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Invariably, selecting the right Black Belts is crucial for the success of Six Sigma. According to Dr. Michael Harry, one of the founders of the Six Sigma Academ

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 Inc, “Training individuals as Black Belts gives them the skills necessary to implement, sustain, and lead a highly focused Six Sigma initiative within a targe

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

Examples of combination products may in

business area or unit”.

The Basic Criteria For Selection Of Black Belts

The overriding benchmark for selecting Black Belts is that the candidate needs to be

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

he best of the best from within the organization. The selection process for Black Belts begins during the project selection stage itself so that the skill sets

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

and experience of Black Belt candidates are matched with the complexities of projects. Another consideration is finding a suitable replacement for the candidate

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

Combination pro

to take over their current responsibilities so that they are able to dedicate 100% to the Six Sigma project.

The most important and outstanding trait of Black

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

Belts is that they are a kind of dedicated workaholic who are obsessed with winning in whatever area they are assigned to and to successfully overcome practical

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

ly all barriers to successful implementation. This includes obstructions so trivial and basic as lack of support from Champions and anyone else in the organizat

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

on, poor project selection, etc. These candidates overcome obstacles even in the absence of sufficient data or lack of Six Sigma infrastructure. The best candid

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

te for Black Belt training is a never say die and never complaining character.

Not surprisingly, everyone wants such candidates in their teams for their outsta

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

ding abilities. They simply excel in whatever situation they are put in and get things done. To bring about a process change, to do things differently in a viab

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

Following aspects would a

le way towards goal achievement and finally to change the fortunes of the organization you need these individuals as Black Belts.

Guidelines For Selection Of B

dd to the challenges in developing combination products:

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

ack Belts

Here are the key points to consider while selecting black belts for successful implementation of Six Sigma:

1. Black Belts Need To Be Selected invar

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

ably from within the organization. Ideally, they are already aware of various processes and the organizational structure and its nuances.

2. There Has To Be A

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

Replacement for the chosen candidate to take over his or her day- to-day duties.

3. Begin Selection Process At The Start of project selection phase itself. Thi

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

pays off by being able to match the skills and abilities of the Black Belt with the project complexity.

4. A Black Belt Needs To Have Excellent Interpersonal

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

Professional from academic institutions, pharmaceutical industries, health care indust

kills. He is not averse to risk-taking; he is faithful to upper management and is respected even outside his department and by peers too. Basically, he is a lea

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

der.

5. The Right Black Belt Attaches His Personal and professional growth to the success of Six Sigma and the organization.

6. You May Need To Convince The D

.

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

partment Head from where the Black Belt is selected that he is needed. The reluctance will basically be because these people don’t want to lose their best emplo

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

Companies that provide selfless information through particip

ees.

At the end of Six Sigma training you will know whether you have selected the best candidate with a long-term perspective whose sole aim is problem solving

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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