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Introduction

Six Sigma is all about quality improvement and was first pioneered by Motorola in the 1980s. Over the last few years, this methodology has received much recognition

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

and several companies have adopted it in order to meet their targets. Six Sigma’s clientele include a long list of well-established manufacturers like General Motors, Ford Motor C

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

Examples of combination products may in

., GE, Honeywell and many more. However, there are still many non-manufacturing companies that have come to the conclusion that Six Sigma will not work for them. This is because S

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

x Sigma was originally developed for helping the manufacturing industry. Organizations such as health care systems, financial service providers and educational systems all doubt t

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

e usefulness of Six Sigma.

Why The Service Sector Feels That Six Sigma Is Not For Them

The most obvious reason why service companies keep away from Six Sigma is because they per

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

Combination pro

eive it as a manufacturing tool. Service organizations feel that because their companies have a large amount of human work force, there are no measurable defects to be corrected.

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

However, experts say this is not true. A recent survey has shown that service companies that have invested in Six Sigma are all saving millions of dollars for every project. Human

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

resources makes up a large part of all service organizations. To conquer this problem, leaders of the industry can be trained in Six Sigma to balance their employment expertise wi

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

h statistics-based analytical tools.

The fear of metrics is another obstacle that stands in the way of the service sector and Six Sigma. Most people feel that Six Sigma sounds to

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

technical. The importance of metrics is to give an insight into the business working processes. Service based companies need to focus all their attention on developing Six Sigma

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

rojects that specialize in their business needs like customer and cash generation. Convincing the service sector about the merits of taking up Six Sigma has proven to be a big cha

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

Following aspects would a

llenge. Most service companies still believe that Six Sigma can only benefit the manufacturing industry.

How Six Sigma Can Benefit The Service Industry Six Sigma goes in to the

dd to the challenges in developing combination products:

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

etails of improving customer service, generating business expansion and gaining knowledge about the service sectors business processes. Most service industries revolve around area

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

of finance, human resources and sales and marketing. Hence, Six Sigma delves deeply into the subject of soft skills. Six Sigma can be applied to a company that provides housekeep

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

ng services. Firstly, the companies working processes would need to be understood.

Using the DMIAC method or the define-measure-improve-analyze-control method, Six Sigma can defi

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

itely implement quality in any industry. As the main aim of this methodology is to reduce defects, the first step would be detecting the particular defect. Secondly, data will be

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

Professional from academic institutions, pharmaceutical industries, health care indust

collected to observe how, why and how often these defects occur. Next, the Six Sigma team implements an outstanding employees method of working as the normal method for all employ

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

es. Finally, new employees are taught the correct techniques.

Six Sigma is useful in the field of sales and marketing as well. According to Six Sigma data, during sales, too much

.

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

face time with a customer can prove to be counter-productive. Changing this process can result in an increase in the percentage of sales per product. Other industries that Six Sig

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

Companies that provide selfless information through particip

a has assisted in the past are the financial service sector, insurance companies, management companies, educational institutions, high-tech companies, state agencies and many more

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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