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Advice You - How To Conduct A Successful S.W.O.T. Analysis
SWOT Analysis: When you and your group wish to identify your Strengths and Weaknesses, the Opportunities available and the Threats facing you.
This is a powerful and highly successful technique that can be applied to an individual, a group, a team, a company, a plan – think about it, even a website! Again, experiment with i
This is a powerful and highly successful technique that can be applied to an individual, a group, a team, a company, a plan – think about it, even a website! Again, experiment with i
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
t. If it helps you to focus your (and your team’s) efforts in the right direction, it’s worth it.
The process is to ask and answer a number of specific questions for each of the 4 categories, documenting the answers. This process, in itself is simple enough. However, so that you are not disappointed with the outcome, take the time
The process is to ask and answer a number of specific questions for each of the 4 categories, documenting the answers. This process, in itself is simple enough. However, so that you are not disappointed with the outcome, take the time
; 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
you need, get the answers you need, face the facts and above all, take action.
TIP Whether working on this for yourself or with your team, always keep in mind the goal you want to achieve for each category.
So, in this context, treat 'you' as either yourself, your team, your improvement group, your company, yo
TIP Whether working on this for yourself or with your team, always keep in mind the goal you want to achieve for each category.
So, in this context, treat 'you' as either yourself, your team, your improvement group, your company, yo
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
ur business.
The starting point of a successful SWOT analysis is to understand that there are 4 general objectives, one for each part of the analysis, the goal you wish to achieve.
Typical Format - the most common approach and widely used format is to construct a 2 row by 2 column matrix with the following information...
STRENG
The starting point of a successful SWOT analysis is to understand that there are 4 general objectives, one for each part of the analysis, the goal you wish to achieve.
Typical Format - the most common approach and widely used format is to construct a 2 row by 2 column matrix with the following information...
STRENG
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
HS in top left quadrant
Capitalise
on your
strengths
WEAKNESSES in top right quadrant
Address
your
weaknesses
OPPORTUNITIES in bottom left quadrant
Take full
advantage
of the
opportunities
available
THREATS in bottom right quadr
Capitalise
on your
strengths
WEAKNESSES in top right quadrant
Address
your
weaknesses
OPPORTUNITIES in bottom left quadrant
Take full
advantage
of the
opportunities
available
THREATS in bottom right quadr
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
nt
Deal with or
minimise the
impact of threats
you face
Although each of the above statements can be regarded as action oriented, they are, in themselves, meaningless. We can't use them to communicate exactly what our plans are going to be, why we have the plans in the first place, what resources we need
Deal with or
minimise the
impact of threats
you face
Although each of the above statements can be regarded as action oriented, they are, in themselves, meaningless. We can't use them to communicate exactly what our plans are going to be, why we have the plans in the first place, what resources we need
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
and who will implement the plans.
So, let's ask a few fundamental questions to put some meat on the skeleton...
---Sidebar---
Add to or tailor the questions to suit you, your team, your organization.
---End Sidebar---
STRENGTHS
What do you do really well?
In what product or
So, let's ask a few fundamental questions to put some meat on the skeleton...
---Sidebar---
Add to or tailor the questions to suit you, your team, your organization.
---End Sidebar---
STRENGTHS
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
service areas do you excel?
What is your value-added?
What makes you unique in the marketplace?
What characteristics are highly regarded?
Answer from your own point of view, your customers’
your teams', your suppliers' and others.
WEAKNESSES
Answer from your own point of view, your customers’
your teams', your suppliers' and others.
WEAKNESSES
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
>What do you not do well? How do you know?
What needs to be improved? In what way, by whom?
Are there weaknesses you don’t see but others do?
What does the team look for that you don’t provide?
What do customers look for that you don't provide?
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
Are decisions based on supposition or hard data?
What are your measures of success telling you?
Are you really prepared to find out?
Answer from your own point of view, your customers’ and
others. Face the Truth
OPPORTUNITIES
What opportun
Answer from your own point of view, your customers’ and
others. Face the Truth
OPPORTUNITIES
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
ties would help you become more successful?
Where would you find them?
What external changes, events can you take advantage of?
technology, demographics, legislation, education
Use PDCA (see footnotes) to identify those that will give you
the greatest return
technology, demographics, legislation, education
Use PDCA (see footnotes) to identify those that will give you
the greatest return
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
HREATS
What financial problems do you have?
Are there internal/external changes that threaten you?
What do you know about your competitors?
Are they successful? Why?, How?
What obstacles impede your progress?
Which obstacles can b
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
e dealt with or overcome?
Use PDCA (see footnotes) to prioritize
O.K., we have done the data gathering, the surveys, the questioning, the 'soul searching'. Redraw the matrix when questioning round is complete replacing the questions asked in each quadrant with a summary of the answers.
Easy for
Use PDCA (see footnotes) to prioritize
O.K., we have done the data gathering, the surveys, the questioning, the 'soul searching'. Redraw the matrix when questioning round is complete replacing the questions asked in each quadrant with a summary of the answers.
Easy for
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 to say I know but...
As long as you have been factual
As long as you have been honest especially with yourself
As long as you are ready and prepared to accept the answers
As long as you are prepared to TAKE ACTION
You have the foundation here to take a snapshot of where you are today, what's working
As long as you have been factual
As long as you have been honest especially with yourself
As long as you are ready and prepared to accept the answers
As long as you are prepared to TAKE ACTION
You have the foundation here to take a snapshot of where you are today, what's working
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
or and against you, and the basis for a series of action plans to get you to where you want to be tomorrow.
Regardless of which quadrant you may be studying, the key
question to ask yourself is...
"What will give us the biggest return"
Many of us are familiar with the "Pareto Principle", perhaps
Regardless of which quadrant you may be studying, the key
question to ask yourself is...
"What will give us the biggest return"
Many of us are familiar with the "Pareto Principle", perhaps
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
more familiar with the term "80-20 Rule"
Pareto Principle
Why the 80-20 rule? Approximately 80% of trouble comes from 20%
of the problems. Also, quite often, 80% of the results we
seek, will come from 20% of our efforts - as long as we are
focused and prioritize.
Although "Pareto" is name
Pareto Principle
Why the 80-20 rule? Approximately 80% of trouble comes from 20%
of the problems. Also, quite often, 80% of the results we
seek, will come from 20% of our efforts - as long as we are
focused and prioritize.
Although "Pareto" is name
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
after the economist Vilfredo Pareto,
it was Dr. Joseph M. Duran who applied the thinking to
management best practices.
Dr. Juran advises us to concentrate on the "vital few" sources
of problems (and in this context, the actions which will
give us the greatest return) and not be distracted by those
of lesser
it was Dr. Joseph M. Duran who applied the thinking to
management best practices.
Dr. Juran advises us to concentrate on the "vital few" sources
of problems (and in this context, the actions which will
give us the greatest return) and not be distracted by those
of lesser
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
mpact or importance.
To conclude, be as creative as you can be in your problem solving, think 'outside the box'. Get others to do the same. As much as I hate them, just think of "yellow stickies" and how a complete disaster became a huge income generator.
If you are worried about change just imagine what will h
To conclude, be as creative as you can be in your problem solving, think 'outside the box'. Get others to do the same. As much as I hate them, just think of "yellow stickies" and how a complete disaster became a huge income generator.
If you are worried about change just imagine what will h
.
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
appen if you do nothing!
"Insanity: doing the same
thing over and over again
and expecting different
results." Einstein
Footnotes
Use some of the great but relatively simple problem solving tools to help focus and determine the priorities. Tools such as as Force Fiel
"Insanity: doing the same
thing over and over again
and expecting different
results." Einstein
Footnotes
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
Analyis, Cause and Effect Diagrams (Fishbone Diagrams),Flowcharting.
For a full explanation of PDCA, the continuous improvement process and its individual stages, just do a search on author 'Andrew Gowans' and the relevant articles will be displayed.
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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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