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Advice You - Become a C.O.P. in 2007-Change On Purpose
More than ever before, 2007 will demand of most companies the ability to achieve measurable results that are specific to profitability, growth, cost containment and operational effectiveness. Of course, none of this will be possible without leadership and organizational change.
This challenge will become a common theme in 2007 that will go uncompromised by the potential market gymnastics that we are likely to face. Without a doubt, success in 2007 will be directly dependent upon both individual and te
This challenge will become a common theme in 2007 that will go uncompromised by the potential market gymnastics that we are likely to face. Without a doubt, success in 2007 will be directly dependent upon both individual and te
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
am performance. More importantly however, is the driving force that creates both individual and team effectiveness. That driving force is leadership at every level in the organization. It doesn’t matter what your position is or what your title is. Leadership does not restrict itself to the caste system of power positions we have come to know. Leadership can and must be demonstrated throughout the organization. In my years of experience in wholesale distribution I have met effective leaders at all level
; 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
in a company including employees that simply drove a forklift to inside sales people and of course at the CEO level. That withstanding, I have also seen a lack of leadership at every one of those levels I mentioned.
Are You Prepared?
You need to ask the following questions as you contemplate the future direction of your company:
• Are your employees doing the right things – for the right reasons?
• Are their actions in alignment with the strategy?
• Do you have a strategic plan?
• Are you doing
Are You Prepared?
You need to ask the following questions as you contemplate the future direction of your company:
• Are your employees doing the right things – for the right reasons?
• Are their actions in alignment with the strategy?
• Do you have a strategic plan?
• Are you doing
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
the right things?
• Are you functioning like a well-oiled machine?
• Do you have a shared end game – or does it just belong to you?
• Do you have a focused employee development plan?
Leaders lead, they are winners. Challenges faced in 2007 will still be subservient to real solutions developed by real leaders. But, it won’t be about theory; it will be about planning and execution. There is no doubt that the New Year will be about change. That’s a good thing. Change shouldn’t be something that happen
• Are you functioning like a well-oiled machine?
• Do you have a shared end game – or does it just belong to you?
• Do you have a focused employee development plan?
Leaders lead, they are winners. Challenges faced in 2007 will still be subservient to real solutions developed by real leaders. But, it won’t be about theory; it will be about planning and execution. There is no doubt that the New Year will be about change. That’s a good thing. Change shouldn’t be something that happen
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
s to you. Effective leaders know this. Effective leaders create change, instigate change and manage change to their advantage to create success.
Not a Spin Zone
That sounds like a bunch of academic tripe and it would be if it stood by itself but I won’t let it. You see, leadership can only be effective if you build a culture engrained with continuous improvement. Change without process, structure and control in itself can turn into uncontrolled chaos. Effective leaders understand this and indoctrinat
Not a Spin Zone
That sounds like a bunch of academic tripe and it would be if it stood by itself but I won’t let it. You see, leadership can only be effective if you build a culture engrained with continuous improvement. Change without process, structure and control in itself can turn into uncontrolled chaos. Effective leaders understand this and indoctrinat
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
change as a living breathing organism and process that needs to be embraced by everyone in a positive sense because it is controlled and managed according to your own strategic initiatives. Continuous improvement is a hand on endeavor that requires an investment of time, resources, education and training. It simply isn’t a slogan like “Kaizen” or “Do It Right & Do It Right The First Time”. All that sounds good but it doesn’t mean anything if we don’t have the horses to win. It doesn’t mean anything if
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
you haven’t built a roadmap to get from here to where you want to go.
Principles of Effective Change Creation
As a leader you must implement change to create continuous improvement. It’s a hand on process. You can’t lead from afar. A former colleague of mine used to always say; “It’s easy to be brave from a distance.” Arguably that may be one of the truest statements made when it comes to the instigation of change. Change is hard work. It requires process tools that are sensitive to your organizati
Principles of Effective Change Creation
As a leader you must implement change to create continuous improvement. It’s a hand on process. You can’t lead from afar. A former colleague of mine used to always say; “It’s easy to be brave from a distance.” Arguably that may be one of the truest statements made when it comes to the instigation of change. Change is hard work. It requires process tools that are sensitive to your organizati
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
onal culture. Consider these principles for managing change:
• Employees throughout your organization generally have the talent and the ability to be successful at meeting new challenges to growth and profitability.
• Employees understand change that is essential to achieve goals if those goals are clearly stated.
• Employees gain increased respect for leaders that become the architects of change. This is especially true if the leader encourages and solicits input from the employees.
• Leaders must
• Employees throughout your organization generally have the talent and the ability to be successful at meeting new challenges to growth and profitability.
• Employees understand change that is essential to achieve goals if those goals are clearly stated.
• Employees gain increased respect for leaders that become the architects of change. This is especially true if the leader encourages and solicits input from the employees.
• Leaders must
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
systematically manage the change they create with fearless abandon demonstrating a purposeful and disciplined approach that engages the entire organization through active participation in the success process.
• Employee ownership of change, the vision – end game and the strategic initiatives is one ingredient that is absolutely essential to success.
Change Can Take on Many Forms
MACHIAVELLI wrote in the forward to “The Prince”;
“There is nothing more difficult to carry out, nor more doubtful of suc
• Employee ownership of change, the vision – end game and the strategic initiatives is one ingredient that is absolutely essential to success.
Change Can Take on Many Forms
MACHIAVELLI wrote in the forward to “The Prince”;
“There is nothing more difficult to carry out, nor more doubtful of suc
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
ess, nor more dangerous to handle, than to initiate a new order of things. For the reformer has enemies in all those who profit by the old order, and only lukewarm defenders in all those who would profit by the new order, this luke warmness arising partly from fear of their adversaries, who have the laws in their favor, and partly from the incredulity of mankind, who do not truly believe in anything new until they have actual experience of it.”
Organizations change for many reasons. Change can be the
Organizations change for many reasons. Change can be the
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
esult of a crisis like war, a natural disaster or government intervention. Innovation, technology and external market forces can create change. More importantly, change can be driven by the desire to succeed utilizing performance gap analysis, organizational assessment and the plain old motive of profit being the driving force that instigates man to create change.
Effective leaders know that creating and managing change starts with the human side of the equation. Behavioral change becomes a necessity
Effective leaders know that creating and managing change starts with the human side of the equation. Behavioral change becomes a necessity
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
for almost every success initiative employed. This often means more effective coaching, training, skill development, and accountability. Process improvement is often a platform that supports change in the organization. And last but not least, change becomes a meaningful part of organizational structure and culture. This often requires a realignment of reporting relationships and responsibilities. From an organizational culture perspective, change may demand adjustments to some managerial styles, values
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
and even belief systems to some degree. This is often the most challenging aspect of managing change. The leader may find himself facing the old clich? – “If you can’t change the manager --- change the manager.”
The organizational culture itself must embody a commitment for taking ownership of the strategic vision – end game and raising the performance expectations is a matter of fact and not chance.
Eight Reasons Why Change Efforts Fail
There are eight basic reasons change efforts can fail. Underst
The organizational culture itself must embody a commitment for taking ownership of the strategic vision – end game and raising the performance expectations is a matter of fact and not chance.
Eight Reasons Why Change Efforts Fail
There are eight basic reasons change efforts can fail. Underst
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
nding these reasons and avoiding the causes will improve your chances of effectively creating and managing change.
1. Not establishing a great enough sense of urgency ---- Many executives tell me that they don’t feel the sense of urgency they’d like to see in their employees. If you are going to be effective at creating and managing change, every employee has to be excited enough about the potential results that a real sense of urgency is created. This starts with communicating in vivid detail the rea
1. Not establishing a great enough sense of urgency ---- Many executives tell me that they don’t feel the sense of urgency they’d like to see in their employees. If you are going to be effective at creating and managing change, every employee has to be excited enough about the potential results that a real sense of urgency is created. This starts with communicating in vivid detail the rea
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
son for change, the results of the expected change and most importantly, how each employee impacts the change and how the change will impact them.
2. Not creating a powerful enough guiding coalition---- The specific group you assemble to lead the specifics of the change effort must function as a team. Choose wisely. They must also be empowered with enough authority and responsibility to get the job done. Do not micro manage.
3. Lacking a vision ---- A vision is imperative to any change process. Exact
2. Not creating a powerful enough guiding coalition---- The specific group you assemble to lead the specifics of the change effort must function as a team. Choose wisely. They must also be empowered with enough authority and responsibility to get the job done. Do not micro manage.
3. Lacking a vision ---- A vision is imperative to any change process. Exact
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
y where do you expect to go? What is expected to get done and exactly what is the expected outcome. Not having answers to these basic questions is like putting a nail strip across a racetrack.
4. Not communicating the vision ---- Make sure the vision-end game is communicated with laser like clarity. Even more important is making sure that all employees own the vision and it is not a command sent down from above by the corporate weenies. Use every vehicle possible to communicate the new vision and stra
4. Not communicating the vision ---- Make sure the vision-end game is communicated with laser like clarity. Even more important is making sure that all employees own the vision and it is not a command sent down from above by the corporate weenies. Use every vehicle possible to communicate the new vision and stra
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
egies.
5. Failure to remove obstacles or deal with critical constraints ---- Don’t fail to kill any “Sacred Cows”. They have no place in strategic growth. If they happen to be family issues – deal with them before you initiate change. Empowering employees to act on the vision is essential. Seek out and identify obstacles to change. This can often be accomplished by identifying critical constraints by doing a SWOT analysis. Get rid of the obstacles and overcome the critical constraints. Eliminate any s
5. Failure to remove obstacles or deal with critical constraints ---- Don’t fail to kill any “Sacred Cows”. They have no place in strategic growth. If they happen to be family issues – deal with them before you initiate change. Empowering employees to act on the vision is essential. Seek out and identify obstacles to change. This can often be accomplished by identifying critical constraints by doing a SWOT analysis. Get rid of the obstacles and overcome the critical constraints. Eliminate any s
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
ystems or structures that seriously undermine the vision. Encourage employees to take calculated risk.
6. Not systematically planning and creating short term wins ----Plan and create short-term wins. Establish milestones along the way. Praise for progress. Plan for visible performance improvements and then create those improvements and acknowledge the milestone achievement. Apply a reward if the milestone warrants it.
7. Declaring victory too soon ---- Be careful here. It is desirable to acknowledge
6. Not systematically planning and creating short term wins ----Plan and create short-term wins. Establish milestones along the way. Praise for progress. Plan for visible performance improvements and then create those improvements and acknowledge the milestone achievement. Apply a reward if the milestone warrants it.
7. Declaring victory too soon ---- Be careful here. It is desirable to acknowledge
.
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
hort term gains but don’t declare that the battle is over until it’s over. Don’t use your increased credibility to change systems, structures, & policies that don’t fit the vision. Make sure you have the right people in the right seat on the bus.
8. Not anchoring the changes in the organizational culture ---- To be effective change must become such a part of the culture that it could function on autopilot. Institutionalize the new approaches communicating the connections between the new behaviors and
8. Not anchoring the changes in the organizational culture ---- To be effective change must become such a part of the culture that it could function on autopilot. Institutionalize the new approaches communicating the connections between the new behaviors and
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
orporate success. Developing the means to ensure leadership development and succession.
Creating, instigating and managing change takes passion and courage. It’s not for the weak of heart. It is not for those who embrace simple traditional expectations. Effective leaders reach beyond these expectations. They become agents of change. Most companies will thrive on the concept of change, achievement, responsibility and accountability. Make it part of your culture --- become a C.O.P ---Change on Purpose.
Creating, instigating and managing change takes passion and courage. It’s not for the weak of heart. It is not for those who embrace simple traditional expectations. Effective leaders reach beyond these expectations. They become agents of change. Most companies will thrive on the concept of change, achievement, responsibility and accountability. Make it part of your culture --- become a C.O.P ---Change on Purpose.
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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