Top Adding - Finance

“Our thoughts create our reality – where we put our focus is the direction we tend to go”

- Peter McWilliams

This article departs from the technical aspects of Exiting a business 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

nd focuses on the emotional challenges of Exiting a business – specifically the challenge of breaking out of your ‘comfort zone’.

A ‘comfort zone’ can be described as a place where we all

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

Examples of combination products may in

return to’ on a consistent basis, or a place that provides us with a sense of security because we can predict and control the outcome of many of our actions in that ‘zone’. It is a place i

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

n our minds where we find a sense of control and where the world immediately around us has a sense of order. This is a personal place that we design through our thoughts and habits.

Busin

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

ss owners live in ‘comfort zones’ because every day that we report to work, we are confronted with challenges that have been created in the building of our businesses. Exiting a business r

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

Combination pro

quires that you step out of that comfort zone and develop new patterns of thought geared around your Exit.

Changing the way that one thinks is a difficult task. This is particularly true

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

for busy business owners because we habituate ways of acting, much like the manner in which we drive our automobiles. We do not consciously think to hit the accelerator, look over our shou

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

der and slightly turn the wheel when changing lanes – we simply do it by habit.

In 1960, Dr. Maxwell Maltz wrote the following in his best selling book,
Psycho-Cybernetics:

“[l

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

ke changing lanes in a car] . . . in much the same way our attitudes, emotions and beliefs [towards our businesses] tend to become habitual. In the past we ‘learned’ that certain attitudes

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

, ways of feeling and thinking were ‘appropriate’ to certain situation. Now, we tend to think, feel and act the same way whenever we encounter what we interpret as ‘the same sort of situat

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

on’. What we need to understand is that these habits . . . can be modified, changed, or reversed, simply by taking the trouble to make a conscious decision – and then by practicing or ‘act

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

Following aspects would a

ng out’ the new response or behavior. The pianist can consciously decide to strike a different key, if he chooses. The dancer can consciously ‘decide’ to learn a new step – and there is n

dd to the challenges in developing combination products:

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

o agony about it. It does require constant watchfulness and practice until the new behavior pattern is thoroughly learned.”

Dr. Maltz was describing the manner in which we can make decisi

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

ns to change our behavior. And I submit that formulating a proper Exit Strategy can be as easy or as difficult as we choose to make it.

So, what can we do today to address this ‘comfort z

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

ne challenge’?

The answer is that we can make a commitment to learn about HOW to Exit a Business. We empower ourselves to control our Exits only when we make a commitment to the endeavor.

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

Exiting a business has a unique set of rules and decision making criteria that must be internalized and habituated in order to produce the best results.

A commitment to learning HOW to E

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

Professional from academic institutions, pharmaceutical industries, health care indust

it a business will ‘reorder’ your thoughts and actions towards the eventual achievement of your Exit goal. Devote at least thirty (30) minutes per week towards doing a little research on w

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

ys that you can exit your business and you will begin to change your thinking. Thus, you will change your habits and will be prepared to meet the challenges of your Exit with a mind that i

.

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

s ready for this new action.

For more information about forming good Exit Strategy Habits feel free to view our website, www.exit

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

Companies that provide selfless information through particip

ngyourbusiness.com. And we leave you with our steady reminder that a pro-active approach to an Exit Strategy is the only approach to a successful Exit Strategy.

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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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