Subjects - Business

Although Six Sigma sounds like a distant star in a galaxy far, far away, the term is very easy to explain, once you know sigma is the character in the Greek alphabet that is used in mathematical statistics to identify a standard deviation. A standard deviation is defined by how tightl

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 the various outputs of a process are clustered around the mean in a set of data. In other words, how divergent the outputs are from the statistical average. In statistical terms, Six Sigma means that if there were 1 million opportunities for a defect (defined as anything outside of

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

Examples of combination products may in

ustomer specifications) to occur, no more than 3.4 defects would be permitted, so that the quality of the output is near perfect. As such Six Sigma is seen as the ultimate goal in achieving almost immaculate processes through continual improvement.

Six Sigma achieves this by implemen

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

ting a disciplined, data driven methodology for eliminating defects in any process, from the manufacture of a product to after sale customer service. It focuses on process improvement and variation reduction through the application of Six Sigma improvement projects using the following

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

two Six Sigma sub-methodologies:

The Six Sigma DMAIC process (define, measure, analyse, improve, control), the most common Six Sigma improvement tool, which focuses on ensuring the improvement is clearly defined and measured and is used for existing processes that have fallen bel

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

Combination pro

ow customer specifications and require incremental improvement. Data is analysed to identify problems and the improvement is consolidated through process controls.

The Six Sigma DMADV process (define, measure, analyse, design, verify), which is an improvement system used to

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

develop new products or processes to Six Sigma quality levels. It can also be employed if the current process needs more than just incremental improvement.

Both Six Sigma processes, which can be easily calculated using a Six Sigma calculator, are executed by Six Sigma Green Belt

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

s and Six Sigma Black Belts, and are overseen by Six Sigma Master Black Belts. Each Member of the Six Sigma team is given key responsibilities for analysing information that will have an impact on improving processes and customer satisfaction.

The question you’ll be asking now is how

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

much benefit Six Sigma training can give your company. Well, in classic Six Sigma style, just have a look at the data. General Electric, one of the most successful companies to implement Six Sigma training, estimated that it has benefited the company a staggering $10 billion in the fi

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

ve years after implementation. And the Six Sigma Academy estimates that the approximate saving Black Belts give companies is $230,000 per project, of which between four and six can be completed per year. Organisations such as Motorola, who initiated Six Sigma training in 1987 and won

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

he Malcolm Baldrige quality prize for it, ABB, Honeywell and Allied Signal will be happy to attest to this.

Perhaps one of the most critical reasons why Six Sigma has had such tremendous success lies in one of its most distinctive differences from other quality management systems: th

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

Following aspects would a

extent to which it is inextricably linked to business finances. No matter the project at hand, the financial benefits are quantified and used to help prioritise the various stages of improvement. These are then re-evaluated during the analysis phase to ensure that the cost of the imp

dd to the challenges in developing combination products:

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

rovements will be supported by its overall benefit to the company. And the financial benefits are verified once again at the end of the project. Such a rigorous procedure also has the benefit of including all sections of the company in the Six Sigma training, because all are naturally

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

linked to the company’s finances.

Which Six Sigma Training Company is right for your you?

Now that you know what Six Sigma training involves and the reasons why your company should consider employing it, the final question is how to find the right consultant for you

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

r company. Well, the first thing is to define what you want to achieve by implementing Six Sigma, and whether you want it implemented right across the company or only in selected areas. This decision should not be made by you alone, but in conference with other company employees, beca

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

se implementation should be given the highest priority and support if it is to go ahead.

Once you have established the benefits of implementing Six Sigma and got approval for it from your colleagues, you should seek references from your peers in other companies about how their Six Si

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

Professional from academic institutions, pharmaceutical industries, health care indust

gma training was handled. Six Sigma is very much a people business, so it is also important to speak to some of the Black Belts or managers of any shortlisted Six Sigma companies to see if you click with them and they have the required level of experience. The level of experience they

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

have of working in your field isn’t necessarily that relevant compared to the level of mutual understanding and their aptitude as trainers, because good training means your colleagues will have skills that are transferable to other industries. Also, consider the breadth of service bei

.

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

ng offered. Will the people who start out training you still be there at the end? Do they have their own training materials? Will there be a help desk for employees to call after the training has been completed to ask about any Six Sigma problems that may arise in the future?

Finally

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

Companies that provide selfless information through particip

once you have made sure you know the number of defects the process is currently producing and establish the number you will be satisfied with at the end of the project, you are in a position to start the process of finding the best Six Sigma trainer for your company. The best of luck

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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