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Useful Advices - Overcome Traditions That Delay Improvements
INTRODUCTION TO HOW TRADITION STALLS IMPROVEMENTS
If It Ain't Broke, Don't Fix It
A motorist asks a farmer for a glass of water. The farmer obliges, using a hand pump to draw water from a well. The pump handle turns close to a board, and the farmer curses as he scrapes his knuckles against it.
Motorist: Why not move that board? It serves no purpose.
Farmer: It's been there since my father's time. If it was good enough for him, it is good enou
If It Ain't Broke, Don't Fix It
A motorist asks a farmer for a glass of water. The farmer obliges, using a hand pump to draw water from a well. The pump handle turns close to a board, and the farmer curses as he scrapes his knuckles against it.
Motorist: Why not move that board? It serves no purpose.
Farmer: It's been there since my father's time. If it was good enough for him, it is good enou
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
gh for me.
Aping Human Beings
Imagine a cage containing five apes. In the cage, hang a banana on a string over some stairs. Before long, as the story goes, an ape will decide to go up the stairs to grab the banana. As soon as that ape touches the stairs, spray all the apes with icy water. After awhile, another ape will approach the stairs with the same result: All the apes are sprayed with cold water. Do this repeatedly and then just watch when
Aping Human Beings
Imagine a cage containing five apes. In the cage, hang a banana on a string over some stairs. Before long, as the story goes, an ape will decide to go up the stairs to grab the banana. As soon as that ape touches the stairs, spray all the apes with icy water. After awhile, another ape will approach the stairs with the same result: All the apes are sprayed with cold water. Do this repeatedly and then just watch when
; 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
another ape tries to climb the stairs. The other apes will attempt to prevent the ape, even though no cold water is sprayed on them.
Next remove one ape from the cage and replace that ape with a new one. The new ape sees the banana and wants to climb the stairs. To its horror, all of the other apes attack. After another thwarted attempt, the new ape knows that if it tries to climb the stairs, it will be assaulted. Now remove another of the origi
Next remove one ape from the cage and replace that ape with a new one. The new ape sees the banana and wants to climb the stairs. To its horror, all of the other apes attack. After another thwarted attempt, the new ape knows that if it tries to climb the stairs, it will be assaulted. Now remove another of the origi
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
nal five apes and replace it with a new one. The newcomer goes to the stairs and is attacked. The previous newcomer enthusiastically takes part in the punishment although it has no idea why it was not permitted to climb the stairs.
After replacing the third, fourth, and fifth original apes, all the apes that had been sprayed with cold water are gone from the cage. Nevertheless, no ape ever again approaches the stairs.
Why not? 'Because that the
After replacing the third, fourth, and fifth original apes, all the apes that had been sprayed with cold water are gone from the cage. Nevertheless, no ape ever again approaches the stairs.
Why not? 'Because that the
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
way it's always been around here.' Sound familiar?
TRADITIONAL WAYS TO TOE THE LINE
The Pecking-Order Tradition: ' After You, Alphonse '
In most organizations, decisions have to follow a certain pathway. Someone who needs a decision begins the process by asking his or her boss. The boss asks her or his boss. This process continues until someone has the authority and wants to decide. When the decision is finally made, communicating the answer h
TRADITIONAL WAYS TO TOE THE LINE
The Pecking-Order Tradition: ' After You, Alphonse '
In most organizations, decisions have to follow a certain pathway. Someone who needs a decision begins the process by asking his or her boss. The boss asks her or his boss. This process continues until someone has the authority and wants to decide. When the decision is finally made, communicating the answer h
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
s to follow the same path in reverse down through the organizational pathway. Nothing has changed about this process since the days of feudal kings and their lords. But is this the fastest way to make progress? Hardly.
The Hazing Tradition: Get Down!
Organizations don't like to allow newcomers to become part of the group until the new people are put through some ridiculous initiation that had humbled the organization's veterans. Having humiliat
The Hazing Tradition: Get Down!
Organizations don't like to allow newcomers to become part of the group until the new people are put through some ridiculous initiation that had humbled the organization's veterans. Having humiliat
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
ing experiences in common makes everyone feel more comfortable with one another. The apes in the cage would recognize the process.
The Slow Walking Tradition: Take the Tour
Few people like it when pressure is put on them. To avoid that pressure, many people will pretend to be at full effectiveness ' while working well below their self-perceived potential. When the big bosses arrive for an inspection, those who host the visitors will take the bi
The Slow Walking Tradition: Take the Tour
Few people like it when pressure is put on them. To avoid that pressure, many people will pretend to be at full effectiveness ' while working well below their self-perceived potential. When the big bosses arrive for an inspection, those who host the visitors will take the bi
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
brass on a long, slow tour designed to demonstrate that everyone is fully and effectively engaged. Every stop will have been rehearsed for weeks in advance, and everything will be perfect.
This tradition has been around for a long time. During a famine, Catherine the Great took a tour of Russia to see how the peasants were doing. A prosperous-appearing village was erected along the banks of the river just before her arrival. That night, the vil
This tradition has been around for a long time. During a famine, Catherine the Great took a tour of Russia to see how the peasants were doing. A prosperous-appearing village was erected along the banks of the river just before her arrival. That night, the vil
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
age was disassembled and transported down river to be erected again for viewing by the Czarina the next day in a new location.
The Time-Is-Money Tradition: How Much Is This Conversation Going to Cost Me?
Many organizations run themselves to be cost efficient. With stop watches and clipboards in hand, cost analysts ensure that activities not earning an adequate profit are ruthlessly slashed. In this way, profits are increased. Or are they? Some
The Time-Is-Money Tradition: How Much Is This Conversation Going to Cost Me?
Many organizations run themselves to be cost efficient. With stop watches and clipboards in hand, cost analysts ensure that activities not earning an adequate profit are ruthlessly slashed. In this way, profits are increased. Or are they? Some
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
times the effects of the cost cutting actually harm profits.
Here's an example: There's no profit in taking back unsatisfactory products. Stores will put as few people as possible working on this task. There may be 30 customers in the store and 19 of them will be in line to return items while a single clerk works as slowly as possible. But wait in too many of these long lines and customers will buy somewhere else ' where the return lines aren't
Here's an example: There's no profit in taking back unsatisfactory products. Stores will put as few people as possible working on this task. There may be 30 customers in the store and 19 of them will be in line to return items while a single clerk works as slowly as possible. But wait in too many of these long lines and customers will buy somewhere else ' where the return lines aren't
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
o long. A lost customer can cost a company thousands in profits. Sometimes that short-term cutting focus is the wrong way to look at things.
The Isolation Tradition: Solitary Confinement for Learning Development
Most organizations are reluctant to credit innovations and ideas that have prospered in other organizations. Engineers often skeptically refer to the sloppy work that everyone else does. Ironically, this approach is more often known as
The Isolation Tradition: Solitary Confinement for Learning Development
Most organizations are reluctant to credit innovations and ideas that have prospered in other organizations. Engineers often skeptically refer to the sloppy work that everyone else does. Ironically, this approach is more often known as
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
he 'Not Invented Here' Syndrome that almost always means falling behind the competition because everything 'Not Invented Here' is shunned.
The Inertia Tradition: Millwork Is My Trade
In 1848, gold was found at Sutter's Mill in northern California. There were literally large nuggets sitting in the river beds that could be picked up by the handful. Five minutes' labor would pay for a week's expenses. Sutter lost his business as a result. He kept
The Inertia Tradition: Millwork Is My Trade
In 1848, gold was found at Sutter's Mill in northern California. There were literally large nuggets sitting in the river beds that could be picked up by the handful. Five minutes' labor would pay for a week's expenses. Sutter lost his business as a result. He kept
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
trying to earn money with his sawmill while workers quit to carry off fortunes in gold. Similarly, many organizations focus on their past activities rather than grasping the great potential of the present.
STALL ERASERS
Many people find it hard to challenge their old ways of doing business, especially when stalled by tradition. Here are some examples of how leaders have been able to erase harmful traditions:
' Pretend to be a new management te
STALL ERASERS
Many people find it hard to challenge their old ways of doing business, especially when stalled by tradition. Here are some examples of how leaders have been able to erase harmful traditions:
' Pretend to be a new management te
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
m that has been asked to turn around the problems brought about by the prior management's complacency.
' Take the least productive tasks you do now and delegate them to someone else who will do them well and appreciate the opportunity. Encourage that person to delegate her or his least productive tasks in the same way. And so on.
' If the methods you've been using don't work, begin controlled experiments to test all other ways even ways that ca
' Take the least productive tasks you do now and delegate them to someone else who will do them well and appreciate the opportunity. Encourage that person to delegate her or his least productive tasks in the same way. And so on.
' If the methods you've been using don't work, begin controlled experiments to test all other ways even ways that ca
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
l for reversing your direction.
' Turn the best performer's approach into a simple process that those with no experience can duplicate through automated promptings.
' Make it easy and quick for customers to solve the problems they encounter. Assume customers will behave honestly if that can help speed up and ease problems. They'll reward you with continual word-of-mouth praise and increased loyalty.
STALLBUSTERS
Identify Your Organization's T
' Turn the best performer's approach into a simple process that those with no experience can duplicate through automated promptings.
' Make it easy and quick for customers to solve the problems they encounter. Assume customers will behave honestly if that can help speed up and ease problems. They'll reward you with continual word-of-mouth praise and increased loyalty.
STALLBUSTERS
Identify Your Organization's T
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
raditions and Their Original Purposes
Most traditions start with a purpose, but others start by accident. Before changing something, you should find out if the tradition still serves some useful purpose by asking the following questions:
' What traditions does the organization have that slow down or increase the cost of accomplishing important results?
' What benefits do these traditions provide?
' What values were intended to be served by th
Most traditions start with a purpose, but others start by accident. Before changing something, you should find out if the tradition still serves some useful purpose by asking the following questions:
' What traditions does the organization have that slow down or increase the cost of accomplishing important results?
' What benefits do these traditions provide?
' What values were intended to be served by th
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
traditions?
' What problems are created by the traditions?
Identify Empowering Traditions You Can Use to Improve Performance
Traditions are powerful management tools for reinforcing good habits. People are more willing to abandon their own traditions when they learn that another organization's different traditions have led to high performance.
' What traditions do other organizations have that speed up progress, improve the results, and eff
' What problems are created by the traditions?
Identify Empowering Traditions You Can Use to Improve Performance
Traditions are powerful management tools for reinforcing good habits. People are more willing to abandon their own traditions when they learn that another organization's different traditions have led to high performance.
' What traditions do other organizations have that speed up progress, improve the results, and eff
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
ctively reduce costs?
' Which of these traditions are consistent with your organization's values?
' How could the traditions be made more consistent with and supportive of your organization's values?
' Which aspects of these traditions are exciting and fun for people in your organization?
Establish New or Amended Traditions
What aspects of your organization do you want to have operating on automatic pilot for all employees? One of the best e
' Which of these traditions are consistent with your organization's values?
' How could the traditions be made more consistent with and supportive of your organization's values?
' Which aspects of these traditions are exciting and fun for people in your organization?
Establish New or Amended Traditions
What aspects of your organization do you want to have operating on automatic pilot for all employees? One of the best e
.
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
xamples of automatic response is a tradition at Ritz-Carlton hotels. Whenever an employee notices or is told by a guest about a problem, the employee has the responsibility to fix the problem immediately. That tradition ensures that guests receive quick, courteous solutions while feeling encouraged to bring problems to the staff's attention. Higher guest satisfaction and loyalty usually follow from that tradition.
To create or change traditions
To create or change traditions
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
n your organization, ask the following questions:
' What are the three most useful traditions your organization could have?
' How can the new traditions be established so that everyone will be delighted?
' How can you combine elements of existing traditions with useful elements of these new traditions?
' What has been the best way that your organization has previously launched traditions?
Copyright 2007 Donald W. Mitchell, All Rights Reserve
' What are the three most useful traditions your organization could have?
' How can the new traditions be established so that everyone will be delighted?
' How can you combine elements of existing traditions with useful elements of these new traditions?
' What has been the best way that your organization has previously launched traditions?
Copyright 2007 Donald W. Mitchell, 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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