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"Only the overall review of the entire business as an economic system can give real knowledge" - Peter F. Drucker

No one needs to emphasize the holistic approach th

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

e Six Sigma deployment takes on overall business processes. All processes in an organization present at least one opportunity for improvement. Having a limited pictu

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

Examples of combination products may in

re about the limitations of Six Sigma and its applications projects an all together different picture.

At the enterprise level, each company must consider the entir

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

e application of the project and this is certainly beyond the line employee level.

A Little Background

We have all known Six Sigma as a deployment strategy related

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

to company activities and we have examples for justification. We have many glaring examples of successful and not so successful companies in recent history. Motorola

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

Combination pro

, DuPont and General electric are some cases in point. Also known to us are the failures of deployment mostly in non- manufacturing businesses.

While thinking along

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

the same lines, if in your understanding, Six Sigma is not applicable to your organization or industry, perhaps what first step you may take is answer whether it ca

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

n improve the financial situation of your company within an acceptable timeframe. This fundamental answer must be obtained even before the project selection process.

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

Answers to whether Six Sigma can work in all processes and parts of the organization must be put into place.

Thinking Beyond The Shop Floor

Notions and misconcepti

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

ons such as those confining Six Sigma to the shop floor and relegating it as something of a quality implementation tool dedicated for manufacturing industry must be

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

shown its due place for it to show results of any significance. The ‘beyond the factory’ approach encompasses almost all non-manufacturing aspects of the economy, no

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

Following aspects would a

t excluding those in the new economy group. For example, law offices, non-profit organizations, online business and the transport sector.

Three Critical Steps To Ta

dd to the challenges in developing combination products:

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

e Six Sigma Benefits Beyond The Shop Floor

Holistic thinking does not exclude non-production activities within organizations. Activities that don’t produce physical

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

products but are still parts of production activities that go into manufacturing, as well as service industry sectors, such as transport industry or consultancy fir

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

ms, contribute to the economy in a larger meaning by value creation. The following critical steps help reap major benefits in implementation:

• The Strategic Deploy

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

ment: Think through the overall deployment of Six Sigma initiatives across the entire organization.
• The Tactical Deployment: Tactically selecting, conducting

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

Professional from academic institutions, pharmaceutical industries, health care indust

nd closing the projects in all those environments.
• Methodical Deployment Of Operational Tools: Applying the analytic techniques of Six Sigma properly when fac

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

ing common challenges beyond the shop floor, such as skewed (non-normal) distributions of cycle times, or the predominance of discrete data.

Holistic thinking In Si

.

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

x Sigma calls for adopting a statistical approach in its entirety to all aspects of conducting business and looking beyond statistics is an embedded part of deployme

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

Companies that provide selfless information through particip

nt. Judgmental timing and accuracies assume the same degree of significance of decision making. There is not one single sure-fire formula to ensure the success of it

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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