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Advice Pool - Understand What Flows Through Your Business to Find Improvement
I remember once seeing a cartoon which showed two people working a counter. On the wall behind them was a sign which read, “Quality Work, Low Price, Fast Service – Pick
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
Two.” In order to deliver all three, which is what customers expect, it’s important to understand the flows of your organization.
The first flow is, of course, cash
The first flow is, of course, cash
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
Examples of combination products may in
low. This comes in two varieties, money coming into the organization, revenue, and money going out, expenses. Understanding cash flow is not as easy as it appears. Thro
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
ghput accounting and Lean accounting are two methods some companies are using to try and get a better understanding of how cash flows through a business.
The second fl
The second fl
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
w is the product or service flow. This starts with how the product or service is designed. The next step is how the product is built or the service delivered. How is th
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
product or service used? Finally, what happens when the customer is done is the product discarded, recycled, or consumed.
How does information flow through the organi
How does information flow through the organi
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
ation? How does it come into the company and how does it leave? How is it used in the organization, does it follow the work or pull the work forward? What types of feed
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
ack is received?
How does material flow in the company? If a product is built, how are the raw materials or parts brought to the point of assembly. For a service, how
How does material flow in the company? If a product is built, how are the raw materials or parts brought to the point of assembly. For a service, how
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
o the necessary information, materials, and people get to where they are needed?
How does the movement of the workers flow? Is the motion smooth or does it start and s
How does the movement of the workers flow? Is the motion smooth or does it start and s
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
op like rush hour traffic? Are there any wasted motions, like retrieving a paper file from a cabinet in another room or walking over to get a tool which is required for
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
product assembly? Why is the tool at the point where it is needed? Why is the file located in a cabinet in another area?
Creative flow is important to understand. Crea
Creative flow is important to understand. Crea
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
Following aspects would a
tive energy, like any other kind of energy, can be harnessed and managed. Does a research and development department create everything and the rest of the people just d
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
Which markets to tap where the combination products can do fairly well?
Which combination prod
what they’re told? Or are all employees thinking about innovation, how to reduce costs, looking at safety issues, reducing wastes, and improving the environment. Are
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
eople developing skills to identify, articulate and communicate those kinds of things?
The final flow is time. Time is, of course, a factor in all the other flows. Sin
The final flow is time. Time is, of course, a factor in all the other flows. Sin
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
e we can’t change time, rather than looking at how time flows; we need to see how the organization flows through time. How long does it take to accomplish things? Can
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
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
he time be reduced? By reducing the time it takes to do our work, we reduce or eliminate the wasted things we do. Eliminating wasted brings us closer and closer to exce
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
Professional from academic institutions, pharmaceutical industries, health care indust
lence.
By observing the flows in our work, we can see where things run smoothly like a tranquil river. Bottlenecks in the workflow create turmoil, much like the rapids
By observing the flows in our work, we can see where things run smoothly like a tranquil river. Bottlenecks in the workflow create turmoil, much like the rapids
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
in a river.
“Oh, this ol’ river keeps on rollin’, though,
No matter what gets in the way and which way the wind does blow,
And as long as it does I’ll just s
“Oh, this ol’ river keeps on rollin’, though,
No matter what gets in the way and which way the wind does blow,
And as long as it does I’ll just s
.
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
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 here
And watch the river flow.”
- Bob Dylan (Watching The River Flow © 1971 by Big Sky Music)
Any process, any product, any service can be made better in s
And watch the river flow.”
- Bob Dylan (Watching The River Flow © 1971 by Big Sky Music)
Any process, any product, any service can be made better in s
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
Companies that provide selfless information through particip
me way, somehow. So observe and understand the flows of your organization, it will lead to improvement opportunities.
Copyright © 2005 Chuck Yorke - All Rights Reserve
Copyright © 2005 Chuck Yorke - All Rights Reserve
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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