Early diagnosis of Alzheimer's disease using terahertz eye tomography

¶ … USPTO website and pick a patent related to medical device or drug

Review the patent and write brief summary of the finding

Patent #7,828,438 Method and apparatus for early diagnosis of Alzheimer's using non-invasive eye tomography by Terahertz, provides a proposed method of detection and possible diagnosis for early stage Alzheimer's Disease (AD) through a noninvasive scan of the eye to compare the amyloidal plaque in the eye to a control. The findings of the patent is that the method may prove a viable method of detecting plaque deposits in eyes which have been shown in other research to simultaneously deposit on the lenses of the eyes as well as the key areas of the brain which are affected by Alzheimer's

b. Create a market survey plan

Market survey plan would include determination of efficacy of cortisol uptake and usage treatment of obesity, if the obesity population would be inclined to seek out this drug and if physicians would be likely to prescribe it to obese patients. Survey if there are other drug treatments with similar modalities.

c. Identify gaps and enlist how your product will fit in your overall market plan

Obesity treatment both medical and non-medical is a multi-billion dollar industry. Any newcomer in the form of a pharmaceutical or otherwise must be outstanding in its proven ability to produce results. Market share will be difficult to obtain and therefore the product must display marked abilities as well as a novel approach to obesity treatment.

3. Attached is an FDA audit 483

a. Review the FDA audit research finding and summarize what the finding is about

The finding is related to a tissue lab that produces implantable grafts and valves from human donors. The firm has been lax in its development of a program to respond to bacteriostatic complaints, i.e. complaints regarding post implant infections and concerns about the spread of microorganisms from donors to recipients. The length of time associated with a complaint vs. resolution/investigation was greater than 144 days in 70 some cases and the FDA believes this is lax and is reflective of the disorganized manner in which the QA department reviews, reports on and responds to claims of infectious transmission suspected to be linked to implants sourced from the firm. Examples of non-reporting and non-review are given by the FDA audit. Donor testing that does not match with post microbial testing is not reviewed to determine the source of microbial transmission. Lastly, three equipment maintenance issues were detected.

b. Explain all corrective and preventive actions that you will propose to be compliant

QA review and response systems similar to other industry leaders should be created and implemented. All parties responsible for microbial recording, reviewing and complaint review should be trained to use such a system and accountable when reports go active for longer than 60 days without completion and required reporting. Donor vs. implant microbial reviews should be improved. Lastly, mock equipment audits will be performed on a monthly basis to test equipment and make sure it complies with FDA and industry standards for maintenance and cleanliness.

4. Explain "build" vs. "buy" strategy in product development. Illustrate with an example how you would go about making a decision on whether to build it yourself or buy it from a vendor?

The "build" vs. "buy" strategy in product development relates to the decision of creating from scratch a new product or product component or buying the product from a producer who is already building it. The decision is largely one of logic as one must weigh the cost in both time and labor to determine the necessary strategy. It is assumed that the first step in any product development plan is to determine if another firm is already producing a similar or other similar products from what is proposed. If this is the case evaluation of how your product is different or innovative is necessary as is determining if you will continue with your idea and create a prototype to be developed by your firm, another producer or if you will build your product from already produced products on the market. Making this decision is often based on resources available, as well as the cost associated with building the product in any meaningful way. In other words it is one thing to develop a prototype, in research and development it is another to mass produce the product you wish to bring to market. Biomedical devices are often extremely complicated and consisting of many facets, and most often in the current market they are amendments or compliments to existing products. For that reason it is often wise to seek out expert advice on how to produce and develop the mass market needs of the product itself and who to market it to. Building new products is often extremely costly, and it may be wise to seek out a partner to do so or to seek out an expert organization that is already producing a similar product or the base product associated with the innovation that is your product and buy products from them or sell your product idea to them in a partnership situation.