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Some say that in business as in sex: if it is good, it’s great and if it is bad it’s still pretty good. This does not happen to be true. If business is bad, it can get very bad. There are personnel problems, production expenses, overhead,

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

laws, taxes, fines. Faulty financial decisions, inability to accurately evaluate the situation and quickly resolve problems all lead to an extremely high mortality rate among new business: up to 95% do not survive past their first 12 month

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

Examples of combination products may in

s.

Modern business management is an art, based on a certain technology requiring certain skills. There is a technology of how to estimate and evaluate any situation and accurately predict future events and trends. There is a technology of

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

finding exact problems, the underlying reasons behind them and handling those exact reasons to eliminate specific problems. Some of the basics of this technology are presented here to help anyone flourish and prosper.

1. OPERATE BY STATI

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

STICS. Statistics reflect production of something in a unit of time. It is a tool that should be used to locate and handle any routine problem or any severe crisis. Awareness of the key statistics provides you with an insight into what is

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

Combination pro

really going on in your business. They help establish causes of events. Best businesses collect up all their key statistics daily, sometimes hourly. Examples of key statistics could be Gross Income, Value of services Delivered, Number of C

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

ontacts Made, Number of Appointments Made, Number of Closes, Cash/Bills Ratio, Minutes of Operation With No Downtime, Qualified Staff Hired, Dollar Return Value per Promo Ad, etc. Anything can be represented as a statistic.

2. CONDITIONS.

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

Everything that exists, any activity, is always in some condition. These conditions are very well defined, there are only 6 of them. Depending on statistics, every activity is in one of these 6 possible conditions. Any activity starts in

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

the condition of Non-Existence. As it becomes better established and more known, it raises up to Danger. Then, as it expands, it passes through the condition of Emergency into Normal Operation and then may reach Affluence or even Power. So

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

the conditions from the bottom up are: Non-Existence, Danger, Emergency, Normal, Affluence and Power. Each of these conditions has a “formula”, a series of steps which would lead the activity out of any condition it is in and move it into

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

a higher condition. + For example, formula for the condition of Non-Existence is:

· Find a communication line – a channel on which communication can be sent out and received.

· Make yourself known.

· Discover what is needed and want

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

Following aspects would a

ed.

· Do, produce and/or present it.

This is the starting condition for any activity. It is easy to see that any gross non-compliance with any of these 4 steps would make it impossible for any activity to eventually reach Affluence. Peop

dd to the challenges in developing combination products:

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

le either know these conditions and use the formulas or follow conditions intuitively, or completely neglect them, commit gross errors and fail.

Statistically, these 6 conditions look as follows:

- Non-Existence: statistics are crushed t

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

o the bottom or stay extremely low for a long time or it is a brand new activity.

- Danger: statistics drop sharply or there is a gradual drop over a long period of time.

- Emergency: statistics are slightly down or remain unchanged (no

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

rise, no fall).

- Normal Operation: gradual increase in statistics.

- Affluence: significant increase in statistics, very steep uptrend.

- Power: after a period of Affluence statistics go into Normal Operation trend (gradual rise) on a

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

brand new very high level.

3. DATA ANALYSIS/SITUATION ANALYSIS. Accurate analysis of a situation is a science in itself. It is based on the subject called Logic. It is not feasible to get into it at any length here but there are 2 points

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

Professional from academic institutions, pharmaceutical industries, health care indust

that must be understood:

1. There is a cause for every non-optimal situation in business. That cause is defined as something under your control which if handled will resolve the exact problem and revert the statistics.

2. To handle any s

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

ituation you have to handle the exact reason that created it, not something else.

This seems obvious but people often do the opposite. For example, an employee keeps breaking tools, the owner keeps buying better and sturdier tools. What p

.

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

roblem is he trying to solve and what was the cause of that problem in his opinion? The actual reason was that the employee was untrained and needed drilling and apprenticeship. It just required a little bit of an investigation and observa

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

Companies that provide selfless information through particip

tion to figure out.

Operating by statistics, knowing and applying condition formulas and investigating the causes of problems allows any activity to flourish and prosper. I will be happy to answer any questions. Let’s flourish and prosper

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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What are you interested in? We all have a passion for something. So, what is your passion? Are you actively seeking information about your passion? Knowledge, providing it is correct knowledge, will increase your power.

We can all learn a lot from the World's largest employer on how to run a business. Wal-Mart seems to get the program and understand all aspects of their business; from distribution to customer service. Speaking of customer service, Wal-Mart does an excellent job in customer service, they really do.

It’s a classic mistake for business owners. They start a business that is focused on their product and not on the credit end of their business.

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