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Winners in business play rough and don't apologize for it.

Toyota has steadily attacked the Big Three where their will to defend was weakest, moving up t

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

he line from compact cars to mid- and full-size vehicles and on to Detroit's last remaining profit centers, light trucks and SUVs. All the while, Toyota

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

Examples of combination products may in

has dared its rivals to duplicate a production system that gives the company unmatchable productivity and quality.

Dell is similarly relentless, and ruth

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

less, in dealing with competitors. Last summer, the day after Hewlett-Packard announced weak results because of price competition in PCs, Dell announced

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

a further across-the-board cut – delivering a swift kick to a tough rival when it was down.

Wal-Mart is well known for its uncompromising stance toward s

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

Combination pro

ppliers. In 1996, Rubbermaid, a $2 billion business that a few years earlier had been Fortune's most admired company, ventured to contest Wal-Mart's pres

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

sure on suppliers to lower their prices – and Wal-Mart simply cut Rubbermaid off. (Newell acquired a struggling Rubbermaid in 1999.) Wal-Mart doesn't pu

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

ll punches with competitors, either. In recent years, as Kmart floundered in bankruptcy proceedings, Wal-Mart rolled out a knockoff of Kmart's Martha Ste

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

wart product line, putting pressure on one of the tottering retailer's few areas of success.

Hardly anyone would dispute that Toyota, Dell, and Wal-Mart

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

have epitomized corporate success over the past decade. But the raised eyebrows they provoke – recent BusinessWeek cover articles have included "Can Anyt

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

ing Stop Toyota?" "Is Wal-Mart Too Powerful?" and "What You Don't Know About Dell" – suggest there's something not quite kosher about the way they achieve

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

Following aspects would a

that success.

That's because Toyota, Dell, and Wal-Mart play hardball. What do we mean by this? Hardball players pursue with a single-minded focus com

dd to the challenges in developing combination products:

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

petitive advantage and the benefits it offers – leading market share, great margins, rapid growth, and all the intangibles of being in command. They pick

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

their shots, seek out competitive encounters, set the pace of innovation, test the edges of the possible. They play to win. And they do.

Softball play

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

ers, by contrast, may look good – they may report decent earnings and even get favorable ink in the business press – but they aren't intensely serious abo

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

t winning. They don't accept that you sometimes must hurt your rivals, and risk being hurt yourself, to get what you want. Instead of running smart and

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

Professional from academic institutions, pharmaceutical industries, health care indust

hard, they seem almost to be standing around and watching. They play to play. And though they may not end up out-and-out losers, they certainly don't wi

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

n.

This may reflect the recent emphasis of management science, which itself has gone soft. Indeed, the discourse around a constellation of squishy issue

.

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

s – leadership, corporate culture, customer care, knowledge management, talent management, employee empowerment, and the like – has encouraged the making

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

Companies that provide selfless information through particip

of softball players.

"Hardball", George Stalk, Jr. and Rob Lachenauer, Harvard Business Review, April 2004. Visit CJPS-Enterprises for more information

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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