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Just Other Articles - Getting to Consensus
The need to get people in an organization to pull together comes out often in discussions about communication.
Let’s think of it as getting to consens
Let’s think of it as getting to consens
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
us, to roll a bunch of similar issues into one ball. Further, let’s think of getting to consensus as a process. That is, something that happens as the
; 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
result of a series of deliberate actions on our part.
We start the process by analyzing the current situation - how far from consensus do we now stand
We start the process by analyzing the current situation - how far from consensus do we now stand
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
Do we have embittered, untrusting people in the group? Or are we at the other end of the spectrum, with everyone nearly in agreement? We’ll call this
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
the diagnostic stage.
That means we have to listen, rather than talk. Sure, we’re probably anxious to get going and to convert them to our way of thin
That means we have to listen, rather than talk. Sure, we’re probably anxious to get going and to convert them to our way of thin
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
ing right away. But, before that we need to let them talk, and we need to hear them.
That means our listening has to be real and focused. No preparing
That means our listening has to be real and focused. No preparing
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
responses or rebuttals while the other person speaks, just listening and absorbing what they say, both explicitly and implicitly (through body languag
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
, for example).
After we complete our diagnosis, we get our turn to talk or otherwise communicate. If the people with whom we want consensus are gener
After we complete our diagnosis, we get our turn to talk or otherwise communicate. If the people with whom we want consensus are gener
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
ally hostile or unwilling to listen, we’ll either need to be very patient or prepared to shock them. Shocking means challenging, confronting their assu
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
ptions and the status quo.
On the other hand, if everyone pretty much agrees with us already, we’ll approach them much more softly. In other words, we
On the other hand, if everyone pretty much agrees with us already, we’ll approach them much more softly. In other words, we
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
won’t rock the boat much.
A key ingredient of our communication will be to explain what’s in it for them. Obviously, we see the benefits of consensus
A key ingredient of our communication will be to explain what’s in it for them. Obviously, we see the benefits of consensus
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 ourselves and for them. But, do they see the beneficial consequences? The need to explain the benefits is often overlooked in our rush to communi
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
ate.
Let’s lay out the advantages and the disadvantages for them clearly. And, yes, tell them about the disadvantages as well as the advantages. By do
Let’s lay out the advantages and the disadvantages for them clearly. And, yes, tell them about the disadvantages as well as the advantages. By do
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
ing so, we’ll increase our credibility. We might even learn something by writing the advantages on one side of a page and the disadvantages on the othe
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
.
After we’ve made our case, we’ll try to stimulate feedback. Try to get a sense of how our message was received and what response it got. Did they re
After we’ve made our case, we’ll try to stimulate feedback. Try to get a sense of how our message was received and what response it got. Did they re
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
spond the way we expected? Did a consensus begin to emerge?
If not, we need to start the process over again, with a new diagnosis. And, we’ll basicall
If not, we need to start the process over again, with a new diagnosis. And, we’ll basicall
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
reiterate the process. But, this time, put even more time into, and emphasis on, their assumptions and expectations. If the process doesn’t work, it’s
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
because they didn’t find enough benefits in our earlier communication.
In the end, consensus is always about them. And, to get them to go along with
In the end, consensus is always about them. And, to get them to go along with
.
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
ur plans for change, we need to be as conscious of their needs as we are of our own.
Summarizing, think of consensus as the end point of a process, ra
Summarizing, think of consensus as the end point of a process, ra
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
ther than something we can immediately organize. That process starts with analysis and listening, then responds to what we heard in the listening phase
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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