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Exceptions to the rule...(these) are in fact emphasising the same rule. But what about the exceptions themsel

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

ves?

Exceptions and incidents require more than a common response. When business is "as usual," it is normal

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

Examples of combination products may in

y not difficult to manage. But now the exception. That is when you can make a difference. That is where you c

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

an show who you are, and what the value is of your approach.

The anecdote published recently in USATODAY ser

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

es as a fine example.

“Office Depot CEO Steve Odland remembers like it was yesterday working in an upscal

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

Combination pro

e French restaurant in Denver,” reads USATODAY (http://www.usatoday.com/money/companies/management/2006-

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

4-14-ceos-waiter-rule_x.htm). It is a story about the CEO in his earlier days working in a restaurant and the

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

incident where he tumbled a sorbet “onto the expensive white gown of an obviously rich and important woman.”

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

Thirty years later “Odland can't get the stain out of his mind, nor the woman's kind reaction. She was s

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

tartled, regained composure and, in a reassuring voice, told the teenage Odland, "It's OK. It wasn't your fau

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

t." When she left the restaurant, she also left the future Fortune 500 CEO with a life lesson: You can tell a

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

Following aspects would a

lot about a person by the way he or she treats the waiter.

The newsstory in USATODAY explains that thi

dd to the challenges in developing combination products:

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

[waiter] rule landed in “a booklet of 33 short leadership observations called Swanson's Unwritten Rules

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

of Management. Among those 33 rules is only one that Swanson says never fails: "A person who is nice to you b

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

t rude to the waiter, or to others, is not a nice person."

Later in the story Steve warns for "...pe

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

ople who have a situational value system, who can turn the charm on and off depending on the status of the pe

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

Professional from academic institutions, pharmaceutical industries, health care indust

son they are interacting with," Swanson writes. "Be especially wary of those who are rude to people perceived

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

to be in subordinate roles."

A manager may do nothing in eighty percent of his time. Yet when there is

.

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

an incident, a real exception, than he can make a difference. Search of those exceptions and evaluate afterwa

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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just came back from speaking at two separate conferences. The attendance level was high and each offered plenty of time for getting to know the attendees. As with most conversations, we inevitably discussed the job market. It was surprising to me the number of people that mentioned that they were aware of the articles I had written on career and professional development. In fact a couple of people congratulated me on a job well done.

1) Being placed on hold endlessly. Don't you just love it when you call a company and they place you on hold, leaving you to listen to their latest on-hold, recorded sales pitch, over and over again....

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