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In direct mail lore, there's a rule stating that you can measure the success of you

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

r efforts by a minimum response rate of 1-2%.

In other words, if you send out 10,000 pieces, you

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

Examples of combination products may in

ll have a successful mailing if at least 100 recipients respond to your offer. (One percent of 10,000 is

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

100.)

That's one view of direct mailing success.

Permit me to offer a different perspec

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

ive: one from the small business world. Specifically, I'm referring to those small business people who w

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

Combination pro

rk by and for themselves. Call them "One-Man Bands," "Working Soloists," "Free Agents," or whatever you'

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

d like.

To help you remember these two perspectives, let's give them a couple of catchy names:

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

1. The "Playing the Percentages" Perspective. This is the "industry standard 1-2% response rate on y

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

ur mailings" perspective you've heard so much about. This is the yardstick favored by businesses that ar

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

e sending large quantities of direct mail to sell mass market products.

For example, if I own a p

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

zza parlor, and I'm doing a "use this card for 10% off on your next order" mailing to all residences wit

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

Following aspects would a

in a three-mile radius of my business, I might have a mailing list of 10,000 names.

You'd better

dd to the challenges in developing combination products:

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

believe that I'm going to watch the overall response rate like a hawk, and I'm going to be looking at p

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

ecisely where those hungry customers are coming from. If most of them are coming from a handful of apart

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

ent complexes next to a college campus, I'll know to send my future mailings to those complexes.

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

>2. The "You Only Need A Few" Perspective. This is the one for those One-Man (or One-Woman) Bands who ar

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

Professional from academic institutions, pharmaceutical industries, health care indust

selling services that take a fair amount of time to provide. Like marketing consulting, public relation

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

services, graphic design, or customized computer software applications.

For these folks, a hand

.

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

ful of new or repeat clients from a promotional mailing is quite enough. After all, as the owner of a on

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

Companies that provide selfless information through particip

-woman graphic design studio told me once, "I don't want to be a victim of my own [direct mail] success.

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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