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The quest for perfection is second only to human survival instincts. These are the two reasons that were solely responsible for civilizations to flourish. That we are wearing clo

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

thes today as a symbol of the quest for perfection and innovation should reinforce this statement.

Was There A Conscious Effort To Develop Six Sigma Into A Competitor To Existin

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

Examples of combination products may in

Systems?

This is a na?ve and unfounded question, as Six Sigma was developed as independently as any other school of quality management systems. If we value the famous quote of

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

M.K. Gandhi that the end result justifies the means, then it clarifies the need to have more than one quality system.

Evolution Of Six Sigma

Six Sigma has its roots in the earl

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

industrial era of Europe during the 18th century and was introduced with just one conceptual normal curve metric by Carl Frederick Gauss. In the 1920s Walter Shewhart showed how

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

Combination pro

3 sigma deviations from the mean required process correction. Later, a Motorola engineer, Bill Smith, coined the term Six Sigma, which was then copyrighted by Motorola.

The Japa

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

nese Mark

The ever quality-conscious Japanese perfected the Six Sigma concept when they took over a Motorola factory in 1970, which manufactured TV sets. The new Japanese manage

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

ent set out on a mission to change the way activities were going on in the factory, placing high emphasis on all activities leading to production. With their zealous approach the

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

later begin producing TV sets with just a 5% number of defects in comparison to the original records under Motorola.

Motorola’s Contribution

Mikel Harry, who is regarded as th

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

e godfather of Six Sigma, along with Bill Smith, the father of Six Sigma, wrote and codified a research report on the quality management system, which highlighted the correlation

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

between the performance of a product in the market with the amount of adjustment required at the point of manufacturing. This report clearly established that the lesser the numbe

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

Following aspects would a

of nonconformities at each stage of manufacturing, the better the performance. The report paved for implementation of “logical filters”, a key approach to problem solving. With

dd to the challenges in developing combination products:

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

the then Motorola CEO, Bob Galvin, playing a key role, later this four stage logical filter came to be known as the skeleton of the present Six Sigma. The four stages, then ident

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

fied, were Measure, Analyze, Improve and Control (MAIC).

A New Road Map

With the results of the efforts of Mikel Harry and Bill Smith paying rich dividends, Motorola’s Corporat

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

Policy Committee had set goals for further improvisation of the system by declaring (in 1989) that they would achieve ten times better quality in service and products, with furt

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

her improvement to 1/10th by 1991.

Galvin was instrumental in spreading the sense of quality in every sphere of business activity until total customer satisfaction was achieved.

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

Professional from academic institutions, pharmaceutical industries, health care indust

Until now, Motorola’s approach was limited to a disciplined statistical approach to problem solving. This approach still got Motorola the coveted Malcolm Baldrige National Quali

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

y Award.

Major Contributors On Its Journey To Perfection

We can’t forget the contributions made by Unisys Corp in 1988. Asea Brown Boveri in 1993 developed Six Sigma into its

.

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

current form, which places importance on bottom lines and customer satisfaction. The current form of Six Sigma has implementation being carried out by key role players: Champions

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

Companies that provide selfless information through particip

Master Black Belts, Black Belts, and Green Belts.

Since then, the Six Sigma methodology has been and is applicable to different industries. The evolution of Six Sigma continues

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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