% rate annually and forecast to reach $7.3 billion by 2013. With a global yearly incidence of ulcers at 37 million reported cases with more than half comprised of diabetic ulcers, there is a tremendous demand for an accurate assessment of wound healing. The ability to accurately assess wound healing would allow for a change in the course of therapy long before it becomes clinically obvious. The associated cost saving potential is substantial, providing a solid foundation in the pursuit of medical reimbursement for the clinical application of this technology.
From a development standpoint, the technology readiness level (TRL) is characterized as having nearly advanced to the midway point. The concept has been proven in animal models and in early human clinical trials to constitute a preliminary proof-of-concept. The first generation device prototype measures absorption and scattering coefficients of tissue in the range of 685 - 830 nm, where differences in absorption reveal changes in tissue oxygenation and blood flow, while differences in scattering correlate to tissue structure and inflammation. In all studies, the performance was stable as both healing and non-healing wounds consistently yielded values of the NIR absorption coefficient μa at the wound center and wound edges greater than values of μa at the control (non-wound) sites. This trend would be expected due to the reduced absorption characteristic of deoxygenated hemoglobin present at the wound site.
A failure mode and hazard analysis indicates that the device is headed toward the designation of generally regarded as safe (GRAS). While there are some minor refinements to consider in the engineering design, the element of risk associated with this device shall be considered low. A preliminary review of the regulatory pathway suggests that such a device would only require a 510(k) FDA approval, and a combination of predicate devices has been identified. The primary barrier to entry will comprise the intellectual property rights attainable for the present technology. A small portfolio of pending patents shall provide some protection, and its value shall be further assessed through a comprehensive patent landscape analysis. A preliminary landscape has identified a list of potential competitors and commercial partners provided herein.|
|Appears in Collections:||Drexel Theses and Dissertations|
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