Subjects - Business

Many small and mid-sized business owners are under the impression that the Six Sigma Process is not for them as it has a repu

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

tation to cost a prohibitive amount of money for companies of their size. Though this was true when the original Six Sigma P

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

Examples of combination products may in

rocess came to be, as it continues to grow and evolve, many smaller companies are now quite capable of affording to implement

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

the latest development of its strategy.

This more affordable Six Sigma Process is commonly called Generation III. It has b

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

een developed specifically for small to mid-sized companies who are seeking to improve their profitability through performanc

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

Combination pro

e. Its affordability has been made possible by way of the internet which now offers online training technology, as well as n

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

ew smaller-scale “live” training options for reducing training expenses.

Naturally, there are a few differences between the

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

riginal, Generation I Six Sigma Process and the new Generation III for small and mid-sized businesses, however, this is what

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

makes it so beneficial to these smaller businesses – it functions with them in mind. Primarily, these differences are made u

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

p of the following:

• Generation I focuses primarily on defect, while Generation III focuses on value.

• Generation I place

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

s emphasis on the provider, while Generation III places emphasis on both the customer and the provider.

• Generation I exper

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

Following aspects would a

t consultants and trainers are referred to as Black Belts, while Generation III expert consultants and trainers are referred

dd to the challenges in developing combination products:

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

to as White Belts.

Instead of making its primary focus the reduction of costs, Generation III of the Six Sigma Process now i

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

nvolves the creation of value. This is an enormous step in the strategy’s outlook. Its aim is to have businesses provide goo

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

s and services of the highest possible value. In terms of Generation III, value means that the product or service is provide

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

d at the right location, on time, in the right amount, and at the lowest possible cost.

To reduce costs, Black Belts of Gene

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

Professional from academic institutions, pharmaceutical industries, health care indust

ration I who train in costly classroom settings leading to a relatively long development before actual results are seen, have

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

been traded in for the Generation III White Belt. White Belts of the Six Sigma Process provide results much more quickly wi

.

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

th less overall training. This is possible due to the White Belt’s narrower focus.

Ultimately, this means that companies, n

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

Companies that provide selfless information through particip

o matter their size, are now ready to take advantage of the benefits and potential offered by taking on the Six Sigma Process

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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Subjects - The Six Sigma Process isn't Just for Big Businesses

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