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Digg It - Thinking Through Problem Solving
Change hits hard, fast, and often. It shifts our focus, changes our direction and alters our plans. Change leaves us stumped by questions we’re not prepared to answer and searching for questions that we never
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
thought to ask. Left on the road, between what we were once sure of and the indecision of which way to go, a problem awaits to be solved.
Problems Begin with One Unanswered Question
Hearing
Problems Begin with One Unanswered Question
Hearing
; 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
the word problem, we automatically think of some catastrophic event requiring kick-off meetings, project teams, and an all-out hunt for the illustrious root cause. Usually, however, problems are much more sub
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
tle than that. They move in quietly, riding the coattails of change or they drag change along, bringing it to our doorsteps. Problems both follow and precede change. Most problems don’t need a grand introduct
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
on. All we need to is to look for them, wait for them, and prepare for them. They are always there, just beneath the surface. And before they took a life of their own, even those problems with the deepest root
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
usually started simply enough as an unanswered question.
What issues currently have your organization tied up in knots? What was the last problem that you attempted to solve? What was the last problem that
What issues currently have your organization tied up in knots? What was the last problem that you attempted to solve? What was the last problem that
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
you ignored?
Problems don't need official-sounding names and formally outfitted team leaders wearing colored belts. Problems are not only exposed through formal processes but are revealed in a moment of cur
Problems don't need official-sounding names and formally outfitted team leaders wearing colored belts. Problems are not only exposed through formal processes but are revealed in a moment of cur
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
osity. Just around the corner of expectation and at the intersection of “why; why not; and if not me, who?” is a chance for every employee to positively influence the course of events.
The following is a cas
The following is a cas
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
in point of a problem in the making:
Friday morning a shipment of boxes was delivered to a distribution warehouse in a small North Carolina town. As had happened on many Friday mornings before, Jason Checki
Friday morning a shipment of boxes was delivered to a distribution warehouse in a small North Carolina town. As had happened on many Friday mornings before, Jason Checki
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
ns received the shipment and pointed to the area where the pallets should be placed. As the boxes were stacked, Jason noticed that the boxes all had yellow stickers. He thought that it was odd and wondered t
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
himself, “Why don’t these boxes have the blue labels that they normally do?” He thought about it for a moment and moved on. He never mentioned the blue labels to anyone in the facility until the following F
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
iday, a week later.
What Happens to a Problem Deferred?
Problems often come first in unseen whispers. They are more than headaches to avoid; they are signals of things to come – flashes of
What Happens to a Problem Deferred?
Problems often come first in unseen whispers. They are more than headaches to avoid; they are signals of things to come – flashes of
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
lights drawing us to attention and calling us to action. Before we can resolve them, we have to increase our ability to predict them, sense them, see them, and examine them.
When I think of organizational pro
When I think of organizational pro
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
lem solving, it brings a poem written by Langston Hughes, “What Happens to a Dream Deferred?”. We sense that something may be wrong, but we stand back. We watch and we wait to see what is going to happen. W
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
watch the market; we see the effects on our competitors and our suppliers. We watch what’s happening around us, to our employees, and to our co-workers. We read the headlines and hear the news of industry f
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
allout and thousands of jobs being lost. Still we fail to consider what those signs might mean for us. Only rarely do we look for opportunities to make a difference.
Pointing his pen at the corporation, tod
Pointing his pen at the corporation, tod
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
y Mr. Hughes might ask:
What happens to a problem deferred?
Does it dry up
like a raisin in the sun?
Or fester like a sore--
And then run?
Does it stink like rotten meat? <
What happens to a problem deferred?
Does it dry up
like a raisin in the sun?
Or fester like a sore--
And then run?
Does it stink like rotten meat? <
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
r>
Or crust and sugar over--
like a syrupy sweet?
Maybe it just sags
like a heavy load.
Or does it explode?
Problems Don’t Just Go Away. You don’t usually have six mon
like a syrupy sweet?
Maybe it just sags
like a heavy load.
Or does it explode?
Problems Don’t Just Go Away. You don’t usually have six mon
.
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
ths to form an assessment committee or three months to train all your people. You can’t afford to lose time pretending that the problem does not exist, or even one day wondering why someone else has not taken
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
ction. It is the job of every person in the company to do what he can, when he can--and hopefully before it is too late.
To read the complete article please go to: http://www.changethis.com/21.ThinkingThroug
To read the complete article please go to: http://www.changethis.com/21.ThinkingThroug
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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