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Most companies contemplating Six Sigma implementation have most of the costs worked out beforehand. This follows the assumption that taking additional

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

work means involving more people. You either hire people on fee base or recruit them on your payroll at a cost. Well, then there is the cost of imple

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

Examples of combination products may in

mentation above this, which can run into quite a few thousands of dollars depending upon the project on hand.

But is that the cost of Six Sigma? Ther

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

are several schools of thoughts and arguments about how to arrive at the cost of Six Sigma and one of which advocates an interesting theory. This app

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

ears to be the closest of all the definitions of Six Sigma.

Cost of Six Sigma

The cost of Six Sigma is the cost of lost opportunities due to errand

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

Combination pro

rocesses or procedures which could have been saved had the procedures or the processes been corrected at the expense of a fraction of the cost.

Cost

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

Consideration Before Project Selection

While contemplating the deployment, one needs to think about the composition of the team as well. The composit

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

on of the team can be so organized to as to contain the cost of hiring. The big question however, is whether the project team be placed within the pur

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

view of the QA department or be kept independent. Should the task force you are considering to form be composed of consulting Black Belts with select

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

nternal employees or should you purely consider only the freshly trained internal Black Belts? Consider whether cost of training will help save the co

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

st of consultation and time, keeping in mind the future projects.

Some Realistic Points Of View

The truth about Six Sigma certification is no one is

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

Following aspects would a

going to certify your organization after the implementation, as there is no such certifying standard just yet. This implies that both the implementat

dd to the challenges in developing combination products:

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

on and achievement are relative, although measurable in terms of cost saved. But there not yet one single universally accepted standard barometer to t

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

ell whether the cost saved is absolute.

Lets just accept it; it is within the reach of the best employees of an organization to pull off wonders for

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

heir employer. They can be trained in-house or they can be asked to study how to books and tools by attending a seminar or two. The next best step tow

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

ards saving cost of Six Sigma is piggy backing on forums and discussion groups. This is absolutely possible, considering that many small enterprises h

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

Professional from academic institutions, pharmaceutical industries, health care indust

ve done this with great a degree of success.

Continuous self-education, forming of the team and introduction to not just Six Sigma tools and procedur

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

es but to the tools of management and cost give a broader picture. Six Sigma is no magic wand; it takes a excellent analytical and reasoning ability w

.

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

th dedicated and sustained efforts towards cost reducing (i.e; when we say problem solving.)

The cost of a Black Belt could run from $100,000 or more

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

Companies that provide selfless information through particip

depending on the project at hand. The number of Black Belts is not something which is entirely decided by you if you are hiring Six Sigma consultants

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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Developing good communication skills is more than just being able to talk or the contents of what you are saying.

Corporate gift baskets are ideal to express your gratitude and goodwill to clients and employees. If you have a group of delegates coming in for a conference, corporate gift baskets are good to welcome or thank them. During the holidays, sending corporate gift baskets to your most valued employees who have assisted you through a rough period of business is also a great gift idea.

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