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“ Every failure is a blessing in disguise, providing it teaches some needed lesson one could no

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

t have learned without it. Most so-called Failures are only temporary defeats.”

Napoleon

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

Examples of combination products may in

ill

With fierce global competition, organizations need to change. Global values (GV) may be t

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

he key term for the millennium. Building on similar values will be crucial for multi-national orga

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

izations. Let’s explore this thought closer. Twenty-first century organizations can no longer crea

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

Combination pro

e values independent of others without any market input. Why should today’s leaders be concerned w

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

ith organizational values? Conflicts in values between leaders and followers can have a dramatic i

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

pact on the bottom-line of an organization. Hamel, author of ,i>Leading the Revolution, mainta

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

ins that these turbulent times are forcing organizations to adapt.

Creating shared valued with th

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

customer is a remarkable concept in today’s competitive climate. Prahalad and Ramaswamy (2004) ar

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

ue that an individual-centered co-creation of value between the customer and company is being gene

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

Following aspects would a

rated. Clearly, a check and balance system is needed because powerful people don’t always do what

dd to the challenges in developing combination products:

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

s right. Thieme explains, “The future is a social construction of reality.…Those possibilities wil

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

l be defined by our horizons and our horizons are in turn defined by the breadth of our understand

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

ng of complex societal changes.” While fewer organizations are embracing co-creation of values in

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

ypercompetitive environments, can any organization afford to be left behind?

References:

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

Professional from academic institutions, pharmaceutical industries, health care indust

Hamel, G. (2002). Leading the Revolution. New York: Penguin Group. Prahalad, C.K. & Ramaswamy, V

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

(2004). The Future of Competition: Co-creating Unique Value with Customers. Boston, MA: Harvard

.

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

Business School Press.

Thieme, R. (2004). The future is not what it used to be. Future Brief. Re

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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Your CV (Curriculum Vitae) – Resume for our American friends sells you to your prospective employer. It has to be straight and to the point. However too many CVs contain irrelevant information. What are the ten things that you shouldn't write in your CV?

A powerful lesson learned from Katina. Read how a major airline put lives ahead of profit...

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