Main Subject - Business

When you think of all the things companies have, you do not always consider 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 knowledge they have. For instance, a company is only as good as its employe

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

Examples of combination products may in

es, its resources, and its knowledge. But, where and what is that knowledge?

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

ow is that knowledge managed within the company?

A basic definition of knowle

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

dge management is this. Knowledge management is a process that companies use

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

Combination pro

to generate value from their assets. Knowledge management can be much more, b

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

t this is the basics of it. Now, there are two types of knowledge management

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

to speak of at this point. One is explicit knowledge.

What is that?

It is t

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

he assets such as ‘paper’ assets such as trade marks, patents, files, employee

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

lists, customer lists, marketing research, and even business plans. The other

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

type of knowledge management is tacit knowledge. This type of knowledge is t

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

Following aspects would a

he stuff inside people’s heads. For obvious reasons this is the hardest knowl

dd to the challenges in developing combination products:

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

dge to manage. How do you know what is there and how do you put a price tag s

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

o to speak on it?

Knowledge management is a much larger concept then this. B

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

ut, companies often strive to figure out what their knowledge assets are and h

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

w to organize and place value on them. In many cases, programs can be used to

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

Professional from academic institutions, pharmaceutical industries, health care indust

help with organization and drawing in the knowledge itself. To find out more

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

on knowledge management, you can check out any of the many websites that expl

.

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

in it in greater detail. In order to be successful at knowledge management, a

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

Companies that provide selfless information through particip

business owner needs to understand the proper way to utilize it and manage it

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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Change can be pretty scary but it is inevitable. Find out the MAIN reason which makes dealing with change difficult.

Many new business owners and entrepreneurs fail to realize that they must treat their businesses as a professional organization from the smallest of details to the greatest.

If you are a true entrepreneur then you are a problem solver. You see a desire of a consumer of a product or service and you ask yourself; can I produce that and still retain a profit? If you can produce it and you are pretty sure you can make money doing it then you are well on your way.

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