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Managing Six Sigma calls for a multidirectional approach as guided by industry specifics, projects on hand, expertise level and commitment of upper management as wel

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

l as the goals envisioned by management.

Managing effectiveness in Six Sigma can be defined as well directed efforts to successful deployment of the methodology to

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

Examples of combination products may in

he project which is chosen to give you the best results. This helps to improve the company’s bottom line.

Managing Six Sigma Effectiveness

Experience and research

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

over the years have time and again proven that grooming leaders results in maintaining the competitiveness that corporations need. Consequently, the end result of th

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

s is seen as improvement to profitability and sustainable and predictable constant improvements.

Effective Leaders: Key contributions to the effectiveness of Six Si

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

Combination pro

gma deployment are by the leaders of high caliber. The leaders like black belts, master black belts and champions are central to the success of the project. Black be

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

ts have to standup to face the challenges during the implementation stages if the implementation has to succeed. The resistance that might crop up has to be dealt wi

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

th using a practical approach.

Selection Of The Right Tools: If black belts are central to the successful implementation of Six Sigma, correct selection of tools is

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

what helps to steer the project towards improvement. Statistically, each one of the tools must be able to measure and show in which way the project is progressing. T

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

he right tools set up checks and balances as each activity in the process can be measured against its original value. Accuracy of measurements and verification sets

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

he stage for mid-way course correction, if needed.

Creating Communication Channels: The utmost importance must be placed on establishing and utilizing communication

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

Following aspects would a

channel for all purposes. This does not stop at just communicating matters of project development but must include human resource plans that aid role players of Six

dd to the challenges in developing combination products:

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

Sigma. Regularity of communication in both written and verbal form is essential so that everyone involved is kept abreast in order to help foster communication. But

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

the main advantage that regular communication brings about is clarity about the status and progress of the project. While developing the communication channels, it s

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

ould be disseminated so that it is understood by all involved.

Establishing An Effective Project Tracking System: Tracking the project effectively is at the core of

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

managing Six Sigma effectiveness. The essence of effectively managing projects lies in the hands of Champions and Black Belts. A watchdog committee of Black Belts a

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

Professional from academic institutions, pharmaceutical industries, health care indust

d Champions must ensure a few key aspects such as developing documented project inventory for at least one year, assuring linkage of customer needs and critical busi

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

ness needs with the project, along with establishing an optimized project scope and size. Although documentation in itself does not ensure the success of Six Sigma,

.

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

t must be taken as the first step towards establishing a permanent culture for the company to follow.

Cost of quality and improvement should be the focus in Six Sig

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

Companies that provide selfless information through particip

ma implementation. One must keep in mind that the transition to problem solving from data collected is continual for optimal effectiveness of Six Sigma implementatio

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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