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You may have noticed the increase of discussion and publication about a topic called 6 Sigma. However, what isn’t as obvious is w

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

hat 6 Sigma actually is. First created by Motorola, 6 Sigma is an intensive, highly focused, and greatly effective quality contro

; 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 strategy. Its primary goal is to maintain the performance of an organization virtually error-free.

When measuring the performa

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

nce of a company, its Sigma level is given. Traditionally operated businesses will usually be found running at a 3 or 4 Sigma per

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

formance level, even though their rate of problems per opportunity usually falls between 6,200 and 67,000 per one million.

On the

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

Combination pro

other hand, an organization running at 6 Sigma will instead see an average of only 3.4 problems per million opportunities. This

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

tremendous difference can make the difference between success and failure in a market where the expectations of customers rise as

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

quickly as the complexity of today’s products and processes.

Surprisingly enough, however, 6 Sigma – though considered an entirel

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

y new and innovative strategy – does not involve any new technologies, theories, or techniques. Instead, its foundation is method

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

s that have existed for a long time and have proven their efficacy time and time again. In fact, 6 Sigma disregards a large amoun

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

t of the density of traditional Total Quality Management (TQM) in favor of a much more direct, common sense-based, and practical m

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

Following aspects would a

indset.

Unfortunately, though, after lifetimes of learning, training, and thinking in traditional ways, the more reality-based 6

dd to the challenges in developing combination products:

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

Sigma does not come naturally to many people. To compensate for this issue, specially trained, proven individuals, known as 6 Sig

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

ma Black Belts, have become available to assist organizations using their proficiency in the application of the 6 Sigma strategy.

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

Of course, all this is not to say that everything about 6 Sigma is obvious and simple. In fact, some of the techniques utilized

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

by the Black Belts are quite advanced, and require state-of-the-art computer technologies.

Fortunately, these tools can be applie

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

Professional from academic institutions, pharmaceutical industries, health care indust

d to quite an easy performance improvement model, frequently referred to by 6 Sigma Black Belts as the Define-Measure-Analyze-Impr

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

ove-Control Model, so that any business can apply 6 Sigma to its own processes.

Now that you know what 6 Sigma is, it’s time to f

.

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

ind out how you can improve the function of your own business and maximize your potential through practical and realistic quality

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

Companies that provide selfless information through particip

control. The strategy has worked wonders for Motorola, and is currently growing its successes with organizations around the globe

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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