Main Subject - Business

Six Sigma implementations aim at achieving near perfect production wherein the number of defects is substantially reduced. However, Six Sigma imp

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

lementations are definitely not easy because they often require a major overhaul of existing business processes, which in turn requires extensive

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

Examples of combination products may in

analysis and documentation.

Understanding The Six Sigma Pyramid

Six Sigma quality levels can be described with the help of a pyramid, wherein

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 base of the pyramid represents the current quality levels of a business. The aim is to move up the pyramid to make gradual improvements in th

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 quality level such as sigma 1 to sigma 2, sigma 2 to sigma 3, and so on until the top quality level, Six Sigma, is not achieved. Every stage or

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

Combination pro

quality level requires the use specialized statistical tools, about which the Six Sigma implementation teams should have in-depth knowledge and e

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

xpertise.

Some Basic Tools

Businesses aiming for achieving sigma 3 or sigma 4 quality levels need to utilize Six Sigma measurement, analysis, a

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

nd documentation tools. These tools will help in measuring the current percentage of material wastage, which is usually in the range of 50 to 60

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

percent if the company’s existing quality level is sigma 1. At sigma 2 levels, the wastage is around 33 percent, which means that there is still

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

plenty of scope for improvement. Once the level of wastage is identified with the help of these tools, the Six Sigma implementation team can then

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

start making the necessary changes in processes to achieve the next quality level.

Industry Specific Tools

A use of a particular Six Sigma tool

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

Following aspects would a

depends on the type of industry. For example, in industries having high volume transactions, it would be impossible to measure and analyze each

dd to the challenges in developing combination products:

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

transaction. As such, only those tools are used that are designed to identify high value transactions based on predetermined logical parameters.

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

These tools will allow a business to give priority to the improvement of most vital processes that deal with high value transactions.

Such tools

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

are necessary for ensuring the success of Six Sigma implementation projects because higher quality levels cannot be achieved until and unless al

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

the high value business processes are not utilized to their full potential. The full potential of a business process can only be realized when i

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

Professional from academic institutions, pharmaceutical industries, health care indust

t reaches maximum optimization levels or achieves Six Sigma quality levels. All this can only be achieved by employing the right Six Sigma tools

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

and techniques in the right business process.

For selecting the right tools, businesses need to opt for the expert advice of Six Sigma professio

.

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

nals. Although the tools are more or less the same used by engineers, supervisors, and other technicians, expert advice is still valued because i

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

Companies that provide selfless information through particip

t is only the Six Sigma professionals who know how to utilize the information generated through Six Sigma tools and techniques in a proper manner

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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