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It’s such a time-honored maxim it seems all but ordained by God. The customer is always right! Yes, a company’s most desirable objective must always be to kee

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

p its customers both loyal and happy. Certainly, it’s the secret to business success.

And how does one achieve this? By paying attention to your customers, i

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

Examples of combination products may in

e., serving them, listening, adjusting, responding. You do whatever they say, making sure your employees do the same. The customer pays the freight, after all

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

they must forever be number one.

So that makes a lot of sense, n’est-ce pas? “Good Business 101. Then again, hell, hmmm… maybe not! One major US airline com

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

any may be an indication that this long-held truism should be shipped out to relic-dom. At this company, you see, it seems the customer ain't always right at

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

Combination pro

ll—it’s the employee!

Let’s try a little quiz: Name the most successful major airline in America today, American, you say? Nah. United? Uh-uh. Delta? TWA? US

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

Air? Wrong, wrong, wrong again! The very best airline today is a relative upstart called Southwest, based in Phoenix of all places. In fact, it’s the ONLY maj

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

or airline to turn a profit in each of the last 25 years.

Southwest leads its industry in quite a few categories: It’s tops in price per earnings, for exampl

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

(with a 27 rating it compares pretty well to American and Delta who each scored a pitiful 5), and it leads the pack too in on-time performance and in custome

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

complaints, where it earns the fewest. Yet its President Herb Kelleher credits the company’s success NOT to an overarching concern for customers, as is usual

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

y a CEO’s boast. Herb e would surely be the first to brag about Southwest’s happy customers and how they do indeed count, but his primary kudos instead target

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

Following aspects would a

the company’s mad, passionate commitment to fully support and nurture its employees.

Though it might be a stretch to say the company’s philosophy is, literal

dd to the challenges in developing combination products:

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

y, the “employee is always right,” one could argue that the Southwest culture has hammered this axiom into place. Some Southwest executives have even been he

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

rd to say out loud, “Our employees come first and customers second.”

“We try to allow our people to be themselves and not have to surrender their personality

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

when they arrive at Southwest,” Kelleher once explained to the media. “We deal with them as individuals.” One industry analyst explains, “Employees at Southw

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

st are selected primarily for attitude, while most companies select primarily for skills. (Like employee-friendly Wal-Mart) they have a particular view for pe

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

Professional from academic institutions, pharmaceutical industries, health care indust

ple who will fit into a team-oriented organization with its family feel and a certain degree of fun built in.”

It’s an appealing point of view. Think for a m

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

ment about your own responses to those you encounter throughout your management day: When you really think about it, where do the best ideas come from, your c

.

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

stomers or your employees? Perhaps your firm conducts ongoing market research surveys and focus groups, as many do, but is the same spotlight and intensity ev

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

Companies that provide selfless information through particip

r pointed in the direction of workers? When it is, you’ll be on the Southwest track, and probably doing well. If it’s not, you may be missing out on a big one

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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