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This article is geared more towards small and medium enterprises requiring runs of 100,000 pieces or less. The same advice applies to larger runs too but it's not quite as big an issue. On the larger runs, the high setup costs I mention below a

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

re more easily absorbed into the entire sots of the job and may only contribute 10-20% to the job cost. On smaller runs, tooling and setup costs can easily make up over 50% of the cost of envelope production.

Having worked in the direct mail i

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

Examples of combination products may in

dustry for a number of years, I've seen many mistakes made, some avoidable, some not so. I can honestly say that one of the most frequent and most avoidable errors I've seen made is not applying any thought to the envelope until the last minute

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

A little forward planning in this respect can save a lot of frustration, and ultimately a lot of money. You can also achieve a lot more with envelope design if you have time, and some good advice from your friendly envelope manufacturer.

I'll

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

try and give you an idea as to why it's a really bad idea to leave it to the last minute. In brief envelope machines are big! They can take hours to set up, and it's still very much a case of allen keys and spanners to adjust them. Special siz

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

Combination pro

s can be enormously expensive to produce unless the quantity of envelopes required is very large.

There are lots of disciplines that make up a direct mail pack of which envelope production is only one. When compared to other areas such as copy

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

riting or printing of the inserts, the production of the envelope can seem insignificant. Thinking this way has the potential to be a big mistake.

The envelope may seem insignificant, and in terms of cost the envelope quite possibly is one of

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

the most insignificant parts of the pack. Realistically though, you can't send the pack without an envelope. Your carefully designed, printed and copywritten pack has very little value until you have an envelope because you can't send it until

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

ou have one.

So, when you plan your pack, think about the envelope at the same time and ask yourself a few questions.

Does the size of the pack that you have designed correspond with a slightly larger sized envelope available from a wholesale

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 it does, then good, but you're still not home and dry yet.

If a stock envelope is available, do you need to print it? You almost certainly will if it's a bulk mailing. Overprinting is a cheap option for stock envelopes but is your design

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

uitable to overprint? There are some considerations and compromises that must be made for overprinting envelopes, and especially for overprinting envelopes in four colours. These are too numerous to mention, but any professional envelope overpr

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

Following aspects would a

inting company will be able to advise on this.

At this stage you may have established that your envelope design can be overprinted, and that you have a stock envelope available easily. If that's the case you can rest easy.

You may, however, h

dd to the challenges in developing combination products:

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

ve discovered that a stock envelope isn't available, or your design isn't suitable to overprint. If that's the case, you need to be thinking about a special making of bespoke envelopes. In this instance, pre-printing your envelopes as flat shee

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

s becomes a possibility and you can also overprint on bespoke envelopes, but the actual making is now a major consideration.

There are two main kinds of envelope production, reel fed and blank (pre-cut envelope shapes) fed. It's unlikely that

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

you will be able to make the envelope from the reel since you have already established that there isn't a stock envelope available, or that you can't overprint. In either of these scenarios, it's likely that you will need to producing an envelo

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

e from blanks.

With blank fed production you need to check for availability of a cutting tool. These are extremely expensive to make, and there can be very long lead times. If you want to avoid the cost of this tooling then early planning will

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

Professional from academic institutions, pharmaceutical industries, health care indust

see you obtaining a list of cutting tools from your envelope supplier, that are close to the size you need. Provided tooling is available you then need to ensure your envelope is ready in good time.

Again though, the simplest advice is to plan

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

ahead. Find yourselves a reliable and knowledgeable envelope producer and ask their advice at the earliest opportunity. If they know their onions, then they will be able to advise how to stay within any budget you may have, artwork specificati

.

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

ns to work to and when you need to think about ordering. Lead times can be surprisingly long in the envelope world, and you don't want to be the unfortunate soul who has to order bespoke envelopes at the last minute. You can bet, it will cost y

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

Companies that provide selfless information through particip

u extra to do so.

If you want to know more about envelope manufacturing then there is a more detailed primer here

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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Many people who think a lot come up with brilliant ideas and concepts. Sometimes these concepts are nice schemes for a Utopia, which does not exist and perhaps cannot exist until someone gets busy and makes it happen. Often ideas are shot down using this exact argument; that they cannot exist because the World is already the way it is. Other ideas are shot down for fundamental reasons such as who will sign onto the idea? Who will sell it and market it and most of all who will buy it.

In fact every company needs a marketing plan in order to plan the way to its success, to steer it and to control or adapt it.

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Digg It - Direct Mail - Don't Forget The Envelope

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