Main Subject - Business

Is your organization quick to pick the low hanging fruit? Do you gravitate first to the quick and easy? Are you prone to delay the bigger projects until you get those little ones out of the way?

Low hanging

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

fruit is, by definition, quick and easy to implement, thus the lure to pick it is compelling. And picking the first piece usually exposes another, leading to an infinite quantity of low hanging temptations.

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

Examples of combination products may in

While some of these quick fixes make excellent investments, many do not, and the nearly infinite supply can become a black hole for your limited resources.

Not only are the quick and easily-visualized fixes

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

compelling, but the more important, strategic opportunities are often exactly the opposite because they can involve fundamental changes in how things are done. The most important initiatives will create an

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

rganization with new capabilities, new capacity, and new potential. These often require disruption to people, processes, resources, policies and/or technology. The complexity and level of departure from the

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

Combination pro

orm can make both the goal and the path harder to visualize. The need for analysis and tough decisions ensures that many important opportunities will never be mistaken for low hanging fruit.

Here are some e

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

xamples of low hanging temptations:

"Let's get this system working right first" -- Increasing cycle count accuracy for inventory that should be disposed of

"First, just let me get organized!" -

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

Reorganizing files, electronic or paper, that are rarely, if ever, used

"I know I can buy these parts for less somewhere else." -- Finding a cheaper supplier for parts that would disappear with strategic r

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

positioning

"While we are at it…" -- Adding that extra software feature while you are in the process of making other changes: "we'll have to test everything anyway"

For a diagram that accentua

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

tes the dangers of pursuing low hanging fruit, visit this article on my website: Strategy, Results and Distrac

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

ions. Even without the diagram, you can probably imagine that success likely depends on a combination of easy and difficult tasks. If your efforts are driven first by ease of implementation, you will squ

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

Following aspects would a

nder resources on low hanging, unimportant fruit.

Are Your Resource Decisions Driven by Low Hanging Temptations?

The most important factor determining the impact of low hanging temptations depends

dd to the challenges in developing combination products:

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

on how clear your employees are about your strategic objectives. Employees make decisions all day long that consume resources. If they do not know and understand your strategic objectives, they will pursue l

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

w hanging fruit. The only way to find out what they are thinking is for management to ask and listen.

Beyond that, you can listen for comments indicative of quick fixes, "We need to get a few things fixed a

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

d out of the way before we can start a bigger project." Strategic initiatives are rarely described as "getting things out of the way."

If you want to avoid the temptation of low hanging fruit, the following

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

are critical:

Have a clear strategy -- A clear strategy, well-communicated, with realistic expectations and only a few top priorities for any one individual makes it easier for everyone to focus on

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

Professional from academic institutions, pharmaceutical industries, health care indust

the right things.

Assess each idea for strategic fit -- Forget ease or difficulty of specific actions and determine the value of an idea relative to the strategic goals first. Assess ease second. T

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

ere is nothing wrong with choosing an easier path as long as the strategic benefits are equally strong. But resist the temptation to invest in high ease/medium strategic over medium or low ease/high strategi

.

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

Remain vigilant -- It is so tempting to tackle the quick and easy but tiny multiplied by infinity is a really big number!

Without strong vision, strategy and discipline, the low hangi

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

Companies that provide selfless information through particip

g fruit will keep you busy for a long, long time, leaving strategic issues to languish. Accelerate progress toward your vision by pursuing the strategic over the easy.

© 2007 Ann Latham. All rights reserved

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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