Main Subject - Business

If you look at Big Business as a consumer you will find some startling changes in common sense business et

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

hics. Banks are defending themselves from class action lawsuits due to unethical practices in charging abs

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

Examples of combination products may in

urd fees for everything from withdrawing your money to closing your accounts. Banks are percieved as being

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

highly ethical due to the fudiciary nature of the business, yet here they are being sued for precisely the

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

opposite. Cell phone service providers, cable providers and a host of other huge national brand companies

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

Combination pro

have slowly changed the face of business by hiding behind huge complex contracts that the consumer signs

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

n order to obtain a simple service. In the contracts are fees that are never discussed and are simply hidd

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

en in the legalese of the contract. If a price is quoted as $40/month the end user is usually surprised to

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

find in the bill an additional $20 to $40 in additional fees.

Over the past 20 years this creep of hidde

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

fees has become accepted by most of the end users as the price of doing business. Only because of the lac

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

k of competition due to mergers and buyouts have these companies been able to retain their customers. Ther

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

Following aspects would a

e has been a remarkable lack of backlash agianst these companies and their neferious ways of doing busines

dd to the challenges in developing combination products:

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

until only recently. Companies have increased their return on investment (ROI) because of trickery rather

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

than true business growth. While applying fee's is an acceptable way to increase revenue for a company th

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

e manner in which they do so is circumspect to say the least. A fee that is never discussed or clearly wri

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

ten is hardly good business.

If you own or plan to own a business, do the right thing and gain customer l

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

Professional from academic institutions, pharmaceutical industries, health care indust

oyalty and trust by making additional charges clear and open in all discussions and contracts. If you are

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

hiding behind large contracts to hide fees and charges as a way of doing business you may be legally in th

.

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

right, but you will also be doing your customers wrong. In fact, as the banks can current attest, you may

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

Companies that provide selfless information through particip

not even be legally in the right and end up in litigation for years that could possibly end your business

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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