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Other Articles - Listening Strategically
Usually, we’re most interested in communicating outwardly; getting our messages out to others. But finding ways to hear what’s going on around
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 can be just as important.
Let’s start by identifying three different types of listening we do. The first type - informal listening - come
Let’s start by identifying three different types of listening we do. The first type - informal listening - come
; 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
naturally, as in listening to another person. I take in what you have to say, and how you say it.
A second type, competitive intelligence, i
A second type, competitive intelligence, i
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
a systematic process for monitoring sources and gathering information. That information is aggregated, processed to bring out the important p
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
oints, and distributed to others who can use it to make decisions.
In this article, we look at a third type, a less rigorous approach to comp
In this article, we look at a third type, a less rigorous approach to comp
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
titive intelligence, one that falls somewhere between simple listening and formal competitive intelligence. Call it strategic listening, a rel
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
tively simple way to stay on top of issues that affect your organization.
Let’s start with objectives, which we normally do when looking at s
Let’s start with objectives, which we normally do when looking at s
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
omething strategically. Ask two key questions, “Why are we doing this?” and “What will we do with the information we gather?”
The first quest
The first quest
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
on focuses our efforts by putting them into the context of our overall goals. The second question, “What will we do with the information we ga
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
her?” relates to more immediate issues. It helps us articulate how we will use the material, and that in turn, affects the way we see our obje
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
tives.
Next, we need a process for gathering, managing, and storing the information we gather. What sorts of sources? How will we get them? W
Next, we need a process for gathering, managing, and storing the information we gather. What sorts of sources? How will we get them? W
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
hat will we do with the material? How will we store it?
Once we’ve listened and gathered our information, we need to manage it. All those mou
Once we’ve listened and gathered our information, we need to manage it. All those mou
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
ds of paper and electronic files must be boiled down into chunks of information that others can use easily.
This part of the process might in
This part of the process might in
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
olve the selection of excerpts or it might involve writing summaries. It might require an argument or simply a statement of facts that allows
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
others to draw their own conclusions.
The final step in the strategic listening chain is to provide feedback to those who provided raw inform
The final step in the strategic listening chain is to provide feedback to those who provided raw inform
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
tion, and to get feedback from those who used the processed information (or intelligence) we provided.
Giving feedback to those who provided
Giving feedback to those who provided
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
aw information could be considered a courtesy, and a way of encouraging them to keep supplying us. Gathering feedback from those who used the
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
processed information will help us determine whether or not we met the objectives that got us started.
In summary, one important form of list
In summary, one important form of list
.
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
ning is strategic; that is, informally gathering and processing information that helps us stay on top of issues that affect our organizations.
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
The four key steps in this process are: setting objectives, developing processes, managing the information, and gathering and getting feedback
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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