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Today, Six Sigma covers a very wide range of industries such as healthcare, banking, manufacturing and construction, to name a few. The 2 methodologies adopted b

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

y Six Sigma take care of the existing process and the new processes that still need to be developed, through DMAIC and DMADV respectively. DMAIC and DMADV are a

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

Examples of combination products may in

cronyms for process improvement methodologies. The methodology is hailed as the finest quality management system or tool that the industry has ever seen.

What M

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

akes Six Sigma The Finest Quality Tool Ever?

Six Sigma came to occupy center stage riding on its success of its founder and pioneer Motorola’s successful implem

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

entation. The comprehensive, structured approach of Six Sigma involves the entire organizational pyramid. The organization needs to dedicate 100% of its time to

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

Combination pro

the usage of unique problem solving techniques, with no nonsense responsibilities.

The comprehensive approach involves top management with designated key roles

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

responsible for identifying and reviewing projects. Middle implementation groups like the Champions and Master Black Belts dedicate their time to removing trans

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

jurisdictional bottlenecks and to problem solving. Trans-jurisdictional bottlenecks are potentially very serious and can possibly derail the implementation. Cham

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

pions handle this very tactfully like seasoned warriors. Master Black Belts are extraordinarily talented in problem solving and in using sophisticated statistica

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

l tools.

Statistical tools are highly customized to the situation and are very versatile. These tools are used to question and measure the processes in any busi

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

ness environment with the goal to rationally analyze and design/correct them. If with Six Sigma, you can achieve 3.4 defects per million opportunities, save mill

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

Following aspects would a

ions of dollars and satisfy customers in addition to making the company lean and mean and appealing to employees and owners alike, the methodology is indeed the

dd to the challenges in developing combination products:

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

ultimate management tool. But is it the ultimate quality management tool that can never fail? Or are there chinks in its implementation armor?

Failure of Six Si

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

gma

Fortune magazine on January 22, 2001 writes about the satellite phone, Iridium, made by Motorola, the pioneer of Six Sigma. The phone was an utter flop as n

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

one bought it. This means that Six Sigma only assures quality but not customer satisfaction. Customers only buy things they really want.

There are certain stat

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

istical snags that experts point at. They are critical of the universal standard rule that Six Sigma uses instead of going case-by-case on different tasks and no

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

Professional from academic institutions, pharmaceutical industries, health care indust

t using more appropriate, common-sense based tools, such as decision, theory and cost- benefit analysis.

The statistical methodology: Some critics are skeptical

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

that Six Sigma is a marketing ploy that helps make money for all those involved, especially the consultants. Since the methodology is taught and practiced in on

.

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

ly one way and since there is an absence of standardization of both implementation and Six Sigma training, it lacks consistency. Still others are scathing in the

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

Companies that provide selfless information through particip

ir criticism that those who claim huge successes were total failures in quality control before Six Sigma and that their focus on small areas brought huge returns

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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