Advice You - Business

Strategic planning is all about creating specific strategic (thoughts). The more your people think about the possibilities,

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

the greater likelihood that you will reach farther than you have ever gone before. So what is stopping you?

Maybe you alway

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

Examples of combination products may in

have had the same people at your strategic planning table. These are good performers who are comfortable with how the compa

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

y is currently performing. Possibly, they have a belief that "If it ain’t broke, why fix it?" The ability to think outside

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

f the box is not their strength.

Or you may have different people, but they all reaffirm what you believe, think and do. Th

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

Combination pro

se individuals are the "Yes, boss! You are right boss!"

However today, you look out your corner office window or read the ec

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

nomic trends in your daily business journal. Suddenly, you realize that the company is not growing given the DOW is over 13,0

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

00 and has reached historical highs in the first six months of 2007. You now know that you are not where you want to be for y

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

ur company or even yourself.

You sit down and take out your strategic plan that is somewhat dusty. As you read its fresh pag

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

s, you see that you have been doing the same things over and over again and getting the same, safe results. However, you hav

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

just finished Blue Ocean Strategy and realize that you are in the red ocean. Now you think:

"To go where we have

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

Following aspects would a

never gone before (the Blue Ocean) and get what we have never got before (incredible results), we must do what we have never

dd to the challenges in developing combination products:

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

one before (take risks, look for possibilities, opportunities)."

You recognize that your Strategic Planning process is l

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

cking people who think outside of the box. Who are possibility thinkers. These people think in terms of Yes, it can be d

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

one! and So what if we fail, we just regroup and try another approach. Possibility thinkers are not afraid of tak

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

ng risks because they know that success comes from failure. To try is better than to not try at all.

Suddenly, you look at

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

Professional from academic institutions, pharmaceutical industries, health care indust

our executive team and your employees with a new lens, a new filter. You are now actively seeking individuals who will chall

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

nge the status quo, but who have the leadership skills to wor

.

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

with your existing executive team.

Possibility thinking is the vehicle to drive your strategic plan to that next level of s

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

Companies that provide selfless information through particip

ccess. And you have now learned that possibility thinking begins within the leadership of each individual, starting with you

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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A Conveyor System is not just the belt that is prominently seen. It is often a complex creation achieved through the application of deft engineering skills. The success of any operation that requires material handling depends on the speed, efficiency and dependability of its Conveyor System. Usually, in major projects, it is not something that is bought off the shelf and installed. It has to be designed and engineered to suit specific requirements.

Are you looking for the wrong results from your current job? Did you leave your last position for the wrong reasons?

Why did Bob love you and buy, while Susie seemed completely uninterested...yet they both wanted your product and your presentations were nearly identical?

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