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It used to be that offset press printers competed with one another and quick printers - those using analog and digital copiers - competed with one another. This is no longer th

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 case. While each type of printer has its advantages, both are now vying for the same business. This is primarily driven by two forces: market demand and technology.

Today's

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

Examples of combination products may in

customer demands various sized orders from smaller runs of less than 2,000 pieces up to direct mail campaigns of 20,000 pieces or more. Furthermore, increasingly the expectati

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

n is to have the job completed in 2- 3 days. Not too long ago an offset printer would send this customer to a quick printer for fast turn-around especially for, say a 2,000 pie

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

ce four color job. Well today, that same offset press printer will most likely accept that job and turn it around in the time demanded. Because more and more customers were re

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

Combination pro

questing this type of service, offset printers have had to adjust.

This is where technology enters the picture. Because the speed and quality of digital copiers has greatly in

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

reased while prices have continued to decline, printers are able to acquire more capability at modest investments. Thereby allowing them to compete head to head with quick prin

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

ters and accept much more of the work they used to turn away.

While this all sounds great for customers and offset press operators, where does it leave the traditional quick pr

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

inter? Well, the short answer is worse off. It is no secret that quick printers can purchase and invest in higher-end equipment that can compete head to head with the offset p

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

ess, but the fundamental problem with that is that quick printers are quick printers because they made a decision to be such, meaning they chose not to be in the offset printing

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

business and really have no desire to do so. This is especially true given the high cost of equipment and skilled labor. So how do quick printers compete? They compete by pa

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

Following aspects would a

rtnering or forming alliances with offset printers, especially those that exclusive serve the print trade industry, in order to satisfy the quick print customer base and gain so

dd to the challenges in developing combination products:

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

e financial benefit. And by partnering, I mean quick printers continue to pass larger jobs on to their offset partners but retain ownership of the customer, thereby gaining the

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

ability to extract some of the margin. In the end this model is not ideal because the quick printer has little control over the production process and the pricing model. Addi

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

tionally, this is a much lower margin business model that cannot sustain as a primary source of revenue in the long term.

At the other end of the spectrum for quick printers, v

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

ry short runs, the news is not much better. Customers are gaining the ability to produce this work themselves for the very same reasons noted above with technology being the ke

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

Professional from academic institutions, pharmaceutical industries, health care indust

y factor. It is not unusual to find the same production-quality equipment found in a quick print shop in corporate offices. These corporate customers still demand finishing se

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

rvices such as binding but the core printing service is increasing being done in-house.

Because quick printers are being squeezed at both ends, they will need to offer services

.

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

that others cannot or are not willing to offer such as end-to-end customized solutions. These types of offerings provide value to the customer by allowing them to focus on thei

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

Companies that provide selfless information through particip

r core business and these offerings are less sensitive to price competition. The future for quick printers is one of change and discovering new ways to bring value to customers

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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