Advice You - Business

Ask any of your sales managers to define sales strategy and you might get a myriad of responses. Some right, some wrong and many just vague. Ask them

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

to define operational effectiveness and you will tend to get more accurate answers depending on the level of the manager.

Strategy is the what – dire

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

Examples of combination products may in

ction of the organization. Organizational effectiveness is the how – how you are getting there. The problem is that if your strategy is unclear, vagu

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

e or downright wrong it doesn’t matter in the long term how effective you are as an organization – sooner or later you will fail due to any number of o

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

utside forces:

- competition
- the economy
- technology
- consumer changes in attitudes
- the global market place
- an aging

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

Combination pro

population

Think of it as a matrix; Draw a four quadrant box. Along the top put Strategy down the left side put operational effectiveness. Therefor

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

e;

The lower left hand box is low operational effectiveness and a vague or no strategy.
The upper left hand box is high operational effectiveness

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

but poor or no strategy.
The lower right hand box is low operational effectiveness but clear and focused strategy.
The upper right hand box

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

is clear and focused strategy and operational effectiveness.

We could go on for pages discussing the various consequences and outcomes depending on wh

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

ich your organization is function in. Let’s instead summarize a critical factor in this illustration, which is not the quadrant you are currently in b

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

ut the direction you are moving. In other words if you are in the lower right (your strategy is clear but you lack operational effectiveness) but bec

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

Following aspects would a

ause of your clear strategy you are becoming better at your operational effectiveness, overall, you are moving in the right direction. However if you

dd to the challenges in developing combination products:

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

are in the upper left hand quadrant (high operational effectiveness but unclear or changing strategy) and because of your lack of clear direction you

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

are becoming less operationally effective you are moving in the wrong direction.

Granted, no organization will ever stay in the same quadrant indefin

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

itely. There are just too many forces at work here such as changes in management, emerging competitors, a fluxing economy and the rapid pace of change

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

in the are of technology.

It is possible however to stay healthy in both areas and the key is to let your operational effectiveness be driven by your

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

Professional from academic institutions, pharmaceutical industries, health care indust

strategy. Herein lies the problem in many organizations today. Management tends to focus more on their operational effectiveness than developing and

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

maintaining a clear, focused and communicated strategy and direction. Sure, many organizations have monthly or yearly strategic planning meetings.

.

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

I have facilitated dozens during the past few years. And the biggest challenge at these meetings is to keep the focus on developing a strategy (The Wh

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

Companies that provide selfless information through particip

at) and not get bogged down in lengthy operational effectiveness (The How) discussions that are doomed to fail without a clear and integrated strategy.

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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No matter what happens in future, to secure present, small business will have to mend their ways with lot of care regarding their financial condition, as one small error could lead to a total disaster taking them towards bankruptcy.

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Advice You - If Your Sales Strategy Is Not Clear Sales Will Suffer

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