Useful Advices - Business

The average office is a veritable paper jungle, with literally tons of correspondence vying for the attention of one and all. The sad truth is, there simply is not enough time in the day to read and assimilat

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

e all of the information that crosses your desk, and still be able to apply it to the work you need to accomplish. Therefore, many of the memos we receive are either tossed immediately, or “filed” for later p

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

Examples of combination products may in

erusal, (meaning thrown on the desk, forgotten about, and finally tossed due to being out-of-date.)

However, there is a marked exception to this rule. There are memos that weather the storm, rise to the top

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

f the In Bin tornado, and get read. Why is that? The answer is very simple:

They Are Interesting!

Imagine that! An interesting memo? An attention-grabbing sticky note? A motivating email? It is possibl

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

e, and you may have seen a few in your own workplace. But they are very rare. The reason? Most individuals who are forced to author these Mediocre Memos are doing so under pressure, or are unwilling or un

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

Combination pro

ble to give the appropriate time and thought to their creation. They may feel “Nobody’s going to read it anyway.” Well, with that attitude, they’re right.

However, the authors of the exceptional memos have

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

taken a slightly different stance: They are determined to take the information they have to share, and mold it in to a format they would be excited to read themselves. They are convinced that, presented in t

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

he right way, their information will be of interest to everyone on their mailing list. On this solid positive foundation, the exceptional memo writer can then build his or her masterpiece.

Perhaps describing

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

a lowly office memorandum as a potential masterpiece is a touch melodramatic, but consider: If the information contained in the memo were not of importance, why waste the time, effort and paper producing it?

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

If the information is important enough to go through the authoring process, is it not important enough to make extraordinary? Of course it is, and it is the extraordinary memo that gets read.

So, what exact

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

y goes in to the production of an extraordinary memo?

As already stated, the extraordinary memo must begin with a positive attitude about the memo’s worth and the value of making it extraordinary.

The next s

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

Following aspects would a

tep involves gathering all the necessary information that may be included in the memo being written, and then eliminating at least half of it. Yes, eliminating at least half of it. Why? A memo very quickly

dd to the challenges in developing combination products:

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

overstays its welcome if it is too lengthy for its own good. Most vital messages can be relayed in several sentences rather than several pages. Eliminate all the “fluff” such as background data, unnecessary

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

tatistics, obvious explanations, repetitive charts and graphs, etc. If your audience truly requires all of the above information to understand and appreciate your topic, a memo is not the best format for your

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

presentation. (You may want to consider scheduling a meeting or series of meetings wherein you are able to present the information with visual aids and data sheets included.)

Now that you are left with a li

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

t of vital information to be included in your memo, you must ask yourself the same all-important question every marketing master and advertising ace has been asking for decades: “What’s in it for them?” In ot

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

Professional from academic institutions, pharmaceutical industries, health care indust

her words, what does my reader want and need to get out of this message? After all, just like a marketing master, your bottom line goal is to sell! You need to sell your reader on your message, and make them

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

buy in to it. You need to convince them that it is to their benefit to read and apply your message.

Therefore, you need to ask and answer the “What’s in it for them?” question, then apply the answer to 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

ay you write your message.

This simple question will turn a drab request in to an emotional appeal. A boring list of details becomes an encouraging outline of benefits. A dead thank you becomes a sincere ge

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

Companies that provide selfless information through particip

sture of appreciation and respect. A potentially boring collection of thoughts has received the attention it deserves because in the end, a mediocre memo has been deftly transformed in to an extraordinary one

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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