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Detailed Roadmap to Process Improvement

Lean Six Sigma utilizes DMAIC, a highly structured and sta

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

ndardized approach to process improvement. This approach paves the way for corporations in today’s

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

Examples of combination products may in

competitive business environment to meet and exceed ever-increasing customer expectations.

DMAIC i

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

an acronym for five interconnected phases: Define, Measure, Analyze, Improve, and Control. The use

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

of these five phases ensures that Lean Six Sigma projects are clearly defined and implemented, and

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

Combination pro

that results are standardized into daily operations Proven tool that people can use to improve 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

ir jobs

Numerous qualitative and quantitative tools have been developed, which have proven to be e

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

ffective within virtually any business environment. These tools compose the underlying structure of

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

Lean Six Sigma and have been adopted into the daily working practices of many leading companies. A

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

ong the more common of the tools are the following:

Breakthrough contributor to the financial bott

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

om line

The Lean Six Sigma improvement process is based on financially prioritizing projects. This

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

Following aspects would a

prioritization is based on the projects impact to net savings and customer satisfaction.

A financ

dd to the challenges in developing combination products:

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

al analyst provides business team support to establish the forecasted value of the project; and wil

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

l also work with the Lean Six Sigma Black Belt or Green Belt to validate the financial success of t

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

he project upon completion.

An excellent starting point for any lean six sigma is 5S. 5S is valuab

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

e for organization and cleaning which in turn creates an environment that is helpful to the other a

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

Professional from academic institutions, pharmaceutical industries, health care indust

reas of lean six sigma.

5S overview
Sort: Eliminate whatever is not needed.
Straighten:

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

Organize whatever remains.
Shine: Clean the work area.
Standardize: Schedule regular clea

.

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

ing and maintenance.
Sustain: Make 5S a way of life.

Other areas of of lean six sigma include

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

Companies that provide selfless information through particip

:
Cause & Effect Diagrams
Value Stream Maps
Design of Experiments
Control Chart

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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