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Digg It - Struggle Is Not Required - Seven Key Sources
Struggle is not required for success. Are you surprised to hear that?
Personally, I grew up with the philosophy that you needed to work hard to succeed. This doesn't really serve me today.
What I've done for you in this article is identify seven key sources of struggle.
Personally, I grew up with the philosophy that you needed to work hard to succeed. This doesn't really serve me today.
What I've done for you in this article is identify seven key sources of struggle.
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
For each of these struggles, I'm sharing a remedy. Finally, we'll look at what the rewards are for squelching these struggles!
URGENCY
Struggle: When there is urgency, there is hurry. There is strong emphasis on what is "in your face" and the important things tend to b
URGENCY
Struggle: When there is urgency, there is hurry. There is strong emphasis on what is "in your face" and the important things tend to b
; 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
ignored. A decision made in this mode of thinking can often be one that is not grounded.
Remedy: Take a moment to breathe. Remind yourself that some of those things don't need immediate attention. Just that little pause can give you great perspective.
Reward: Satisfa
Remedy: Take a moment to breathe. Remind yourself that some of those things don't need immediate attention. Just that little pause can give you great perspective.
Reward: Satisfa
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
tion in being able to move forward in a purposeful, directed way.
SCARCITY
Struggle: When we feel there isn't enough, we tighten up. We may feel as though there is no support available. Perhaps the financial base isn't what we feel is necessary. How will we get all that
SCARCITY
Struggle: When we feel there isn't enough, we tighten up. We may feel as though there is no support available. Perhaps the financial base isn't what we feel is necessary. How will we get all that
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
e need?
Remedy: Remember that there is always enough. It may be that you just need to do the project in phases as the support comes to you. As you relax into the challenge, more solutions will come to you as to how to get the results you want.
Reward: Your attitude wil
Remedy: Remember that there is always enough. It may be that you just need to do the project in phases as the support comes to you. As you relax into the challenge, more solutions will come to you as to how to get the results you want.
Reward: Your attitude wil
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
have a positive effect on those around you. What a great legacy to spread to those who are learning from you!
LACK OF FOCUS
Struggle: Who hasn't found themselves going in circles trying to decide what needs to be done first?
Remedy: List your items and prioritize.
LACK OF FOCUS
Struggle: Who hasn't found themselves going in circles trying to decide what needs to be done first?
Remedy: List your items and prioritize.
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
se the Covey quadrants relating to importance and urgency. Once you have decided on those items that are both urgent and important, you know where to start. Work down your priority list from there.
Reward: What a wonderful thing! You may have moved yourself so fluidly
Reward: What a wonderful thing! You may have moved yourself so fluidly
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
through the most pressing, important items that you have the freedom for more personal time.
Once you realize you are able to do this, you'll feel more confident scheduling your free days ahead of time, knowing that you'll be in the position to enjoy them!
SELF-IMPOSED DEA
SELF-IMPOSED DEA
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
LINES
Struggle: Have you ever over promised and then found that you are getting lots of pressure for the finished product at the last minute? Sometimes in the interest of pleasing others and showing how good we are, we say that we can do things in minimal time.
Remedy:
Struggle: Have you ever over promised and then found that you are getting lots of pressure for the finished product at the last minute? Sometimes in the interest of pleasing others and showing how good we are, we say that we can do things in minimal time.
Remedy:
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
This is super stress that is not necessary if you take the time to schedule realistic deadlines. It's important to factor in any obstacles that can get in the way of smooth completion so that you are able to move toward the deadline at a solid, steady pace.
Reward: Clien
Reward: Clien
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
s are pleased that you have met or exceeded your promised due date. Those around you are thrilled that you are not "biting their heads off" as you did when you were overstressed with deadlines you were not meeting.
NEGATIVE SELF-TALK
Struggle: We can really cloud our th
NEGATIVE SELF-TALK
Struggle: We can really cloud our 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
nking with lots of self-reminders of how we performed poorly on previous projects. It's easy for those negative memories to dominate because they are the painful ones. How difficult it is to feel passionate and motivated when this heaviness is hanging over us.
Remedy: T
Remedy: T
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
ke the time to think of those times that you were successful. Notice what you are doing well now. At the end of each day, really acknowledge yourself for what you did accomplish. It's easy to forget about that when we are making exaggerated notations to ourselves of our s
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
ortcomings for the day.
Reward: Passion comes alive when there is room for it! Getting rid of those gremlins jumping around in our heads can make a huge difference in our energy level!
FEAR OF CRITICISM
Struggle: When we have fear of being criticized, it is easy to try
Reward: Passion comes alive when there is room for it! Getting rid of those gremlins jumping around in our heads can make a huge difference in our energy level!
FEAR OF CRITICISM
Struggle: When we have fear of being criticized, it is easy to try
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
to please everyone all the time. We tend to moderate our words, our actions, and look over our shoulder to see who's watching. This is a sure-fire way to stumble at what we're doing (we're not watching ...too busy looking to see who else is watching). How can we be creat
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
ve when we're so concerned who may not like our original idea?
Remedy: We may please some of the people all the time. We may please all of the people some of the time. But we won't please everyone ALL of the time. Just accept that fact. Complete your projects with you
Remedy: We may please some of the people all the time. We may please all of the people some of the time. But we won't please everyone ALL of the time. Just accept that fact. Complete your projects with you
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
creative juices flowing. Be aware of new ideas you may have that will make things go better.
Reward: Your creativity will grow exponentially. When you look for it and accept it without fear, you will come up with more innovative ideas.
ALLOWING URGENT ISSUES TO PUSH OU
Reward: Your creativity will grow exponentially. When you look for it and accept it without fear, you will come up with more innovative ideas.
ALLOWING URGENT ISSUES TO PUSH OU
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
THE IMPORTANT ONES
Struggle: How frustrating it is to feel as though you are supposed to be doing three or more things at once!
Remedy: As is usually the case, you need to pause for just a moment to get a sense of just what it is you need to be doing right now. Some th
Struggle: How frustrating it is to feel as though you are supposed to be doing three or more things at once!
Remedy: As is usually the case, you need to pause for just a moment to get a sense of just what it is you need to be doing right now. Some th
.
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
ngs that may seem huge are really not that important in the scheme of things. Perhaps some of those items can be taken care of by someone other than you. Focus on what you know needs to be taken care of.
Reward: Others will respect you when they see you taking charge i
Reward: Others will respect you when they see you taking charge i
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
a centered, empowered way. You will find that you are able to feel accomplished because you were not swept away by extra issues that were not best handled by you at that time.
We've looked at seven key sources of struggle. Without them your path could be so much smoother
We've looked at seven key sources of struggle. Without them your path could be so much smoother
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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