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The first thing we do—let’s sue all the eye doctors. This 21st Century update on Shakespe

According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product

are’s famous quotation accurately sums up the attitude of many who have had a less than

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

optimal medical outcome for their eye condition.

Many people seek legal redress for a bad

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

medical result for which there is no legal blame. It may be that medical malpractice can

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

not be proven, or it makes no economic sense to try to prove malpractice.

Often the calls

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

I receive are spurred by nothing more than hurt feelings. Perhaps the patient simply fel

ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc

t that the doctor treated him or her with disrespect and wishes to get back at the doctor

easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi

by filing suit. The law does not provide a remedy for hurt feelings and, and it makes n

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

o economic sense to pursue a medical malpractice case unless the damages are severe and t

and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ

he liability fairly clear.

Medical malpractice litigation involves injuries suffered as

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

the result of careless medical practice. There are two important points to understand ab

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

out medical malpractice litigation.

First, not every bad or sub-optimal result from medi

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

cal care or a medical procedure constitutes malpractice. You cannot collect from the doc

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

tor’s insurance company simply because medical care did not achieve the desired result. N

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

egligence can never be assumed simply because an injury occurred. It must be proven in a

t?

As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel

legally sufficient way.

Second, even if you were the victim of medical malpractice, there

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

are numerous factors that play into the question of whether you have a winnable case. T

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

he fact that a doctor was negligent is only one of many considerations. Because of the m

.

As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de

any complex issues that make up a medical malpractice case, medical malpractice is not

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

the type of litigation a person should try to pursue without engaging a qualified lawyer.

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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Most companies that are worthy of raising venture capital have proprietary Intellectual Property (IP). In fact, the quality of the IP and the management team are often the two most important aspects of a venture capitalist’s investment decision. The challenge that many ventures face, however, is that most investors will not sign non-disclosure agreements (NDAs), and NDAs are critical to maintaining the proprietary nature of the IP. This article details the appropriate strategy for addressing proprietary IP in your business plan in order to attract investor attention while retaining the confidentiality of your inventions.

All of the talking heads have been telling us that this market is different. You are going to have to be patient and soon (hopefully in your lifetime) the DOW and the Nasdaq will be back at their old highs. They cite all the statistics about how the economy is improving - consumers are spending, the consumer confidence index looks OK, unemployment is getting better, blah, blah, blah...

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