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Six Sigma And The Green Belts

In an organization implementing Six Sigma, the Black Belts are generally supported by the Green Belts. Black Belts do most of the problem-

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

solving and analytical work. The cost of training, hiring and renting new Black Belts is a major factor that eats into the Six Sigma projects savings. This in turn leads

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

Examples of combination products may in

to a decline in the returns on investment. An increasing trend for companies employing Six Sigma in order to save more money per year is to use the unconventional appro

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

ach of training Green Belts at least two to three years before even considering hiring Black Belts. Green Belt projects take up less time and the training is not so exte

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

sive. Using the Six Sigma methodologies, organizations deploying Six Sigma can recover a large part of the early waste. This does not require the superior skills and kno

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

Combination pro

wledge of a black belt. This approach allows the organization to grow and educates managers on the use of statistical techniques, which in all probability they haven’t l

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

earnt while going through training or schooling. Using Green Belts can save a lot on time, training, money and effort.

Creating A Road Map

As with any Six Sigma projec

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

t, a road map is required to proceed. This is especially related to organizations that are new to Six Sigma and don’t have any experienced Black Belts to take control. S

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

x Sigma deals with collecting information, statistics and figures related to a certain process and then using this information to improve the process in order to satisfy

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

the customer. Training involves using the DMAIC model or the define-measure-analyze-improve-control model. However, using this model alone does not yield desirable resu

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

lts. Green Belts need to study the organization’s culture and then create a road map for constant improvement.

Skills, Tools And Attributes Required

The Green Belt mus

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

Following aspects would a

t first figure out how a process performs and how stable that process is. The only way to exhibit stability is by learning, creating and using process-behavior charts. T

dd to the challenges in developing combination products:

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

ese charts can be used to detect process variation and its various causes. A Green Belt must determine how a process runs or functions by using run charts. Understanding

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

customer needs is also another important tool that is required. Create a QFD or a quality function deployment, which converts customer needs into in-depth product requi

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

rements. These requirements should then be employed in the design, production, support and marketing departments. Reduction in the variation that exists in the process w

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

ill result in an increase in customer satisfaction. The Green Belt must be willing to seek out customers and talk to them about their wants and needs.

Most organization

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

Professional from academic institutions, pharmaceutical industries, health care indust

create problem-solving processes. Ensure that everyone concerned with the process knows how to use this method. Six Sigma can be used at the most suitable time to aid i

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

n problem solving. The Green Belt must practice these problem-solving measures in order to solve actual problems. Follow the DMAIC model to make improvements. The Green

.

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

Belt will have to be trained in all the processes that are used in fundamental Six Sigma applications. After the process has been enhanced, monitor it to make sure that

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

Companies that provide selfless information through particip

no changes take place. Monitoring can be done with the help of control charts. Green Belts should learn the art of control charting by actually making handwritten charts

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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Package design is not decoration. Did you know that 80 percent of all purchasing decisions are made in-store? As traditional media is being revolutionized right before our eyes, your packaging will most likely be the first introduction a consumer has to your product and we all know how important first impressions are. Your package is a valuable asset that can make or break the sale of your item and should be considered as important as the item itself. There are 4 key attributes to ensure a successful package design.

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A conversation with a successful businessman lifts up the value of good neighborliness in creating good business.

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