Biomedical Innovations

¶ … 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 Review the "claims" and present the details of what the patent claims The system is novel in that it does not use laser light, but instead claims to use a form of light that is non-damaging and can record layered images of the eye scan and then amalgamate them together to form a complete picture of the plaque deposits in the eyes (terahertz waves).

The claims of the patent are that the particular method will provide a three dimensional picture of the lens of the eye, through various terahertz technology scanning recording and refining that will be easily utilized and non-invasive to detect AD in stages early enough to facilitate early stage treatment, the most promising forms of current treatment for the disease.

The patent also notes in history that most other forms of detection require surgical intervention and that all other present forms of non-invasive detection only detect late stage abnormalities in the brain. c. Think of how you would design a similar product without infringing the patent claims A similar product might be developed that used differing light technologies, i.e. magnetic resonance imaging specific to the fine details of the lenses of the eye.

Other forms of light that are recordable might also be tried to develop a similar product with varied claims and similar results. 2. Think of a product / medical device or drug Drug to treat obesity that interacted with cortisol formation and storage. a.

Outline all the market information you need and how would you go about getting them Market information needed would include the severity and etiology of obesity as well as the proposed stress/cortisol causality of obesity, and how it creates obesity as a symptom rather than a disease state.

Additionally, current drug research would have to be reviewed to determine if this line of reasoning is valid and if there have been any previous cortisol drug or supplement treatments for obesity or links to stress related cortisol formation, usage and storage can be related to the state of obesity. Current patent search for cortisol related drug treatment. Current related research regarding stress/cortisol and obesity via peer reviewed medical journal search and review of articles. Survey obesity research centers for current findings on cortisol/stress related obesity treatments.

Review market competitors for all obesity related drug treatments regarding marketing, channels, effectiveness studies and other pertinent information. 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.