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Advice You - Rasberries and Problem Solving
6 steps to a new understanding of old problems.
A Gardner I am not, but a few years ago some Raspberries were transplanted and took over the North side of my house. As I was taking my evening stroll in my yard, I noticed that they were loaded with sweet red berries. I decided to spend the time picking several quarts
A Gardner I am not, but a few years ago some Raspberries were transplanted and took over the North side of my house. As I was taking my evening stroll in my yard, I noticed that they were loaded with sweet red berries. I decided to spend the time picking several quarts
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
of the elusive red berries. Red raspberries and a cup of ice cream sure sounded good to me.
The raspberries were elusive because every time I thought all were picked, more would appear when a leaf or bush was moved and another angle of view was used. After going over the entire growth in one direction, more missed
The raspberries were elusive because every time I thought all were picked, more would appear when a leaf or bush was moved and another angle of view was used. After going over the entire growth in one direction, more missed
; 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
berries were noted on the way back. So a simple task of picking the berries turns into a hunting mission!
As a manager, supervisor or salesperson we often take a situation we face, quickly evaluate and then act. My question is, “How many berries have we missed?” “Could there be other information or solutions that ar
As a manager, supervisor or salesperson we often take a situation we face, quickly evaluate and then act. My question is, “How many berries have we missed?” “Could there be other information or solutions that ar
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 hidden under another leaf?” “Was the elusive right answer missed?”
This is where Outcome Based Thinking comes in. If we follow the steps and actually dig into the steps deep enough, it can change our view and solution to the situation we face. After all our purpose in most situations is to create an opportunity or
This is where Outcome Based Thinking comes in. If we follow the steps and actually dig into the steps deep enough, it can change our view and solution to the situation we face. After all our purpose in most situations is to create an opportunity or
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
eliminate a problem.
We can also look at trying to avoid Albert Einstein’s definition of insanity: “Doing the same thing over and over and expecting a different outcome!” How many of us have fallen into this trap?
What if you could find alternate solutions, more creative solutions and have different outcomes to th
We can also look at trying to avoid Albert Einstein’s definition of insanity: “Doing the same thing over and over and expecting a different outcome!” How many of us have fallen into this trap?
What if you could find alternate solutions, more creative solutions and have different outcomes to 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
e situations you face today? How much time, effort and frustration might be saved? Here are 6 steps to getting a different outcome!
1. What are your real expectations in this situation? Are they clearly defined so you can have a strong focus? Do others understand the expectation and focus as well?
Jerry continuall
1. What are your real expectations in this situation? Are they clearly defined so you can have a strong focus? Do others understand the expectation and focus as well?
Jerry continuall
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
y falls just short of his monthly objectives. So which your outcome is the most desirable: 1.) getting the objectives on track, or 2.) getting Jerry’s performance on track? How do the two different questions change your focus?
My suggestion is to ask yourself at least six different objectives, write them down and th
My suggestion is to ask yourself at least six different objectives, write them down and th
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
en compare, combine or prioritize them into one very focused objective that will address all or most of the six. Now you’re not leaving berries on vine.
2. How well do I understand the other person or party? What don’t I know about them and their view of the situation? How can I find more of their “berries”? What i
2. How well do I understand the other person or party? What don’t I know about them and their view of the situation? How can I find more of their “berries”? What i
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
s it they may really want out of this?
So what does Jerry want out of his work? How did he get into the position? What motivates him? What are his values, beliefs, perceptions of the situation? What are his expectations in this situation? In short, “What’s in it for him from his view, not yours?”
The suggestion her
So what does Jerry want out of his work? How did he get into the position? What motivates him? What are his values, beliefs, perceptions of the situation? What are his expectations in this situation? In short, “What’s in it for him from his view, not yours?”
The suggestion her
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
e is to find out as much as one can about the situation and the other parties involved to gain an understanding of how they may be viewing it. Do the research, ask questions, talk to people and use other resources until you have a greater understanding of their position. Come up with at least six key motivators for t
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
he other party.
3. Determine a “Stop Loss Point”. In other words, at what point is the situation not a win – win for either side. At what point does the situation become to burdensome or the return in time and effort just is not there?
Jerry is just unwilling to make any changes in his thinking, habits or skills, e
3. Determine a “Stop Loss Point”. In other words, at what point is the situation not a win – win for either side. At what point does the situation become to burdensome or the return in time and effort just is not there?
Jerry is just unwilling to make any changes in his thinking, habits or skills, e
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
ven after multiple attempts. Do we continue to put effort into the situation?
Far too many times I have seen people (including myself) “Marry” an issue or idea well past the “Stop Loss Point” and end up with more frustration and problems because of it. Unless you’re Superman you do not have to save the world! Let it
Far too many times I have seen people (including myself) “Marry” an issue or idea well past the “Stop Loss Point” and end up with more frustration and problems because of it. Unless you’re Superman you do not have to save the world! Let it
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
go!
4. What are the potential hurdles, resistance or problems that may arise from the situation? Am I looking at all the internal and external influences that can affect it?
If we can get Jerry turned around what affect will it have? If we can’t get the performance how will it affect us? Knowing what Jerry wants,
4. What are the potential hurdles, resistance or problems that may arise from the situation? Am I looking at all the internal and external influences that can affect it?
If we can get Jerry turned around what affect will it have? If we can’t get the performance how will it affect us? Knowing what Jerry wants,
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
what affect will it have on other areas if he gets it? Who else might any given solution affect? In what way?
My suggestion is to list all the different areas the situation may affect and how they may be affected. What barriers or resistance might come from these areas?
5. In what ways can we turn the hurdles and r
My suggestion is to list all the different areas the situation may affect and how they may be affected. What barriers or resistance might come from these areas?
5. In what ways can we turn the hurdles and r
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
esistance into a positive? Take the items in step four and turn them into reasons for rather than against.
Jerry feels he has reached his ability limit in the position and does not know what to do. How do you take this and turn it into a positive for him? What might be some solutions that will keep you within your “
Jerry feels he has reached his ability limit in the position and does not know what to do. How do you take this and turn it into a positive for him? What might be some solutions that will keep you within your “
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
Stop Loss Point”? How could you approach him on this?
The more information acquired in step two, the more powerful this step becomes. How do you fit your solutions into Jerry’s values, beliefs and perceptions? How do you get him to create his own solution?
6. The Action, what action does each party have to take to
The more information acquired in step two, the more powerful this step becomes. How do you fit your solutions into Jerry’s values, beliefs and perceptions? How do you get him to create his own solution?
6. The Action, what action does each party have to take to
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
make the solution work? What is the time line? Who is accountable? Accountable to whom?
Jerry has agreed to a plan of action and accountability to meet his new personal performance goals which he has developed.
This may seem a bit much for some problems and yet if that problem is reoccurring or you are not achievin
Jerry has agreed to a plan of action and accountability to meet his new personal performance goals which he has developed.
This may seem a bit much for some problems and yet if that problem is reoccurring or you are not achievin
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
g what you want, maybe it’s how you think and approach things? Are you seeing and finding all the berries in the patch?
If you have reoccurring situations that create frustration and loss for you, give the Six Steps of Outcome Based Thinking a try. We call this “Billionaire Thinking” because successful people apply
If you have reoccurring situations that create frustration and loss for you, give the Six Steps of Outcome Based Thinking a try. We call this “Billionaire Thinking” because successful people apply
.
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
this process in all aspects of their lives. How would this type of thinking affect you or your team?
Many of our participants in training comment, “This really makes me think differently.” or “I never really looked at it that way before.” That is the power of Outcome Based Thinking.
For more on problem solving, cre
Many of our participants in training comment, “This really makes me think differently.” or “I never really looked at it that way before.” That is the power of Outcome Based Thinking.
For more on problem solving, cre
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
ative thinking, innovation or coaching, contact Business Architects through their web site at www.busarc.com. Outcome Based Thinking is based on the book Psychology of Persuasion by Dr. Kevin Hoganwww.kevinhogan.com
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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