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It would be fair to say that Starbucks has penetrated the cultural fabric of America quite extensively. Now, it is al

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

so attempting to do the same with the rest of the world. It has become a place to get together with friends, an exten

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

Examples of combination products may in

ed office, a pick-up joint, and many other things - different things to different people.

Starbucks is a consumer co

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

ncept that was pretty much unimaginable until it was implemented, scaled, funded, and scaled further. Howard Schultz

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

nvisioned the concept after experiencing the popularity of coffee bars in Italy. For those who were gutsy enough to i

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

Combination pro

vest in the concept (Jamie Shennan of Trinity Ventures, for example, who is still on the Board, and invested in 1990;

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

Starbucks went public in 1992) the deal paid off handsomely.

The world’s #1 specialty coffee retailer, Starbucks op

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

rates and licenses more than 8,500 coffee shops in more than 30 countries. The shops offer coffee drinks and food ite

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

ms, as well as beans, coffee accessories, teas, and CDs. Starbucks operates more than 5,200 of its shops in five coun

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

ries (mostly in the US), while licensees operate more than 2,800 units (primarily in shopping centers and airports).

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

t reports an employee count of 96,700 in 2004.

As the US continues on its quest towards finding business concepts th

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

Following aspects would a

at cannot be off-shored and out-sourced, clearly, high-touch retail and consumer concepts such as Starbucks are highl

dd to the challenges in developing combination products:

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

desirable.

Here is one that I like to fantasize about: Jazz Bars and Dance Floors of the ambience, musical quality,

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

and vibrancy that we see in the movie, Ray, celebrating the life and music of Jazz legend Ray Charles.

As American

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

ulture degenerates further into becoming more and more sedentary, obese, isolated, on-line, and uninteresting, I wond

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

r when would the pendulum swing far enough, that someone will get frustrated enough to start something new. A new pla

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

Professional from academic institutions, pharmaceutical industries, health care indust

ce to “connect”, a new way to “enjoy”, and consequently a new way to “employ”...

My hope is, that those who will lau

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

ch that quest will rediscover the joys of Swing and Foxtrot, as Herman Hesse described in his celebrated novel Steppe

.

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

nwolf.

I haven’t done the business plan, and I haven’t run the numbers but I sure hope there would be money in such

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

Companies that provide selfless information through particip

venture, if done creatively, with the thoughtfulness and business savvy of how Starbucks was launched upon the world

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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