Advice You - Business

Is knowledge management much to do about the dichotomy between the generalist and the specialist.

“The proc

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

ess of Knowledge Management or KM incorporates the desire to expand our range of inquiry with the need to simpl

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

Examples of combination products may in

ify our decisions.” (Wikipedia).

Simplifying our decisions. We are to decide over more and more discipline

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

s. That is a fact.

Take for example Internet. Below are sumerized six out of the twenty-four categories at ezi

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

nearticles dedicated to the subject:

Blogging-RSS
Affiliate-Revenue
Security

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

Combination pro

Podcasting

SEO

PPC-Advertising

So there are twenty-four categories and ea

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

ch category probably will have its expert. The main expert on the topic. Then you will have authors who will wr

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

te more about all of the areas.

Now you are managing a company where ten out of the twenty-four expertises are

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

needed in the daily operation. How much should you know as a manager or even as an entrepreneur? You will most

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

certainly not start a business if you do not know the first thing about it. Internet in this case.

But the mo

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

re you are dealing with growth and the more people you are to direct, the more you must KNOW how to manage - -

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

Following aspects would a

the knowledge.

The knowledge management function as described here is allocated with the generalist. He or she

dd to the challenges in developing combination products:

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

should know just enough to manage the knowledge of the others in the process.

It is the challenge to concentr

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

ate on what you need to know, rather than first trying to know it yourself. (This happens a lot however, and th

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

t is not strange if you think about it; you want to KNOW where you are...)

For example. Each expert will not o

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

nly know through (to a certain dept) a specific topic, he or she will also have a certain approach in gathering

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

Professional from academic institutions, pharmaceutical industries, health care indust

this knowledge. You can think of someone who needs to examine in dept a certain topic itself, where the same k

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

ind of expert would more easily trust on the hint of another guru in the area.

Even amongst specialists there

.

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

is a big variation in the organizing approach. As a manager you should focus on the process and on matching the

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

Companies that provide selfless information through particip

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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