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E-Folder - One Key to Strategic Planning is to Confront Your Assumptions
Strategic planning for business is all about strategy specific to planning so that the desired results for that business are achieved. Webster defines the origins of the word strategy as "the ability of a general to
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
deceive the enemy." In today’s modern world, this simply means to out think and out last the competition.
One of the most consistent behaviors that I observe in my role as an executive business coach when taking clients thr
One of the most consistent behaviors that I observe in my role as an executive business coach when taking clients thr
; 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
ough a strategic planning process is the failure to identify basic assumptions and even more important to confront those assumptions. Within the first 2 sessions when working with my clients, I tell the following story. (Thi
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
s source of this story in unknown.)
"Have any of you ever heard of the Bill and Hilary Story?" (Note: The response I am looking for is "Which One?") "Am I glad you asked," is my next response. Then I continue. "Ther
"Have any of you ever heard of the Bill and Hilary Story?" (Note: The response I am looking for is "Which One?") "Am I glad you asked," is my next response. Then I continue. "Ther
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 is a locked room with only one door with a window wide open. Bill and Hilary are dead on the floor. Near them are a table and chair. Broken glass and water are on the floor near the chair and table. How did Bill and Hilar
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
y die?"
What continues to amaze me is all the answers such as:
What continues to amaze me is all the answers such as:
- Someone dropped down from the air/heating vent
- Someone crawled through the window
- Hilary poisoned Bill
- Bill poisoned Hil
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
ary
Hilary and Bill strangled each other
After I receive the answers, I begin to probe to learn what Bill and Hilary look like. Besides the deer in the headlights look (I should know what they look lik
After I receive the answers, I begin to probe to learn what Bill and Hilary look like. Besides the deer in the headlights look (I should know what they look lik
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
), I hear the following:
E
- Bill is wearing a blue or black, suit
- Hilary is wearing pink or brown suit
- Bill is dressed in formal attire
- Hilary is dressed in an evening gown
E
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
veryone describes them with the basic assumption that Bill and Hilary are human beings, but do not confront this assumption. I continued to probe until someone tells me that Hilary is a woman with blond hair or Bill is a tall
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
man. When I ask them where in the information presented (I retell the initial story) does it state that Bill and Hilary are a man and a woman? Then I ask them to remove this assumption and to rethink the question as to how
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
Bill and Hilary died? Very quickly, someone will answer that Bill and Hilary are goldfish.
My final question to this story is "What was the purpose of this story?" Discussion now focuses on the two key areas:
My final question to this story is "What was the purpose of this story?" Discussion now focuses on the two key areas:
- As
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
sumptions are within us
Assumptions are so ingrained that sometimes we can’t even recognize them
Assumptions must always be challenged
Assumptions can lead to dangerous consequences
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
After the Bill and Hilary story, I share with my clients a real example of a dangerous assumption. One of my corporate coaching clients owned a health food store. As the group was discussing and sharing their assumptions, t
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
his client made the statement that "Everyone needs a health store."
I challenged that assumption by the following statement: "My 102 year old grandmother, my 87 year old Uncle and my 80 year old mother never, ever stepped in
I challenged that assumption by the following statement: "My 102 year old grandmother, my 87 year old Uncle and my 80 year old mother never, ever stepped in
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
ide a health food store. " Then I continued with the statement, "I believe your assumption is false and is based upon what you what to believe rather than what is."
The client was somewhat taken aback because this was her ba
The client was somewhat taken aback because this was her ba
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
sic assumption for starting the business. And I must be honest that she left me as a client because I confronted her core belief. Her business still continues to struggle. I believe that her business challenges had as much
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
to do with her assumptions than with her marketing and sales skills.
When you make an unchallenged or unconfronted assumption such as "Everyone needs my business," you then make marketing and selling decisions based upon tha
When you make an unchallenged or unconfronted assumption such as "Everyone needs my business," you then make marketing and selling decisions based upon tha
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
t assumption. The consequences can continue to reinforce what you are trying to change. Ever heard of Einstein's defintion of insanity? "Doing the same things over and over again and hoping for different results."
So as you
So as you
.
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
r proceed through your strategic planning process, make sure to confront those assumptions or you just may end up like Bill and Hilary – two dead goldfish.
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
P.S. If you are an executive business coach, small business owner or executive and wish to share the Bill and Hilary Story, please do so. My simple request is to please let me know if your results are similar to mine
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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