Advice You - Business

A Mega-Frame is like the ornate framing that surrounds a picture or painting. It encloses and defines information. Amateur and professional artists deeply appreciate the value of framing: the right frames will enhance their pictures - the wron

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

g frames will devalue them. Many an artist has created works that have not become truly expressive or beautiful until they have been enclosed in the right frame.

Framing has a long and rich history. The Sophists of ancient Greece were masterf

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

Examples of combination products may in

ul framers and re-framers. Aristotle coined the word “atechnoi” to describe it. One of ancient Rome’s greatest orators, Cicero, elevated frames (“statis”) to an art form. His speeches are still studied by students of influence and rhetoric.

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

Mega-framing describes Strategic or psychological framing and underpins the art of managing perception. It takes in the ‘big picture’ rather than detail. It may be an overarching theme that enjoins or describes the detail in your presentation

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

, or it may link all your points to a lesson, a purpose or a moral.

Mega-frames are powerful because they allow you to enclose your message within a framework of higher intentions, virtues or a big-picture concept generally understood or held

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

Combination pro

to be true by most people. This is termed frame alignment, and it refers to the linkage of a message to a set of common interests, values or beliefs, so as to position a speaker and audience as one.

In selecting a mega-frame, your aim can be

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

to link your total presentation to one major idea, high principle or key value.

Every society is rooted in deep sets or clusters of ideals. In western society, for example, we ‘believe’ in democracy. From that belief comes a raft of ‘virtues

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

, represented by abstracts such as Freedom of Speech, the Right to Choose, Respect for Individual Rights, Freedom of Movement, Equity in Society (in some quarters), and so on.

The key is to establish a legitimate association between your idea

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

/message/proposal/action and a universal virtue or value. Examine the following words and see if you can detect a “virtue” in them. Put them into a sentence, internalise them and notice the emotional responses they bring about.

• goodness •

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

health • love • peace • choice • dream • happiness • fairness • liberty • vision • truth • justice • rights • honesty • opportunity • ethics • safeguard • success • strength • prosperity • freedom • righteousness • s

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

elf-control • family • safety • purity • empowerment • compassion • protection • relief • scientific • respect

The above words represent values embraced by most people in western worlld. They are anchors for the aspirations of our

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

Following aspects would a

communities and few individuals would venture to challenge them. Each person will have his or her own personal interpretation of what they mean, however, in all but a few cases, the feelings people associate with the words will be positive one

dd to the challenges in developing combination products:

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

s.

Virtue mega-frames educe unconscious acceptance of the content in which they are wrapped. They add immense power to your presentation because most people embrace them as self-evident truths. Review the following opening sentences and notic

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

e how a strong virtue frame helps the speaker evoke powerful emotional responses to support her case:

“This is not an issue about governments resuming private land to subdivide and on-sell. This is an issue about freedom. Freedom from the gre

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

dy intentions of bureaucrats who want to fund their grandiose projects by robbing you of your birthright; freedom to live your life on a piece of rural Australia without fear that the land of your labour can be snatched from you; freedom from

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

the whims of fat-cats who live hundreds of miles away, never having experienced life in a close rural community.

I know that, as small landowners, you value freedom above all else. Why else would have you chosen to build your life here, free

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

Professional from academic institutions, pharmaceutical industries, health care indust

from all the contaminations of big-city life? Now is the time to fight for the justice of your cause; to fight for your freedom; to send an unequivocal message to those who would destroy your community forever.

And know that your calls will

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

be heard by many decent-minded country Australians. They will help you in your fight, because they know that you must never, never, never, give in to bully boys from the big city, who, like common thieves, would take your freedom from you. The

.

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

y know that the price of giving in would be their freedom too.”

In everyday life, you unconsciously assess information through the filters of your values, beliefs, decisions and attitudes. Emotions, or feelings, erupt from the filtering proc

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

Companies that provide selfless information through particip

ess and drive action. It’s a natural process and stepping up to virtue mega-frames taps into that process. It allows you to filter your message through the core values, beliefs and embraced virtues of your audience.

(c) 2006 Desmond Guilfoyl

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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In the last article Part 4a published on [June 01, 2006 08:10:51 pm], I have shared how several tools are used in the IMPROVE PHASE. I have covered how to use Benchmarking and Cost Benefit Analysis. In this issue, I will cover others tools such as Control lot and testing and Pilot the action / solution.

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