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As we move slowly into 2006, what are our thoughts? How is the year going to turn out? How successful will we be and what will happen to our businesses? The businesses we either own or manage. Looking back on the past few years with 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 changes from 9/11 onwards many have failed to see the subtle shifts in many industries and unsubtle shifts in others. The Airline industry, for instance, is in a subtle shift. From large airplanes to smaller Biz Jets, to even large

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

Examples of combination products may in

airplanes, and the largest carriers filing for Chapter 11. How’s it going to pan out in 2006?

One thing that most of us fail to see is that while there are trends, the economists wouldn’t exist if there weren’t, there are also drama

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

ic changes. Changes that catch us unaware. One change could however trigger a flood of new ideas and then we’d have a trend, once again. Perhaps video iPod’s is an unsubtle shift for the advertising industry. The way we watch TV and a

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

verts is about to change. We can select shows to down load and we can use TiVo skip ads.

Now we as managers would want to be watching out for radical departures from the norm. As a manager and leader, as a great leader, we need to an

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

Combination pro

icipate changes, good and bad and be in place to work with them. Just as a surfer positions for a great wave. It’s all about positioning and timing, as well as watching the trend but expecting the unexpected. The rogue wave with a rig

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

ht break, which just appears.

Unfortunately too many managers focus on reaction mode. Problem solving, reacting and appearing to be the hero. Mostly managers do this because they are judged by what they solved not what they avoided o

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

created! In this mode businesses maintain but hardly ever outperform previous year’s results. It’s all an act. The big picture is not understood and small fires become large by design.

Now if we were able to anticipate better we’d b

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

more able to avoid the fires all together. This anticipation would lead to managers allowing the strategies to be executed. Good anticipation comes from strategic exploration.

The road to exploration can be step by step (reductionis

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

ic) or holistic (a systems approach). It’s a little of an art and a science. So this means practice, persistence and patience are required to develop your ability. As you improve your ability it will increase at an increasing rate and

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

you will ‘see’ the future changes. Powerful stuff!

So in order to be more anticipatory managers need to read widely, books, newspapers and journals but these days this includes many eZines, Blogs and even podcasts. There are many inf

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

Following aspects would a

luential thinkers giving their ideas on how the world is changing.

So what are we looking for? We’re looking for the signs of change. Just like we can’t see wind but we can see leaves move. We can judge direction and speed by seeing

dd to the challenges in developing combination products:

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

the shadows of clouds moving or ripples across the water. We need to find the indicators of change.

An example of predicting change and preparing. A large American cosmetic manufacturer read in a scientific journal, an article for a

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

ew simplified approach for making a colloidal gel. So they knew that there was a change coming in the base materials they used. Who was going to take this scientific discovery and bring it to their industry and how was it going to imp

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

ct their industry? Would they be first? They needed to figure out where the leaves were moving to find an indication that this new method had been applied.

Nine months later a very small article in a local newspaper happened to menti

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

n a French cosmetic company had found a way of substantially reducing costs. Now this was not the Wall Street Journal or New York Times. Merely some small town paper that had picked up the story as a filler. Amazing that it was picked

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

Professional from academic institutions, pharmaceutical industries, health care indust

up by the cosmetic company? Luck or design?

The US manufacturer now had something to go on. The leaves had moved. It took a few months to uncover the company and discover that the new process substantially altered the landscape, suc

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

that they would no longer be profitable using the ‘old’ processes. They had to negotiate a license or create their own ‘new’ process in a hurry.

No amount of re engineering, TQM, consulting or application of IT systems would have ma

.

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

e this company, and in fact the whole industry, competitive. Their world had changed. As Joel Barker would have said their paradigm shifted. It shifted them back to zero. They saw this and acted before they lost their industry to a ne

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

Companies that provide selfless information through particip

technology.

What advance is going to occur in your industry that would set you back to being a wanna be? How would you know if a competitor had developed this technology? What leaves are you watching? It may be closer than you think

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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