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It is not easy to implant the concept of Six Sigma into the culture of a company. This is because Six Sigma hardly bears any comparison with other quality management t

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

ools, barring a few similarities with Malcolm Baldridge National Quality Award. But unlike the Baldridge Award, Six Sigma gets to the core of the business sphere with

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

Examples of combination products may in

roven tools. But what really stands out as the major difference between Six Sigma and all other quality management tools is the whole army of highly trained employees

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

oming from various professional and organizational backgrounds, not just from the quality assurance specialization. This is why they are called internal change agents.

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

It is irrelevant to say whether Six Sigma evolved as an alternative to other quality tools or management tools. However, some similarities can be seen between Six Sig

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

Combination pro

ma and other similar programs. Certain tools and concepts of continuity in improvement are shared across all quality programs. But it is the set of differences that ma

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

e the Six Sigma environment a unique one.

Six Sigma Environment

At the core, the concepts of Six Sigma gels completely with the fundamentals of doing business. This

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

s underlined in the basic emphasis that is given to total customer satisfaction, taking profitability to different sphere through maximization techniques. To quote an

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

xpert, “Six Sigma speaks the language of business”.

The success of Six Sigma depends a lot on the environment in which it is being implemented. The conduciveness of t

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

he environment for Six Sigma implementation is brought about when the vision of upper management is shared by everyone in an organization. This becomes clearer when se

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

n against the backdrop of huge number of personnel working for it. It could be different in an ISO 9000 environment as the onus of implementation is relegated to the q

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

Following aspects would a

ality assurance department. Satisfied customers, a more realistic workload for employees, an improved work culture and finally a rising bottom line and profitability f

dd to the challenges in developing combination products:

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

r the owners, are all contributors to the success of Six Sigma.

Linking Six Sigma to Financial Gains

Next, Six Sigma does not just focus on manufacturing or producti

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

on-related activities alone, but the entire gamut of doing business. Cross-functional implementation coupled with recognizing opportunities for improvements in all key

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

areas of business can be neglected but at the cost of relegating Six Sigma to the status of other traditional quality programs. The finance and planning departments ar

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

also included in Six Sigma implementation.

The powerful tools available with Six Sigma help to improve functioning of key departments. For example, marketing and sal

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

Professional from academic institutions, pharmaceutical industries, health care indust

s can collect customer input. Feedback in the form of customer satisfaction levels can help the finance department adjust the accounting method to focus on predominan

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

tly costs and benefits. Human Resource can concentrate on rewards and recognition based on universal criteria, tracking employee satisfaction etc.

Business becomes “a

.

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

usual” with Six Sigma once the project selection does not remain the sole jurisdiction of the quality team. When individual department heads begin to own responsibili

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

Companies that provide selfless information through particip

ies for business goals, the environment can be said to have arrived where it was expected. It is “business as usual” from here onwards within the Six Sigma environment

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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Ten simple statements that briefly explain some of the primary benefits that can come from a thoughtfully designed and developed corporate image. This article is great for those in need of Marketing, Advertising, Graphic Design or Web Design consultation.

Many people wish to help entrepreneurs get started and become successful. Of course if you have never run a business before, well it can be tough indeed. Now then if one were to use a little creativity to apply themselves then it might be possible to help a whole lot of people fairly easily you see?

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