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The old and standard business administration concepts included in any current MBA program are very importa

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

nt, but today the companies are very different.

This new situation strong demands a new MBA program inclu

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

Examples of combination products may in

ing the General Control Theory, the control engineering, the new business technologies, the Management by

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

Exception concept automated by computer systems, the Feedback Control System and several other subjects li

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 Internet Marketing & Sales.

As we know the CIO is the abbreviation of "Chief Information Officer" and i

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

Combination pro

a new professional, usually between the CEO and the other Directors including the IT Director. He don't r

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

eplace the IT Director, with the exception in small companies.

A CIO Chief Information Officer has entrep

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

eneurial experience and at the same time technical experience in Information Technologies. The entrepreneu

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

usually has only the entrepreneurial experience and the IT manager has only on technical matters. However

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

business is more and more the information system and the information system is more and more the business

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

The companies are more and more electronics, as for examples the ERP Enterprise Resources Planning, the

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

Following aspects would a

RM Customer Relationship Management, the Voice over IP VoIP, the sophisticated Call Centers, Business Inte

dd to the challenges in developing combination products:

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

lligence BI, the Internet, the new Internet Marketing, etc. Therefore, to survive a modern business admini

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

trator must learn those new ways to do the business and how to manage those modern enterprises.

In other

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

ords, the current MBA will be substituted by a CIO in a very short period of time. And a recent report fro

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

m the Association to Advance Collegiate Schools of Business, the primary accrediting body in North America

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

Professional from academic institutions, pharmaceutical industries, health care indust

lambasted its members for maintaining a curriculum that is out of touch with modern business practices. As

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

a matter of fact, the current MBA it's an 60-years old curriculum in the begin of this digital age.

Publi

.

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

shing Guidelines: You may publish my article in your newsletter, on your website or in your print publicat

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

Companies that provide selfless information through particip

on provided you include the resource box at the end. Notification would be appreciated but is not required

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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