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Useful Advices - Process Improvement Through Benefit Communication
When I worked at Westvaco, I faced a variety of challenges in getting our various processes to perform at the levels we wanted and expected them to. I found that it was never a single large problem that needed to be fixed, but a series of little problems that held us back from being as effective or as profitable as we wanted t
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
o be.
During my twenty plus years as a Plant engineer, I learned lots of interesting technical tricks for getting the most out of any machine. My maintenance manager and I seldom just repaired anything. We always tried to find a way to make it better. Sometimes our trial taught us why something was designed that way in the fi
During my twenty plus years as a Plant engineer, I learned lots of interesting technical tricks for getting the most out of any machine. My maintenance manager and I seldom just repaired anything. We always tried to find a way to make it better. Sometimes our trial taught us why something was designed that way in the fi
; 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
st place, but we always learned from our mistakes and did better next time.
Preventative maintenance to us was more about constant improvement than it was maintaining the status quo. We were always on the lookout for ways to make things run faster, easier and most of all be more reliable. Despite the fact that we loved tinker
Preventative maintenance to us was more about constant improvement than it was maintaining the status quo. We were always on the lookout for ways to make things run faster, easier and most of all be more reliable. Despite the fact that we loved tinker
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
ing with stuff, we really did not like working on stuff that was broken and managers were anxious to get going again.
No matter what miracle we pulled out of our pockets to get stuff going after a breakdown, there was still lost production during the time it was down to dealt with and communicated to upper managers. Some of m
No matter what miracle we pulled out of our pockets to get stuff going after a breakdown, there was still lost production during the time it was down to dealt with and communicated to upper managers. Some of m
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
bosses dealt with these situations better than others. Some motivated us to do a better job and some did not. Looking back on these times I now have a much better understanding of how to motivate employees to do a good job no matter what the circumstances.
After working on number of process improvement projects, I learned th
After working on number of process improvement projects, I learned 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
at the most important element in the success of any project was the people involved in it. If even one member of the team had an interest in the project failing, then he could drag the whole project down. And the team members must learn to communicate with each other as well as those who will benefit from the project.
After
After
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
eaving Westvaco, I did a stint in sales. I soon found I did not know the least thing about sales. I finally thanked my new employer for giving me a chance but told him he would be better off without me. I then set out to learn all I could about sales and marketing.
The result of these studies has changed my life and the way I
The result of these studies has changed my life and the way I
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
approach problems. I sure wish I had had these skills when I was at Westvaco because I sure could have done a better job of communicating funding requests and project benefits.
So what is my new approach to process improvement? I look for the benefits to all involved. Everyone involved must benefit for the process improvemen
So what is my new approach to process improvement? I look for the benefits to all involved. Everyone involved must benefit for the process improvemen
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
to be a success. And these benefits have to be effectively communicate to each one. You can;t assume they will appreciate what you are trying to accomplish.
And the basic steps I have learned from those who manifest their own destiny are listed here.
Step one: Know what you are trying to accomplish. This is often way hard
And the basic steps I have learned from those who manifest their own destiny are listed here.
Step one: Know what you are trying to accomplish. This is often way hard
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
er than it sounds. In any business situation, there are many conflicting parameters that are involved in any project. The key to success is to figure out what you want to accomplish and figure out what are your real limitations and what are the limits that you have artificially imposed on yourself.
Step two: Ask for what you
Step two: Ask for what you
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
ant. You may have to ask for funding. You may have to ask for cooperation from the employees. You may need an exemption from an environmental regulation. What ever it is, you have to ask for it to get it. Many projects are doomed from the start because managers assume their requests will not be heard or that they don’t know th
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
right way to ask.
Step three: Get a clear picture of the completed project in mind before starting. This goes hand in hand with knowing what you want to accomplish. It also helps you focus on how you plan to accomplish it. You must be able to see your desired result in your mind before you can begin a successful process impr
Step three: Get a clear picture of the completed project in mind before starting. This goes hand in hand with knowing what you want to accomplish. It also helps you focus on how you plan to accomplish it. You must be able to see your desired result in your mind before you can begin a successful process impr
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
ovement project.
Step four: Take action toward your desires. There are many famous saying like "the journey of a thousand miles begins with just one step" that are appropriate here. Fill in your own grandfather's sayings here. But the important part is to get started. The "right first time" philosophy does not always apply he
Step four: Take action toward your desires. There are many famous saying like "the journey of a thousand miles begins with just one step" that are appropriate here. Fill in your own grandfather's sayings here. But the important part is to get started. The "right first time" philosophy does not always apply he
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
e. You may have to experiment a little to know exactly where you are going. Edison made lots of light bulbs that did not work before he hit in the correct combination. You have to be willing to take a little risk to get your project moving.
Step five: Be thankful for your projects success. You have to know that you will succe
Step five: Be thankful for your projects success. You have to know that you will succe
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
ed and know that you are enjoying the process of getting there. So be thankful for each step in the process. Even so called mistakes that eventually lead you to the correct desired result are events to be thankful for.
Finally, in improving any process, you need to consider the people that are going to be involved. How will e
Finally, in improving any process, you need to consider the people that are going to be involved. How will e
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
ch person individually benefit from this improvement? All the people involved, owners who put up the money, customers who will use the product, employees that will operate the process and the engineers who will design the process all have to know what they will personally benefit from the success of this project.
So if you ha
So if you ha
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
ve any type process that you want to improve, I can put together a way to help you improve it. I don’t believe in perfection. There is nothing that can’t be done better if you put your creative mind to work on it.
Listed below are some various categories of ways I can help you improve your process or even you own personal lif
Listed below are some various categories of ways I can help you improve your process or even you own personal lif
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
. It is all about the benefits.
If you were to take some time to search through my web site, you would soon learn about how I have used this same process improvement methodology in everything from building an automated batch distillation column in the early days to PLC’s to modifying my own Jeep Cherokee to go places that it
If you were to take some time to search through my web site, you would soon learn about how I have used this same process improvement methodology in everything from building an automated batch distillation column in the early days to PLC’s to modifying my own Jeep Cherokee to go places that it
.
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
was never intended to go.
You would read about some of the strange places I have visited and adventures I have been on in Jeeps , sports cars and boats. I have learned something about communicating with people of various cultures from each one.
The same techniques that I use to motivate project team members also work in any
You would read about some of the strange places I have visited and adventures I have been on in Jeeps , sports cars and boats. I have learned something about communicating with people of various cultures from each one.
The same techniques that I use to motivate project team members also work in any
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
anager employee relationship. In fact, they work for training your dog, improving your health and in relating to your spouse.
So next time you set out to improve a business process, make sure you effectively communicate the benefits of the project to all those that will be involved. You will be much more successful if you do
So next time you set out to improve a business process, make sure you effectively communicate the benefits of the project to all those that will be involved. You will be much more successful if you do
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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