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Just Other Articles - What Do You Do When Change Happens?
When new exciting opportunities come along that could catapult your business forward, you may believe you have more time and no immediate urgency. Often, no action is taken, not even to study the business potential for the opportunity. Why? You have to think outside of your comfort zone to evaluate the oppor
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
tunity. You know change would be required and everything is running smoothly right now, thank you.
Each day brings new opportunities and challenges to your business. As a leader, you constantly face three options: going all out for the new opportunities, meeting challenges head on when they are still manage
Each day brings new opportunities and challenges to your business. As a leader, you constantly face three options: going all out for the new opportunities, meeting challenges head on when they are still manage
; 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
ble, and doing nothing. In every case, whether explicit or not, you make a decision about how to deal with the change. Delaying the decision is really the same as deciding to do nothing.
When potentially difficult challenges are looming, there also appears to be more time and no urgency. At first, the chall
When potentially difficult challenges are looming, there also appears to be more time and no urgency. At first, the chall
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
enge does not seem too big. You decide you can deal with it later. Again, you do not even evaluate the potential business impact of the challenge if left unchecked. Let it wait. Or, you may perceive the challenge to be gigantic and requiring a massive response including significant changes and disruption to yo
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
r business. Too scary?
What happens if we let these decisions go? Eventually opportunities disappear and either we lose out completely, or our ability to participate is dramatically reduced and at higher cost. At best, your overall business stays on its current steady course. That is, of course, if challen
What happens if we let these decisions go? Eventually opportunities disappear and either we lose out completely, or our ability to participate is dramatically reduced and at higher cost. At best, your overall business stays on its current steady course. That is, of course, if challen
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
ges you have not dealt with are not dragging your business in the opposite direction.
Challenges threaten to hurt business with higher costs, lower sales, or drain resources that reduce productivity or your ability to deal with opportunities effectively. What happens if you ignore them when they emerge? The
Challenges threaten to hurt business with higher costs, lower sales, or drain resources that reduce productivity or your ability to deal with opportunities effectively. What happens if you ignore them when they emerge? The
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
become crises. Even if you are aware of the need to make a decision, the longer you delay the greater the pressure to make a decision. When the issue reaches a crisis point, the odds of making a good, informed, decision at that point are extremely low. Most people do not manage crises well due to lack of p
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
lanning or a proactive approach to dealing with challenges that created the crisis in the first place. Then all of the knee jerk reactions and blame games start as the entire business is disrupted by the crisis.
Look back to 1829, when Martin Van Buren, Governor of the great state of New York, wrote a letter
Look back to 1829, when Martin Van Buren, Governor of the great state of New York, wrote a letter
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
to US President Andrew Jackson. Van Buren was concerned that progressive change would result in a different future: “President Jackson, the canal system of this country is being threatened by the spread of railroads. We must preserve the canals for the following reasons:
1. If canal boats are supplanted by
1. If canal boats are supplanted by
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
railroads, serious unemployment will result. …
2. Boat builders would suffer, whip and harness makers would be left destitute. …
3. Canal boats are absolutely essential to the defense of the United States.”
He continued on to say that people were never intended to travel at such breakneck speeds with engin
2. Boat builders would suffer, whip and harness makers would be left destitute. …
3. Canal boats are absolutely essential to the defense of the United States.”
He continued on to say that people were never intended to travel at such breakneck speeds with engin
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
s roaring and scaring mothers and children and flying across the country - at 15 mph!
Imagine if Van Buren could foresee the potential for New York as a major hub for imports and exports into and out of the US and Europe. A great port city where goods will be transported rapidly across the entire country. Pr
Imagine if Van Buren could foresee the potential for New York as a major hub for imports and exports into and out of the US and Europe. A great port city where goods will be transported rapidly across the entire country. Pr
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
oviding work for thousands of people in shipyards, train depots, import/export trading, financing, and so on.
Fortunately, that change happened. Certainly, it was a disruptive crisis to the people and businesses supported by the canal system. However, the ultimate benefit to the US economy was staggering.
Fortunately, that change happened. Certainly, it was a disruptive crisis to the people and businesses supported by the canal system. However, the ultimate benefit to the US economy was staggering.
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
ven those venerable and threatening high-speed trains have since largely been supplanted by the trucking and airline industry. Progress requires change – even dramatic change.
Why is it that we can see the changes coming from the very germ of a great idea, or from the first prick from a burr hinting of probl
Why is it that we can see the changes coming from the very germ of a great idea, or from the first prick from a burr hinting of probl
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
ems on the horizon, and all too often we do nothing? For each change, there is an optimal time for making decisions to pursue the opportunity or tackle the challenge.
Perhaps the biggest issue to overcome in dealing with change is the fear of failure. W. Edwards Deming said, “It is not necessary to change.
Perhaps the biggest issue to overcome in dealing with change is the fear of failure. W. Edwards Deming said, “It is not necessary to change.
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
Survival is not mandatory.” Ironic, isn’t it that we desire to be successful and if we’re diligent, we may even develop long-term goals and business plans for charting our roadmap forward. How many times have the assumptions you made about the market, competitors, customers, technology, or government regulati
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
ons or the economy remained exactly as you predicted and very accurate from year to year?
The truth is these factors change all the time. If we are to succeed, we need to be aware of them and we need to make changes and adjustments in our own business in order to achieve our goals. We can assume then that i
The truth is these factors change all the time. If we are to succeed, we need to be aware of them and we need to make changes and adjustments in our own business in order to achieve our goals. We can assume then that i
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
we do not change we will inevitably assure the failure of our businesses, regardless of how comfortable we may be at the present time. Perhaps the real concern for many is the perception that they were the creators of the change that appears to be hurting the business. Whereas leaving things alone will let e
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
xternal circumstances drive the conclusion.
Good leaders learn to make a habit of anticipating opportunities and challenges and prepare to deal with or exploit them. The earlier they become aware of an impending impacting event, the sooner they can analyze, plan, decide, and implement changes that will keep
Good leaders learn to make a habit of anticipating opportunities and challenges and prepare to deal with or exploit them. The earlier they become aware of an impending impacting event, the sooner they can analyze, plan, decide, and implement changes that will keep
.
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
heir businesses performing at their best.
Someone once said, “If we don’t change, we’ll end up where we’re going.” Do you know where that will be? The constant you need to hold on to is your mission, or purpose for your business, and your values, or the principles for guiding the behavior of your people.
Someone once said, “If we don’t change, we’ll end up where we’re going.” Do you know where that will be? The constant you need to hold on to is your mission, or purpose for your business, and your values, or the principles for guiding the behavior of your people.
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
You can enjoy any opportunity or meet any challenge with your entire organization intact and rallying around the change if you stay focused on your mission and values. Otherwise, you may end up somewhere that may not match anyone’s expectations and without any more options. Change will happen – make it good
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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