Advice You - Business

To create a credible presentation, you must provide supporting materials to back up your claims. Although people might like you and want to bel

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

ieve you, a well-crafted presentation includes proofs demonstrating that what you say is true. Proofs serve a number of purposes including:

1)

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

Examples of combination products may in

Clarifying your position or main ideas

2) Showing that your claims are true and accurate

3) Creates not only a lasting but also a memorable 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.

pression

Proofs are the life blood of your presentation. Without proofs, you are simply providing the audience with a flimsy verbal outline of

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

main ideas. Your credibility suffers. Your presentation becomes generic and even unbelievable. The material that gives your presentation meat a

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

Combination pro

nd weight are the various proofs that you can provide.

Types of proofs include:

1) Facts and figures: Information that can be verified and co

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

firmed by an outside source.

2) Statistics: data explaining something in terms of size or frequency. Statistics are powerful because they soun

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

like facts and figures. However, statistics can be easily manipulated. When evaluating statistics always consider the source. Compare your sta

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

istics to others and if possible, seek multiple sources to ensure they are accurate. When presenting statistics, quote the statistic completely

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

, and use only current information.

3) Statements by authority: quotes from an expert on your subject. If the person you're quoting from is no

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

well known, provide her credentials along with her quote. Statements by popular figures like politicians, television or radio personalities ma

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

Following aspects would a

be used, as well, but should not be confused with statements by authority, nor should they be presented as such.

4) Testimony: supporting sta

dd to the challenges in developing combination products:

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

ements by others. Testimony can be expert, prestige or lay. Expert testimony is the same as "statements by authority" as described above. Prest

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

ige testimony is supporting statements made by an individual held in high esteem, like a well-liked politician, a famous business personality o

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

a movie star. Lay testimony is supporting statements made by someone from the community who is not necessarily an expert on the subject. Lay t

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

stimony is often used to show that a problem or issue is prevalent, and is identified by others as a problem.

5) Narratives: examples in the f

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

Professional from academic institutions, pharmaceutical industries, health care indust

rm of a story. Narratives should have a beginning, a middle, and an ending, and should be interesting without including unnecessary details.

F

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

acts and figures, statistics and testimony are the only supporting materials that can prove that your presentation is credible. Without such ty

.

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

es of proof, your argument will be weakened. However, a well-supported presentation will also include narratives to demonstrate how the subject

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

Companies that provide selfless information through particip

impacts the audience in human terms. Use a combination of types of proofs to build a well-supported argument that also interests your listeners

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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If you sell goods or services by telephone, fax, or the internet, then the timing of your delivery MUST comply with federal law.

Often small businesses reach a ceiling in selling their goods to their customers. By exploring how they add value to their customers, they can find a range of extra products and services that they can also sell at little or no cost to themselves. Truly the sales ceiling is set by the entrepreneur’s imagination.

In the previous article, the author dealt with Part 8 of the Baldrige Values and Concepts – Management by Fact. This Part 9 issue will share his research on Public Responsibility and Citizenship: one of the Eleven Values and Concepts of Malcolm Baldrige Criteria. He compared the direction set by the CEO of the researched companies and CEO of Baldirge winners.

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