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By giving due recognition to an employee for their hard work, they can be motivated to perform better. Observed in different companies and institutions, the job of an employee can ap

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

preciated by means of incentives or additional compensation.

In Six Sigma, an important tool used in business, the team’s quality improvement and potentiality to excel is gauged. B

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

Examples of combination products may in

eing a continuous process, it is very often termed as a leadership philosophy, in which case, the commitment and dedication of the workers are also taken into consideration.

Three d

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

fferent levels of experts on a day-to-day basis manage the Six Sigma program. These experts comprise of the Master Black Belt, the black belt and the green belt. Team leaders and mem

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

bers need to be given a satisfactory compensation, as it is instrumental in building a sense of accomplishment and loyalty in them.

The primary function of the Black Belts is to lea

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

Combination pro

d and create teams implementing Six Sigma. Even though the objective is implementation of a measurement-based strategy there are no written rules and norms for the compensation of th

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

six-sigma leaders or the team members. Being able to explain the Six Sigma principles and philosophies very effectively, black belts are a key to the Six Sigma process. Therefore, i

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

t is necessary to compensate their work accordingly.

Job Of The Black Belts

One of the most important elements of the Six Sigma project is to identify and appoint the Black belts.

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

The black belts are not be formally trained in the engineering or statistician field they belong to. However, taking their ability and knowledge in to consideration, they could be as

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

igned with various roles both in technical or statistical aspects. They are expected to read the statistical reports and formulate necessary remedies for all the loopholes involved.

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

One of the many jobs of the black belt is to keep the team members informed about the project updates in the various departments. This also involves policymaking and rewarding or cor

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

Following aspects would a

recting failures done by the members.

Managing Compensation Issues

In accordance with Six Sigma principles, Black Belts have a considerable understanding of the DMAIC model (define

dd to the challenges in developing combination products:

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

measure, analyze, improve, control). Companies could formulate a team-based bonus system for the improvement of every single member of the Six Sigma project. These members are the m

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

ost valuable assets for the company, and timely recognition should be given. The bonuses should be goal oriented.

According to the Six Sigma Academy, completing nearly 4 to 6 projec

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

ts per year, Black Belts save approximately $230,000 per project. The base pay offered to the level of the Six Sigma employees should be in the organizations top featured range. If a

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

other employee, for e.g. the manager, is asked to devote some of his time to the Six Sigma process, his contribution should also be equally compensated.

Innovative ways to give the

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

Professional from academic institutions, pharmaceutical industries, health care indust

six-sigma employees their deserved compensation should be thought of. Other than the base pay given, special recognition namely through award ceremonies, dinner parties or plaques co

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

uld also be given. These acknowledgements act as a boost to the morale of not only the Black Belts, but also the other members of the Six Sigma project.

Additionally, the team’s per

.

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

ormance also depends on the leaders way of working. If a black belt is not satisfied with the compensation allotted, it could lead to a plummeting team performance affecting the comp

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

Companies that provide selfless information through particip

any’s profit in return. Therefore, to help the company to keep profits intact and the workers to be contented with their job, proper acknowledgement should be given from time to time

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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