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E-Folder - New Perspectives on Tough Strategic Decisions
Strategic planning offers a great opportunity to generate new ideas, confirm or refocus direction, and gain momentum. However, to arrive motivated, confident, and in a better place usually involves a bit of a journey.
At the heart of our strategic expeditions, divergent needs and competing demands are likely encountered. The
At the heart of our strategic expeditions, divergent needs and competing demands are likely encountered. The
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
biggest challenge is that even with extensive preparation, research, data and discussion; there isn't always a "best" path forward. Without clear ‘right' answers, frustration, compromise, and the possibility of getting lost become high-stake risks.
Constantly challenged to help my clients work through strategic dilemmas, I
Constantly challenged to help my clients work through strategic dilemmas, I
; 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
started to think more about the ancient Chinese concept of Yin and Yang. Attracted to the concept in the area of work/life balance, I set out to see how the philosophy might be beneficial to business planning. The more I have been able to learn, looking through a Yin and Yang lens has proven to not only be useful, but in some
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
situations, eye opening.
Western culture views opposing ideas differently from how we tend to think about our choices. If you can visualize two disconnected half circles that might be a good representation of how we tend to make our business decisions, separate and unrelated, black and white, right or wrong. Yin and Yang di
Western culture views opposing ideas differently from how we tend to think about our choices. If you can visualize two disconnected half circles that might be a good representation of how we tend to make our business decisions, separate and unrelated, black and white, right or wrong. Yin and Yang di
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
ffer in that although they are opposites, the two relate. The familiar Yin and Yang symbol depicts two ideas that are very much interrelated and connected. There is a part of Yin in Yang (the dot) and vice versa. The two forces interact and must be balanced. The forces are both opposite and dependent on each other.
So how ca
So how ca
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
n Yin and Yang help us with strategic planning? Let's look at an example of a common business dilemma.
Competing demands between how to address the internal needs (organization, employees) of a business and the external needs (stockholders/investors, customers, society) often exist. Our solutions and planning discussions are
Competing demands between how to address the internal needs (organization, employees) of a business and the external needs (stockholders/investors, customers, society) often exist. Our solutions and planning discussions are
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
often based on applying resources to either one or the other initiative. We tend to view the needs as separate and apart, when in reality they may be very much related. There is no right strategy to satisfy stockholders without taking into account the needs of the employees. The two are interdependent and the needs of both m
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
ust be balanced and continually managed. Yin and Yang do not exclude each other. They are mutually dependent. The solution to the dilemma involves a solution that includes both.
In Built to Last authors James C. Collins and Jerry I. Porras discuss a block that leaders tend to get caught in called "The Tyranny of the Or", the
In Built to Last authors James C. Collins and Jerry I. Porras discuss a block that leaders tend to get caught in called "The Tyranny of the Or", the
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
belief that you cannot live with two contradictory ideas at the same time. For example it is impossible to maintain low expenses and quality, nor maintain stability and foster change at the same time. This perspective is contrasted against "The Genius of the And", the idea that you can and must have both at once, taking on t
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
wo extremes at the same time instead of choosing between A and B.
"A visionary company doesn't simply balance between idealism and profitability: it seeks to be highly idealistic and highly profitable. A visionary company doesn't simply balance between preserving a tightly held core ideology and stimulating vigorous change a
"A visionary company doesn't simply balance between idealism and profitability: it seeks to be highly idealistic and highly profitable. A visionary company doesn't simply balance between preserving a tightly held core ideology and stimulating vigorous change a
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
nd movement; it does both to an extreme. In short, a visionary company doesn't want to blend yin and yang into a grey, indistinguishable circle that is neither highly yin nor highly yang; it aims to be distinctly yin and distinctly yang - both at the same time, all the time."
There are a number of excellent tools that are ca
There are a number of excellent tools that are ca
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
n be used to help with strategic planning that speak directly to the concept of 'interrelated but competing demands'. Two that are worth mentioning here are The Balanced Scorecard and SWOT
The Balanced Scorecard designed by Robert Kaplan and David Norton offers large and small businesses alike the opportunity to measure perf
The Balanced Scorecard designed by Robert Kaplan and David Norton offers large and small businesses alike the opportunity to measure perf
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
ormance on a set of related but competing goals. Learning and development, system and process and customer goals are just as important as financial goals to achieve desired results. The tool is used to keep these competing but complementary initiatives in the forefront, especially as real world challenges enter the picture.
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
SWOT an organizational assessment tool is designed to help leverage organizational strengths and opportunities while identifying limitations and potential marketplace threats or risks. The model offers a framework that helps identify new forward-thinking ideas by looking from opposite perspectives combined in new ways.
Anoth
Anoth
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
er term we use for two opposing ideas is a paradox. With a paradox there is a dilemma and tension. Instead of viewing the tension negatively, try thinking about it as both healthy and beneficial. The possible interdependencies may provide richer thinking and stronger solutions when the focus becomes not choosing one or the ot
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
her, but how to achieve a dynamic balance between the two. The challenge is to get comfortable with contradictions and be able to hold both truths at once. Most of us have a hard time with shades of gray. The more we become comfortable with paradoxes when we feel the tension, the less we may get stopped or blocked. By learnin
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
g to accept two conflicting ideas it frees us up to move forward.
Here are a few common strategic choices that center on competing ideas:
Productivity improvements or more business
Working in the business (client demands) or on it (strategy, innovation)
Personal struggles between top down management and bottom u
Here are a few common strategic choices that center on competing ideas:
Productivity improvements or more business
Working in the business (client demands) or on it (strategy, innovation)
Personal struggles between top down management and bottom u
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
p participation
Short term results or long term growth opportunities
Stability (current state of affairs) or investing in the future
Slowing down or getting there faster
Chaos and order
Regarding the last point, Margaret Wheatley in one of my all-time favorite leadership book,
Leadership and
Short term results or long term growth opportunities
Stability (current state of affairs) or investing in the future
Slowing down or getting there faster
Chaos and order
Regarding the last point, Margaret Wheatley in one of my all-time favorite leadership book,
Leadership and
.
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
the New Science suggests that we are coming to a new definition of order.
"Control is not order." "Flexibility, superior results and customer satisfaction are the watchwords in an environment of ever changing demands and requirements- Unpredictability,
Inconsistency, Chaos."
"No single person or school of thought has
"Control is not order." "Flexibility, superior results and customer satisfaction are the watchwords in an environment of ever changing demands and requirements- Unpredictability,
Inconsistency, Chaos."
"No single person or school of thought has
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
the answer, because what's required is far beyond isolated answers. We can realize that we must inquire together to find the new. We can turn to one another as our best hope for inventing and discovering the worlds we are seeking."
What strategic choices have you been wrestling with that can benefit from a new point of view
What strategic choices have you been wrestling with that can benefit from a new point of view
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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