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It is considered that professionals in our society are knowledge workers. Are Doct

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

ors, Accountants and Lawyers really knowledge workers?

Well in reality not ALL pr

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

Examples of combination products may in

ofessionals are knowledge workers, but they work in the areas we consider knowledg

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 based. Many of these professions are actually parasites in locked down domains b

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

all hogging information from others. Many time lawyers work very hard to hide the

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

Combination pro

laws, government forms and access.

If all these professionals are knowledge worke

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

rs, why then lets teach them how to think then? It would be good if we use the Hum

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

an Knowledge MindMap to teach these folks to think. Maybe they might pull their ow

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

n weight rather than living off the creme.

Being a professional is only a label e

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

nabling the worker to charge more than they are worth generally and calling them k

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

nowledge workers is a justification to continue. Although 15-20% probably are wort

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

Following aspects would a

h it.

Now then, William Sheridan, Founder of The Human Knowledge MindMap states;

dd to the challenges in developing combination products:

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

“They are all knowledge workers, but most don't have a clear overview of the basis

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

of knowledge skills for knowledge work.”

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

r2/WebMindMapBook.pdf" target="_blank">http://www3.sympatico.ca/cypher2/WebMindMap

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

Book.pdf

Indeed and thus it would be wise to help fix these issues and get th

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

Professional from academic institutions, pharmaceutical industries, health care indust

em to use MindMapping to better do their jobs as knowledge workers. Helping profes

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

sional knowledge workers stay knowledgeable is a key to the future knowledge socie

.

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

ty and we must consider the importance of this endeavor if we are to propel our na

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

Companies that provide selfless information through particip

tion forward. I sincerely hope that this article has helped propel thought in 2007

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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