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Just Other Articles - Five Ways to Turn Resistance into Opportunity
Resistance. It isn’t something people cherish or enjoy encountering. We experience resistance everywhere at work:
People don’t like that idea.
People don’t want the work flow to change.
Someone doesn’t agree with the feedback they rece
People don’t like that idea.
People don’t want the work flow to change.
Someone doesn’t agree with the feedback they rece
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
ived and becomes defensive.
Someone doesn’t see the value in a revised policy and they become resistant.
People don’t want to buy what we have to sell.
I’ve had leaders and supervisors tell me that resistance is the number one problem t
Someone doesn’t see the value in a revised policy and they become resistant.
People don’t want to buy what we have to sell.
I’ve had leaders and supervisors tell me that resistance is the number one problem t
; 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
hey face. But I don’t agree with that perspective and let me tell you why . . .
Examining Resistance
Why do people dread, avoid or even fear resistance? Because they haven’t stopped to think about it.
Imagine a meeting where eve
Examining Resistance
Why do people dread, avoid or even fear resistance? Because they haven’t stopped to think about it.
Imagine a meeting where eve
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
ryone agrees. Imagine this meeting - where there is no dissension, no difference of opinion. At first you might consider this to be nirvana. Imagine the bliss: We are in agreement! No heated discussions! No frowns! No stress!
And w
And w
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
hile the stress would be low and no resistance would be found, there would be something else missing.
Progress.
If no one proposes a new idea, the organization will never move forward. If no one suggests that something isn’t as g
Progress.
If no one proposes a new idea, the organization will never move forward. If no one suggests that something isn’t as g
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
ood or effective or useful as it could be, nothing will ever change. And if no one challenges the new ideas that are raised to help make them even better, the wrong problems may be addressed and the results worse than before you began.
T
T
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
he bottom line is that innovation and progress require resistance. It is just a fact of life. So in reality, it doesn’t make much sense to call resistance a problem. That is like saying that it is a problem that our air is 78% nitrogen
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
and we need to fix it!
The air is the air – we don’t worry about the relatively small amount of oxygen in it. We know that our bodies are designed to convert that oxygen into life. So too, resistance is just resistance. It exists! And
The air is the air – we don’t worry about the relatively small amount of oxygen in it. We know that our bodies are designed to convert that oxygen into life. So too, resistance is just resistance. It exists! And
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
because it exists our ideas can be challenged and examined, our processes get improved, we have machines that fly through the air, light coming from a bulb, and thousands of other things. In part, because of resistance.
The Next Steps
The Next Steps
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
If you buy my premise that resistance just exists – that while it can be challenging to deal with, it can be as positive (if not more so) as it feels negative – you have some new approaches that can help you.
1. Expect it. W
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
y would you be surprised to find resistance? It doesn’t matter how brilliant our idea, or beneficial the change you propose, somebody will “push back” or be resistant to the idea from the start. Recognizing this will allow you to plan fo
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
r some of that resistance and provide ideas to alleviate the concern. In other words, you can plan for it.
2. Don’t take it personally. Again, resistance is a natural occurrence. Don’t take people’s reaction to your idea as being
2. Don’t take it personally. Again, resistance is a natural occurrence. Don’t take people’s reaction to your idea as being
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
about you. Get over yourself! The resistance exists naturally as people think about the implications of the new ideas or change. Their resistance isn’t a personal attack.
3. Avoid defensiveness. Think about it. You suggest a n
3. Avoid defensiveness. Think about it. You suggest a n
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
ew idea to a colleague. They reply, talking about all of the problems with this idea and why it won’t work. Your response is defensiveness… you raise your voice to make sure they hear you … you speak a bit more rapidly … And is your defe
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
nsiveness greeted with reduced resistance? Not in my experience. Defensiveness, while natural too, and sometimes hard to avoid, doesn’t reduce the resistance we experience – typically it adds to the strength of that resistance. Hint: W
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
hen you realize that the resistance isn’t personal, it is much easier to avoid defensiveness.
4. Embrace it. If something is naturally occurring and in the end beneficial, why wouldn’t we embrace it and recognize that resistance i
4. Embrace it. If something is naturally occurring and in the end beneficial, why wouldn’t we embrace it and recognize that resistance 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
s just a part of the change or idea adoption process. View resistance as the file to help you smooth the rough edges off your idea – providing the benefit of improving your proposal.
5. Acknowledge it. Once you intellectually kno
5. Acknowledge it. Once you intellectually kno
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
w that resistance will occur and you know that becoming defensive about it doesn’t really help you, you will search for a new strategy. Here it is: acknowledge the resistance. Let people be heard. Ask them questions about their perspect
.
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
ive. Try hard to understand it. You don’t have to agree with them, to acknowledge or value your perspective. By acknowledging their perspective, they are much more likely to be open to hear your ideas, and much more likely to turn the c
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
onversation into something productive.
Resistance can be your friend. As you change your perspective you will become more comfortable with it, and more adept at understanding that resistance can help your teams and your organization grow
Resistance can be your friend. As you change your perspective you will become more comfortable with it, and more adept at understanding that resistance can help your teams and your organization grow
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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