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First let's define Six Sigma in terms we can all understand. It's a quality control process that is data driven What that means is the result is measured in numb

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

ers, in particular, numbers of defects . To achieve Six Sigma you should have less than 3.4 defects per million opportunities. Opportunities for what? I guess a

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

Examples of combination products may in

illion opportunities to screw up.

The list of big companies that are utilizing Six Sigma is huge. But is it right for the small and medium business? GE and Moto

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

rola will find it hard to gain any more market share thany they already have. The best way for them to increase profits is to decrease costs. But is that really

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

rue for a small or medium sized manufacturer? Anything that strives to reduce the number of defects and increase customer satisfaction is a positive for your bus

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

Combination pro

ness. That's a no brainer. The issue is more how deeply do you immerse your business, and your employees in to a process that can take the focus off of what they

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

enjoy doing.

Let me state that in another way. Many of your employees are employees because that's what they want to do. They don't want the headache or the as

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

ociated risk of running a business, or being a manager or director. Six Sigma is a very disciplined and detail oriented process. Because of this it can drastical

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

ly alter the nature of an employees task. In some cases, this will be a positive. The employee may feel energized by the change and the challenge. Others will bo

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

st productivity simply due to the Hawthorne effect. A significant number will however see this as an unwelcome change to the job they want to do.THERE IS NOTHING

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

WRONG WITH THIS!

We simply must accept the fact that not everyone is dedicated to advancing his or her career and embracing all challenges and changes. Most peo

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

Following aspects would a

ple work because they have to. They work so that they can support their families and enjoy time away from work with other pursuits. This is not a character flaw

dd to the challenges in developing combination products:

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

r a sign of laziness. It's just the decision they've made, nothing more and nothing less. When we try to impose radical change on the work portion of thier lives

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

they have the freedom to move on to another company. And that's the best case scenario. Generally what happens is the employee becomes disenfranchised and produ

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

tivity suffers.

Obviously our goal isn't to decrease productivity so what's a small business to do? Like everything else you need to take it slow at first. The

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

est advice is to decide what you want out of it before you even begin. Then you can make a better decision about using a Six Sigma consultant, and whether or not

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

Professional from academic institutions, pharmaceutical industries, health care indust

you need one. You should also set a realistic goal for what an acceptable defect rate should be and what the cost is for a given range of defects. Six Sigma has

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

this process as part of it but many of the Black belt consultants seem to get caught up in reaching that magic number of zero defects. That's a nice goal but if

.

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

the cost of reaching it is ten times the cost of the defects, who cares? Go with the defect rate you have and keep cashing the checks. In short, don't fix what i

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

Companies that provide selfless information through particip

n't broken. Fine tuning to keep or gain market share is one thing, reorganzing your entire business in a risky pursuit of a 1.5% profit increase is quite another

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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Recruiting staff is another essential element that you need for your business to grow. And a key part of the recruitment process is the interview. When you conduct an interview you need to know what you're trying to achieve and how to make it work for you.

Home nursing jobs are nursing jobs for people who can provide care to those who require personalized patient care. In home nursing jobs, the nurses have to mingle with patients and their family members. Home nursing jobs offer quality and affordable home nursing services for the needy elderly sick or disabled persons in the home. Home nurses provide periodic services to patients at home. They care for a wide range of patients, such as elderly people who are confined to the bed, those recovering from illnesses and accidents, and those resting after childbirth.

Tips on avoiding some of the pitfalls that many people fall into when buying a business.

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