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E-Folder - The Value of Core Values in Strategic Thinking and Business Planning
Business planning emphasizes strengths, weaknesses, opportunities and threats. A Vision and/or Mission are standard fare. However, the most meticulous strategy plan can still derail without the guidance of
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
> core values. They are the standards for behavior that define your culture. Defining core values is a critical step. From there, the real work begins.
Two high profile cases offer classic examples. Bot
Two high profile cases offer classic examples. Bot
; 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
companies have carefully crafted value statements. The difference in outcomes lies in leadership walking the talk.
Case #1: Johnson & Johnson Value Stateme
Case #1: Johnson & Johnson Value Stateme
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
t
We believe our first responsibility is to our doctors, nurses and patients, to mothers and fathers and all others who use our products and services. In meeting their needs, everything we do must
We believe our first responsibility is to our doctors, nurses and patients, to mothers and fathers and all others who use our products and services. In meeting their needs, everything we do must
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 of high quality.
The Tylenol poisoning deaths that occurred in the Chicago area proved to be regionally isolated. Johnson & Johnson's management took no chances and immediately recalled all produ
The Tylenol poisoning deaths that occurred in the Chicago area proved to be regionally isolated. Johnson & Johnson's management took no chances and immediately recalled all produ
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
t from all store shelves nationally. They acted instantly in accordance with their values. If their statement read our first responsibility is to our shareholders, we might have seen a more short sighted
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
response. Strong adherence to values simplified their decision and not only preserved but strengthened their brand.
Case #2 Arthur Andersen Value Statement
We believe in integrit
Case #2 Arthur Andersen Value Statement
We believe in integrit
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
, respect and always speaking as one firm. We believe in maintaining a passion for excellence in people, service and innovation. And we believe in demonstrating a commitment to personal g
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
owth through training and development. In fact, these values are minimum standards for anyone within our organization. Each has roots in the thinking of Arthur Andersen himself. And each guides
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
s toward a brighter future ahead.
Andersen has become an easy target. But, there are lessons to be learned. Integrity was their number one stated value. At some point, integrity
Andersen has become an easy target. But, there are lessons to be learned. Integrity was their number one stated value. At some point, integrity
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
was replaced by greed. Andersen developed a cavalier consulting arm to design and build businesses, while its other arm audited those businesses. They successfully lobbied to prevent legislation to limit such
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
conflicts of interest. Are these the actions of an organization that stands for integrity? We witnessed the results, a values domino effect. In contrast to Tylenol's customers, Andersen cli
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
nts rushed for the exits, never to return.
Impact on Customers
Who is the number one over-the-counter pain relief brand today?
Who has fallen from Big Three Accounting status?
How did the adhe
Impact on Customers
Who is the number one over-the-counter pain relief brand today?
Who has fallen from Big Three Accounting status?
How did the adhe
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
ence to core values contribute to each scenario?
Are core values just for big companies?
If you are a restaurateur, what happens when an expensive cut of meat accidentally fall
Are core values just for big companies?
If you are a restaurateur, what happens when an expensive cut of meat accidentally fall
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 the floor? What if it was the last serving? Do you maintain the same standards for meat in the kitchen as you do for spoons in the dining room? Core values cannot be conditional.
You are a manufacturer and a
You are a manufacturer and a
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
e potentially late with an end of month delivery. Defective product is discovered as the truck is being loaded. What do you do? Prioritized values provide your people with the answer. If you have institutionalize
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
your values, executive involvement is unnecessary.
What are your organization's values?
If your business plan was written primarily to impress your bankers and investors, a values statement is
What are your organization's values?
If your business plan was written primarily to impress your bankers and investors, a values statement is
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
ikely missing. If you need to check to find out, it might just as well be missing. If your core values are not communicated and understood by all, what are your criteria for decisions in times of crisis?
.
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
ustained Success and Values Driven Leadership When a crisis occurs, your success depends on your people's ability to make prompt decisions. Will you prosper like Tylenol or collapse like Andersen? Does y
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
ur organization possess both the values and character it will need in time of crisis? Your customers will sense the strength of your leadership and quickly respond either with deeper loyalty or permanent departure
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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