A group of investors had placed several million dollars into a “Biotechnology” company. The company had developed an in vitro diagnostic device, but despite having been in business for almost four years, had not sold any of the product. The investors were continually being told that market introduction, and millions of dollars in sales, were anticipated “within two weeks”.

 

The investors called Westbury Diagnostics, Inc. in for a single day of consulting. The purpose of the consult was to inspect the company, and critique its device. After the visit, Westbury issued a full report indicating that the device was several months away from being able to be manufactured reliably, and released to the market.

Based upon the initial report, Westbury was called in to perform an in-depth analysis of the device. This analysis included a brief market survey, as well as a full study of the product’s ability to be manufactured reliably. Within two weeks, Westbury had arranged to have the device tested in one of the major NYC hospital laboratories it has in its network, in an actual clinical setting. It also tested several of the devices in its own laboratory. Unfortunately, the analysis revealed that in actual practice, the product was clumsy, and that the lab technicians did not like it. In addition, we found that even at full production levels, as envisioned, the product would cost more to manufacture, than a customer would be willing to pay.

 

The final report to the investors summarized all of the findings, and also contained suggestions for modifications that might make it acceptable to the lab clinicians, at a higher sales price. Westbury performed its entire study, including the clinical evaluation, at a cost that was less than the investors were then losing, every three days.

A manufacturer of in vitro devices was having a major problem on their production line. The problem had resulted in a delay in manufacturing. This in turn led to a delay in stocking, and had created a back order situation. A Westbury client suggested that the manufacturer contact us. After listening to the problem over the phone, our product development staff recognized the symptoms, and realized that this was a problem that we had experience with.

 

Since time was of the essence, the Westbury staff recommended immediate actions, over the phone, for the manufacturer to take. This was rapidly followed up by a full report, complete with references to the scientific literature. Westbury then prepared a protocol that allowed the client to inexpensively test for, and monitor, the situation in the future. In this way the problem was avoided entirely.

As a result of corporate restructuring and downsizing, a manufacturer of in vitro diagnostic devices found itself with a familiar problem. It was in the midst of conducting a critical and time dependent multifaceted line extension project, when the company was “downsized”. As a result, it did not have the R&D resources required to analyze data that was being obtained in the ongoing study.
 
The analysis was critical, because the data was required to plan for additional, extensive lab work, required for the final product approval. Westbury Diagnostics, Inc. was contacted and asked to submit a proposal for both the data analyses, and the lab work. An in depth proposal itemizing the project in a step by step fashion was drafted, completed, and sent off within one week.
 
The company decided to pursue the project, but informed Westbury that they could not approve funding of a project that large, until the next fiscal year (six months later). Realizing the time and monetary constraints that the potential client was under, Westbury took the initiative to put together a second proposal to perform the data analysis portion of the study quickly, and inexpensively. In doing this, data from those facets of the study that were found to require no further work were able to be put into a final package, that could be sent off for review. The company was able to convert time that would have been wasted, waiting for endless approvals, into time that was used positively to move the project forward.

R&D gun for hire

Long Island Business News
July 19, 2002

Lorrence Green is known for inventing Long Island’s first biotechnology product, a test kit for measuring streptococcus antibodies. Since 1981, Dr. Green has developed over 40 tests currently used by clinics and hospitals to detect microbes. In March 1999, Green moved Westbury into the Long Island Forum for Technology’s incubator at SUNY Farmingdale and has been there ever since. His invaluable experience in the microbiology sector of diagnostics has led him to commercialize and patent multiple biotech products. In addition, Westbury Diagnostics has a proven track record of outsourcing clinical trials and succesful FDA submissions.

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Westbury Diagnostics, Inc. is a full service organization which works with clients to generate solutions to problems in the bioscience industry. We specialize in unique niche projects that require a broad range of abilities under a single roof. We help identify issues or conflicts in your project, formulate solutions and develop them in house. Our clients seek custom R&D work, due diligence, or FDA guidance in the bioscience and venture capital sectors.

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