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Listening to seasoned musicians play jazz can be a rewarding experience. Even if we are not jazz enthusiasts, we can appreciate the talent that becomes quickly evident, as melodies are created in a seemingly spontaneous fashion, but with notes flying together in an underlying the

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

me.

What isn't evident, is what's behind this top-level performance. There certainly is obvious physical dexterity -- the ability to produce what is required upon demand. But, playing good jazz requires agility as well as ability -- the innovativeness to continually introduce ne

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

Examples of combination products may in

w ideas in response to the mood created by the notes just played. Each phrase has to be linked with the next for continuity. There must be integration of thoughts and ideas.

The best excitement is created when teams of musicians improvise to create new harmonies. The players hav

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 mastered the rudiments, become very dexterous, agile and adroit, and trained themselves to be spontaneous. In their terms, they "cook."

Take away these ingredients and the players get clumsy, stumble in execution and produce bad results. The music becomes stale and the listene

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

r grows disinterested. What's the consequence? .......Losing the audience.

What does this have to do with manufacturing?

Consider that the U.S. has significantly lost world market share in key industries over fifteen years. Also consider that the complexion of manufactur

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

Combination pro

ng is rapidly changing, in the process of a global re-segmentation of markets. With more companies competing worldwide, pressure is on for U.S. manufacturers to give a top performance -- designing and building the best quality product in the shortest time possible.

Sour Notes

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

How do we compare today with that new standard? We have spaghetti factory flows, poor interaction between functional departments, physical walls, classes of workers, poorly integrated information systems, and component factories separated from assembly by states and, someti

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

mes, continents.

As a result, we find ourselves clumsy in moving parts across the factory floor, stale or too slow with introducing new products to respond to market demand, stumbling in execution of production, and severe quality problems. What's the consequence? Losing busines

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

s.

Jazz in the Factory

How can we tune ourselves to be top performers in the next decade We must start with the fundamentals, the rudiments. Any organization, just as in a jazz group, is only as good as its weakest player. As individual skills are raised, so is the perfo

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

rmance of the organizational unit. We must be ready and skilled in physical movement. Physical dexterity is paramount in the hands of a classical pianist, a jazz saxophonist, and in the production cycle.

We must remove the obstacles that prevent us from manufacturing with high v

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

locity -- our set-ups, the excessive material handling, our poor physical flow, and all production interruptions. We must streamline the physical flow, integrate our processes and close the distances between supply, production, assembly, distribution, and our end customer. The em

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

Following aspects would a

phasis must be on quickly satisfying the service chain of events from the time a customer needs something until he is satisfied.

Being Innovative

We must be adroit in introducing new products and quick in getting them to the market to satisfy demand. We must create a dyn

dd to the challenges in developing combination products:

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

amic integrated environment where people can work together in generating and sharing thoughts. Just as a jazz musician is free to choose his notes, in business there must be built-in flexibility to allow members to explore, and be creative.

Fostering innovation, among many other

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

things, requires good organization of information. Our current systems and procedures have been developed at length to control an unwieldy information channel. Our functional organizations are stifling; natural and functional conflicts create internal adverse relationships that

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

prevent the sharing of ideas.

Only when we get past the stifling paper flow, disparate computer systems, and functional organizational walls, will the homogeneity of ideas begin to generate at a fast pace. Linking computers is part of the answer, but it's also streamlining the i

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

formation flow, and consolidating the knowledge of the idea producers. We need to organize for ease of sharing information for innovation.

Playing in Harmony

Having the ability to produce spontaneously upon demand requires an organization that is quick and resourceful. I

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

Professional from academic institutions, pharmaceutical industries, health care indust

t requires short lines of communication, and velocity throughout the work chain. This means not only being able to enact the physical events swiftly, but also completing the business cycles quickly.

A jazz stage band keeps good time by closing physical proximity between players.

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

This is so there is a minimum of delay in hearing the rhythm. In business, close proximity is critical to producing velocity. Each element of a business cycle must be linked with the next for continuity.

Every member must be in tune with the overall needs of the market, and clo

.

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

se enough to one another to be spontaneous in helping each other support the common mission -- serving the customer. Team play is a basic necessity to produce the results required to be competitive in the next decade.

When a manufacturing company becomes physically dexterous

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

Companies that provide selfless information through particip

in the factory, organized to be adroit and innovative throughout, and its members work in concert toward a common theme of satisfying the requirements of a dynamic market, it will be a world-class competitor, it will possess enterprise agility, and that's when it will "cook."

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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Digg It - Enterprise Agility: Jazz In The Factory

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