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If one does not understand a person, one tends to regard him

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

as a fool.

Carl Jung

Sadly, public discou

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

Examples of combination products may in

rse today seems to have degenerated into warring parties spitting

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

epithets at one another. With little inclination to see the othe

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

r’s point of view, the parties are reduced to name calling, label

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

Combination pro

ing and the simplification of complex issues. The only commonalit

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

y is the shared belief that the other guy is a jerk.

Thanks t

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

o Jung’s pioneering work on personality type, we know that there

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

are at least sixteen discrete ways to view any data set. This mea

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

ns that given any situation, there are sixteen different, though

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

perfectly normal, ways of evaluating it. Not surprisingly, sixte

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

Following aspects would a

en different points of view might yield very different conclusion

dd to the challenges in developing combination products:

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

s.

Too often we tend to ignore or demean points of view that d

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

on’t match our own. Respecting that there are other, equally vali

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

d ways of approaching the same subject, can yield tremendous insi

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

ght and improve the quality of our own decisions.

The next tim

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

Professional from academic institutions, pharmaceutical industries, health care indust

e you run into a point of view that doesn’t match your own, pay a

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

ttention. Don’t dismiss it. By the same token, don’t assume that

.

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

different is better. But it just might be, that the different dru

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

Companies that provide selfless information through particip

mmer your hearing isn’t another jerk; it could be Gene Krupa.

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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Once an entrepreneur has grown from working in his basement or garage to having employees the question about benefits will ultimately rise. That leaves small business owners in cross roads between spending money on benefits and spending money on growth.

The moment you decide to look for a new job is a great time to take stock and ask yourself some important questions. But are you asking yourself the best questions? What could make the difference and get you that ideal job?

In the previous article, the author dealt with Part 9 of the Baldrige Values and Concepts – Public Responsibility and Citizenship. This Part 8 issue will share his research on Focus on Results and Creating Value: one of the Eleven Values and Concepts of Malcolm Baldrige Criteria. He compared the direction set by the CEO of the researched companies and CEO of Baldirge winners.

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