Useful Articles - Business

Peter Drucker said: “Every few hundred years throughout Western history, a sharp transformation has occurred. In a matter of a few decades, society altogether rearranges itself, its world’s views, its social and polit

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

ical structure, its arts, its key institutions. Fifty years later a New World exists. And the people born into that world cannot even imagine the world in which their grandparents lived and into which their own parent

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

Examples of combination products may in

s were born.”

Unfortunately, for most people who live in a hierarchy, the speed of learning tends to be limited by those at the top. If they were a smart Henry Ford or Thomas Watson Jr., the organisation could lear

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

n faster than their world changed. If they were not that smart they might get an initial foothold but eventually competition and change would weed them out. We cannot learn faster than the world changes. Many outcomes

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

/outputs especially for business organisations depended on a much wider range of knowledge, skills, values, technologies and competencies. This forces us to learn and grasp a broader range at a faster speed. Why sho

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

Combination pro

uld Bill Clinton be so concerned over a cloned sheep? Why should a commission be set up to investigate cloning? Only because they were surprised by news, for what was assumed to be possible only in science fiction, an

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

d by the fact that no one in the government has the faintest clue on the likely consequences. Today change is nonlinear and not first order.

Otto von Bismarck, the German statesman (1815-1898) said: “Fools say they l

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

earn from experience. I prefer to learn from others’ experience.” Therefore, you too can profit from your competitors’ success and failure. The incandescent light bulb first emerged some thirty years before Thomas E

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

dison found the right filament. Henry Ford’s revolutionary assembly line came emulated Singers sewing machine and Campbell Soup meatpacking.

David Kearns former Chairman of Xerox in 1989 said: “We realize that we are

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

in a race without a finish line. As we improve, so does our competition.” But having done that, one has to quickly outpace your competitors in learning. Successful organisations are not only more profitable than th

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

ir competitors but also grow faster than they are. Many companies who are unable to learn faster than the competition degenerated from fast track to derailment as their competitors overtook them.

It is insufficient f

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

Following aspects would a

or a company to be merely a learning organisation, particularly, if it is learning the wrong things. During the pioneering days in China, some foreign investors resorted to cheating the tax authorities on import dutie

dd to the challenges in developing combination products:

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

s and declarations because everybody was doing it. It was easier for the local small operators to close down their operations and disappear into oblivion to evade the authorities. It is equally easier for them to spr

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

out somewhere else in China. However in the case of the foreign investors, they could not just disappear overnight as they had bigger investments and landed up paying the hefty fines for their misdeeds. These foreign

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

investors learned the wrong things from their small local counterparts.

At times too, the company needs to unlearn some of its earlier erroneous philosophy and lessons. In this fast changing world, the key question t

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

o survival is how fast this company can unlearn and relearn the new models and policies that can ensure its survival. Therefore it is also important to unlearn faster than your competitors.

Unfortunately, companies f

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

Professional from academic institutions, pharmaceutical industries, health care indust

all into the trap of learning the fads of management of downsizing and re-engineering. The vicious cycle continues with staff downsizing resulted in a skeleton force too weak to do anything then to further re-engineer

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

ing of the processes which results in the remaining staff being frustrated and leaving eventually.

These fads are much like your photos during your own teenage days and when you reminisce, you wonder how in the world

.

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

you ever got involved with that Company CEOs need to understand the basics in running businesses remain unchanged – handed down from our father, grandfathers and forefathers. CEOs should by all means learn from the

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

Companies that provide selfless information through particip

various new management theories but not to be mesmerised by them or to blindly apply them.

Therefore, you need to learn faster than your competitors. Also ensure you stop unlearn the wrong things and stop doing them

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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If there's one thing managers know best, it is this: recognition is a powerful motivator. If you praise your employees and acknowledge stellar efforts on their part, you will make them feel better about themselves and the hard work they put in.

How you sell your business and at what price are critical considerations to be aware of BEFORE the sales transaction is ever contemplated. This article presents strategies for sale that consider virtually every kind of potential buyer.

Different Types of Station Contact Reaching radio hosts (for the purpose of trying to get booked for an interview) can take on various forms, depending on the type of station the show is done at. What's best? All of them at the same time, of course. But since that's cost prohibitive for almost any guest, you have to pinpoint what will do an acceptable job for an acceptable price.

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