Cases - Business

Machiavelli emphasized on building a strong organization structure where responsibilities and accountabilities are clear

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

ly defined and offender should be dealt with no mercy. As per him an organization or kingdom can be built on the support

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

Examples of combination products may in

of either the people or the nobles.

“A principality is created either by the people or by the nobles, accordingly as on

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 or other of them has the opportunity; for the nobles, seeing they cannot withstand the people, begin to cry up the rep

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

tation of one of themselves, and they make him a prince, so that under his shadow they can give vent to their ambitions.

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

Combination pro

The people, finding they cannot resist the nobles, also cry up the reputation of one of themselves, and make him a princ

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

e so as to be defended by his authority. He who obtains sovereignty by the assistance of the nobles maintains himself wi

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

h more difficulty than he who comes to it by the aid of the people, because the former finds himself with many around hi

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

m who consider themselves his equals, and because of this he can neither rule nor manage them to his liking. But he who

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

eaches sovereignty by popular favor finds himself alone, and has none around him, or few, who are not prepared to obey h

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

m.” ( Machiavelli, Chapter 22)

Machiavelli mentioned throughout his book that the kingdom built on the goodwill and s

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

Following aspects would a

upport of people have more chances of surviving for a length of time than one built on magnanimity or benevolence of the

dd to the challenges in developing combination products:

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

nobles. Similarly if the employees, majority shareholders and customers believes in the vision of the leader and don’t b

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

etray him then the leader will have far higher chances of survival. As it happened in the recent case of General Motors

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

he CEO able to convince the Board that the company has an ability to turn the business itself rather than making a deal

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

ith Nissan. The main backer of the prospective deal – Major shareholder Kerkorian had to eat the humble pie and ended up

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

Professional from academic institutions, pharmaceutical industries, health care indust

selling 14 million shares in the open market. If the company had gone Kerkorian way it may have ended up in loosing its

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

freedom and as most experts believe Kerkorian would have been one of the key members in post deal management formation.

.

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 such a dire situation the end should justify the means and GM exactly did what Machiavelli suggested listening to the

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

Companies that provide selfless information through particip

core stake holders rather than nobles who are looking for their own personal benefits and chance to overthrow the Prince

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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Cases - Machiavelli: The Prince - Lessons in Organizational Structure

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