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Read The New York Times, turn on CNBC, or open your browser to Google News. You’ll see that file-sharing is the biggest challenge to the 1999 Digital Millennium Copyright Act (DMCA) and one of

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

the most important stories facing the media industry in 2007.

The process of sharing files between networked computers has been around in academic circles for a couple of decades but, when a 19-year ol

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

Examples of combination products may in

undergraduate invented Napster in 1999, he provided the tool to facilitate free transfer of MP3 formatted music between personal computers anywhere in the world.

Literally overnight, individuals and c

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

rporations owning music copyrights confronted a daunting new reality. The Recording Industry Association of America (RIAA), which represents five major record labels and many smaller labels, launched a

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

eries of high-profile lawsuits based on the DMCA. While these actions led to the demise of Napster, to this day RIAA continues its crusade against Napster clones in the courts.

Digitally, where music g

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

Combination pro

es, movies will follow. In 2005, YouTube, a free video-sharing website allowing users to upload, view, and share video clips, was born. Content includes movie and television clips as well as music video

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

. Google was so smitten it plunked down $1.76 billion in stock to acquire the company.

Now the legal circus and media sideshow that lawyers, analysts, and pundits predicted five months ago is center st

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

ge. Many other “traditional media” giants (such as NBC Universal and News Corp.) that own lots of content, and therefore have major concerns about YouTube, were lining up to fight.

It was Viacom that t

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

ok the first swing with a billion-dollar lawsuit, charging YouTube with copyright violation “on a massive scale.” At issue are 160,000 unauthorized clips of Viacom-owned shows like “SpongeBob SquarePant

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

” and “MTV Unplugged.”

Google/YouTube is seeking refuge in the “safe harbor” provision of the DMCA, which exempts anybody who removes copyrighted content as soon as the owner requests it. Timing is a s

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

cond issue, since DMCA became law in 1998, the year Google was founded but YouTube did not even exist.

From a media standpoint, the inherent conflicts are evergreen. The enduring themes are “traditiona

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

Following aspects would a

l vs. new,” “ownership vs. accessibility,” and “solid vs. sexy.” Such storylines oblige Viacom to take a few extra steps to ensure that it is not perceived as stodgily blocking innovation, nor some ogre

dd to the challenges in developing combination products:

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

depriving mass audiences of a few simple harmless pleasures (which is exactly the perception that once burdened RIAA).

Among such steps:

Assemble representatives from the major content creators (autho

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

s, publishers, musicians, film makers) and owners (publishers, record companies, TV and film studios) and create a formal alliance to “preserve and protect” copyright holders. Such a step adds credibili

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

y to the cause but also reminds the world that individuals, not just a corporate behemoth, have vital interests here.

Open another front in the battle by delivering the key message that, under current

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

aw, the cost of enforcing copyrights is placed solely on the “victims of infringement,” many of whom don’t have the resources to fight what may turn into a long and protracted battle.

Target that pivot

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

Professional from academic institutions, pharmaceutical industries, health care indust

l audience of young people raised in an era of on-demand video channels with less consciousness of how the work of actual writers and directors is being usurped. To change their mindset will require a l

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

ngthy and expensive outreach effort across all traditional and new media, perhaps even advertising on Google.

It is, however, the recipe for long-term success. Indeed, we’re talking about issues manage

.

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

ent at a fundamental level. Absent a raising of mass awareness on behalf of the artists involved, the issue of file sharing will recur in one form or another with predictable regularity – Napster one da

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

Companies that provide selfless information through particip

, Grokster the next, YouTube today.

The way to win the long-haul battle is by putting the most sympathetic, and directly comprehensible, human face on the complex legal and technological issues at play

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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All too often, we are guilty of forcing our cashiers to follow a series of service steps in an effort to standardize our delivery system. To that end, we simply process people through a line. As guests, if we wanted that, we could simply have a terminal where we enter our own order. That idea would be as successful as the failed full-serve restaurants where you had to cook your own steak!

No matter how many times you tell them, most salespeople don't do enough prospecting to keep their pipelines full. They frequently don't enjoy cold calling and would far rather be negotiating or closing a deal. This is a sweeping generalisation but it holds true in many organisations. By outsourcing you are assured of a steady stream of new prospects.

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