Advice You - Business

When manufacturers first consider a product, they often discount the issue of packaging. They seem to think such decisions can wait until the product is ready

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

for production. In many cases this may be true. However, some thought must go into packaging very early in the design process; because if a product requires

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

Examples of combination products may in

ustom packaging or shrink wrappings this could play a vital role in the budgeting and marketing of that product.

Let us face it, as consumers we love custom

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

ackaging. Something unique and individual that helps pull us into the world of that product. And there is something strangely wonderful about shrink wrappings

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

It conveys that valuable message: This product was made for you and no one else. And ripping that shrink wrapping makes us truly take ownership of the produc

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

Combination pro

. However, as much as we as consumers may like these things, we as business people understand that custom packaging and even shrink wrappings bring with them

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

unique costs that must be evaluated. Custom packaging may require the use of industrial designers, it may require extra rounds of testing; and shrinking wrapp

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

ings involve an extra layer of costs which may not be required on all products.

Custom packaging may also present storage and shipping problems. A custom pac

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

age may not be as easy stacked on a warehouse floor, or as easily prepared for shipping. And although custom packaging often attracts consumers, it may do the

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

opposite. For this reason, your product may need to go through focus group testing on the custom packaging alone. Another cost.

But, on the other hand, we al

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

know a square box can be dull; and we all know that products without shrink wrappings look "cheaper" to many consumers. So where does that leave us? It leav

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

Following aspects would a

s us where we often find ourselves when faced with any business decision. It leaves us forced to weigh our options. However, we think there are series of ques

dd to the challenges in developing combination products:

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

ions you might consider which can help you weigh your options in smart and efficient manner.

In regards to custom packaging, ask yourself these questions: Is

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

your product unique? Does your product require some special understanding or explanation? Does your product appeal to an upscale market? If you answered "yes"

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

to any or all of these questions, then we feel that custom packaging should be considered. Unique products, products which require special explanation, or up

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

cale products can benefit from custom packaging.

In regards to shrink wrappings, ask yourself these questions: Is the product perishable or viewed as perisha

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

Professional from academic institutions, pharmaceutical industries, health care indust

le? Could handling the product by others easily damage it? And does cleanness or sterility play a role in the use of your product? Again, a "yes" answer to an

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

of these questions means you should at least consider the use of shrink wrappings.

We hope this brief article has helped you get a handle on some of the iss

.

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 you need to confront when making packaging decisions. Custom packing and shrink wrappings can add value and appeal to your product, but they come with a un

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

Companies that provide selfless information through particip

que set of costs. Only by properly examining your product and its customer base will you be able to determine if your product is worth this additional expense

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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