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Advice You - The Six R's for Changing MInds and Overcoming Resistance
This article borrows from Howard Gardner’s book, “Changing Minds” (2004). In order to get people in conflict to cooperate or collaborate sufficiently to se
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
ttle or resolve their differences, and perhaps achieve reconciliation, it is necessary that they change their minds. The reason they are in dispute is beca
; 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
se they are of two different minds about a particular thing, which is what they are fighting over. People do not change their minds easily. Some people ar
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
prepared to be burned at the stake, literally, rather than change their minds, or admit to a change of belief. People cling to the artifacts of their own
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
inds with great stubbornness. This is called resistance. When a mediator seeks to bring parties together, she will encounter resistance. If there were no
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
resistance, if changing minds was easy, there would be no need for mediators.
Howard Gardner has identified six R’s, which are helpful in helping people to
Howard Gardner has identified six R’s, which are helpful in helping people to
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
change their minds. They are: reason, research, resonance, re-description, rewards and real world events.
Reason is employed by way of the use of argument
Reason is employed by way of the use of argument
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
in order to persuade.
Research is used in order to collect facts, also with the purpose of persuading, often a mediation is a conflict between competing fa
Research is used in order to collect facts, also with the purpose of persuading, often a mediation is a conflict between competing fa
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
ts.
Resonance appeals to the feeling part of the human personality. Does a proposal feel right? Some people rely heavily upon resonance, and prefer it to
Resonance appeals to the feeling part of the human personality. Does a proposal feel right? Some people rely heavily upon resonance, and prefer it to
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
a reasoned and researched position. Orators and advertisers seek a message that will resonate their audience.
Re-description can be profoundly effective.
Re-description can be profoundly effective.
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
Matters are often expressed in the negative, but when changed into a positive form of expression, convey a completely different and more attractive meaning.
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
Mediations are often a persistent attempt to re-describe the problem in order to make solutions seem more attractive.
Rewards are an important part of an
Rewards are an important part of an
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
negotiation, and are usually accompanied by penalties. This is often known as the “stick and carrot” approach.
Real world events can have the effect of c
Real world events can have the effect of c
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
anging parties’ perceptions completely. Such events may be quite trivial, like going out for lunch. After lunch, what was said in the morning and rejected
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
out of hand may, with the benefit of the simple event of several hours passing and a meal, seem much more attractive.
The ever-present problem of the media
The ever-present problem of the media
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
or is that parties do not want to budge, but unless there is some change they start to get impatient. So the job of the mediator is to continue to make som
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
progress, so that there is a perception of movement. This is necessary in order to keep the parties at the negotiating table. So it is helpful to the med
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
ator to be able to play upon the six R’s, developing a facility with each one, in order to keep the parties going through the process in a productive way.
.
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
ltimately, the matter must be resolved, not by the mediator but by the parties themselves. The combined focused attention of their minds is what will accom
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
lish the result that they have come to mediation to achieve. The mediator, by using the six R’s, helps to maintain the process to its successful conclusion
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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