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Main Subject - Values Matter - Even for Super Bowl Champions
I was trying to figure out a way to work the Pittsburgh Steelers into a Weekly Insight, particularly after our hometown team earned the right to be called “World Champions.” I realize that not everyone who reads these Weekly Insights hails from Western Pennsylvania (and some of you might not ca
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
re for the Steelers at all), but hang in there with me on this one.
“Steelers mean business” was the title of an Associated Press article on February 4, 2006. Dr. Joanne G. Dujansky, the founder of KEYGroup, a Pittsburgh business that counsels companies on creating a successful corporate cultu
; 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
e was quoted in the article as follows: “The Steelers’ winning tradition didn’t start yesterday. It started when Art Rooney purchased the franchise 73 years ago and set in motion a strategy for success that embraced his vision and values.”
Note that Mr. Rooney’s strategy included “values” as w
Note that Mr. Rooney’s strategy included “values” as w
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
ell as “vision.” This past week a student in my marketing strategy class did some research on jetBlue Airways. When she could not find their mission statement on the company website, she emailed the company and asked if they would provide her with jetBlue’s mission statement. The company resp
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
nded that they did not have a mission statement. Instead, they found success in the marketplace by living out their core values: safety, caring, integrity, fun and passion.
The key words here are “living out.” Values do matter.
With that in mind, let’s examine some of the principles outlined
The key words here are “living out.” Values do matter.
With that in mind, let’s examine some of the principles outlined
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
in the book Lasting Change: The Shared Values Process™ that Makes Companies Great (by Rob Lebow and William L. Simon). The authors take the concept of values and define two components:
• People Values – basic human issues that affect daily work performance such as honesty, truthfulness, trust
• People Values – basic human issues that affect daily work performance such as honesty, truthfulness, trust
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
risk-taking, and receptivity to new ideas
• Business values – define how the organization and its people function; these are the principles upon which everyone in the organization operates; business values clarify who we are, what we stand for, and why we do business the way we do
For an orga
• Business values – define how the organization and its people function; these are the principles upon which everyone in the organization operates; business values clarify who we are, what we stand for, and why we do business the way we do
For an orga
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
nization to function effectively, these two are always in balance.
It’s interesting that the authors contend that although every company has a set of Business Values, most people, even managers, aren’t aware of them. Or even better, just ask several people what the Business Values are for your
It’s interesting that the authors contend that although every company has a set of Business Values, most people, even managers, aren’t aware of them. Or even better, just ask several people what the Business Values are for your
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
organization and get ready for a lot of different answers.
In my tenure as President of Zion Industries, I learned that Business Values can’t be taught. They must be “absorbed” by individuals in the organization as they see executives and managers making decisions based on Business Values—and
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
explaining to the employees the “why” behind tough decisions (“We did this because our Values state…”).
There is a great story in this book about old man Coleman, the founder of the company. Although retired, he dropped in one day on a production meeting. He listened as the executives in the
There is a great story in this book about old man Coleman, the founder of the company. Although retired, he dropped in one day on a production meeting. He listened as the executives in the
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
oom discussed a defective gas jet in one of the products that leaked under pressure. They had to make a decision: should the company, famed for its impeccable quality, publicly admit the defect and launch a product recall?
Since only a few of the several hundred thousand units already on store
Since only a few of the several hundred thousand units already on store
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
shelves were thought to have the leaking problem, the marketing person suggested that they just wait until the bad ones were found and sent back, thus avoiding a costly recall.
Mr. Coleman slammed the table and demanded, “What’s the matter with you people! Don’t you know that Coleman lanterns
Mr. Coleman slammed the table and demanded, “What’s the matter with you people! Don’t you know that Coleman lanterns
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
have to work?!”
To the company founder, the values were clear. There was no room for negotiation or discussion about a defective product. Is there such clarity in your organization?
Values do matter. Values drive decision making. Values drive behavior. Values drive thinking. Yet how much
Values do matter. Values drive decision making. Values drive behavior. Values drive thinking. Yet how much
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
time do we spend thinking about our Personal Values, our Business Values? How often do we assess whether the Business Values we espouse, the ones printed on the wall, etc. are actually being lived out day to day in the marketplace—during the good and bad times?
Living out your values makes the
Living out your values makes the
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
m meaningful. Consider these words regarding values:
“As officers and employees of _______...we are responsible for conducting the business of the Company in accordance with all applicable laws and in a moral and honest manner. _____ stands on the foundation of its Vision and Values. Everyth
“As officers and employees of _______...we are responsible for conducting the business of the Company in accordance with all applicable laws and in a moral and honest manner. _____ stands on the foundation of its Vision and Values. Everyth
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
ng we do evolves from our vision and Values statements.” The above is a short extract from Enron’s award-winning Code of Ethics. As events have shown, Enron’s Values were not meaningful at all; in fact, they were meaningless. And their lack of meaning stemmed from the actions and attitudes of
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
their executives.
And so the challenge becomes one of understanding and committing to my own Personal Values and to the Business Values of my organization. Here’s an assignment for each of us to do this week in response to this challenge.
1. Write down your Personal Values. What do you stan
And so the challenge becomes one of understanding and committing to my own Personal Values and to the Business Values of my organization. Here’s an assignment for each of us to do this week in response to this challenge.
1. Write down your Personal Values. What do you stan
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
for? Do these values really guide your behavior?
2. Write down your organization’s Business Values. What does your company stand for? Can you think of decisions made during the past month or so that were made because of your Business Values? Do you see your company’s Business Values reflec
2. Write down your organization’s Business Values. What does your company stand for? Can you think of decisions made during the past month or so that were made because of your Business Values? Do you see your company’s Business Values reflec
.
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
ted in your personal actions within your organization? How about in the lives of company employees?
Values do matter—but only if they are lived out. Values are more “caught” than “taught.” Thus, our children, our employees, our community know our values, not by reading our Core Values docume
Values do matter—but only if they are lived out. Values are more “caught” than “taught.” Thus, our children, our employees, our community know our values, not by reading our Core Values docume
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
t, but by watching us every day. How are we doing?
What do you think? Does this make sense to you? If you’d like to share your thoughts with me, please do so at keith@daystarconsulting.com or visit http://www.daystarconsulting.com
What do you think? Does this make sense to you? If you’d like to share your thoughts with me, please do so at keith@daystarconsulting.com or visit http://www.daystarconsulting.com
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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