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Six Sigma concepts and philosophies were originally developed for improving the overall quality of business processes in the manufacturing sector. Companies like Motorola and GE were among the first

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

few that successfully introduced Six Sigma concepts in their business processes. However, with the development of newer tools and techniques, Six Sigma is now deemed appropriate for the services sect

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

Examples of combination products may in

or as well. The usability of Six Sigma in the services sector is easily evident from the increasing number of finance and insurance companies that are opting for Six Sigma.

Consumers are increasingl

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

y becoming aware of the quality of services being offered to them, making it essential for the services industry to implement quality improvement techniques like Six Sigma for conforming to customer

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

expectations. This is especially true for the insurance industry where the relationship between the insurer and the insured is still largely governed by sustained personal contact. By implementing Si

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

Combination pro

x Sigma programs, insurance companies have been able to offer quality services at affordable rates to their customers.

Identifies Key Business Processes

Unlike other quality management practices su

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

ch as Total Quality Management (TQM) whose effectiveness is difficult to measure, Six Sigma based improvement programs make use of statistical tools, which can measure the effect of changes being mad

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

e in a very short time. Six Sigma focuses on process orientation, enabling organizations to identify key business processes that are necessary for improving customer satisfaction. This helps managers

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

in understanding the exact requirements of their customers and in altering business processes to suit customer needs and expectation.

Follows A Disciplined Approach

Six Sigma has helped insurance

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

companies in improving quality as well as reducing costs of services offered. It has enabled insurance companies to follow a disciplined approach, which has helped in preventing errors, minimizing ha

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

nd-offs, and eliminating rework and workarounds. It has also helped in increasing the speed of business processes used in the insurance industry.

Helps In Making Informed Decisions

Six Sigma has en

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

Following aspects would a

abled managers in taking informed decisions based on statistical data. With the use of Six Sigma tools and techniques, managers no longer have to rely on their perceptions or gut feelings for renderi

dd to the challenges in developing combination products:

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

ng the level of services promised to policyholders, clients, and prospects.

Helps In Building Customer Loyalty

Six Sigma emphasizes on understanding the needs of the customers before making any cha

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

nges to business processes. This helps insurance companies in building customer loyalty among their policyholders, which is necessary for the long-term success of any business organization. Insurance

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

companies can also hope to increase their market share, as satisfied customers are most likely to recommend a company that offers quality services while advising a friend, relative or business assoc

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

iate. Helps In Reducing Costs

Six Sigma tools and techniques aim at streamlining business processes in such a way that helps in reducing costs. This helps insurance companies to improve their savi

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

Professional from academic institutions, pharmaceutical industries, health care indust

ngs and avoid drastic cost-saving measures such as downsizing, which can have a negative effect on employee morale. It can also create doubts in the mind of policyholders and prospects as downsizing

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

usually attracts a lot of negative publicity.

Six Sigma has helped the insurance industry in bridging the gap between planned strategies and actual operations by providing analytical and in-process

.

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

performance measurement tools. These tools are used for comparing planned goals and objectives with actual outcomes and for finding the reasons as to why a particular business process is not giving t

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

Companies that provide selfless information through particip

he desired results. Once the exact problem has been pinpointed, managers can make the necessary changes that will help in improving overall quality of services rendered to policyholders and prospects

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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