Main Subject - Business

Lean manufacturing is a business performance improvement tool that focuses on enhancing value, cost, deliver

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, and people. It helps expose waste and makes continuous improvement possible by identifying and eliminatin

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

Examples of combination products may in

g non-value-adding activities in design, production, supply chain and management.

Organizations that are ap

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

plying lean technology to their manufacturing processes are achieving the greatest improvements in speed, ef

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

ficiency, and profitability. Conversely, they all share a common characteristic, and each fully utilizes the

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

Combination pro

knowledge, skills and enthusiasm of people at all levels.

While the fundamentals of lean manufacturing are

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

somewhat spontaneous, many of the successful components of a lean toolbox have been developed over years of

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

trial and error. Supplying the right level of training allows your organization to quickly learn similar to

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

ols and realize the benefits of lean without the trial and error method.

Lean manufacturing training provid

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

es a common perspective and language that allows every individual to participate in continuous business impr

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

vement. Knowledgeable and supportive leadership is an indispensable part of a successful lean thinking orga

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

Following aspects would a

nization. Without this critical ingredient, lean efforts will either wither from a lack of resources or dege

dd to the challenges in developing combination products:

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

nerate into random acts of improvement that have a limited impact.

The training package also includes progr

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

ams designed for organizations which want to develop a core group of highly capable, in-house experts. These

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

individuals receive all-embracing training and one-on-one mentoring that allows them to attempt complex pro

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

blems and deliver impressive returns. As an option, the program also offers Six Sigma training for industry

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

Professional from academic institutions, pharmaceutical industries, health care indust

standards for yellow, green or black belt certification.

A lean training program is also designed for direc

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

t labor employees, and helps to remove the mystery and apprehension regarding this new technology. The empha

.

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

sis is that lean results in a more effective business which is better able to compete in the world markets.

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

Companies that provide selfless information through particip

Many participants discover that lean is a common-sense approach that makes work easier and more interesting

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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If you're a creative person working in a job where being free-spirited is frowned upon, take heart. You have much to offer the corporate world. It isn't necessary to become a business clone, so maintain your individuality and fit in despite the critics.

An interesting aspect of the proposed new Security & Exchange Commission (SEC) regulations on Executive Compensation relate to the need to supply justification for their decisions (see February 2006 issue for details of the proposed regulation).

You have the opportunity to join a non-profit organization as their bookkeeper and while you may have a great deal of experience working within the business for profit world there are some differences between the two types of organizations that are important to consider.

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