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On-demand publishing helps legions of writers accomplish the second most common New Year's Resolution: publishing a book! It is important to remember that "Getting Published" the right way de

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

pends upon more than just finishing your manuscript and sending it off to a publishing company.

There are a number of important factors to consider.

Publication Timeframe

Between traditiona

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

Examples of combination products may in

l publishers and digital book mills, the timeframe for your book's publication may range between 24 months and 24 hours. Both extremes should be avoided. Traditional publishing houses often ta

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

ke up to 24 months to reject a book. Author stories are common about publishers who initially accepted their book for mainstream publication, only to reject it 18-24 months later because the "

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

arketing Department" didn't consider it feasible. If you have experienced a similar situation, you are a good candidate for on-demand publishing.

On the other hand, digital dot-com book mills

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

Combination pro

on the Internet claim to publish books instantly. One even features a graphic of a "machine" publishing your book for you. How comforting! Machines can do anything in 24 hours, except love so

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

mething. After the time you invested in your book, you should seek a publishing process that is a bit more... human.

The proper timeframe for book publication is somewhere in between those tw

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

o extremes. Six weeks is not unreasonable. Nor is 6 months.

Up-Front Costs

Between traditional publishers and off-set vanity presses, the up-front costs for book publication range between $0

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

and tens-of-thousands of dollars. Just like the timeframe range, both extremes should be avoided. Publishing in the tens-of-thousands range is primarily paying for an off-set print run for boo

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

ks that will then need to be stored (incurring another fee for inventory management).

On the other hand, free publishing requires something even more valuable than a one-time finite fee, like

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

your publishing rights (or something even worse). One dot-com book mill's CEO describes his company's business model in the following trite terms: "One man's trash is another man's treasure."

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

Following aspects would a

The "trash" he refers to are the books they publish. Not surprisingly, this is the same company that has a "machine" publishing books for them. Yes, machines often generate trash. Proceed wit

dd to the challenges in developing combination products:

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

caution.

The proper cost is somewhere in between.

Recurring Back-End Costs

Most authors are unaware of back-end costs at all (and publishers take advantage of that). Be different. Inform y

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

ourself by reading and understanding this next section.

Back-end costs include your author's copy price, your retail price/profit margin differential, and your royalties. Most authors focus s

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

olely on the one-time-only front-end cost, even though the back-end costs are recurring month after month for the life of the book.

To see a side-by-side comparison of 4 leading on-demand pub

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

lisher's back-end costs for a 5.5" x 8.5" hardback book (224 pages) with a dust jacket visit http://outskirtspress.com/marketing/case-pb.gif. This is based upon an actual book published by an

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

Professional from academic institutions, pharmaceutical industries, health care indust

n-demand publisher, titled (Pretty Blue, for which the author selected the trim size, the hardback edition upgrade, and set the retail price ($24.95), the distributor discount (20%), and the

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

royalty (29%).

If you have already published your book with an on-demand publisher, closely examine what your back-end costs are costing you, and make the appropriate changes. Sometimes, chan

.

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

ging publishers is more profitable in the long-run, even if it means absorbing another up-front publishing fee. Of course, only you can make that decision, but by knowing the differences betw

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

Companies that provide selfless information through particip

een finite up-front costs, and on-going back-end costs, you are better equipped to make those decisions profitably. Don't just accomplish that New Year's Resolution in 2007. Accomplish it well

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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