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Six Sigma is a management methodology for accuracy in manufacturing, etc. to make sure things

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

are done right the first time and with that comes increases of economies of scale-fewer return

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

Examples of combination products may in

, etc. Such processes are especially important in Military, Health Care, manufacturing, trans

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

ortation and computer industries.

When every thing is right with fewer returns, less time is

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

pent fixing your mistakes, thus higher profits. Some of this could be classified as Micro-man

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

Combination pro

gement of little details which goes against the theories of Fly by the seat of your pants, ent

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

epreneurs, yet when working on lower margins in low cost high volume matured industry sectors,

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

if you cannot do it the Six Sigma way, you will be passed and put out of business by someone

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

ho is.

So I would say to those in any industry that the devil is in the details and Six Sigma

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

is worth a read. You should start with Jack Welch's Biography and then go pick up a Six Sigma

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

anagement book, yes you should be aware of this. I would also recommend that entrepreneurs al

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

Following aspects would a

o respect those resumes, which contain Six Sigma Black Belt in them. Although as I study this

dd to the challenges in developing combination products:

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

tuff I can tell you that you still need an entrepreneur and visionary out front and most are f

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

om the gut and few can do both.

So companies should be careful if they are looking for a prob

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

lem solver or General Patton hard charger when you have a perfection systems guy of Six Sigma,

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

most likely they are NOT the same animal and many times they will not even get along personall

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

Professional from academic institutions, pharmaceutical industries, health care indust

. Just make sure there is mutual respect and admiration for each of the others abilities. Too

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

often Sign Sigma's think they know it all and forget the reality of the market or the customer

.

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

The sales teams or counter person is gold for information. Six Sigma black belts or whateve

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

Companies that provide selfless information through particip

cool titles they give them now a days need to be full spectrum to work. Consider this in 2006

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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If you are opening a dollar store, or any other business for that matter, one of the challenges that will present itself is to continually growing your business. Yet building your business is just what happens with effective marketing. You don’t have to break the bank to develop and execute a successful, high-impact marketing program. You do need to take the time to develop a marketing plan and that plan must be supported with a reasonable marketing budget.

As the benchmark of any good advertising campaign, a slogan or tag line is the lasting impression it has on the consumer. A great line can be worth its weight in gold. It often plays role as the brand's core promise, rather than a pithy memorable phrase. A slogan can be a call to action, not only for the consumer, but also for the entire organization and sales force.

When it comes to your business, the way you communicate is essential. Remember how your 10th grade English teacher would tell you how important your writing skills will be in life? The teacher was right. When you own a business, everything you communicate gives off an impression.

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