Main Subject - Business

A well-designed document is an effective document. It gets your message across to your intended audience—whether your aim is to give information, sell a widg

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

et, or help someone grasp a concept.

I have graphic design software on my computer, and I think I have a pretty good eye. Why do I need a graphic designer?

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

Examples of combination products may in

Strictly speaking, you don’t—any more than you need a hairstylist, a mechanic, or a lawyer. You could cut your own hair, fix your own car, and represent you

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

rself in court. Most of us, though, recognize that we can’t be experts at everything, and that an amateur job will generally look…well, amateur. The musi

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

is not in the violin—and great designs aren’t guaranteed by even the most sophisticated software. Even if you have an innately good design sense, getting

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

Combination pro

up to speed on everything a graphic designer needs to know takes time and effort that might be better spent on whatever it is that you do best.

Isn’t it

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

expensive?

The total cost of a project will depend on a number of factors:

• what you want—just as it costs more to paint your whole house than to pain

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

t just the bathroom, you can expect to pay more for a book design than for a straightforward business card design

• how quickly you want it—rush charges may

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

apply if you decide your handouts need a new look the night before the big meeting

• how well prepared you are—more on that in a moment.

Designers make 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

their business to know how to grab a reader’s attention, and help that reader absorb and even remember the message. So consider this: maybe you can’t afford

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

not to have your documents professionally designed.

Aha—so it will cost me an arm and a leg!

Not necessarily. Here are several ways to save money,

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

Following aspects would a

time, and/or sanity:

• Involve a graphic designer as early as possible in any project—even before any copy is written. The designer will often be able to su

dd to the challenges in developing combination products:

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

gest ways to save on printing and other costs.

• Start with a small job—say, a one-page handout rather than your whole participants’ manual. Then gradually

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

revamp the rest of your materials as your budget allows.

• Understand that once you “sign off on” (approve) a mocked-up design and give the go-ahead for lay

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

out to begin, any further changes to the design or to the copy itself will increase the project’s costs—sometimes substantially. Even small alterations can c

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

ause ripple effects that are very time-consuming to fix. And you will be charged for that time—just as your house painter would charge to repaint a room if y

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

Professional from academic institutions, pharmaceutical industries, health care indust

u decided you detested the chartreuse you originally chose and would really rather the walls were a nice shade of taupe.

So be certain that everyone who mig

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

ht want input into the design or wording—the conference committee, your assistant, your significant other, your cat—has seen and approved it before you sign

.

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

off.

• For the same reasons, be sure you give the designer the final version of the disk file—and that it matches the hard copy you provide.

Time to act

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

Companies that provide selfless information through particip

So now, in the time you have read about how and why to get the most, make the first move by contacting a graphic designer NOW.

© 2006 BG Communication

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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