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There is a time to be born and a time to die. Correct timing is everything The right timing is absolutely important. There is an old Chinese saying that for a

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

business to flourish, you need to have the correct timing.

If a company ventures into a particular market too early in the product life cycle, perhaps at

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

Examples of combination products may in

the introduction stage, it may not be able to reap the full benefits. The grounds may be hard and it has to invest substantial resources into developing the m

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

arket. In the process, the early entrants may end up paying the high “tuition” fees as they will make all the mistakes. A case in point is the early pioneer

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

of companies into China as most of them lost money because China’s business infrastructure was very backward then.

However, if the company enters the market

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

Combination pro

too late, for instance at the saturation or decline stage in the product life cycle, it runs the risk of curtailing its future growth potential as competit

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

ion will be very intense. Examples include the many dot.coms and telecom start-up companies. They seemed to make a lot of sense then – proven leaders with r

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

eal assets and business plans. The timing was bad as the high tech stock collapsed in the early 2000s.

The best time to enter the market is during its growth

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

stage. The ability to recognise this opportunity and take timely action is also important. Both IBM and Digital Equipment Corporation had better access to t

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

he technology than Bill Gates and Paul Allen. These giants recognise the opportunity but only limit their scope of their technology to serving their existin

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

g corporate customers with their existing and constantly upgraded products.

Consequently, both companies did not recognise the timing to take the actions and m

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

Following aspects would a

issed the PCs precursors – the dedicated electronic word processors that made Wang Computers successful. The latter missed the timing and did not see that p

dd to the challenges in developing combination products:

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

rsonal computers could replace word processors by executing far more functions than wordprocessing. Microsoft saw the timing and opportunity.

No one at IBM

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

, DEC or Wang Computers took much notice of the MITS Altair 8800: the “World’s First Microcomputer Kit to Rival Commercial Models”. That headline in Popular

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

Electronics magazine in January 1974inspired Gates and Allen to write a version of the well-known BASIC computer knowledge for the machine to run on. The res

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 is history. In the book, The Road Ahead, Bill Gates remarked: “Getting in on the first stages of the PC revolution looked like the opportunity of a lifeti

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

Professional from academic institutions, pharmaceutical industries, health care indust

e, and we seized it.”

It is therefore important to identify the right timing and trend. One must however not mistake fad for trend. Trends are unstoppable an

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

d last much longer than fads. In the 1970s, it was the microwave technology, in the 1980s, the VCR and the 1990s, the PCs and the Internet. In the 2000s, we

.

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

expect it to be the wellness technology to be sweeping the corporate world. The “corporate wellness” as well as “physical wellness” will also become the tr

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

Companies that provide selfless information through particip

endsetters. Therefore be prepared as Neil Peart said: “Luck comes when preparation meets opportunity.”

There is a season for everything. Timing is everything

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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Columnist Nan Russell shares career insights learned over 20 years in the corporate world, including as a Vice President at QVC

When corporations do not include the input of their highest producing employees, when considering major changes, they can easily find themselves with the challenge of replacing those top producers. Managers should not be afraid to ask their best employees what they think of impending changes, before instituting them.

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