Digg It - Business

The key is understanding at what layer you are managing your career and business, and where th

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

e opportunities are. When you can move to the right layer that most of your problems will disa

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

Examples of combination products may in

pear, and great opportunities to multiply results, revenues, efficiencies, profits, and employ

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

e results will go through the roof.

Do you know where you are in the levels of pealing back t

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

e layers of your career and business? It reminds me of the great philosopher, Shrek, who said

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

Combination pro

that Ogre’s come in layers. Well, so do businesses.

So, let's look at how MOST careers and co

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

panies are run. This isn't to say that you do it this way, but I want you to evaluate at what

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

layer you are working on, or at least how much time you spend at each layer.

Technica

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

or Business Focus

I've found that the more technical a business, the more technical

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

the thinking of the owners, top executives, and everyone all of the way down the ladder.

A si

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

ple explanation is to think of a cook in a restaurant that loves cooking, wants to go across t

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

Following aspects would a

e street and start his own restaurant. He is SURE that he can run a business better than this

dd to the challenges in developing combination products:

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

oss, so he's on his way across the street to his own business.

Of course, since he pictures h

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

mself as "a cook" he starts his new business working in the kitchen, making a better steak, a

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

better gourmet meal, a better tasting whatever. But no one is walking through the front door.

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

e hasn't learned that his main job is to RUN a BUSINESS not play cook.

In every profession, w

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

Professional from academic institutions, pharmaceutical industries, health care indust

all start with the knowledge and technical skills that are required in the profession. But as

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

we advance in our careers and move up the ladder of success, our technical skills become less

.

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

ritical in our continued success. When we are in a management position or have our own busines

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

Companies that provide selfless information through particip

, it becomes the business and communication skills that are critical for our continued success

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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